97-7036. Consolidation, Elimination, and Clarification of Various Regulations

[Federal Register Volume 62, Number 56 (Monday, March 24, 1997)]
[Rules and Regulations]
[Pages 13938-13970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7036]

[[Page 13937]]

_______________________________________________________________________

Part II

Department of Justice

_______________________________________________________________________

Drug Enforcement Administration

_______________________________________________________________________

21 CFR Part 1300, et al.

Consolidation, Elimination, and Clarification of Various Regulations;
Final Rule

Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules
and Regulations

[[Page 13938]]

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1307, 1308,
1309, 1310, 1311, 1312, 1313, and 1316

[DEA Number 139F]
RIN NUMBER 1117-AA33

Consolidation, Elimination, and Clarification of Various
Regulations

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule is issued by the Acting Deputy Administrator
of the Drug Enforcement Administration to institute the proposed
changes to Title 21, Code of Federal Regulations, Parts 1300 through
1316, published in the Federal Register on March 5, 1996 (61 FR 8503).
In concert with the President's National Performance Review, Regulatory
Reinvention Initiative (NPR), DEA proposed to consolidate, eliminate,
and clarify many of its regulations; to address areas of confusion
frequently raised by the pharmaceutical, chemical, and health care
industries; and to correct inaccurate citations, office designations,
and typographical errors.

EFFECTIVE DATE: March 28, 1997.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, D.C. 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: On March 5, 1996, DEA published in the
Federal Register a notice of proposed rule making (NPRM) entitled
Consolidation, Elimination, and Clarification of Various Regulations
(61 FR 8503). This NPRM was the culmination of a comprehensive review
of Title 21, Code of Federal Regulations (21 CFR), parts 1300 through
1316. Title 21 contains the rules and regulations by which DEA
implements the Controlled Substances Act, the Narcotic Addict Treatment
Act, the Controlled Substances Import/Export Act, the Chemical
Diversion and Trafficking Act, and the Domestic Chemical Diversion
Control Act. DEA undertook this review to update, simplify, and
consolidate its regulations in concert with the President's Regulatory
Reform Initiative under the NPR; to clarify areas of confusion which
have been raised by the pharmaceutical, chemical, and health care
industries; and to correct inaccurate citations, office designations,
and typographical errors. In so doing it was DEA's intention to reduce
some of the regulatory burden on the affected industries. Interested
parties were given 120 days to submit written comments regarding the
proposed rule.

Comments

Twenty-five organizations submitted comments in response to the
proposed rule. One organization expressed support for the entire
proposed rule as published, two others expressed support for one
specific element within the proposal with no further substantive
comment, and six others expressed their support for the comments
submitted by their industry trade group. These and the comments of the
other sixteen respondents are addressed below.

Part 1300

Two commentors expressed their support for the consolidation of the
definitions in new Secs. 1300.01 and 1300.02. One commentor suggested
that the definition of ``home infusion pharmacy'' be deleted as
unnecessary because all retail pharmacies are qualified to provide home
infusion services, and the expression ``compounds for intramuscular
infusion'' is confusing since the commentor was unaware of any pharmacy
which actually compounds, as opposed to dispenses, intramuscular
infusion solutions. DEA agrees that a definition of home infusion
pharmacy is unnecessary as the distinction between home infusion
services and other dispensing activities is adequately addressed within
Sec. 1306.11(e), which permits the retention of faxed Schedule II
prescriptions as original documents for home infusion prescriptions.
Therefore, the definition of home infusion pharmacy will be removed
from Sec. 1300.01 and the words ``home infusion pharmacy'' in
Sec. 1306.11(e) will be replaced by the word ``pharmacy.'' When the
original rule was published, DEA determined that there were in fact
pharmacies which compound solutions for intramuscular injection. Even
if this activity is no longer being performed by pharmacies, keeping
this phrase in the definition allows for the possibility that in the
future such activities may again be conducted.
One commentor recommended that the definition of ``inventory'' be
modified to include the terms ``bulk active drug substance, in-process
materials (work in progress), and finished dosage form inventory.''
This definition, which was previously contained in part 1303, was not
changed as part of this proposed rule and will, therefore, remain
unchanged in the Final Rule. However, due to this comment and other
questions previously raised by industry, a new definition of
``inventory'' will be published for comment in the near future.
One commentor expressed the opinion that the definitions of
``hearing'', ``interested person'', and ``proceeding'' are unclear with
respect to proceedings pursuant to 21 U.S.C. 952; that a definition of
research be added which is in accordance with DEA's Policy Statement on
Coincident Activities of Researchers, 60 FR 55310 (10/31/95); that the
definitions which are repeated in Secs. 1300.01 and 1300.02 be removed
from one of the sections; and that the references to ``this section''
in Sec. 1300.02(b)(12) and to ``this part'' in
Sec. 1300.02(b)(28)(i)(B) are unclear. DEA does not agree that the
definitions of ``hearing'', ``interested person'', and ``proceeding''
are not sufficiently clear. These definitions were not changed as part
of the proposal and are sufficiently precise to fulfill their intended
purpose.
Since the only ambiguity regarding the term ``research'' addressed
in the cited Policy Statement related to whether certain manufacturing
activities may be conducted as coincident activities of a researcher
registration or require a manufacturer registration, a statement
consistent with the espoused policy will be added to the table of
coincident activities, Sec. 1301.13(e)(1)(v), noting that dosage form
development is not an authorized coincident activity of a researcher
registration.
The purpose of providing two sets of definitions, one for
controlled substance handlers and one for chemical handlers, was to
direct an interested person to a single source for all definitions
relevant to that person's business activity. Therefore, it was deemed
more appropriate and less confusing to repeat those few definitions
which are common to both groups rather than to compel each person to
identify which definitions pertain to them. The reference to ``this
section'' in Sec. 1300.02(b)(12) will be replaced with the phrase ``for
purposes of this definition'' and the reference to ``this part'' in
Sec. 1300.02(b)(28)(i)(B) will be changed to reflect the part to which
it refers, i.e. part 1310.

Part 1301

Two commentors expressed support for the proposed change to
Sec. 1301.21, Exemptions to Registrations and Fees. Another commentor
expressed support for the proposal to extend the renewal period for
bulk manufacturers to 120 days contained in Sec. 1301.13. One commentor
stated that references to the

[[Page 13939]]

``Secretary'' in Sec. 1301.32 are unclear; the reference to ``these
substances'' in Sec. 1301.34(b)(3) should be clarified; the reference
to ``hearing'' in Sec. 1301.35(b) could be misinterpreted as referring
to third-party hearings and recommended that the phrase ``in response
to a show cause order'' be added; Sec. 1301.42 should reference the
possibility that the hearing could involve the granting of any
application for registration to import by adding the phrase ``to import
or'' after the words ``for registration''; and Sec. 1301.46 should be
clarified to indicate that if an application for registration to import
a Schedule I or II substance is granted, the order should include an
explanation of the basis for such granting by adding the phrase ``to
import or'' after the words ``for registration''. The references in
Sec. 1301.32 will be changed to identify the individual in question as
the Secretary of Health and Human Services; the term ``these
substances'' comes directly from the applicable statute and, therefore,
cannot be changed by regulation; the phrase ``in response to a show
cause order'' will be added to Sec. 1301.35(b); and the phrase ``to
import or'' will be added to Secs. 1301.42 and 1301.46.

Part 1304

Two comments were received supporting the acceptability of filing
Schedule III-V prescriptions without marking them with a red ``C'' if
the pharmacy can retrieve certain information with its data processing
system as required by Sec. 1304.04(h)(2). One commentor recommended
that the sentence ``Registrants who desire to continue maintaining
central records will make notification to the local Special Agent in
Charge as provided in paragraph (a) of this section'' be removed from
Sec. 1304.04(e). This sentence was in fact removed in the proposed
rule.
Two commentors supported the change to Sec. 1304.11(c) which allows
a registrant to conduct its biennial inventory on any date within two
years from the date of its previous biennial inventory. One of these
commentors noted that the proposed regulatory language implementing the
proposed rule had not changed. The corrected language was published in
the Federal Register on March 21, 1996 (61 FR 11594). One commentor
suggested that the requirements of Sec. 1304.11(e)(3)(ii) were
misstated. The commentor believed that DEA was intending to require
dispensers and researchers to make an exact inventory count of Schedule
III-V drugs in opened containers when the containers held fewer than
1,000 tablets or capsules, and an estimate if the containers held more
than 1,000. The language in the proposed rule, which is unchanged from
the existing regulation, is correct as stated in the proposed rule.
Two comments were received which recommended that the terms
``receipt'' and ``distribution'' contained in Secs. 1304.22(a)(2)(iv)
and 1304.22(a)(2)(vii) be changed to ``acquisition to inventory'' and
``reduction from inventory'' for purposes of clarity and consistency
with the terms used for ARCOS reporting. The recommended terms will be
incorporated into those sections.
Four commentors expressed their support for the change to
Sec. 1304.33 which puts ARCOS reporting on a quarterly rather than a
monthly schedule. One commentor recommended that Sec. 1304.33(b) be
modified to specify that controlled substances in the various stages of
production be included in the year-end ARCOS inventory. The language in
the current regulation indicating that registrants should identify
whether each reported substance is in storage or in process of
manufacturing was inadvertently omitted and will be reinstated. The
final rule will also be amended to permit quarterly reporting, as well
as annual reporting, of manufacturing transactions if the reporting
registrant so chooses.

Part 1305

One commentor objected to the removal of the information from the
regulations which is contained on the back of DEA-222 Order Forms, as
this information might be needed at a training site which is a non-
registered location and, therefore, would be unavailable for reference
purposes. When needed for training or other off-site purposes, the
backs of the order forms containing the requisite information could be
photocopied and provided to students at least as easily as providing
copies of the CFR. Therefore, the information will be deleted as
originally proposed.
One commentor suggested that the phrase used in Sec. 1305.06(b),
``last line completed,'' was inconsistent with the recently changed
term used on the DEA-222 Order Forms themselves. The commentor is
correct. The phrase used on the Order Forms, ``No. of lines
completed,'' was adopted recently for purposes of clarity and has been
substituted in the final rule for the language contained in the
proposed rule. Another commentor recommended that Sec. 1305.06(b) be
modified to acknowledge that some substances may require more than one
line to fully describe the substance being ordered. DEA believes that
the amount of space provided on a single line is generally sufficient
to completely identify the controlled substance. This same commentor
recommended that Sec. 1305.09(e) be amended to explain that an item on
an Order Form can be partially filled with less but not more than the
quantity ordered. The paragraph in question states that a purchaser
must record the date and quantity of the items received on copy 3 of
the Order Form. The statement being recommended for inclusion in
paragraph (e) is clearly and appropriately contained in paragraph (b)
of this section which relates to what can be supplied. This commentor
also recommended that Sec. 1305.11(a)(1) be modified to explain when an
Order Form is not ``complete.'' DEA believes that the term ``complete''
is self-explanatory, i.e. the purchaser must enter all the information
called for in the spaces provided except those that specifically state
that the information is to be filled in by the supplier.

Part 1306

Five commentors expressed support for the extension of time to 7
days from 72 hours within which pharmacies must obtain written
prescriptions to cover emergency oral prescriptions for Schedule II
controlled substances, as required by Sec. 1306.11(d)(4).
Five comments were received regarding the proposal to allow
pharmacies to retain faxed Schedule II prescription records as original
documents for patients in a home hospice setting. One commentor
supported the change without further elaboration. A second commentor
recommended that the terms ``terminal illness'' or ``terminally ill''
be substituted for the word ``hospice,'' so as to make the rule less
restrictive; if the terms hospice or home hospice were retained, it was
recommended that they be defined. The last three commentors suggested
that the rule be changed to allow pharmacies to accept faxed Schedule
II prescriptions for individuals in all hospice settings, not just
individuals in home hospice settings who have been released from
registered institutions and are receiving daily skilled nursing care.
It was suggested by two of these commentors that this would be best
achieved by replacing the relevant language in the proposed rule with
the phrase: ``a hospice certified by Medicare under Title XVIII or
licensed by the state.'' As stated in the proposed rule, it was DEA's
intention to allow faxed Schedule II prescriptions to be retained as
original documents in order

[[Page 13940]]

to ease the recordkeeping burden for physicians and pharmacies for non-
institutionalized patients who require frequent and/or unanticipated
changes in their Schedule II narcotic medication. It was DEA's belief
that individuals residing in a hospice facility licensed by the state
would already be covered by the existing exception to the rule afforded
to patients residing in Long Term Care Facilities. This proposal was
directed at individuals who require a similar level of care but reside
at home rather than in an institution. However, based on the comments
received and to insure that no properly affected individuals will be
inadvertently excluded from the exception, the recommended phrase, ``a
hospice certified by Medicare under Title XVIII or licensed by the
state,'' will be incorporated into the final rule.
Two commentors expressed support for the removal of the
requirement, previously contained in Sec. 1306.13(b), that a pharmacist
determine that subsequent partial fillings of Schedule II prescriptions
for patients in Long Term Care Facilities are still necessary. One
commentor pointed out that a sentence was needlessly repeated in this
paragraph; one of which will be removed.
Two commentors voiced their support for the proposal to permit
Schedule III-V prescription information to be transferred for refill
purposes up to the maximum number of times authorized by the physician
among pharmacies sharing a real-time, on-line electronic database.

Part 1308

One commentor disagreed with the proposal to remove the tables of
exempted and excluded products from Secs. 1308.24, 1308.26, 1308.32,
and 1308.34. This commentor expressed concern that by removing the
tables, DEA would not be obligated to publish changes to the tables as
they occur, thus denying interested parties an opportunity to comment
and/or adapt operations as needed. The requirement to publish all
approvals of exempted and excluded products in the Federal Register in
order to allow an opportunity for comment remains unchanged in the
following sections: 1308.23(e), 1308.25(c), 1308.31(c), and 1308.33(d).
The tables will continue to be published for comment in the Federal
Register each year. Therefore, the proposal to remove these tables will
have no effect on the ability of interested parties to comment and/or
adapt their operations. Another commentor suggested that the rule be
modified to require DEA to provide state scheduling authorities which
do not receive the Federal Register separate notification of changes to
the lists of exempted and excluded products. States which do not
receive copies of the Federal Register directly can request updated
lists from the local DEA office or from DEA Headquarters.

Part 1316

Four commentors expressed support for the change to Sec. 1316.13
which replaces the present schedule of administrative inspections with
a system whereby the frequency of inspections will be determined by
factors such as the prior history of the registrant, the potential for
diversion, and the existence of pharmaceutical controlled substances
found in the illicit market. Three of these commentors suggested adding
a requirement that an exit interview be conducted at the completion of
the investigation. Although it is DEA policy to conduct an exit
interview, there are occasions when it would be premature and/or
inadvisable to discuss results at the completion of the on-site portion
of the investigation. Therefore, DEA declines to add such a
requirement.
In the proposed rule the table of registration categories under
Sec. 1301.13(e)(1)(iv) incorrectly included instructing as an
authorized activity with Schedule I substances. The words ``or
Instructing'' are being removed in the Final Rule. In the proposed rule
Sec. 1304.22(c) should have included a reference to paragraph
(a)(2)(vii) of this section which will be inserted in the Final Rule.
In the proposed rule the authority citation for subpart A of part 1316
omitted Section ``830(a)'' of 21 U.S.C. inadvertently. It is being
reinstated in the Final Rule. A typographical error in Sec. 1316.12
which was overlooked for correction in the proposed rule is being
corrected in the Final Rule; the reference should read ``21 U.S.C.
842(a)(6)'' not ``21 U.S.C. (a)(6).''
In addition to the comments previously discussed, several
commentors also identified typographical errors in the proposed rule
which will be corrected in the final rule.
Five of the commentors took this occasion to recommend that DEA
adopt new regulations and procedures in a number of areas that go
beyond what was published in the proposed rule. A number of these are
matters of internal procedures which do not require regulatory changes
and are under development and discussion with the commentors, e.g.
batch certification and renewal of applications. Several
recommendations addressed issues which were not part of this rulemaking
and since other interested parties have not been given an opportunity
to comment on them, were not considered, e.g. permitting pharmacies to
receive controlled substances from LTCFs for disposal purposes,
requiring hospitals to provide suffix information for affiliated
practitioners, adding an Affidavit for Power of Attorney to allow
pharmacies to be operated by an acquirer under the existing
registration pending approval of the new application.
Several commentors recommended that the regulations be changed to
permit registered distributors to utilize cross-docking/freight-
forwarding facilities. Although this was not part of the proposed rule,
on December 18, 1996, DEA published a proposed rule to permit such
activities. Still other commentors proposed changes which would modify
specific requirements mandated by law and, therefore, cannot be altered
by regulation, e.g. written prescriptions for Schedule II controlled
substances. As was stated in the proposed rule, DEA is committed to
constant self-examination, responsiveness to technological innovation,
and working with industry to develop effective and minimally intrusive
methods of preventing and detecting the diversion of controlled
substances. The comments which suggested additional changes not
proposed as part of this NPRM will be evaluated and, where appropriate,
addressed in future meetings and conferences with the regulated
industry.
The Acting Deputy Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)) as amended by the Small Business
Regulatory Enforcement Act of 1996 (Pub. L. 104-121), has reviewed this
final rule and based on the supplemental information above certifies
that this rulemaking will not have a significant economic impact on a
substantial number of small entities. This final rule imposes no
additional regulatory burdens on small businesses. To the contrary, it
is primarily intended to streamline and simplify various regulations in
order to provide regulatory relief to registrants. Various regulations
and reports were either eliminated or reduced to allow greater
flexibility in complying with existing requirements. For example, the
frequency of reports to ARCOS were reduced to quarterly from monthly;
some pharmacies will be permitted to transfer prescription information
for refill purposes more frequently; all pharmacies will be permitted
to retain faxed prescriptions as original

[[Page 13941]]

documents for hospice patients; pharmacies will no longer be required
to determine if additional partial fillings of prescriptions are
necessary for patients in LTCFs; and all registrants will be given the
flexibility to establish the date for their biennial inventory.
This rulemaking has been drafted in accordance with Executive Order
12866, section 1(b), Principles of Regulation. The Office of Management
and Budget has reviewed this final rule and determined that it is not a
``significant regulatory action'' under Executive Order 12866, section
3(f), Regulatory Planning and Review.
This regulation will not have substantial direct effects on the
States, on the relationship between the national government and the
States, or on distribution of power and responsibilities among the
various levels of government. Therefore, in accordance with Executive
Order 12612, it is determined that this final rule does not have
sufficient federalism implications to warrant the preparation of a
Federalism Assessment.

List of Subjects in 21 CFR Parts 1300-1316

Administrative practice and procedure, Drug traffic control,
Exports, Imports, Labeling, List I and List II chemicals, Narcotics,
Packaging and containers, Prescription drugs, Reporting requirements,
Research, Security measures, Seizures and forfeitures.
For the reasons stated in the preamble, 21 CFR Ch. II is amended as
follows:
21 CFR part 1300 is added to read as follows:

PART 1300--DEFINITIONS

Sec.
1300.01 Definitions relating to controlled substances.
1300.02 Definitions relating to listed chemicals.

Authority: 21 U.S.C. 802, 871(b), 951, 958(f)

Sec. 1300.01 Definitions relating to controlled substances.

(a) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802), except that certain
terms used in part 1316 of this chapter are defined at the beginning of
each subpart of that part.
(b) As used in parts 1301 through 1308 and part 1312 of this
chapter, the following terms shall have the meanings specified:
(1) The term Act means the Controlled Substances Act, as amended
(84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import
and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
(2) The term Administration means the Drug Enforcement
Administration.
(3) The term Administrator means the Administrator of the Drug
Enforcement Administration. The Administrator has been delegated
authority under the Act by the Attorney General (28 CFR 0.100).
(4) The term anabolic steroid means any drug or hormonal substance,
chemically and pharmacologically related to testosterone (other than
estrogens, progestins, and corticosteroids) that promotes muscle
growth, and includes:
(i) Boldenone;
(ii) Chlorotestosterone (4-chlortestosterone);
(iii) Clostebol;
(iv) Dehydrochlormethyltestosterone;
(v) Dihydrotestosterone (4-dihydrotestosterone);
(vi) Drostanolone;
(vii) Ethylestrenol;
(viii) Fluoxymesterone;
(ix) Formebulone (formebolone);
(x) Mesterolone;
(xi) Methandienone;
(xii) Methandranone;
(xiii) Methandriol;
(xiv) Methandrostenolone;
(xv) Methenolone;
(xvi) Methyltestosterone;
(xvii) Mibolerone;
(xviii) Nandrolone;
(xix) Norethandrolone;
(xx) Oxandrolone;
(xxi) Oxymesterone;
(xxii) Oxymetholone;
(xxiii) Stanolone;
(xxiv) Stanozolol;
(xxv) Testolactone;
(xxvi) Testosterone;
(xxvii) Trenbolone; and
(xxviii) Any salt, ester, or isomer of a drug or substance
described or listed in this paragraph, if that salt, ester, or isomer
promotes muscle growth. Except such term does not include an anabolic
steroid which is expressly intended for administration through implants
to cattle or other nonhuman species and which has been approved by the
Secretary of Health and Human Services for such administration. If any
person prescribes, dispenses, or distributes such steroid for human
use, such person shall be considered to have prescribed, dispensed, or
distributed an anabolic steroid within the meaning of this paragraph.
(5) The term basic class means, as to controlled substances listed
in Schedules I and II:
(i) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.11(b) of this
chapter;
(ii) Each of the opium derivatives, including its salts, isomers,
and salts of isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical designation,
listed in Sec. 1308.11(c) of this chapter;
(iii) Each of the hallucinogenic substances, including its salts,
isomers, and salts of isomers whenever the existence of such salts,
isomers, and salts of isomers is possible within the specific chemical
designation, listed in Sec. 1308.11(d) of this chapter;
(iv) Each of the following substances, whether produced directly or
indirectly by extraction from substances of vegetable origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis:
(A) Opium, including raw opium, opium extracts, opium fluid
extracts, powdered opium, granulated opium, deodorized opium and
tincture of opium;
(B) Apomorphine;
(C) Codeine;
(D) Etorphine hydrochloride;
(E) Ethylmorphine;
(F) Hydrocodone;
(G) Hydromorphone;
(H) Metopon;
(I) Morphine;
(J) Oxycodone;
(K) Oxymorphone;
(L) Thebaine;
(M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of
this chapter;
(N) Cocaine; and
(O) Ecgonine;
(v) Each of the opiates, including its isomers, esters, ethers,
salts, and salts of isomers, esters, and ethers whenever the existence
of such isomers, esters, ethers, and salts is possible within the
specific chemical designation, listed in Sec. 1308.12(c) of this
chapter; and
(vi) Methamphetamine, its salts, isomers, and salts of its isomers;
(vii) Amphetamine, its salts, optical isomers, and salts of its
optical isomers;
(viii) Phenmetrazine and its salts;
(ix) Methylphenidate;
(x) Each of the substances having a depressant effect on the
central nervous system, including its salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and salts of
isomers is possible within the specific chemical designation, listed in
Sec. 1308.12(e) of this chapter.
(6) The term commercial container means any bottle, jar, tube,
ampule, or other receptacle in which a substance is

[[Page 13942]]

held for distribution or dispensing to an ultimate user, and in
addition, any box or package in which the receptacle is held for
distribution or dispensing to an ultimate user. The term commercial
container does not include any package liner, package insert or other
material kept with or within a commercial container, nor any carton,
crate, drum, or other package in which commercial containers are stored
or are used for shipment of controlled substances.
(7) The term compounder means any person engaging in maintenance or
detoxification treatment who also mixes, prepares, packages or changes
the dosage form of a narcotic drug listed in Schedules II, III, IV or V
for use in maintenance or detoxification treatment by another narcotic
treatment program.
(8) The term controlled substance has the meaning given in section
802(6) of Title 21, United States Code (U.S.C.).
(9) The term customs territory of the United States means the
several States, the District of Columbia, and Puerto Rico.
(10) The term detoxification treatment means the dispensing, for a
period of time as specified below, of a narcotic drug or narcotic drugs
in decreasing doses to an individual to alleviate adverse physiological
or psychological effects incident to withdrawal from the continuous or
sustained use of a narcotic drug and as a method of bringing the
individual to a narcotic drug-free state within such period of time.
There are two types of detoxification treatment: Short-term
detoxification treatment and long-term detoxification treatment.
(i) Short-term detoxification treatment is for a period not in
excess of 30 days.
(ii) Long-term detoxification treatment is for a period more than
30 days but not in excess of 180 days.
(11) The term dispenser means an individual practitioner,
institutional practitioner, pharmacy or pharmacist who dispenses a
controlled substance.
(12) The term export means, with respect to any article, any taking
out or removal of such article from the jurisdiction of the United
States (whether or not such taking out or removal constitutes an
exportation within the meaning of the customs and related laws of the
United States).
(13) The term exporter includes every person who exports, or who
acts as an export broker for exportation of, controlled substances
listed in any schedule.
(14) The term hearing means:
(i) In part 1301 of this chapter, any hearing held for the
granting, denial, revocation, or suspension of a registration pursuant
to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
(ii) In part 1303 of this chapter, any hearing held regarding the
determination of aggregate production quota or the issuance,
adjustment, suspension, or denial of a procurement quota or an
individual manufacturing quota.
(iii) In part 1308 of this chapter, any hearing held for the
issuance, amendment, or repeal of any rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(15) The term import means, with respect to any article, any
bringing in or introduction of such article into either the
jurisdiction of the United States or the customs territory of the
United States, and from the jurisdiction of the United States into the
customs territory of the United States (whether or not such bringing in
or introduction constitutes an importation within the meaning of the
tariff laws of the United States).
(16) The term importer includes every person who imports, or who
acts as an import broker for importation of, controlled substances
listed in any schedule.
(17) The term individual practitioner means a physician, dentist,
veterinarian, or other individual licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which he/she
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacist, a pharmacy,
or an institutional practitioner.
(18) The term institutional practitioner means a hospital or other
person (other than an individual) licensed, registered, or otherwise
permitted, by the United States or the jurisdiction in which it
practices, to dispense a controlled substance in the course of
professional practice, but does not include a pharmacy.
(19) The term interested person means any person adversely affected
or aggrieved by any rule or proposed rule issuable pursuant to section
201 of the Act (21 U.S.C. 811).
(20) The term inventory means all factory and branch stocks in
finished form of a basic class of controlled substance manufactured or
otherwise acquired by a registrant, whether in bulk, commercial
containers, or contained in pharmaceutical preparations in the
possession of the registrant (including stocks held by the registrant
under separate registration as a manufacturer, importer, exporter, or
distributor).
(21) The term isomer means the optical isomer, except as used in
Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in
Sec. 1308.11(d) of this chapter, the term isomer means the optical,
positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this
chapter, the term isomer means the optical or geometric isomer.
(22) The term jurisdiction of the United States means the customs
territory of the United States, the Virgin Islands, the Canal Zone,
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
(23) The term label means any display of written, printed, or
graphic matter placed upon the commercial container of any controlled
substance by any manufacturer of such substance.
(24) The term labeling means all labels and other written, printed,
or graphic matter:
(i) Upon any controlled substance or any of its commercial
containers or wrappers, or
(ii) Accompanying such controlled substance.
(25) The term Long Term Care Facility (LTCF) means a nursing home,
retirement care, mental care or other facility or institution which
provides extended health care to resident patients.
(26) The term maintenance treatment means the dispensing for a
period in excess of twenty-one days, of a narcotic drug or narcotic
drugs in the treatment of an individual for dependence upon heroin or
other morphine-like drug.
(27) The term manufacture means the producing, preparation,
propagation, compounding, or processing of a drug or other substance or
the packaging or repackaging of such substance, or the labeling or
relabeling of the commercial container of such substance, but does not
include the activities of a practitioner who, as an incident to his/her
administration or dispensing such substance in the course of his/her
professional practice, prepares, compounds, packages or labels such
substance. The term manufacturer means a person who manufactures a drug
or other substance, whether under a registration as a manufacturer or
under authority of registration as a researcher or chemical analyst.
(28) The term mid-level practitioner means an individual
practitioner, other than a physician, dentist, veterinarian, or
podiatrist, who is licensed, registered, or otherwise permitted by the
United States or the jurisdiction in which he/she practices, to
dispense a controlled substance in the course of professional practice.
Examples of mid-level practitioners include, but are not limited to,
health care providers such as nurse practitioners, nurse midwives,

[[Page 13943]]

nurse anesthetists, clinical nurse specialists and physician assistants
who are authorized to dispense controlled substances by the state in
which they practice.
(29) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(30) The term narcotic drug means any of the following whether
produced directly or indirectly by extraction from substances of
vegetable origin or independently by means of chemical synthesis or by
a combination of extraction and chemical synthesis:
(i) Opium, opiates, derivatives of opium and opiates, including
their isomers, esters, ethers, salts, and salts of isomers, esters, and
ethers whenever the existence of such isomers, esters, ethers and salts
is possible within the specific chemical designation. Such term does
not include the isoquinoline alkaloids of opium.
(ii) Poppy straw and concentrate of poppy straw.
(iii) Coca leaves, except coca leaves and extracts of coca leaves
from which cocaine, ecgonine and derivatives of ecgonine or their salts
have been removed.
(iv) Cocaine, its salts, optical and geometric isomers, and salts
of isomers.
(v) Ecgonine, its derivatives, their salts, isomers and salts of
isomers.
(vi) Any compound, mixture, or preparation which contains any
quantity of any of the substances referred to in paragraphs (b)(31)(i)
through (v) of this section.
(31) The term narcotic treatment program means a program engaged in
maintenance and/or detoxification treatment with narcotic drugs.
(32) The term net disposal means, for a stated period, the quantity
of a basic class of controlled substance distributed by the registrant
to another person, plus the quantity of that basic class used by the
registrant in the production of (or converted by the registrant into)
another basic class of controlled substance or a noncontrolled
substance, plus the quantity of that basic class otherwise disposed of
by the registrant, less the quantity of that basic class returned to
the registrant by any purchaser, and less the quantity of that basic
class distributed by the registrant to another registered manufacturer
of that basic class for purposes other than use in the production of,
or conversion into, another basic class of controlled substance or a
noncontrolled substance or in the manufacture of dosage forms of that
basic class.
(33) The term pharmacist means any pharmacist licensed by a State
to dispense controlled substances, and shall include any other person
(e.g., pharmacist intern) authorized by a State to dispense controlled
substances under the supervision of a pharmacist licensed by such
State.
(34) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust,
partnership, association, or other legal entity.
(35) The term prescription means an order for medication which is
dispensed to or for an ultimate user but does not include an order for
medication which is dispensed for immediate administration to the
ultimate user. (e.g., an order to dispense a drug to a bed patient for
immediate administration in a hospital is not a prescription.)
(36) The term proceeding means all actions taken for the issuance,
amendment, or repeal of any rule issued pursuant to section 201 of the
Act (21 U.S.C. 811), commencing with the publication by the
Administrator of the proposed rule, amended rule, or repeal in the
Federal Register.
(37) The term purchaser means any registered person entitled to
obtain and execute order forms pursuant to Section 1305.04 and Section
1305.06.
(38) The term readily retrievable means that certain records are
kept by automatic data processing systems or other electronic or
mechanized recordkeeping systems in such a manner that they can be
separated out from all other records in a reasonable time and/or
records are kept on which certain items are asterisked, redlined, or in
some other manner visually identifiable apart from other items
appearing on the records.
(39) The terms register and registration refer only to registration
required and permitted by sections 303 or 1007 of the Act (21 U.S.C.
823 or 957).
(40) The term registrant means any person who is registered
pursuant to either section 303 or section 1008 of the Act (21 U.S.C.
823 or 958).
(41) The term supplier means any registered person entitled to fill
order forms pursuant to Sec. 1305.08 of this chapter.

Sec. 1300.02 Definitions relating to listed chemicals.

[[Page 13944]]

which has been created to evade the requirements of the Act.
(10) The term customs territory of the United States means the
several States, the District of Columbia, and Puerto Rico.
(11) The term encapsulating machine means any manual, semi-
automatic, or fully automatic equipment which may be used to fill
shells or capsules with any powdered, granular, semi-solid, or liquid
material.
(12) The term established business relationship with a foreign
customer means the regulated person has exported a listed chemical at
least once within the past six months, or twice within the past twelve
months to a foreign manufacturer, distributor, or end user of the
chemical that has an established business in the foreign country with a
fixed street address. A person or business which functions as a broker
or intermediary is not a customer for purposes of this definition. The
term also means that the regulated person has provided the
Administration with the following information in accordance with the
waiver of 15-day advance notice requirements of Sec. 1313.24 of this
chapter:
(i) The name and street address of the chemical exporter and of
each regular customer;
(ii) The telephone number, telex number, contact person, and where
available, the facsimile number for the chemical exporter and for each
regular customer;
(iii) The nature of the regular customer's business (i.e.,
importer, exporter, distributor, manufacturer, etc.), and if known, the
use to which the listed chemical or chemicals will be applied;
(iv) The duration of the business relationship;
(v) The frequency and number of transactions occurring during the
preceding 12-month period;
(vi) the amounts and the listed chemical or chemicals involved in
regulated transactions between the chemical exporter and regular
customer;
(vii) The method of delivery (direct shipment or through a broker
or forwarding agent); and
(viii) Other information that the chemical exporter considers
relevant for determining whether a customer is a regular customer.
(13) The term established record as an importer means that the
regulated person has imported a listed chemical at least once within
the past six months, or twice within the past twelve months from a
foreign supplier. The term also means that the regulated person has
provided the Administration with the following information in
accordance with the waiver of the 15-day advance notice requirements of
Sec. 1313.15 of this chapter:
(i) The name, DEA registration number (where applicable), street
address, telephone number, telex number, and, where available, the
facsimile number of the regulated person and of each foreign supplier;
and
(ii) The frequency and number of transactions occurring during the
preceding 12 month period.
(14) The term hearing means any hearing held for the granting,
denial, revocation, or suspension of a registration pursuant to
sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
(15) The term international transaction means a transaction
involving the shipment of a listed chemical across an international
border (other than a United States border) in which a broker or trader
located in the United States participates.
(16) The term jurisdiction of the United States means the customs
territory of the United States, the Virgin Islands, the Canal Zone,
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
(17) The term listed chemical means any List I chemical or List II
chemical.
(18) The term List I chemical means a chemical specifically
designated by the Administrator in Sec. 1310.02(a) of this chapter
that, in addition to legitimate uses, is used in manufacturing a
controlled substance in violation of the Act and is important to the
manufacture of a controlled substance.
(19) The term List II chemical means a chemical, other than a List
I chemical, specifically designated by the Administrator in
Sec. 1310.02(b) of this chapter that, in addition to legitimate uses,
is used in manufacturing a controlled substance in violation of the
Act.
(20) The term name means the official name, common or usual name,
chemical name, or brand name of a substance.
(21) The term person includes any individual, corporation,
government or governmental subdivision or agency, business trust,
partnership, association, or other legal entity.
(22) The term readily retrievable means that certain records are
kept by automatic data processing systems or other electronic or
mechanized recordkeeping systems in such a manner that they can be
separated out from all other records in a reasonable time and/or
records are kept on which certain items are asterisked, redlined, or in
some other manner visually identifiable apart from other items
appearing on the records.
(23) The terms register and registration refer only to registration
required and permitted by sections 303 or 1007 of the Act (21 U.S.C.
823 or 957).
(24) The term registrant means any person who is registered
pursuant to either section 303 or section 1008 of the Act (21 U.S.C.
823 or 958).
(25) The term regular customer means a person with whom the
regulated person has an established business relationship for a
specified listed chemical or chemicals that has been reported to the
Administration subject to the criteria established in
Sec. 1300.02(b)(12).
(26) The term regular importer means, with respect to a listed
chemical, a person that has an established record as an importer of
that listed chemical that is reported to the Administrator.
(27) The term regulated person means any individual, corporation,
partnership, association, or other legal entity who manufactures,
distributes, imports, or exports a listed chemical, a tableting
machine, or an encapsulating machine, or who acts as a broker or trader
for an international transaction involving a listed chemical, tableting
machine, or encapsulating machine.
(28) The term regulated transaction means:
(i) A distribution, receipt, sale, importation, or exportation of a
listed chemical, or an international transaction involving shipment of
a listed chemical, or if the Administrator establishes a threshold
amount for a specific listed chemical, a threshold amount as determined
by the Administrator, which includes a cumulative threshold amount for
multiple transactions, of a listed chemical, except that such term does
not include:
(A) A domestic lawful distribution in the usual course of business
between agents or employees of a single regulated person; in this
context, agents or employees means individuals under the direct
management and control of the regulated person;
(B) A delivery of a listed chemical to or by a common or contract
carrier for carriage in the lawful and usual course of the business of
the common or contract carrier, or to or by a warehouseman for storage
in the lawful and usual course of the business of the warehouseman,
except that if the carriage or storage is in connection with the
distribution, importation, or exportation of a listed chemical to a
third person, this paragraph does not relieve a distributor, importer,
or

[[Page 13945]]

exporter from compliance with parts 1309, 1310, and 1313 of this
chapter;
(C) Any category of transaction or any category of transaction for
a specific listed chemical or chemicals specified by regulation of the
Administrator as excluded from this definition as unnecessary for
enforcement of the Act;
(D) Any transaction in a listed chemical that is contained in a
drug that may be marketed or distributed lawfully in the United States
under the Federal Food, Drug, and Cosmetic Act unless--
(1) the drug contains ephedrine or its salts, optical isomers, or
salts of optical isomers as the only active medicinal ingredient or
contains ephedrine or its salts, optical isomers or salts of optical
isomers and therapeutically insignificant quantities of another active
medicinal ingredient. For purposes of this paragraph, the term
``therapeutically insignificant quantities'' shall apply if the product
formulation (i.e., the qualitative and quantitative composition of
active ingredients within the product) is not listed in any of the
following compendiums: American Pharmaceutical Association (Apha)
Handbook of Nonprescription Drugs; Drug Facts and Comparisons
(published by Wolters Kluwer Company); or USP DI (published by
authority of the United States Pharmacopeial Convention, Inc.); or the
product is not listed in Sec. 1310.15 of this chapter as an exempt drug
product. For drug products having formulations not found in the above
compendiums, the Administrator shall determine, pursuant to a written
request as specified in Sec. 1310.14 of this chapter, whether the
active medicinal ingredients are present in quantities considered
therapeutically significant for purposes of this paragraph; or
(2) The Administrator has determined pursuant to the criteria in
Sec. 1310.10 of this chapter that:
(i) The drug or group of drugs is being diverted to obtain the
listed chemical for use in the illicit production of a controlled
substance; and
(ii) The quantity of ephedrine or other listed chemical contained
in the drug included in the transaction or multiple transactions equals
or exceeds the threshold established for that chemical by the
Administrator;
(E) Any transaction in a chemical mixture listed in Sec. 1310.13 of
this chapter.
(ii) A distribution, importation, or exportation of a tableting
machine or encapsulating machine except that such term does not include
a domestic lawful distribution in the usual course of business between
agents and employees of a single regulated person; in this context,
agents or employees means individuals under the direct management and
control of the regulated person.
(29) The term retail distributor means a distributor whose List I
chemical activities are restricted to the sale of drug products that
are regulated as List I chemicals pursuant to
Sec. 1300.02(b)(28)(i)(D), directly to walk-in customers for personal
use.
(30) The term tableting machine means any manual, semi-automatic,
or fully automatic equipment which may be used for the compaction or
molding of powdered or granular solids, or semi-solid material, to
produce coherent solid tablets.

PART 1301--[AMENDED]

1. The authority citation for part 1301 continues to read as
follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 952,
956, 957, 958, unless otherwise noted.

2. Section 1301.01 is revised to read as follows:

Sec. 1301.01 Scope of this part 1301.

Procedures governing the registration of manufacturers,
distributors, dispensers, importers, and exporters of controlled
substances pursuant to Sections 301-304 and 1007-1008 of the Act (21
U.S.C. 821-824 and 957-958) are set forth generally by those sections
and specifically by the sections of this part.
3. Section 1301.02 is revised to read as follows:

Sec. 1301.02 Definitions.

Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
4. Part 1301 is amended by revising Secs. 1301.11 through 1301.52
and the undesignated center headings and by removing Secs. 1301.53
through 1301.63 and the undesignated center headings:

Registration

Sec.
1301.11 Persons required to register.
1301.12 Separate registrations for separate locations.
1301.13 Application for registration; time for application;
expiration date; registration for independent activities;
application forms, fees, contents and signature; coincident
activities.
1301.14 Filing of application; acceptance for filing; defective
applications.
1301.15 Additional Information.
1301.16 Amendments to and withdrawal of applications.
1301.17 Special procedures for certain applications.
1301.18 Research protocols.

Exceptions to Registration and Fees

1301.21 Exception from fees.
1301.22 Exemption of agents and employees; affiliated
practitioners.
1301.23 Exemption of certain military and other personnel.
1301.24 Exemption of law enforcement officials.
1301.25 Registration regarding ocean vessels, aircraft, and other
entities.
1301.26 Exemptions from import or export requirements for personal
medical use.

Action on Applications for Registration: Revocation or Suspension of
Registration

1301.31 Administrative review generally.
1301.32 Action on applications for research in Schedule I
substances.
1301.33 Application for bulk manufacture of Schedule I and II
substances.
1301.34 Application for importation of Schedule I and II
substances.
1301.35 Certificate of registration; denial of registration.
1301.36 Suspension or revocation of registration; suspension of
registration pending final order; extension of registration pending
final order.
1301.37 Order to show cause.

Hearings

1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance; waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.

Modification, Transfer, and Termination of Registration

1301.51 Modification in registration.
1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.

Registration

Sec. 1301.11 Persons required to register.

(a) Every person who manufactures, distributes, dispenses, imports,
or exports any controlled substance or who proposes to engage in the
manufacture, distribution, dispensing, importation or exportation of
any controlled substance shall obtain a registration unless exempted by
law or pursuant to Secs. 1301.22-1301.26. Only persons actually engaged
in such activities are required to obtain a registration; related or
affiliated persons who are not engaged in such activities are not
required to be registered. (For example, a stockholder or parent
corporation of a corporation manufacturing controlled substances is not
required to obtain a registration.)

Sec. 1301.12 Separate registrations for separate locations.

(a) A separate registration is required for each principal place of
business or professional practice at one general physical location
where controlled

[[Page 13946]]

substances are manufactured, distributed, imported, exported, or
dispensed by a person.
(b) The following locations shall be deemed not to be places where
controlled substances are manufactured, distributed, or dispensed:
(1) A warehouse where controlled substances are stored by or on
behalf of a registered person, unless such substances are distributed
directly from such warehouse to registered locations other than the
registered location from which the substances were delivered or to
persons not required to register by virtue of subsection 302(c)(2) or
subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or
957(b)(1)(B));
(2) An office used by agents of a registrant where sales of
controlled substances are solicited, made, or supervised but which
neither contains such substances (other than substances for display
purposes or lawful distribution as samples only) nor serves as a
distribution point for filling sales orders; and
(3) An office used by a practitioner (who is registered at another
location) where controlled substances are prescribed but neither
administered nor otherwise dispensed as a regular part of the
professional practice of the practitioner at such office, and where no
supplies of controlled substances are maintained.

Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.

(a) Any person who is required to be registered and who is not so
registered may apply for registration at any time. No person required
to be registered shall engage in any activity for which registration is
required until the application for registration is granted and a
Certificate of Registration is issued by the Administrator to such
person.
(b) Any person who is registered may apply to be reregistered not
more than 60 days before the expiration date of his/her registration,
except that a bulk manufacturer of Schedule I or II controlled
substances or an importer of Schedule I or II controlled substances may
apply to be reregistered no more than 120 days before the expiration
date of their registration.
(c) At the time a manufacturer, distributor, researcher, analytical
lab, importer, exporter or narcotic treatment program is first
registered, that business activity shall be assigned to one of twelve
groups, which shall correspond to the months of the year. The
expiration date of the registrations of all registrants within any
group will be the last date of the month designated for that group. In
assigning any of the above business activities to a group, the
Administration may select a group the expiration date of which is less
than one year from the date such business activity was registered. If
the business activity is assigned to a group which has an expiration
date less than three months from the date of which the business
activity is registered, the registration shall not expire until one
year from that expiration date; in all other cases, the registration
shall expire on the expiration date following the date on which the
business activity is registered.
(d) At the time a retail pharmacy, hospital/clinic, practitioner or
teaching institution is first registered, that business activity shall
be assigned to one of twelve groups, which shall correspond to the
months of the year. The expiration date of the registrations of all
registrants within any group will be the last day of the month
designated for that group. In assigning any of the above business
activities to a group, the Administration may select a group the
expiration date of which is not less than 28 months nor more than 39
months from the date such business activity was registered. After the
initial registration period, the registration shall expire 36 months
from the initial expiration date.
(e) Any person who is required to be registered and who is not so
registered, shall make application for registration for one of the
following groups of controlled substances activities, which are deemed
to be independent of each other. Application for each registration
shall be made on the indicated form, and shall be accompanied by the
indicated fee. Fee payments shall be made in the form of a personal,
certified, or cashier's check or money order made payable to the ``Drug
Enforcement Administration''. The application fees are not refundable.
Any person, when registered to engage in the activities described in
each subparagraph in this paragraph, shall be authorized to engage in
the coincident activities described without obtaining a registration to
engage in such coincident activities, provided that, unless
specifically exempted, he/she complies with all requirements and duties
prescribed by law for persons registered to engage in such coincident
activities. Any person who engages in more than one group of
independent activities shall obtain a separate registration for each
group of activities, except as provided in this paragraph under
coincident activities. A single registration to engage in any group of
independent activities listed below may include one or more controlled
substances listed in the schedules authorized in that group of
independent activities. A person registered to conduct research with
controlled substances listed in Schedule I may conduct research with
any substances listed in Schedule I for which he/she has filed and had
approved a research protocol.
(1)

----------------------------------------------------------------------------------------------------------------
Application Registration
Business activity Controlled DEA application fee period Coincident
substances forms (dollars) (years) activities allowed
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing............ Schedules I New--225....... 875 1 Schedules I through
through V. Renewal--225a.. 875 V: May distribute
that substance or
class for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
Schedules II
through V: May
conduct chemical
analysis and
preclinical
research (including
quality control
analysis) with
substances listed
in those schedules
for which
authorization as a
manufacturer was
issued.
(ii) Distributing............ Schedules I New--225....... 438 1 ....................
through V. Renewal--225a.. 438

[[Page 13947]]

(iii) Dispensing or Schedules II New--224....... 210 3 May conduct research
Instructing (Includes through V. Renewal--224a.. 210 and instructional
Practitioner Hospital/ activities with
Clinic, Retail Pharmacy, those substances
Teaching Institution). for which
registration was
granted, except
that a mid-level
practitioner may
conduct such
research only to
the extent
expressly
authorized under
state statute. A
pharmacist may
manufacture an
aqueous or
oleaginous solution
or solid dosage
form containing a
narcotic controlled
substance in
Schedule II through
V in a proportion
not exceeding 20
percent of the
complete solution,
compound, or
mixture.
(iv) Research................ Schedule I..... New--225....... 70 1 A researcher may
Renewal--225a.. 70 manufacture or
import the basic
class of substance
or substances for
which registration
was issued,
provided that such
manufacture or
import is set forth
in the protocol
required in Section
1301.18 and to
distribute such
class to persons
registered or
authorized to
conduct research
with such class of
substance or
registered or
authorized to
conduct chemical
analysis with
controlled
substances.
(v) Research................. Schedules II New--225....... 70 1 May conduct chemical
through V. Renewal--225a.. 70 analysis with
controlled
substances in those
schedules for which
registration was
issued; manufacture
such substances if
and to the extent
that such
manufacture is set
forth in a
statement filed
with the
application for
registration or
reregistration and
provided that the
manufacture is not
for the purposes of
dosage form
development; import
such substances for
research purposes;
distribute such
substances to
persons registered
or authorized to
conduct chemical
analysis,
instructional
activities, or
research with such
substances, and to
persons exempted
from registration
pursuant to Section
1301.24; and
conduct
instructional
activities with
controlled
substances.
(vi) Narcotic Treatment Narcotic Drugs New--363....... 70 1 ....................
Program (including in Schedules Renewal--363a.. 70
compounder). II through V.
(vii) Importing.............. Schedules I New--225....... 438 1 May distribute that
through V. Renewal--225a.. 438 substance or class
for which
registration was
issued; may not
distribute any
substance or class
for which not
registered.
(viii) Exporting............. Schedules I New--225....... 438 1 ....................
through V. Renewal--225a.. 438

[[Page 13948]]

(ix) Chemical Analysis....... Schedules I New--225....... 70 1 May manufacture and
through V. Renewal--225a.. 70 import controlled
substances for
analytical or
instructional
activities; may
distribute such
substances to
persons registered
or authorized to
conduct chemical
analysis,
instructional
activities, or
research with such
substances and to
persons exempted
from registration
pursuant to Section
1301.24; may export
such substances to
persons in other
countries
performing chemical
analysis or
enforcing laws
relating to
controlled
substances or drugs
in those countries;
and may conduct
instructional
activities with
controlled
substances.
----------------------------------------------------------------------------------------------------------------

(2) DEA Forms 224, 225, and 363 may be obtained at any area office
of the Administration or by writing to the Registration Unit, Drug
Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005.
(3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable,
to each registered person approximately 60 days before the expiration
date of his/her registration; if any registered person does not receive
such forms within 45 days before the expiration date of his/her
registration, he/she must promptly give notice of such fact and request
such forms by writing to the Registration Unit of the Administration at
the foregoing address.
(f) Each application for registration to handle any basic class of
controlled substance listed in Schedule I (except to conduct chemical
analysis with such classes), and each application for registration to
manufacture a basic class of controlled substance listed in Schedule II
shall include the Administration Controlled Substances Code Number, as
set forth in part 1308 of this chapter, for each basic class to be
covered by such registration.
(g) Each application for registration to import or export
controlled substances shall include the Administration Controlled
Substances Code Number, as set forth in part 1308 of this chapter, for
each controlled substance whose importation or exportation is to be
authorized by such registration. Registration as an importer or
exporter shall not entitle a registrant to import or export any
controlled substance not specified in such registration.
(h) Each application for registration to conduct research with any
basic class of controlled substance listed in Schedule II shall include
the Administration Controlled Substances Code Number, as set forth in
part 1308 of this chapter, for each such basic class to be manufactured
or imported as a coincident activity of that registration. A statement
listing the quantity of each such basic class of controlled substance
to be imported or manufactured during the registration period for which
application is being made shall be included with each such application.
For purposes of this paragraph only, manufacturing is defined as the
production of a controlled substance by synthesis, extraction or by
agricultural/horticultural means.
(i) Each application shall include all information called for in
the form, unless the item is not applicable, in which case this fact
shall be indicated.
(j) Each application, attachment, or other document filed as part
of an application, shall be signed by the applicant, if an individual;
by a partner of the applicant, if a partnership; or by an officer of
the applicant, if a corporation, corporate division, association, trust
or other entity. An applicant may authorize one or more individuals,
who would not otherwise be authorized to do so, to sign applications
for the applicant by filing with the Registration Unit of the
Administration a power of attorney for each such individual. The power
of attorney shall be signed by a person who is authorized to sign
applications under this paragraph and shall contain the signature of
the individual being authorized to sign applications. The power of
attorney shall be valid until revoked by the applicant.

Sec. 1301.14 Filing of application; acceptance for filing; defective
applications.

(a) All applications for registration shall be submitted for filing
to the Registration Unit, Drug Enforcement Administration, Department
of Justice, Post Office Box 28083, Central Station, Washington, DC
20005. The appropriate registration fee and any required attachments
must accompany the application.
(b) Any person required to obtain more than one registration may
submit all applications in one package. Each application must be
complete and should not refer to any accompanying application for
required information.
(c) Applications submitted for filing are dated upon receipt. If
found to be complete, the application will be accepted for filing.
Applications failing to comply with the requirements of this part will
not generally be accepted for filing. In the case of minor defects as
to completeness, the Administrator may accept the application for
filing with a request to the applicant for additional information. A
defective application will be returned to the applicant within 10 days
following its receipt with a statement of the reason for not accepting
the application for filing. A defective application may be corrected
and resubmitted for filing at any time; the Administrator shall accept
for filing any application upon resubmission by the applicant, whether
complete or not.
(d) Accepting an application for filing does not preclude any
subsequent request for additional information pursuant to Sec. 1301.15
and has no bearing on whether the application will be granted.

Sec. 1301.15 Additional information.

The Administrator may require an applicant to submit such documents
or

[[Page 13949]]

written statements of fact relevant to the application as he/she deems
necessary to determine whether the application should be granted. The
failure of the applicant to provide such documents or statements within
a reasonable time after being requested to do so shall be deemed to be
a waiver by the applicant of an opportunity to present such documents
or facts for consideration by the Administrator in granting or denying
the application.

Sec. 1301.16 Amendments to and withdrawal of applications.

(a) An application may be amended or withdrawn without permission
of the Administrator at any time before the date on which the applicant
receives an order to show cause pursuant to Sec. 1301.37. An
application may be amended or withdrawn with permission of the
Administrator at any time where good cause is shown by the applicant or
where the amendment or withdrawal is in the public interest.
(b) After an application has been accepted for filing, the request
by the applicant that it be returned or the failure of the applicant to
respond to official correspondence regarding the application, when sent
by registered or certified mail, return receipt requested, shall be
deemed to be a withdrawal of the application.

Sec. 1301.17 Special procedures for certain applications.

(a) If, at the time of application for registration of a new
pharmacy, the pharmacy has been issued a license from the appropriate
State licensing agency, the applicant may include with his/her
application an affidavit as to the existence of the State license in
the following form:

Affidavit for New Pharmacy

I, ____________________, the ____________________ (Title of
officer, official, partner, or other position) of
____________________ (Corporation, partnership, or sole proprietor),
doing business as ____________________ (Store name) at
____________________ (Number and Street), ____________________
(City) ____________ (State) ____________ (Zip code), hereby certify
that said store was issued a pharmacy permit No. ________ by the
________________ (Board of Pharmacy or Licensing Agency) of the
State of ____________ on ____________ (Date).
This statement is submitted in order to obtain a Drug
Enforcement Administration registration number. I understand that if
any information is false, the Administration may immediately suspend
the registration for this store and commence proceedings to revoke
under 21 U.S.C. 824(a) because of the danger to public health and
safety. I further understand that any false information contained in
this affidavit may subject me personally and the above-named
corporation/partnership/business to prosecution under 21 U.S.C. 843,
the penalties for conviction of which include imprisonment for up to
4 years, a fine of not more than $30,000 or both.
----------------------------------------------------------------------
Signature (Person who signs Application for Registration)
State of---------------------------------------------------------------
County of--------------------------------------------------------------
Subscribed to and sworn before me this ________ day of ________,
19______.
----------------------------------------------------------------------
Notary Public
(b) Whenever the ownership of a pharmacy is being transferred from
one person to another, if the transferee owns at least one other
pharmacy licensed in the same State as the one the ownership of which
is being transferred, the transferee may apply for registration prior
to the date of transfer. The Administrator may register the applicant
and authorize him to obtain controlled substances at the time of
transfer. Such registration shall not authorize the transferee to
dispense controlled substances until the pharmacy has been issued a
valid State license. The transferee shall include with his/her
application the following affidavit:

Affidavit for Transfer of Pharmacy

I, ____________________, the ____________________ (Title of
officer, official, partner or other position) of
____________________ (Corporation, partnership, or sole proprietor),
doing business as ____________________ (Store name) hereby certify:
(1) That said company was issued a pharmacy permit
No.____________by the ____________________ (Board of Pharmacy of
Licensing Agency) of the State of ____________ and a DEA
Registration Number ____________________ for a pharmacy located at
____________________ (Number and Street) ____________ (City)
____________ (State) ____________ (Zip Code); and
(2) That said company is acquiring the pharmacy business of
____________________ (Name of Seller) doing business
as____________________with DEA Registration Number ____________ on
or about ____________ (Date of Transfer) and that said company has
applied (or will apply on ____________ (Date) for a pharmacy permit
from the board of pharmacy (or licensing agency) of the State of
____________ to do business as ____________________ (Store name) at
____________________ (Number and Street) ____________________ (City)
____________ (State) ____________ (Zip Code).
This statement is submitted in order to obtain a Drug
Enforcement Administration registration number.
I understand that if a DEA registration number is issued, the
pharmacy may acquire controlled substances but may not dispense them
until a pharmacy permit or license is issued by the State board of
pharmacy or licensing agency.
I understand that if any information is false, the Administration
may immediately suspend the registration for this store and commence
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to
public health and safety. I further understand that any false
information contained in this affidavit may subject me personally to
prosecution under 21 U.S.C. 843, the penalties for conviction of which
include imprisonment for up to 4 years, a fine of not more than $30,000
or both.

----------------------------------------------------------------------
Signature (Person who signs Application for Registration)
State of---------------------------------------------------------------
County of--------------------------------------------------------------
Subscribed to and sworn before me this____day of____________,
19____.
----------------------------------------------------------------------
Notary Public

(c) The Administrator shall follow the normal procedures for
approving an application to verify the statements in the affidavit. If
the statements prove to be false, the Administrator may revoke the
registration on the basis of section 304(a)(1) of the Act (21 U.S.C.
824(a)(1)) and suspend the registration immediately by pending
revocation on the basis of section 304(d) of the Act (21 U.S.C.
824(d)). At the same time, the Administrator may seize and place under
seal all controlled substances possessed by the applicant under section
304(f) of the Act (21 U.S.C. 824(f)). Intentional misuse of the
affidavit procedure may subject the applicant to prosecution for fraud
under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining
controlled substances through registration by fraudulent means may
subject the applicant to prosecution under section 403(a)(3) of the Act
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense
include imprisonment for up to 4 years, a fine not exceeding $30,000 or
both.

Sec. 1301.18 Research protocols.

(a) A protocol to conduct research with controlled substances
listed in Schedule I shall be in the following form and contain the
following information where applicable:
(1) Investigator:
(i) Name, address, and DEA registration number; if any.
(ii) Institutional affiliation.
(iii) Qualifications, including a curriculum vitae and an
appropriate bibliography (list of publications).
(2) Research project:
(i) Title of project.
(ii) Statement of the purpose.
(iii) Name of the controlled substances or substances involved and
the amount of each needed.

[[Page 13950]]

(iv) Description of the research to be conducted, including the
number and species of research subjects, the dosage to be administered,
the route and method of administration, and the duration of the
project.
(v) Location where the research will be conducted.
(vi) Statement of the security provisions for storing the
controlled substances (in accordance with Sec. 1301.75) and for
dispensing the controlled substances in order to prevent diversion.
(vii) If the investigator desires to manufacture or import any
controlled substance listed in paragraph (a)(2)(iii) of this section, a
statement of the quantity to be manufactured or imported and the
sources of the chemicals to be used or the substance to be imported.
(3) Authority:
(i) Institutional approval.
(ii) Approval of a Human Research Committee for human studies.
(iii) Indication of an approved active Notice of Claimed
Investigational Exemption for a New Drug (number).
(iv) Indication of an approved funded grant (number), if any.
(b) In the case of a clinical investigation with controlled
substances listed in Schedule I, the applicant shall submit three
copies of a Notice of Claimed Investigational Exemption for a New Drug
(IND) together with a statement of the security provisions (as
proscribed in paragraph (a)(2)(vi) of this section for a research
protocol) to, and have such submission approved by, the Food and Drug
Administration as required in 21 U.S.C. 355(i) and Sec. 130.3 of this
title. Submission of this Notice and statement to the Food and Drug
Administration shall be in lieu of a research protocol to the
Administration as required in paragraph (a) of this section. The
applicant, when applying for registration with the Administration,
shall indicate that such notice has been submitted to the Food and Drug
Administration by submitting to the Administration with his/her DEA
Form 225 three copies of the following certificate:

I hereby certify that on ____________________ (Date), pursuant
to 21 U.S.C. 355(i) and 21 CFR 130.3, I, ____________________ (Name
and Address of IND Sponsor) submitted a Notice of Claimed
Investigational Exemption for a New Drug (IND) to the Food and Drug
Administration for:
----------------------------------------------------------------------
(Name of Investigational Drug).

----------------------------------------------------------------------
(Date)

----------------------------------------------------------------------
(Signature of Applicant).

(c) In the event that the registrant desires to increase the
quantity of a controlled substance used for an approved research
project, he/she shall submit a request to the Registration Unit, Drug
Enforcement Administration, Post Office Box 28083, Central Station,
Washington, DC 20005, by registered mail, return receipt requested. The
request shall contain the following information: DEA registration
number; name of the controlled substance or substances and the quantity
of each authorized in the approved protocol; and the additional
quantity of each desired. Upon return of the receipt, the registrant
shall be authorized to purchase the additional quantity of the
controlled substance or substances specified in the request. The
Administration shall review the letter and forward it to the Food and
Drug Administration together with the Administration comments. The Food
and Drug Administration shall approve or deny the request as an
amendment to the protocol and so notify the registrant. Approval of the
letter by the Food and Drug Administration shall authorize the
registrant to use the additional quantity of the controlled substance
in the research project.
(d) In the event the registrant desires to conduct research beyond
the variations provided in the registrant's approved protocol
(excluding any increase in the quantity of the controlled substance
requested for his/her research project as outlined in paragraph (c) of
this section), he/she shall submit three copies of a supplemental
protocol in accordance with paragraph (a) of this section describing
the new research and omitting information in the supplemental protocol
which has been stated in the original protocol. Supplemental protocols
shall be processed and approved or denied in the same manner as
original research protocols.

Exceptions to Registration and Fees

Sec. 1301.21 Exemption from fees.

(a) The Administrator shall exempt from payment of an application
fee for registration or reregistration:
(1) Any hospital or other institution which is operated by an
agency of the United States (including the U.S. Army, Navy, Marine
Corps., Air Force, and Coast Guard), of any State, or any political
subdivision or agency thereof.
(2) Any individual practitioner who is required to obtain an
individual registration in order to carry out his or her duties as an
official of an agency of the United States (including the U.S. Army,
Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any
political subdivision or agency thereof.
(b) In order to claim exemption from payment of a registration or
reregistration application fee, the registrant shall have completed the
certification on the appropriate application form, wherein the
registrant's superior (if the registrant is an individual) or officer
(if the registrant is an agency) certifies to the status and address of
the registrant and to the authority of the registrant to acquire,
possess, or handle controlled substances.
(c) Exemption from payment of a registration or reregistration
application fee does not relieve the registrant of any other
requirements or duties prescribed by law.

Sec. 1301.22 Exemption of agents and employees; affiliated
practitioners.

(a) The requirement of registration is waived for any agent or
employee of a person who is registered to engage in any group of
independent activities, if such agent or employee is acting in the
usual course of his/her business or employment.
(b) An individual practitioner who is an agent or employee of
another practitioner (other than a mid-level practitioner) registered
to dispense controlled substances may, when acting in the normal course
of business or employment, administer or dispense (other than by
issuance of prescription) controlled substances if and to the extent
that such individual practitioner is authorized or permitted to do so
by the jurisdiction in which he or she practices, under the
registration of the employer or principal practitioner in lieu of being
registered him/herself.
(c) An individual practitioner who is an agent or employee of a
hospital or other institution may, when acting in the normal course of
business or employment, administer, dispense, or prescribe controlled
substances under the registration of the hospital or other institution
which is registered in lieu of being registered him/herself, provided
that:
(1) Such dispensing, administering or prescribing is done in the
usual course of his/her professional practice;
(2) Such individual practitioner is authorized or permitted to do
so by the jurisdiction in which he/she is practicing;
(3) The hospital or other institution by whom he/she is employed
has verified that the individual practitioner is so permitted to
dispense, administer, or prescribe drugs within the jurisdiction;

[[Page 13951]]

(4) Such individual practitioner is acting only within the scope of
his/her employment in the hospital or institution;
(5) The hospital or other institution authorizes the individual
practitioner to administer, dispense or prescribe under the hospital
registration and designates a specific internal code number for each
individual practitioner so authorized. The code number shall consist of
numbers, letters, or a combination thereof and shall be a suffix to the
institution's DEA registration number, preceded by a hyphen (e.g.,
APO123456-10 or APO123456-A12); and
(6) A current list of internal codes and the corresponding
individual practitioners is kept by the hospital or other institution
and is made available at all times to other registrants and law
enforcement agencies upon request for the purpose of verifying the
authority of the prescribing individual practitioner.

Sec. 1301.23 Exemption of certain military and other personnel.

(a) The requirement of registration is waived for any official of
the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public
Health Service, or Bureau of Prisons who is authorized to prescribe,
dispense, or administer, but not to procure or purchase, controlled
substances in the course of his/her official duties. Such officials
shall follow procedures set forth in part 1306 of this chapter
regarding prescriptions, but shall state the branch of service or
agency (e.g., ``U.S. Army'' or ``Public Health Service'') and the
service identification number of the issuing official in lieu of the
registration number required on prescription forms. The service
identification number for a Public Health Service employee is his/her
Social Security identification number.
(b) The requirement of registration is waived for any official or
agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or
Public Health Service who or which is authorized to import or export
controlled substances in the course of his/her official duties.
(c) If any official exempted by this section also engages as a
private individual in any activity or group of activities for which
registration is required, such official shall obtain a registration for
such private activities.

Sec. 1301.24 Exemption of law enforcement officials.

(a) The requirement of registration is waived for the following
persons in the circumstances described in this section:
(1) Any officer or employee of the Administration, any officer of
the U.S. Customs Service, any officer or employee of the United States
Food and Drug Administration, and any other Federal officer who is
lawfully engaged in the enforcement of any Federal law relating to
controlled substances, drugs or customs, and is duly authorized to
possess or to import or export controlled substances in the course of
his/her official duties; and
(2) Any officer or employee of any State, or any political
subdivision or agency thereof, who is engaged in the enforcement of any
State or local law relating to controlled substances and is duly
authorized to possess controlled substances in the course of his/her
official duties.
(b) Any official exempted by this section may, when acting in the
course of his/her official duties, procure any controlled substance in
the course of an inspection, in accordance with Sec. 1316.03(d) of this
chapter, or in the course of any criminal investigation involving the
person from whom the substance was procured, and may possess any
controlled substance and distribute any such substance to any other
official who is also exempted by this section and acting in the course
of his/her official duties.
(c) In order to enable law enforcement agency laboratories,
including laboratories of the Administration, to obtain and transfer
controlled substances for use as standards in chemical analysis, such
laboratories shall obtain annually a registration to conduct chemical
analysis. Such laboratories shall be exempted from payment of a fee for
registration. Laboratory personnel, when acting in the scope of their
official duties, are deemed to be officials exempted by this section
and within the activity described in section 515(d) of the Act (21
U.S.C. 885(d)). For purposes of this paragraph, laboratory activities
shall not include field or other preliminary chemical tests by
officials exempted by this section.
(d) In addition to the activities authorized under a registration
to conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix),
laboratories of the Administration shall be authorized to manufacture
or import controlled substances for any lawful purpose, to distribute
or export such substances to any person, and to import and export such
substances in emergencies without regard to the requirements of part
1312 of this chapter if a report concerning the importation or
exportation is made to the Drug Operations Section of the
Administration within 30 days of such importation or exportation.

Sec. 1301.25 Registration regarding ocean vessels, aircraft, and other
entities.

(a) If acquired by and dispensed under the general supervision of a
medical officer described in paragraph (b) of this section, or the
master or first officer of the vessel under the circumstances described
in paragraph (d) of this section, controlled substances may be held for
stocking, be maintained in, and dispensed from medicine chests, first
aid packets, or dispensaries:
(1) On board any vessel engaged in international trade or in trade
between ports of the United States and any merchant vessel belonging to
the U.S. Government;
(2) On board any aircraft operated by an air carrier under a
certificate of permit issued pursuant to the Federal Aviation Act of
1958 (49 U.S.C. 1301); and
(3) In any other entity of fixed or transient location approved by
the Administrator as appropriate for application of this section (e.g.,
emergency kits at field sites of an industrial firm).
(b) A medical officer shall be:
(1) Licensed in a state as a physician;
(2) Employed by the owner or operator of the vessel, aircraft or
other entity; and
(3) Registered under the Act at either of the following locations:
(i) The principal office of the owner or operator of the vessel,
aircraft or other entity or
(ii) At any other location provided that the name, address,
registration number and expiration date as they appear on his/her
Certificate of Registration (DEA Form 223) for this location are
maintained for inspection at said principal office in a readily
retrievable manner.
(c) A registered medical officer may serve as medical officer for
more than one vessel, aircraft, or other entity under a single
registration, unless he/she serves as medical officer for more than one
owner or operator, in which case he/she shall either maintain a
separate registration at the location of the principal office of each
such owner or operator or utilize one or more registrations pursuant to
paragraph (b)(3)(ii) of this section.
(d) If no medical officer is employed by the owner or operator of a
vessel, or in the event such medical officer is not accessible and the
acquisition of controlled substances is required, the master or first
officer of the vessel, who shall not be registered under the Act, may
purchase controlled substances

[[Page 13952]]

from a registered manufacturer or distributor, or from an authorized
pharmacy as described in paragraph (f) of this section, by following
the procedure outlined below:
(1) The master or first officer of the vessel must personally
appear at the vendor's place of business, present proper identification
(e.g., Seaman's photographic identification card) and a written
requisition for the controlled substances.
(2) The written requisition must be on the vessel's official
stationery or purchase order form and must include the name and address
of the vendor, the name of the controlled substance, description of the
controlled substance (dosage form, strength and number or volume per
container) number of containers ordered, the name of the vessel, the
vessel's official number and country of registry, the owner or operator
of the vessel, the port at which the vessel is located, signature of
the vessel's officer who is ordering the controlled substances and the
date of the requisition.
(3) The vendor may, after verifying the identification of the
vessel's officer requisitioning the controlled substances, deliver the
control substances to that officer. The transaction shall be
documented, in triplicate, on a record of sale in a format similar to
that outlined in paragraph (d)(4) of this section. The vessel's
requisition shall be attached to copy 1 of the record of sale and filed
with the controlled substances records of the vendor, copy 2 of the
record of sale shall be furnished to the officer of the vessel and
retained aboard the vessel, copy 3 of the record of sale shall be
forwarded to the nearest DEA Division Office within 15 days after the
end of the month in which the sale is made.
(4) The vendor's record of sale should be similar to, and must
include all the information contained in, the below listed format.

Sale of Controlled Substances to Vessels

(Name of registrant)---------------------------------------------------

(Address of registrant)------------------------------------------------

(DEA registration number)----------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Packages
Line No. packages ordered Size of packages Name of product distributed Date distributed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........................................................ ................. ................. ................. ................. .................
2........................................................ ................. ................. ................. ................. .................
3........................................................ ................. ................. ................. ................. .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnote: Line numbers may be continued according to needs of the vendor.

Number of lines completed----------------------------------------------
Name of vessel---------------------------------------------------------
Vessel's official number-----------------------------------------------
Vessel's country of registry-------------------------------------------
Owner or operator of the vessel----------------------------------------

Name and title of vessel's officer who presented the requisition
________
Signature of vessel's officer who presented the requisition ________

(e) Any medical officer described in paragraph (b) of this section
shall, in addition to complying with all requirements and duties
prescribed for registrants generally, prepare an annual report as of
the date on which his/her registration expires, which shall give in
detail an accounting for each vessel, aircraft, or other entity, and a
summary accounting for all vessels, aircraft, or other entities under
his/her supervision for all controlled substances purchased, dispensed
or disposed of during the year. The medical officer shall maintain this
report with other records required to be kept under the Act and, upon
request, deliver a copy of the report to the Administration. The
medical officer need not be present when controlled substances are
dispensed, if the person who actually dispensed the controlled
substances is responsible to the medical officer to justify his/her
actions.
(f) Any registered pharmacy that wishes to distribute controlled
substances pursuant to this section shall be authorized to do so,
provided:
(1) The registered pharmacy notifies the nearest Division Office of
the Administration of its intention to so distribute controlled
substances prior to the initiation of such activity. This notification
shall be by registered mail and shall contain the name, address, and
registration number of the pharmacy as well as the date upon which such
activity will commence; and
(2) Such activity is authorized by state law; and
(3) The total number of dosage units of all controlled substances
distributed by the pharmacy during any calendar year in which the
pharmacy is registered to dispense does not exceed the limitations
imposed upon such distribution by Sec. 1307.11(a)(4) and (b) of this
chapter.
(g) Owners or operators of vessels, aircraft, or other entities
described in this section shall not be deemed to possess or dispense
any controlled substance acquired, stored and dispensed in accordance
with this section. Additionally, owners or operators of vessels,
aircraft, or other entities described in this section or in Article 32
of the Single Convention on Narcotic Drugs, 1961, or in Article 14 of
the Convention on Psychotropic Substances, 1971, shall not be deemed to
import or export any controlled substances purchased and stored in
accordance with that section or applicable article.
(h) The Master of a vessel shall prepare a report for each calendar
year which shall give in detail an accounting for all controlled
substances purchased, dispensed, or disposed of during the year. The
Master shall file this report with the medical officer employed by the
owner or operator of his/her vessel, if any, or, if not, he/she shall
maintain this report with other records required to be kept under the
Act and, upon request, deliver a copy of the report to the
Administration.
(i) Controlled substances acquired and possessed in accordance with
this section shall not be distributed to persons not under the general
supervision of the medical officer employed by the owner or operator of
the vessel, aircraft, or other entity, except in accordance with
Sec. 1307.21 of this chapter.

Sec. 1301.26 Exemptions from import or export requirements for
personal medical use.

Any individual who has in his/her possession a controlled substance
listed in schedules II, III, IV, or V, which he/she has lawfully
obtained for his/her personal medical use, or for administration to an
animal accompanying him/her, may enter or depart the United States with
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C.
952-955), providing the following conditions are met:
(a) The controlled substance is in the original container in which
it was dispensed to the individual; and
(b) The individual makes a declaration to an appropriate official
of the U.S. Customs Service stating:
(1) That the controlled substance is possessed for his/her personal
use, or for an animal accompanying him/her; and

[[Page 13953]]

(2) The trade or chemical name and the symbol designating the
schedule of the controlled substance if it appears on the container
label, or, if such name does not appear on the label, the name and
address of the pharmacy or practitioner who dispensed the substance and
the prescription number, if any; and
(c) The importation of the controlled substance for personal
medical use is authorized or permitted under other Federal laws and
state law.

Action on Application for Registration: Revocation or Suspension of
Registration

Sec. 1301.31 Administrative review generally.

The Administrator may inspect, or cause to be inspected, the
establishment of an applicant or registrant, pursuant to subpart A of
part 1316 of this chapter. The Administrator shall review the
application for registration and other information gathered by the
Administrator regarding an applicant in order to determine whether the
applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21
U.S.C. 958) of the Act have been met by the applicant.

Sec. 1301.32 Action on applications for research in Schedule I
substances.

(a) In the case of an application for registration to conduct
research with controlled substances listed in Schedule I, the
Administrator shall process the application and protocol and forward a
copy of each to the Secretary of Health and Human Services (Secretary)
within 7 days after receipt. The Secretary shall determine the
qualifications and competency of the applicant, as well as the merits
of the protocol (and shall notify the Administrator of his/her
determination) within 21 days after receipt of the application and
complete protocol, except that in the case of a clinical investigation,
the Secretary shall have 30 days to make such determination and notify
the Administrator. The Secretary, in determining the merits of the
protocol, shall consult with the Administrator as to effective
procedures to safeguard adequately against diversion of such controlled
substances from legitimate medical or scientific use.
(b) An applicant whose protocol is defective shall be notified by
the Secretary within 21 days after receipt of such protocol from the
Administrator (or in the case of a clinical investigation within 30
days), and he/she shall be requested to correct the existing defects
before consideration shall be given to his/her submission.
(c) If the Secretary determines the applicant qualified and
competent and the research protocol meritorious, he/she shall notify
the Administrator in writing of such determination. The Administrator
shall issue a certificate of registration within 10 days after receipt
of this notice, unless he/she determines that the certificate of
registration should be denied on a ground specified in section 304(a)
of the Act (21 U.S.C. 824(a)). In the case of a supplemental protocol,
a replacement certificate of registration shall be issued by the
Administrator.
(d) If the Secretary determines that the protocol is not
meritorious and/or the applicant is not qualified or competent, he/she
shall notify the Administrator in writing setting forth the reasons for
such determination. If the Administrator determines that grounds exist
for the denial of the application, he/she shall within 10 days issue an
order to show cause pursuant to Sec. 1301.37 and, if requested by the
applicant, hold a hearing on the application pursuant to Section
1301.41. If the grounds for denial of the application include a
determination by the Secretary, the Secretary or his duly authorized
agent shall furnish testimony and documents pertaining to his
determination at such hearing.
(e) Supplemental protocols will be processed in the same manner as
original research protocols. If the processing of an application or
research protocol is delayed beyond the time limits imposed by this
section, the applicant shall be so notified in writing.

Sec. 1301.33 Application for bulk manufacture of Schedule I and II
substances.

(a) In the case of an application for registration or
reregistration to manufacture in bulk a basic class of controlled
substance listed in Schedule I or II, the Administrator shall, upon the
filing of such application, publish in the Federal Register a notice
naming the applicant and stating that such applicant has applied to be
registered as a bulk manufacturer of a basic class of narcotic or
nonnarcotic controlled substance, which class shall be identified. A
copy of said notice shall be mailed simultaneously to each person
registered as a bulk manufacturer of that basic class and to any other
applicant therefor. Any such person may, within 60 days from the date
of publication of the notice in the Federal Register, file with the
Administrator written comments on or objections to the issuance of the
proposed registration.
(b) In order to provide adequate competition, the Administrator
shall not be required to limit the number of manufacturers in any basic
class to a number less than that consistent with maintenance of
effective controls against diversion solely because a smaller number is
capable of producing an adequate and uninterrupted supply.
(c) This section shall not apply to the manufacture of basic
classes of controlled substances listed in Schedules I or II as an
incident to research or chemical analysis as authorized in
Sec. 1301.13(e)(1).

Sec. 1301.34 Application for importation of Schedule I and II
substances.

(a) In the case of an application for registration or
reregistration to import a controlled substance listed in Schedule I or
II, under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C.
952(a)(2)(B)), the Administrator shall, upon the filing of such
application, publish in the Federal Register a notice naming the
applicant and stating that such applicant has applied to be registered
as an importer of a Schedule I or II controlled substance, which
substance shall be identified. A copy of said notice shall be mailed
simultaneously to each person registered as a bulk manufacturer of that
controlled substance and to any other applicant therefor. Any such
person may, within 30 days from the date of publication of the notice
in the Federal Register, file written comments on or objections to the
issuance of the proposed registration, and may, at the same time, file
a written request for a hearing on the application pursuant to
Sec. 1301.43. If a hearing is requested, the Administrator shall hold a
hearing on the application in accordance with Sec. 1301.41. Notice of
the hearing shall be published in the Federal Register, and shall be
mailed simultaneously to the applicant and to all persons to whom
notice of the application was mailed. Any such person may participate
in the hearing by filing a notice of appearance in accordance with
Sec. 1301.43 of this chapter. Notice of the hearing shall contain a
summary of all comments and objections filed regarding the application
and shall state the time and place for the hearing, which shall not be
less than 30 days after the date of publication of such notice in the
Federal Register. A hearing pursuant to this section may be
consolidated with a hearing held pursuant to Sec. 1301.35 or
Sec. 1301.36 of this part.
(b) The Administrator shall register an applicant to import a
controlled substance listed in Schedule I or II if he/she determines
that such registration is consistent with the public interest and with
U.S. obligations under international treaties, conventions, or

[[Page 13954]]

protocols in effect on May 1, 1971. In determining the public interest,
the following factors shall be considered:
(1) Maintenance of effective controls against diversion of
particular controlled substances and any controlled substance in
Schedule I or II compounded therefrom into other than legitimate
medical, scientific research, or industrial channels, by limiting the
importation and bulk manufacture of such controlled substances to a
number of establishments which can produce an adequate and
uninterrupted supply of these substances under adequately competitive
conditions for legitimate medical, scientific, research, and industrial
purposes;
(2) Compliance with applicable State and local law;
(3) Promotion of technical advances in the art of manufacturing
these substances and the development of new substances;
(4) Prior conviction record of applicant under Federal and State
laws relating to the manufacture, distribution, or dispensing of such
substances;
(5) Past experience in the manufacture of controlled substances,
and the existence in the establishment of effective control against
diversion;
(6) That the applicant will be permitted to import only:
(i) Such amounts of crude opium, poppy straw, concentrate of poppy
straw, and coca leaves as the Administrator finds to be necessary to
provide for medical, scientific, or other legitimate purposes; or
(ii) Such amounts of any controlled substances listed in Schedule I
or II as the Administrator shall find to be necessary to provide for
the medical, scientific, or other legitimate needs of the United States
during an emergency in which domestic supplies of such substances are
found by the Administrator to be inadequate; or
(iii) Such amounts of any controlled substance listed in Schedule I
or II as the Administrator shall find to be necessary to provide for
the medical, scientific, or other legitimate needs of the United States
in any case in which the Administrator finds that competition among
domestic manufacturers of the controlled substance is inadequate and
will not be rendered adequate by the registration of additional
manufacturers under section 303 of the Act (21 U.S.C. 823); or
(iv) Such limited quantities of any controlled substance listed in
Schedule I or II as the Administrator shall find to be necessary for
scientific, analytical or research uses; and
(7) Such other factors as may be relevant to and consistent with
the public health and safety.
(c) In determining whether the applicant can and will maintain
effective controls against diversion within the meaning of paragraph
(b) of this section, the Administrator shall consider among other
factors:
(1) Compliance with the security requirements set forth in
Secs. 1301.71-1301.76; and
(2) Employment of security procedures to guard against in-transit
losses within and without the jurisdiction of the United States.
(d) In determining whether competition among the domestic
manufacturers of a controlled substance is adequate within the meaning
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as
section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the
Administrator shall consider:
(1) The extent of price rigidity in the light of changes in:
(i) raw materials and other costs and
(ii) conditions of supply and demand;
(2) The extent of service and quality competition among the
domestic manufacturers for shares of the domestic market including:
(i) Shifts in market shares and
(ii) Shifts in individual customers among domestic manufacturers;
(3) The existence of substantial differentials between domestic
prices and the higher of prices generally prevailing in foreign markets
or the prices at which the applicant for registration to import is
committed to undertake to provide such products in the domestic market
in conformity with the Act. In determining the existence of substantial
differentials hereunder, appropriate consideration should be given to
any additional costs imposed on domestic manufacturers by the
requirements of the Act and such other cost-related and other factors
as the Administrator may deem relevant. In no event shall an importer's
offering prices in the United States be considered if they are lower
than those prevailing in the foreign market or markets from which the
importer is obtaining his/her supply;
(4) The existence of competitive restraints imposed upon domestic
manufacturers by governmental regulations; and
(5) Such other factors as may be relevant to the determinations
required under this paragraph.
(e) In considering the scope of the domestic market, consideration
shall be given to substitute products which are reasonably
interchangeable in terms of price, quality and use.
(f) The fact that the number of existing manufacturers is small
shall not demonstrate, in and of itself, that adequate competition
among them does not exist.

Sec. 1301.35 Certificate of registration; denial of registration.

(a) The Administrator shall issue a Certificate of Registration
(DEA Form 223) to an applicant if the issuance of registration or
reregistration is required under the applicable provisions of sections
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the
issuance of registration or reregistration is not required, the
Administrator shall deny the application. Before denying any
application, the Administrator shall issue an order to show cause
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold
a hearing on the application pursuant to Sec. 1301.41.
(b) If in response to a show cause order a hearing is requested by
an applicant for registration or reregistration to manufacture in bulk
a basic class of controlled substance listed in Schedule I or II,
notice that a hearing has been requested shall be published in the
Federal Register and shall be mailed simultaneously to the applicant
and to all persons to whom notice of the application was mailed. Any
person entitled to file comments or objections to the issuance of the
proposed registration pursuant to Sec. 1301.33(a) may participate in
the hearing by filing notice of appearance in accordance with
Sec. 1301.43. Such persons shall have 30 days to file a notice of
appearance after the date of publication of the notice of a request for
a hearing in the Federal Register.
(c) The Certificate of Registration (DEA Form 223) shall contain
the name, address, and registration number of the registrant, the
activity authorized by the registration, the schedules and/or
Administration Controlled Substances Code Number (as set forth in part
1308 of this chapter) of the controlled substances which the registrant
is authorized to handle, the amount of fee paid (or exemption), and the
expiration date of the registration. The registrant shall maintain the
certificate of registration at the registered location in a readily
retrievable manner and shall permit inspection of the certificate by
any official, agent or employee of the Administration or of any
Federal, State, or local agency engaged in enforcement of laws relating
to controlled substances.

[[Page 13955]]

Sec. 1301.36 Suspension or revocation of registration; suspension of
registration pending final order; extension of registration pending
final order.

(a) For any registration issued under section 303 of the Act (21
U.S.C. 823), the Administrator may:
(1) Suspend the registration pursuant to section 304(a) of the Act
(21 U.S.C. 824(a)) for any period of time.
(2) Revoke the registration pursuant to section 304(a) of the Act
(21 U.S.C. 824(a)).
(b) For any registration issued under section 1008 of the Act (21
U.S.C. 958), the Administrator may:
(1) Suspend the registration pursuant to section 1008(d) of the Act
(21 U.S.C. 958(d)) for any period of time.
(2) Revoke the registration pursuant to section 1008(d) of the Act
(21 U.S.C. 958(d)) if he/she determines that such registration is
inconsistent with the public interest as defined in section 1008 or
with the United States obligations under international treaties,
conventions, or protocols in effect on October 12, 1984.
(c) The Administrator may limit the revocation or suspension of a
registration to the particular controlled substance, or substances,
with respect to which grounds for revocation or suspension exist.
(d) Before revoking or suspending any registration, the
Administrator shall issue an order to show cause pursuant to
Sec. 1301.37 and, if requested by the registrant, shall hold a hearing
pursuant to Sec. 1301.41.
(e) The Administrator may suspend any registration simultaneously
with or at any time subsequent to the service upon the registrant of an
order to show cause why such registration should not be revoked or
suspended, in any case where he/she finds that there is an imminent
danger to the public health or safety. If the Administrator so
suspends, he/she shall serve with the order to show cause pursuant to
Sec. 1301.37 an order of immediate suspension which shall contain a
statement of his findings regarding the danger to public health or
safety.
(f) Upon service of the order of the Administrator suspending or
revoking registration, the registrant shall immediately deliver his/her
Certificate of Registration, any order forms, and any import or export
permits in his/her possession to the nearest office of the
Administration. The suspension or revocation of a registration shall
suspend or revoke any individual manufacturing or procurement quota
fixed for the registrant pursuant to part 1303 of this chapter and any
import or export permits issued to the registrant pursuant to part 1312
of this chapter. Also, upon service of the order of the Administrator
revoking or suspending registration, the registrant shall, as
instructed by the Administrator:
(1) Deliver all controlled substances in his/her possession to the
nearest office of the Administration or to authorized agents of the
Administration; or
(2) Place all controlled substances in his/her possession under
seal as described in sections 304(f) or 1008(d)(6) of the Act (21
U.S.C. 824(f) or 958(d)(6)).
(g) In the event that revocation or suspension is limited to a
particular controlled substance or substances, the registrant shall be
given a new Certificate of Registration for all substances not affected
by such revocation or suspension; no fee shall be required to be paid
for the new Certificate of Registration. The registrant shall deliver
the old Certificate of Registration and, if appropriate, any order
forms in his/her possession to the nearest office of the
Administration. The suspension or revocation of a registration, when
limited to a particular basic class or classes of controlled
substances, shall suspend or revoke any individual manufacturing or
procurement quota fixed for the registrant for such class or classes
pursuant to part 1303 of this chapter and any import or export permits
issued to the registrant for such class or classes pursuant to part
1312 of this chapter. Also, upon service of the order of the
Administrator revoking or suspending registration, the registrant
shall, as instructed by the Administrator:
(1) Deliver to the nearest office of the Administration or to
authorized agents of the Administration all of the particular
controlled substance or substances affected by the revocation or
suspension which are in his/her possession; or
(2) Place all of such substances under seal as described in
sections 304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or
958(d)(6)).
(h) Any suspension shall continue in effect until the conclusion of
all proceedings upon the revocation or suspension, including any
judicial review thereof, unless sooner withdrawn by the Administrator
or dissolved by a court of competent jurisdiction. Any registrant whose
registration is suspended under paragraph (e) of this section may
request a hearing on the revocation or suspension of his/her
registration at a time earlier than specified in the order to show
cause pursuant to Sec. 1301.37. This request shall be granted by the
Administrator, who shall fix a date for such hearing as early as
reasonably possible.
(i) In the event that an applicant for reregistration (who is doing
business under a registration previously granted and not revoked or
suspended) has applied for reregistration at least 45 days before the
date on which the existing registration is due to expire, and the
Administrator has issued no order on the application on the date on
which the existing registration is due to expire, the existing
registration of the applicant shall automatically be extended and
continue in effect until the date on which the Administrator so issues
his/her order. The Administrator may extend any other existing
registration under the circumstances contemplated in this section even
though the registrant failed to apply for reregistration at least 45
days before expiration of the existing registration, with or without
request by the registrant, if the Administrator finds that such
extension is not inconsistent with the public health and safety.

Sec. 1301.37 Order to show cause.

(a) If, upon examination of the application for registration from
any applicant and other information gathered by the Administration
regarding the applicant, the Administrator is unable to make the
determinations required by the applicable provisions of section 303
and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the
applicant, the Administrator shall serve upon the applicant an order to
show cause why the registration should not be denied.
(b) If, upon information gathered by the Administration regarding
any registrant, the Administrator determines that the registration of
such registrant is subject to suspension or revocation pursuant to
section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the
Administrator shall serve upon the registrant an order to show cause
why the registration should not be revoked or suspended.
(c) The order to show cause shall call upon the applicant or
registrant to appear before the Administrator at a time and place
stated in the order, which shall not be less than 30 days after the
date of receipt of the order. The order to show cause shall also
contain a statement of the legal basis for such hearing and for the
denial, revocation, or suspension of registration and a summary of the
matters of fact and law asserted.
(d) Upon receipt of an order to show cause, the applicant or
registrant must,

[[Page 13956]]

if he/she desires a hearing, file a request for a hearing pursuant to
Sec. 1301.43. If a hearing is requested, the Administrator shall hold a
hearing at the time and place stated in the order, pursuant to
Sec. 1301.41.
(e) When authorized by the Administrator, any agent of the
Administration may serve the order to show cause.

Hearings

Sec. 1301.41 Hearings generally.

(a) In any case where the Administrator shall hold a hearing on any
registration or application therefor, the procedures for such hearing
shall be governed generally by the adjudication procedures set forth in
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by
sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by
Secs. 1301.42-1301.46 of this part, and by the procedures for
administrative hearings under the Act set forth in Secs. 1316.41-
1316.67 of this chapter.
(b) Any hearing under this part shall be independent of, and not in
lieu of, criminal prosecutions or other proceedings under the Act or
any other law of the United States.

Sec. 1301.42 Purpose of hearing.

If requested by a person entitled to a hearing, the Administrator
shall hold a hearing for the purpose of receiving factual evidence
regarding the issues involved in the denial, revocation, or suspension
of any registration, and the granting of any application for
registration to import or to manufacture in bulk a basic class of
controlled substance listed in Schedule I or II. Extensive argument
should not be offered into evidence but rather presented in opening or
closing statements of counsel or in memoranda or proposed findings of
fact and conclusions of law.

Sec. 1301.43 Request for hearing or appearance; waiver.

(a) Any person entitled to a hearing pursuant to Sec. 1301.32 or
Secs. 1301.34-1301.36 and desiring a hearing shall, within 30 days
after the date of receipt of the order to show cause (or the date of
publication of notice of the application for registration in the
Federal Register in the case of Sec. 1301.34), file with the
Administrator a written request for a hearing in the form prescribed in
Sec. 1316.47 of this chapter.
(b) Any person entitled to participate in a hearing pursuant to
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30
days of the date of publication of notice of the request for a hearing
in the Federal Register, file with the Administrator a written notice
of intent to participate in such hearing in the form prescribed in
Sec. 1316.48 of this chapter. Any person filing a request for a hearing
need not also file a notice of appearance.
(c) Any person entitled to a hearing or to participate in a hearing
pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 may, within the
period permitted for filing a request for a hearing or a notice of
appearance, file with the Administrator a waiver of an opportunity for
a hearing or to participate in a hearing, together with a written
statement regarding such person's position on the matters of fact and
law involved in such hearing. Such statement, if admissible, shall be
made a part of the record and shall be considered in light of the lack
of opportunity for cross-examination in determining the weight to be
attached to matters of fact asserted therein.
(d) If any person entitled to a hearing or to participate in a
hearing pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 fails to file
a request for a hearing or a notice of appearance, or if such person so
files and fails to appear at the hearing, such person shall be deemed
to have waived the opportunity for a hearing or to participate in the
hearing, unless such person shows good cause for such failure.
(e) If all persons entitled to a hearing or to participate in a
hearing waive or are deemed to waive their opportunity for the hearing
or to participate in the hearing, the Administrator may cancel the
hearing, if scheduled, and issue his/her final order pursuant to
Sec. 1301.46 without a hearing.

Sec. 1301.44 Burden of proof.

(a) At any hearing on an application to manufacture any controlled
substance listed in Schedule I or II, the applicant shall have the
burden of proving that the requirements for such registration pursuant
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any
other person participating in the hearing pursuant to Sec. 1301.35(b)
shall have the burden of proving any propositions of fact or law
asserted by such person in the hearing.
(b) At any hearing on the granting or denial of an applicant to be
registered to conduct a narcotic treatment program or as a compounder,
the applicant shall have the burden of proving that the requirements
for each registration pursuant to section 303(g) of the Act (21 U.S.C.
823(g)) are satisfied.
(c) At any hearing on the granting or denial of an application to
be registered to import or export any controlled substance listed in
Schedule I or II, the applicant shall have the burden of proving that
the requirements for such registration pursuant to sections 1008(a) and
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other
person participating in the hearing pursuant to Sec. 1301.34 shall have
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
(d) At any other hearing for the denial of a registration, the
Administration shall have the burden of proving that the requirements
for such registration pursuant to section 303 or section 1008(c) and
(d) of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
(e) At any hearing for the revocation or suspension of a
registration, the Administration shall have the burden of proving that
the requirements for such revocation or suspension pursuant to section
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are
satisfied.

Sec. 1301.45 Time and place of hearing.

The hearing will commence at the place and time designated in the
order to show cause or notice of hearing published in the Federal
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter
it may be moved to a different place and may be continued from day to
day or recessed to a later day without notice other than announcement
thereof by the presiding officer at the hearing.

Sec. 1301.46 Final order.

As soon as practicable after the presiding officer has certified
the record to the Administrator, the Administrator shall issue his/her
order on the granting, denial, revocation, or suspension of
registration. In the event that an application for registration to
import or to manufacture in bulk a basic class of any controlled
substance listed in Schedule I or II is granted, or any application for
registration is denied, or any registration is revoked or suspended,
the order shall include the findings of fact and conclusions of law
upon which the order is based. The order shall specify the date on
which it shall take effect. The Administrator shall serve one copy of
his/her order upon each party in the hearing.

Modification, Transfer and Termination of Registration

Sec. 1301.51 Modification in registration.

Any registrant may apply to modify his/her registration to
authorize the handling of additional controlled substances or to change
his/her name or address, by submitting a letter of request to the
Registration Unit, Drug Enforcement Administration,

[[Page 13957]]

Department of Justice, Post Office Box 28083, Central Station,
Washington, DC 20005. The letter shall contain the registrant's name,
address, and registration number as printed on the certificate of
registration, and the substances and/or schedules to be added to his/
her registration or the new name or address and shall be signed in
accordance with Sec. 1301.13(j). If the registrant is seeking to handle
additional controlled substances listed in Schedule I for the purpose
of research or instructional activities, he/she shall attach three
copies of a research protocol describing each research project
involving the additional substances, or two copies of a statement
describing the nature, extent, and duration of such instructional
activities, as appropriate. No fee shall be required to be paid for the
modification. The request for modification shall be handled in the same
manner as an application for registration. If the modification in
registration is approved, the Administrator shall issue a new
certificate of registration (DEA Form 223) to the registrant, who shall
maintain it with the old certificate of registration until expiration.

Sec. 1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.

(a) Except as provided in paragraph (b) of this section, the
registration of any person shall terminate if and when such person
dies, ceases legal existence, or discontinues business or professional
practice. Any registrant who ceases legal existence or discontinues
business or professional practice shall notify the Administrator
promptly of such fact.
(b) No registration or any authority conferred thereby shall be
assigned or otherwise transferred except upon such conditions as the
Administration may specifically designate and then only pursuant to
written consent. Any person seeking authority to transfer a
registration shall submit a written request, providing full details
regarding the proposed transfer of registration, to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537.
(c) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substances (without
transferring such business activities to another person) shall return
for cancellation his/her certificate of registration, and any
unexecuted order forms in his/her possession, to the Registration Unit,
Drug Enforcement Administration, Department of Justice, Post Office Box
28083, Central Station, Washington, DC 20005. Any controlled substances
in his/her possession may be disposed of in accordance with
Sec. 1307.21 of this chapter.
(d) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substance (by transferring
such business activities to another person) shall submit in person or
by registered or certified mail, return receipt requested, to the
Special Agent in Charge in his/her area, at least 14 days in advance of
the date of the proposed transfer (unless the Special Agent in Charge
waives this time limitation in individual instances), the following
information:
(1) The name, address, registration number, and authorized business
activity of the registrant discontinuing the business (registrant-
transferor);
(2) The name, address, registration number, and authorized business
activity of the person acquiring the business (registrant-transferee);
(3) Whether the business activities will be continued at the
location registered by the person discontinuing business, or moved to
another location (if the latter, the address of the new location should
be listed);
(4) Whether the registrant-transferor has a quota to manufacture or
procure any controlled substance listed in Schedule I or II (if so, the
basic class or class of the substance should be indicated); and
(5) The date on which the transfer of controlled substances will
occur.
(e) Unless the registrant-transferor is informed by the Special
Agent in Charge, before the date on which the transfer was stated to
occur, that the transfer may not occur, the registrant-transferor may
distribute (without being registered to distribute) controlled
substances in his/her possession to the registrant-transferee in
accordance with the following:
(1) On the date of transfer of the controlled substances, a
complete inventory of all controlled substances being transferred shall
be taken in accordance with Sec. 1304.11 of this chapter. This
inventory shall serve as the final inventory of the registrant-
transferor and the initial inventory of the registrant-transferee, and
a copy of the inventory shall be included in the records of each
person. It shall not be necessary to file a copy of the inventory with
the Administration unless requested by the Special Agent in Charge.
Transfers of any substances listed in Schedule I or II shall require
the use of order forms in accordance with part 1305 of this chapter.
(2) On the date of transfer of the controlled substances, all
records required to be kept by the registrant-transferor with reference
to the controlled substances being transferred, under part 1304 of this
chapter, shall be transferred to the registrant-transferee.
Responsibility for the accuracy of records prior to the date of
transfer remains with the transferor, but responsibility for custody
and maintenance shall be upon the transferee.
(3) In the case of registrants required to make reports pursuant to
part 1304 of this chapter, a report marked ``Final'' will be prepared
and submitted by the registrant-transferor showing the disposition of
all the controlled substances for which a report is required; no
additional report will be required from him, if no further transactions
involving controlled substances are consummated by him. The initial
report of the registrant-transferee shall account for transactions
beginning with the day next succeeding the date of discontinuance or
transfer of business by the transferor-registrant and the substances
transferred to him shall be reported as receipts in his/her initial
report.
5. Section 1301.75 is amended by revising paragraph (b) to read as
follows:

Sec. 1301.75 Physical security controls for practitioners.

* * * * *
(b) Controlled substances listed in Schedules II, III, IV, and V
shall be stored in a securely locked, substantially constructed
cabinet. However, pharmacies and institutional practitioners may
disperse such substances throughout the stock of noncontrolled
substances in such a manner as to obstruct the theft or diversion of
the controlled substances.
* * * * *
6. Section 1301.76 is amended by revising paragraph (c) to read as
follows:

Sec. 1301.76 Other security controls for practitioners.

* * * * *
(c) Whenever the registrant distributes a controlled substance
(without being registered as a distributor, as permitted in
Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply
with the requirements imposed on nonpractitioners in Sec. 1301.74(a),
(b), and (e).

Sec. 1301.72 [Amended]

7. In 21 CFR 1301.72(b)(4)(i)(b) remove the word ``lay'' and add,
in its place, the word ``lag'.

[[Page 13958]]

PART 1302--[AMENDED]

1. The authority citation for part 1302 continues to read as
follows:

Authority: 21 U.S.C. 821, 825, 871(b), 958 (e).

2. Section 1302.02 is revised to read as follows:

Sec. 1302.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
3. Section 1302.04 is revised to read as follows:

Sec. 1302.04 Location and size of symbol on label and labeling.

The symbol shall be prominently located on the label or the
labeling of the commercial container and/or the panel of the commercial
container normally displayed to dispensers of any controlled substance.
The symbol on labels shall be clear and large enough to afford easy
identification of the schedule of the controlled substance upon
inspection without removal from the dispenser's shelf. The symbol on
all other labeling shall be clear and large enough to afford prompt
identification of the controlled substance upon inspection of the
labeling.

Sec. 1302.05 [Removed]

4. Section 1302.05 is removed.
5. Section 1302.06 is redesignated as Sec. 1302.05 and revised to
read as follows:

Sec. 1302.05 Effective dates of labeling requirements.

All labels on commercial containers of, and all labeling of, a
controlled substance which either is transferred to another schedule or
is added to any schedule shall comply with the requirements of
Sec. 1302.03, on or before the effective date established in the final
order for the transfer or addition.
6. Section 1302.07 is redesignated as Sec. 1302.06 and revised to
read as follows:

Sec. 1302.06 Sealing of controlled substances.

On each bottle, multiple dose vial, or other commercial container
of any controlled substance, there shall be securely affixed to the
stopper, cap, lid, covering, or wrapper or such container a seal to
disclose upon inspection any tampering or opening of the container.
7. Section 1302.08 is redesignated as Sec. 1302.07 and revised to
read as follows:

Sec. 1302.07 Labeling and packaging requirements for imported and
exported substances.

(a) The symbol requirements of Secs. 1302.03-1302.05 apply to every
commercial container containing, and to all labeling of, controlled
substances imported into the jurisdiction of and/or the customs
territory of the United States.
(b) The symbol requirements of Secs. 1302.03-1302.05 do not apply
to any commercial containers containing, or any labeling of, a
controlled substance intended for export from the jurisdiction of the
United States.
(c) The sealing requirements of Sec. 1302.06 apply to every bottle,
multiple dose vial, or other commercial container of any controlled
substance listed in schedule I or II, or any narcotic controlled
substance listed in schedule III or IV, imported into, exported from,
or intended for export from, the jurisdiction of and/or the customs
territory of the United States.

PART 1303--[AMENDED]

1. The authority citation for part 1303 continues to read as
follows:

Authority: 21 U.S.C. 821, 826, 871(b).

2. Section 1303.02 is revised to read as follows:

Sec. 1303.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
3. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

----------------------------------------------------------------------------------------------------------------
Section Remove Add
----------------------------------------------------------------------------------------------------------------
1303.12(b)............................ (or BND) each place it appears.....
1303.12(b)............................ Drug Control Section............... Drug & Chemical Evaluation Section.
1303.12(d)............................ Drug Control Section............... Drug & Chemical Evaluation Section.
1303.12(e)(1)......................... subsance........................... substance.
1303.12(e)(3)......................... 1301.22(b)......................... 1301.13.
1303.21(a)............................ 1301.45 and 1301.46................ 1301.36.
1303.22, introductory text............ (or BND) each place it appears.....
1303.22, introductory text............ Drug Control Section............... Drug & Chemical Evaluation Section.
1303.26............................... 1301.45 or 1301.46................. 1301.36.
1303.27............................... Drug Control Section............... Drug & Chemical Evaluation Section.
1303.32(b)............................ 1301.45 or 1301.46................. 1301.36.
1303.35(a)............................ aggregrate......................... aggregate.
----------------------------------------------------------------------------------------------------------------

PART 1304--[AMENDED]

1. The authority citation for part 1304 is revised to read as
follows:

Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless
otherwise noted.

2. Section 1304.02 is revised to read as follows:

Sec. 1304.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
3. Section 1304.03 is amended by removing paragraphs (g) and (h),
and revising paragraph (f) to read as follows:

Sec. 1304.03 Persons required to keep records and file reports.

* * * * *
(f) Registered persons using any controlled substances while
conducting preclinical research, in teaching at a registered
establishment which maintains records with respect to such substances
or conducting research in conformity with an exemption granted under
section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(i) or 360b(j)) at a registered establishment which
maintains records in accordance with either of those sections, are not
required to keep records if he/she notifies the Administration of the
name, address, and registration number of the establishment maintaining
such records. This notification shall be given at the time the person
applies for registration or reregistration and shall be made in the
form of an attachment to the application, which shall be filed with the
application.
4. Section 1304.04 is amended by removing ``excuted'' in paragraph
(a),

[[Page 13959]]

introductory text, and by adding ``executed'' in its place and by
revising paragraphs (e) and (h) to read as follows:

Sec. 1304.04 Maintenance of records and inventories.

* * * * *
(e) All central recordkeeping permits previously issued by the
Administration expired September 30, 1980.
* * * * *
(h) Each registered pharmacy shall maintain the inventories and
records of controlled substances as follows:
(1) Inventories and records of all controlled substances listed in
Schedules I and II shall be maintained separately from all other
records of the pharmacy, and prescriptions for such substances shall be
maintained in a separate prescription file; and
(2) Inventories and records of controlled substances listed in
Schedules III, IV, and V shall be maintained either separately from all
other records of the pharmacy or in such form that the information
required is readily retrievable from ordinary business records of the
pharmacy, and prescriptions for such substances shall be maintained
either in a separate prescription file for controlled substances listed
in Schedules III, IV, and V only or in such form that they are readily
retrievable from the other prescription records of the pharmacy.
Prescriptions will be deemed readily retrievable if, at the time they
are initially filed, the face of the prescription is stamped in red ink
in the lower right corner with the letter ``C'' no less than 1 inch
high and filed either in the prescription file for controlled
substances listed in Schedules I and II or in the usual consecutively
numbered prescription file for non-controlled substances. However, if a
pharmacy employs an ADP system or other electronic recordkeeping system
for prescriptions which permits identification by prescription number
and retrieval of original documents by prescriber's name, patient's
name, drug dispensed, and date filled, then the requirement to mark the
hard copy prescription with a red ``C'' is waived.
5. Section 1304.11 is revised to read as follows:

Sec. 1304.11 Inventory requirements.

(a) General requirements. Each inventory shall contain a complete
and accurate record of all controlled substances on hand on the date
the inventory is taken, and shall be maintained in written,
typewritten, or printed form at the registered location. An inventory
taken by use of an oral recording device must be promptly transcribed.
Controlled substances shall be deemed to be ``on hand'' if they are in
the possession of or under the control of the registrant, including
substances returned by a customer, ordered by a customer but not yet
invoiced, stored in a warehouse on behalf of the registrant, and
substances in the possession of employees of the registrant and
intended for distribution as complimentary samples. A separate
inventory shall be made for each registered location and each
independent activity registered, except as provided in paragraph (e)(4)
of this section. In the event controlled substances in the possession
or under the control of the registrant are stored at a location for
which he/she is not registered, the substances shall be included in the
inventory of the registered location to which they are subject to
control or to which the person possessing the substance is responsible.
The inventory may be taken either as of opening of business or as of
the close of business on the inventory date and it shall be indicated
on the inventory.
(b) Initial inventory date. Every person required to keep records
shall take an inventory of all stocks of controlled substances on hand
on the date he/she first engages in the manufacture, distribution, or
dispensing of controlled substances, in accordance with paragraph (e)
of this section as applicable. In the event a person commences business
with no controlled substances on hand, he/she shall record this fact as
the initial inventory.
(c) Biennial inventory date. After the initial inventory is taken,
the registrant shall take a new inventory of all stocks of controlled
substances on hand at least every two years. The biennial inventory may
be taken on any date which is within two years of the previous biennial
inventory date.
(d) Inventory date for newly controlled substances. On the
effective date of a rule by the Administrator pursuant to
Secs. 1308.45, 1308.46, or 1308.47 of this chapter adding a substance
to any schedule of controlled substances, which substance was,
immediately prior to that date, not listed on any such schedule, every
registrant required to keep records who possesses that substance shall
take an inventory of all stocks of the substance on hand. Thereafter,
such substance shall be included in each inventory made by the
registrant pursuant to paragraph (c) of this section.
(e) Inventories of manufacturers, distributors, dispensers,
researchers, importers, exporters and chemical analysts. Each person
registered or authorized (by Sec. 1301.13 or Secs. 1307.11-1307.13 of
this chapter) to manufacture, distribute, dispense, import, export,
conduct research or chemical analysis with controlled substances and
required to keep records pursuant to Sec. 1304.03 shall include in the
inventory the information listed below.
(1) Inventories of manufacturers. Each person registered or
authorized to manufacture controlled substances shall include the
following information in the inventory:
(i) For each controlled substance in bulk form to be used in (or
capable of use in) the manufacture of the same or other controlled or
non-controlled substances in finished form, the inventory shall
include:
(A) The name of the substance and
(B) The total quantity of the substance to the nearest metric unit
weight consistent with unit size.
(ii) For each controlled substance in the process of manufacture on
the inventory date, the inventory shall include:
(A) The name of the substance;
(B) The quantity of the substance in each batch and/or stage of
manufacture, identified by the batch number or other appropriate
identifying number; and
(C) The physical form which the substance is to take upon
completion of the manufacturing process (e.g., granulations, tablets,
capsules, or solutions), identified by the batch number or other
appropriate identifying number, and if possible the finished form of
the substance (e.g., 10-milligram tablet or 10-milligram concentration
per fluid ounce or milliliter) and the number or volume thereof.
(iii) For each controlled substance in finished form the inventory
shall include:
(A) The name of the substance;
(B) Each finished form of the substance (e.g., 10-milligram tablet
or 10-milligram concentration per fluid ounce or milliliter);
(C) The number of units or volume of each finished form in each
commercial container (e.g., 100-tablet bottle or 3-milliliter vial);
and
(D) The number of commercial containers of each such finished form
(e.g. four 100-tablet bottles or six 3-milliliter vials).
(iv) For each controlled substance not included in paragraphs
(e)(1) (i), (ii) or (iii) of this section (e.g., damaged, defective or
impure substances awaiting disposal, substances held for quality
control purposes, or substances maintained for extemporaneous
compoundings) the inventories shall include:
(A) The name of the substance;
(B) The total quantity of the substance to the nearest metric unit
weight or the

[[Page 13960]]

total number of units of finished form; and
(C) The reason for the substance being maintained by the registrant
and whether such substance is capable of use in the manufacture of any
controlled substance in finished form.
(2) Inventories of distributors. Each person registered or
authorized to distribute controlled substances shall include in the
inventory the same information required of manufacturers pursuant to
paragraphs (e)(1) (iii) and (iv) of this section.
(3) Inventories of dispensers and researchers. Each person
registered or authorized to dispense or conduct research with
controlled substances shall include in the inventory the same
information required of manufacturers pursuant to paragraphs (e)(1)
(iii) and (iv) of this section. In determining the number of units of
each finished form of a controlled substance in a commercial container
which has been opened, the dispenser shall do as follows:
(i) If the substance is listed in Schedule I or II, make an exact
count or measure of the contents, or
(ii) If the substance is listed in Schedule III, IV or V, make an
estimated count or measure of the contents, unless the container holds
more than 1,000 tablets or capsules in which case he/she must make an
exact count of the contents.
(4) Inventories of importers and exporters. Each person registered
or authorized to import or export controlled substances shall include
in the inventory the same information required of manufacturers
pursuant to paragraphs (e)(1) (iii) and (iv) of this section. Each such
person who is also registered as a manufacturer or as a distributor
shall include in his/her inventory as an importer or exporter only
those stocks of controlled substances that are actually separated from
his stocks as a manufacturer or as a distributor (e.g., in transit or
in storage for shipment).
(5) Inventories of chemical analysts. Each person registered or
authorized to conduct chemical analysis with controlled substances
shall include in his inventory the same information required of
manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this
section as to substances which have been manufactured, imported, or
received by such person. If less than 1 kilogram of any controlled
substance (other than a hallucinogenic controlled substance listed in
Schedule I), or less than 20 grams of a hallucinogenic substance listed
in Schedule I (other than lysergic acid diethylamide), or less than 0.5
gram of lysergic acid diethylamide, is on hand at the time of
inventory, that substance need not be included in the inventory.
Laboratories of the Administration may possess up to 150 grams of any
hallucinogenic substance in Schedule I without regard to a need for an
inventory of those substances. No inventory is required of known or
suspected controlled substances received as evidentiary materials for
analysis.

Secs. 1304.12-1304.19 [Removed]

6. Sections 1304.12, 1304.13, 1304.14, 1304.15, 1304.16, 1304.17,
1304.18 and 1304.19 are removed.
7. Section 1304.21 is amended by revising paragraphs (a) and (c) to
read as follows:

Sec. 1304.21 General requirements for continuing records.

(a) Every registrant required to keep records pursuant to
Sec. 1304.03 shall maintain on a current basis a complete and accurate
record of each such substance manufactured, imported, received, sold,
delivered, exported, or otherwise disposed of by him/her, except that
no registrant shall be required to maintain a perpetual inventory.
(b) * * *
(c) Separate records shall be maintained by a registrant for each
independent activity for which he/she is registered, except as provided
in Sec. 1304.22(d).
* * * * *
8. Section 1304.22 is revised to read as follows:

Sec. 1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers and exporters.

Each person registered or authorized (by Sec. 1301.13(e) or
Secs. 1307.11-1307.13 of this chapter) to manufacture, distribute,
dispense, import, export or conduct research with controlled substances
shall maintain records with the information listed below.
(a) Records for manufacturers. Each person registered or authorized
to manufacture controlled substances shall maintain records with the
following information:
(1) For each controlled substance in bulk form to be used in, or
capable of use in, or being used in, the manufacture of the same or
other controlled or noncontrolled substances in finished form,
(i) The name of the substance;
(ii) The quantity manufactured in bulk form by the registrant,
including the date, quantity and batch or other identifying number of
each batch manufactured;
(iii) The quantity received from other persons, including the date
and quantity of each receipt and the name, address, and registration
number of the other person from whom the substance was received;
(iv) The quantity imported directly by the registrant (under a
registration as an importer) for use in manufacture by him/her,
including the date, quantity, and import permit or declaration number
for each importation;
(v) The quantity used to manufacture the same substance in finished
form, including:
(A) The date and batch or other identifying number of each
manufacture;
(B) The quantity used in the manufacture;
(C) The finished form (e.g., 10-milligram tablets or 10-milligram
concentration per fluid ounce or milliliter);
(D) The number of units of finished form manufactured;
(E) The quantity used in quality control;
(F) The quantity lost during manufacturing and the causes
therefore, if known;
(G) The total quantity of the substance contained in the finished
form;
(H) The theoretical and actual yields; and
(I) Such other information as is necessary to account for all
controlled substances used in the manufacturing process;
(vi) The quantity used to manufacture other controlled and
noncontrolled substances, including the name of each substance
manufactured and the information required in paragraph (a)(1)(v) of
this section;
(vii) The quantity distributed in bulk form to other persons,
including the date and quantity of each distribution and the name,
address, and registration number of each person to whom a distribution
was made;
(viii) The quantity exported directly by the registrant (under a
registration as an exporter), including the date, quantity, and export
permit or declaration number of each exportation;
(ix) The quantity distributed or disposed of in any other manner by
the registrant (e.g., by distribution of complimentary samples or by
destruction), including the date and manner of distribution or
disposal, the name, address, and registration number of the person to
whom distributed, and the quantity distributed or disposed; and
(x) The originals of all written certifications of available
procurement quotas submitted by other persons (as

[[Page 13961]]

required by Sec. 1303.12(f) of this chapter) relating to each order
requiring the distribution of a basic class of controlled substance
listed in Schedule I or II.
(2) For each controlled substance in finished form,
(i) The name of the substance;
(ii) Each finished form (e.g., 10-milligram tablet or 10-milligram
concentration per fluid ounce or milliliter) and the number of units or
volume of finished form in each commercial container (e.g., 100-tablet
bottle or 3-milliliter vial);
(iii) The number of containers of each such commercial finished
form manufactured from bulk form by the registrant, including the
information required pursuant to paragraph (a)(1)(v) of this section;
(iv) The number of units of finished forms and/or commercial
containers acquired from other persons, including the date of and
number of units and/or commercial containers in each acquisition to
inventory and the name, address, and registration number of the person
from whom the units were acquired;
(v) The number of units of finished forms and/or commercial
containers imported directly by the person (under a registration or
authorization to import), including the date of, the number of units
and/or commercial containers in, and the import permit or declaration
number for, each importation;
(vi) The number of units and/or commercial containers manufactured
by the registrant from units in finished form received from others or
imported, including:
(A) The date and batch or other identifying number of each
manufacture;
(B) The operation performed (e.g., repackaging or relabeling);
(C) The number of units of finished form used in the manufacture,
the number manufactured and the number lost during manufacture, with
the causes for such losses, if known; and
(D) Such other information as is necessary to account for all
controlled substances used in the manufacturing process;
(vii) The number of commercial containers distributed to other
persons, including the date of and number of containers in each
reduction from inventory, and the name, address, and registration
number of the person to whom the containers were distributed; (viii)
The number of commercial containers exported directly by the registrant
(under a registration as an exporter), including the date, number of
containers and export permit or declaration number for each
exportation; and
(ix) The number of units of finished forms and/or commercial
containers distributed or disposed of in any other manner by the
registrant (e.g., by distribution of complimentary samples or by
destruction), including the date and manner of distribution or
disposal, the name, address, and registration number of the person to
whom distributed, and the quantity in finished form distributed or
disposed.
(b) Records for distributors. Each person registered or authorized
to distribute controlled substances shall maintain records with the
same information required of manufacturers pursuant to paragraphs
(a)(2) (i), (ii), (iv), (v), (vii), (viii) and (ix) of this section.
(c) Records for dispensers and researchers. Each person registered
or authorized to dispense or conduct research with controlled
substances shall maintain records with the same information required of
manufacturers pursuant to paragraph (a)(2) (i), (ii), (iv), (vii), and
(ix) of this section. In addition, records shall be maintained of the
number of units or volume of such finished form dispensed, including
the name and address of the person to whom it was dispensed, the date
of dispensing, the number of units or volume dispensed, and the written
or typewritten name or initials of the individual who dispensed or
administered the substance on behalf of the dispenser.
(d) Records for importers and exporters. Each person registered or
authorized to import or export controlled substances shall maintain
records with the same information required of manufacturers pursuant to
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In
addition, the quantity disposed of in any other manner by the
registrant (except quantities used in manufacturing by an importer
under a registration as a manufacturer), which quantities are to be
recorded pursuant to paragraphs (a)(1) (iv) and (v) of this section;
and the quantity (or number of units or volume in finished form)
exported, including the date, quantity (or number of units or volume),
and the export permit or declaration number for each exportation, but
excluding all quantities (and number of units and volumes) manufactured
by an exporter under a registration as a manufacturer, which quantities
(and numbers of units and volumes) are to be recorded pursuant to
paragraphs (a)(1)(xiii) or (a)(2)(xiii) of this section.

Sec. 1304.23-1304.26 [Removed]

9. Sections 1304.23 through 1304.26 are removed.

Sec. 1304.27 [Redesignated as Sec. 1304.23]

10. Section 1304.27 is redesignated as Sec. 1304.23.

Sec. 1304.28 [Redesignated as Sec. 1304.24 and amended]

11. Section 1304.28 is redesignated as Sec. 1304.24 and reference
in Sec. 1304.28(b) to ``Sec. 1304.24'' is revised to read
``Sec. 1304.22'', and in paragraph (d), the words ``part 1401 of this
title'' are revised to read ``42 CFR Part 2.''

Sec. 1304.29 [Redesignated as Sec. 1304.25]

12. Section 1304.29 is redesignated as Sec. 1304.25.
13. Section 1304.31 is revised to read as follows:

Sec. 1304.31 Reports from manufacturers importing narcotic raw
material.

(a) Every manufacturer which imports or manufactures from narcotic
raw material (opium, poppy straw, and concentrate of poppy straw) shall
submit information which accounts for the importation and for all
manufacturing operations performed between importation and the
production in bulk or finished marketable products, standardized in
accordance with the U.S. Pharmacopeia, National Formulary or other
recognized medical standards. Reports shall be signed by the authorized
official and submitted quarterly on company letterhead to the Drug
Enforcement Administration, Drug and Chemical Evaluation Section,
Washington, D.C. 20537, on or before the 15th day of the month
immediately following the period for which it is submitted.
(b) The following information shall be submitted for each type of
narcotic raw material (quantities are expressed as grams of anhydrous
morphine alkaloid):
(1) Beginning inventory;
(2) Gains on reweighing;
(3) Imports;
(4) Other receipts;
(5) Quantity put into process;
(6) Losses on reweighing;
(7) Other dispositions and
(8) Ending inventory.
(c) The following information shall be submitted for each narcotic
raw material derivative including morphine, codeine, thebaine,
oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude
alkaloids and other derivatives (quantities are expressed as grams of
anhydrous base or anhydrous morphine alkaloid for manufacturing opium
and medicinal opium):
(1) Beginning inventory;
(2) Gains on reweighing;

[[Page 13962]]

(3) Quantity extracted from narcotic raw material;
(4) Quantity produced/manufactured/synthesized;
(5) Quantity sold;
(6) Quantity returned to conversion processes for reworking;
(7) Quantity used for conversion;
(8) Quantity placed in process;
(9) Other dispositions;
(10) Losses on reweighing and
(11) Ending inventory.
(d) The following information shall be submitted for importation of
each narcotic raw material:
(1) Import permit number;
(2) Date shipment arrived at the United States port of entry;
(3) Actual quantity shipped;
(4) Assay (percent) of morphine, codeine and thebaine and
(5) Quantity shipped, expressed as anhydrous morphine alkaloid.
(e) Upon importation of crude opium, samples will be selected and
assays made by the importing manufacturer in the manner and according
to the method specified in the U.S. Pharmacopoeia. Where final assay
data is not determined at the time of rendering report, the report
shall be made on the basis of the best data available, subject to
adjustment, and the necessary adjusting entries shall be made on the
next report.
(f) Where factory procedure is such that partial withdrawals of
opium are made from individual containers, there shall be attached to
each container a stock record card on which shall be kept a complete
record of all withdrawals therefrom.
(g) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed
or placed into process for the manufacture of a specified end-product,
it must no longer be accounted for as precursor stocks available for
conversion or use, but rather as end-product in-process inventories.
14. Section 1304.32 is revised to read as follows:

Sec. 1304.32 Reports of manufacturers importing coca leaves.

(a) Every manufacturer importing or manufacturing from raw coca
leaves shall submit information accounting for the importation and for
all manufacturing operations performed between the importation and the
manufacture of bulk or finished products standardized in accordance
with U.S. Pharmacopoeia, National Formulary, or other recognized
standards. The reports shall be submitted quarterly on company
letterhead to the Drug Enforcement Administration, Drug and Chemical
Evaluation Section, Washington, DC 20537, on or before the 15th day of
the month immediately following the period for which it is submitted.
(b) The following information shall be submitted for raw coca leaf,
ecgonine, ecgonine for conversion or further manufacture,
benzoylecgonine, manufacturing coca extracts (list for tinctures and
extracts; and others separately), other crude alkaloids and other
derivatives (quantities should be reported as grams of actual quantity
involved and the cocaine alkaloid content or equivalency):
(1) Beginning inventory;
(2) Imports;
(3) Gains on reweighing;
(4) Quantity purchased;
(5) Quantity produced;
(6) Other receipts;
(7) Quantity returned to processes for reworking;
(8) Material used in purification for sale;
(9) Material used for manufacture or production;
(10) Losses on reweighing;
(11) Material used for conversion;
(12) Other dispositions and
(13) Ending inventory.
(c) The following information shall be submitted for importation of
coca leaves:
(1) Import permit number;
(2) Date the shipment arrived at the United States port of entry;
(3) Actual quantity shipped;
(4) Assay (percent) of cocaine alkaloid and
(5) Total cocaine alkaloid content.
(d) Upon importation of coca leaves, samples will be selected and
assays made by the importing manufacturer in accordance with recognized
chemical procedures. These assays shall form the basis of accounting
for such coca leaves, which shall be accounted for in terms of their
cocaine alkaloid content or equivalency or their total anhydrous coca
alkaloid content. Where final assay data is not determined at the time
of submission, the report shall be made on the basis of the best data
available, subject to adjustment, and the necessary adjusting entries
shall be made on the next report.
(e) Where factory procedure is such that partial withdrawals of
medicinal coca leaves are made from individual containers, there shall
be attached to the container a stock record card on which shall be kept
a complete record of withdrawals therefrom.
(f) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed
or placed into process for the manufacture of a specified end-product,
it must no longer be accounted for as precursor stocks available for
conversion or use, but rather as end-product in-process inventories.

Sec. 1304.33 [Removed]

15. Section 1304.33 is removed.

Sec. 1304.34 [Redesignated as Sec. 1304.33 and reviewes]

16. Section 1304.34 is redesignated as Sec. 1304.33 and revised to
read as follows:

Sec. 1304.33 Reports to ARCOS.

(a) Reports generally. All reports required by this section shall
be filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC
20005 on DEA Form 333, or on media which contains the data required by
DEA Form 333 and which is acceptable to the ARCOS Unit.
(b) Frequency of reports. Acquisition/Distribution transaction
reports shall be filed every quarter not later than the 15th day of the
month succeeding the quarter for which it is submitted; except that a
registrant may be given permission to file more frequently (but not
more frequently than monthly), depending on the number of transactions
being reported each time by that registrant. Inventories shall provide
data on the stocks of each reported controlled substance on hand as of
the close of business on December 31 of each year, indicating whether
the substance is in storage or in process of manufacturing. These
reports shall be filed not later than January 15 of the following year.
Manufacturing transaction reports shall be filed annually for each
calendar year not later than January 15 of the following year, except
that a registrant may be given permission to file more frequently (but
not more frequently than quarterly).
(c) Persons reporting. For controlled substances in Schedules I, II
or narcotic controlled substances in Schedule III, each person who is
registered to manufacture in bulk or dosage form, or to package,
repackage, label or relabel, and each person who is registered to
distribute shall report acquisition/distribution transactions. In
addition to reporting acquisition/distribution transactions, each
person who is registered to manufacture controlled substances in bulk
or dosage form shall report manufacturing transactions on controlled
substances in Schedules I and II, each narcotic controlled substance
listed in Schedules III, IV, and V, and on each psychotropic controlled
substance listed in Schedules

[[Page 13963]]

III and IV as identified in paragraph (d) of this section.
(d) Substances covered. (1) Manufacturing and acquisition/
distribution transaction reports shall include data on each controlled
substance listed in Schedules I and II and on each narcotic controlled
substance listed in Schedule III (but not on any material, compound,
mixture or preparation containing a quantity of a substance having a
stimulant effect on the central nervous system, which material,
compound, mixture or preparation is listed in Schedule III or on any
narcotic controlled substance listed in Schedule V). Additionally,
reports on manufacturing transactions shall include the following
psychotropic controlled substances listed in Schedules III and IV:
(i) Schedule III
(A) Benzphetamine;
(B) Cyclobarbital;
(C) Methyprylon; and
(D) Phendimetrazine.
(ii) Schedule IV
(A) Barbital;
(B) Diethylpropion (Amfepramone);
(C) Ethchlorvynol;
(D) Ethinamate;
(E) Lefetamine (SPA);
(F) Mazindol;
(G) Meprobamate;
(H) Methylphenobarbital;
(I) Phenobarbital;
(J) Phentermine; and
(K) Pipradrol.
(2) Data shall be presented in such a manner as to identify the
particular form, strength, and trade name, if any, of the product
containing the controlled substance for which the report is being made.
For this purpose, persons filing reports shall utilize the National
Drug Code Number assigned to the product under the National Drug Code
System of the Food and Drug Administration.
(e) Transactions reported. Acquisition/distribution transaction
reports shall provide data on each acquisition to inventory
(identifying whether it is, e.g., by purchase or transfer, return from
a customer, or supply by the Federal Government) and each reduction
from inventory (identifying whether it is, e.g., by sale or transfer,
theft, destruction or seizure by Government agencies). Manufacturing
reports shall provide data on material manufactured, manufacture from
other material, use in manufacturing other material and use in
producing dosage forms.
(f) Exceptions. A registered institutional practitioner who
repackages or relabels exclusively for distribution or who distributes
exclusively to (for dispensing by) agents, employees, or affiliated
institutional practitioners of the registrant may be exempted from
filing reports under this section by applying to the ARCOS Unit of the
Administration.

(Approved by the Office of Management and Budget under control
number 1117-0003)

Secs. 1304.35-1304.38 [Removed]

17. Sections 1304.35 through 1304.38 are removed.

PART 1305--[AMENDED]

1. The authority citation for part 1305 continues to read as
follows:

Authority: 21 U.S.C. 821, 828, 871(b) unless otherwise noted.

2. Section 1305.02 is revised to read as follows:

Sec. 1305.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
3. Section 1305.03 is revised to read as follows:

Sec. 1305.03 Distributions requiring order forms.

An order form (DEA Form 222) is required for each distribution of a
Schedule I or II controlled substance except to persons exempted from
registration under part 1301 of this chapter; which are exported from
the United States in conformity with the Act; or for delivery to a
registered analytical laboratory, or its agent approved by DEA.
4. Section 1305.06 is revised to read as follows:

Sec. 1305.06 Procedure for executing order forms.

(a) Order forms shall be prepared and executed by the purchaser
simultaneously in triplicate by means of interleaved carbon sheets
which are part of the DEA Form 222. Order forms shall be prepared by
use of a typewriter, pen, or indelible pencil.
(b) Only one item shall be entered on each numbered line. An item
shall consist of one or more commercial or bulk containers of the same
finished or bulk form and quantity of the same substance. The number of
lines completed shall be noted on that form at the bottom of the form,
in the space provided. Order forms for carfentanil, etorphine
hydrochloride, and diprenorphine shall contain only these substances.
(c) The name and address of the supplier from whom the controlled
substances are being ordered shall be entered on the form. Only one
supplier may be listed on any form.
(d) Each order form shall be signed and dated by a person
authorized to sign an application for registration. The name of the
purchaser, if different from the individual signing the order form,
shall also be inserted in the signature space. Unexecuted order forms
may be kept and may be executed at a location other than the registered
location printed on the form, provided that all unexecuted forms are
delivered promptly to the registered location upon an inspection of
such location by any officer authorized to make inspections, or to
enforce, any Federal, State, or local law regarding controlled
substances.
5. Section 1305.07 is revised to read as follows:

Sec. 1305.07 Power of attorney.

Any purchaser may authorize one or more individuals, whether or not
located at the registered location of the purchaser, to obtain and
execute order forms on his/her behalf by executing a power of attorney
for each such individual. The power of attorney shall be signed by the
same person who signed the most recent application for registration or
reregistration and by the individual being authorized to obtain and
execute order forms. The power of attorney shall be filed with the
executed order forms of the purchaser, and shall be retained for the
same period as any order form bearing the signature of the attorney.
The power of attorney shall be available for inspection together with
other order form records. Any power of attorney may be revoked at any
time by executing a notice of revocation, signed by the person who
signed (or was authorized to sign) the power of attorney or by a
successor, whoever signed the most recent application for registration
or reregistration, and filing it with the power of attorney being
revoked. The form for the power of attorney and notice of revocation
shall be similar to the following:

Power of Attorney for DEA Order Forms

__________ (Name of registrant)
__________ (Address of registrant)
__________ (DEA registration number)

I, __________ (name of person granting power), the undersigned,
who is authorized to sign the current application for registration
of the above-named registrant under the Controlled Substances Act or
Controlled Substances Import and Export Act, have made, constituted,
and appointed, and by these presents, do make, constitute, and
appoint __________ (name of attorney-in-fact), my true and lawful
attorney for me in my name, place, and stead, to execute
applications for books of official order forms and to sign such
order forms in requisition for Schedule I and II controlled
substances, in accordance with section 308 of the Controlled
Substances Act (21 U.S.C. 828)

[[Page 13964]]

and part 1305 of Title 21 of the Code of Federal Regulations. I
hereby ratify and confirm all that said attorney shall lawfully do
or cause to be done by virtue hereof.

----------------------------------------------------------------------
(Signature of person granting power)

I, __________ (name of attorney-in-fact), hereby affirm that I
am the person named herein as attorney-in-fact and that the
signature affixed hereto is my signature.

----------------------------------------------------------------------
(Signature of attorney-in-fact)

Witnesses:
1. __________.
2. __________.
Signed and dated on the ______ day of __________, (year), at
__________.

Notice of Revocation

The foregoing power of attorney is hereby revoked by the
undersigned, who is authorized to sign the current application for
registration of the above-named registrant under the Controlled
Substances Act of the Controlled Substances Import and Export Act.
Written notice of this revocation has been given to the attorney-in-
fact __________ this same day.

----------------------------------------------------------------------
(Signature of person revoking power)
Witnesses:
1. __________.
2. __________.
Signed and dated on the ______ day of __________, (year), at
__________.

6. Section 1305.12 is amended by revising paragraph (b) to read as
follows:

Sec. 1305.12 Lost or stolen order forms.

* * * * *
(b) Whenever any used or unused order forms are stolen or lost
(otherwise than in the course of transmission) by any purchaser or
supplier, he/she shall immediately upon discovery of such theft or
loss, report the same to the Special Agent in Charge of the Drug
Enforcement Administration in the Divisional Office responsible for the
area in which the registrant is located, stating the serial number of
each form stolen or lost. If the theft or loss includes any original
order forms received from purchasers and the supplier is unable to
state the serial numbers of such order forms, he/she shall report the
date or approximate date of receipt thereof and the names and addresses
of the purchasers. If an entire book of order forms is lost or stolen,
and the purchaser is unable to state the serial numbers of the order
forms contained therein, he/she shall report, in lieu of the numbers of
the forms contained in such book, the date or approximate date of
issuance thereof. If any unused order form reported stolen or lost is
subsequently recovered or found, the Special Agent in Charge of the
Drug Enforcement Administration in the Divisional Office responsible
for the area in which the registrant is located shall immediately be
notified.
7. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

----------------------------------------------------------------------------------------------------------------
Section Remove Add
----------------------------------------------------------------------------------------------------------------
1305.04(b).............................. his.................................. his/her
1305.05(b).............................. him (twice).......................... him/her
1305.08(a).............................. he................................... he/she
1305.08(a).............................. his (twice).......................... his/her
1305.09(b).............................. he................................... he/she
1305.09(d).............................. his ovn.............................. his/her own
1305.10(a).............................. hall................................. shall
1305.10(a).............................. he................................... he/she
1305.13(a).............................. He................................... He/She
1305.13(b).............................. he................................... he/she
1305.13(c).............................. he................................... he/she
1305.13(c).............................. 1305.06(e)........................... 1305.06(d)
1305.14................................. he (twice)........................... he/she
1305.14................................. 1301.45 or 1301.46................... 1301.36
1305.16(b).............................. he................................... he/she
----------------------------------------------------------------------------------------------------------------

PART 1306--[AMENDED]

1. The authority citation for part 1306 continues to read as
follows:

Authority: 21 U.S.C. 821, 829, 871(b).

2. Section 1306.02 is revised to read as follows:

Sec. 1306.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.
3. Section 1306.11 is amended by revising paragraphs (a),(d)(4),
and (e), and adding a new paragraph (g) to read as follows:

Sec. 1306.11 Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance
listed in Schedule II, which is a prescription drug as determined under
the Federal Food, Drug, and Cosmetic Act, only pursuant to a written
prescription signed by the practitioner, except as provided in
paragraph (d) of this section. A prescription for a Schedule II
controlled substance may be transmitted by the practitioner or the
practitioner's agent to a pharmacy via facsimile equipment, provided
that the original written, signed prescription is presented to the
pharmacist for review prior to the actual dispensing of the controlled
substance, except as noted in paragraph (e), (f), or (g) of this
section. The original prescription shall be maintained in accordance
with Sec. 1304.04(h) of this chapter.
* * * * *
(d) * * *
(4) Within 7 days after authorizing an emergency oral prescription,
the prescribing individual practitioner shall cause a written
prescription for the emergency quantity prescribed to be delivered to
the dispensing pharmacist. In addition to conforming to the
requirements of Sec. 1306.05, the prescription shall have written on
its face ``Authorization for Emergency Dispensing,'' and the date of
the oral order. The written prescription may be delivered to the
pharmacist in person or by mail, but if delivered by mail it must be
postmarked within the 7 day period. Upon receipt, the dispensing
pharmacist shall attach this prescription to the oral emergency
prescription which had earlier been reduced to writing. The pharmacist
shall notify the nearest office of the Administration if the
prescribing individual practitioner fails to deliver a written
prescription to him; failure of the pharmacist to do so shall void the
authority conferred by this paragraph to dispense without a written
prescription of a prescribing individual practitioner.
(e) A prescription prepared in accordance with Sec. 1306.05 written
for a

[[Page 13965]]

Schedule II narcotic substance to be compounded for the direct
administration to a patient by parenteral, intravenous, intramuscular,
subcutaneous or intraspinal infusion may be transmitted by the
practitioner or the practitioner's agent to the pharmacy by facsimile.
The facsimile serves as the original written prescription for purposes
of this paragraph (e) and it shall be maintained in accordance with
Sec. 1304.04(h) of this chapter.
* * * * *
(g) A prescription prepared in accordance with Sec. 1306.05 written
for a Schedule II narcotic substance for a patient residing in a
hospice certified by Medicare under Title XVIII or licensed by the
state may be transmitted by the practitioner or the practitioner's
agent to the dispensing pharmacy by facsimile. The practitioner or the
practitioner's agent will note on the prescription that the patient is
a hospice patient. The facsimile serves as the original written
prescription for purposes of this paragraph (g) and it shall be
maintained in accordance with Sec. 1304.04(h) of this chapter.
4. Section 1306.13 is amended by revising paragraph (b) to read as
follows:

Sec. 1306.13 Partial filling of prescriptions.

* * * * *
(b) A prescription for a Schedule II controlled substance written
for a patient in a Long Term Care Facility (LTCF) or for a patient with
a medical diagnosis documenting a terminal illness may be filled in
partial quantities to include individual dosage units. If there is any
question whether a patient may be classified as having a terminal
illness, the pharmacist must contact the practitioner prior to
partially filling the prescription. Both the pharmacist and the
prescribing practitioner have a corresponding responsibility to assure
that the controlled substance is for a terminally ill patient. The
pharmacist must record on the prescription whether the patient is
``terminally ill'' or an ``LTCF patient.'' A prescription that is
partially filled and does not contain the notation ``terminally ill''
or ``LTCF patient'' shall be deemed to have been filled in violation of
the Act. For each partial filling, the dispensing pharmacist shall
record on the back of the prescription (or on another appropriate
record, uniformly maintained, and readily retrievable) the date of the
partial filling, quantity dispensed, remaining quantity authorized to
be dispensed, and the identification of the dispensing pharmacist. The
total quantity of Schedule II controlled substances dispensed in all
partial fillings must not exceed the total quantity prescribed.
Schedule II prescriptions for patients in a LTCF or patients with a
medical diagnosis documenting a terminal illness shall be valid for a
period not to exceed 60 days from the issue date unless sooner
terminated by the discontinuance of medication.
* * * * *
5. Section 1306.14 is amended by revising the heading and adding a
new paragraph (c) to read as follows:

Sec. 1306.14 Labeling of substances and filing of prescriptions.

* * * * *
(c) All written prescriptions and written records of emergency oral
prescriptions shall be kept in accordance with requirements of
Sec. 1304.04(h) of this chapter.

Sec. 1306.15 [Removed]

6. Section 1306.15 is removed.
7. The center undesignated heading preceding Sec. 1306.21 and
Sec. 1306.21 are revised to read as follows:

Controlled Substances Listed in Sechedules III, IV, and V

Sec. 1306.21 Requirement of prescription.

(a) A pharmacist may dispense directly a controlled substance
listed in Schedule III, IV, or V which is a prescription drug as
determined under the Federal Food, Drug, and Cosmetic Act, only
pursuant to either a written prescription signed by a practitioner or a
facsimile of a written, signed prescription transmitted by the
practitioner or the practitioner's agent to the pharmacy or pursuant to
an oral prescription made by an individual practitioner and promptly
reduced to writing by the pharmacist containing all information
required in Sec. 1306.05, except for the signature of the practitioner.
(b) An individual practitioner may administer or dispense directly
a controlled substance listed in Schedule III, IV, or V in the course
of his/her professional practice without a prescription, subject to
Sec. 1306.07.
(c) An institutional practitioner may administer or dispense
directly (but not prescribe) a controlled substance listed in Schedule
III, IV, or V only pursuant to a written prescription signed by an
individual practitioner, or pursuant to a facsimile of a written
prescription or order for medication transmitted by the practitioner or
the practitioner's agent to the institutional practitioner-pharmacist,
or pursuant to an oral prescription made by an individual practitioner
and promptly reduced to writing by the pharmacist (containing all
information required in Section 1306.05 except for the signature of the
individual practitioner), or pursuant to an order for medication made
by an individual practitioner which is dispensed for immediate
administration to the ultimate user, subject to Sec. 1306.07.
8. Section 1306.23 is amended by revising the introductory text to
read as follows:

Sec. 1306.23 Partial filling of prescriptions.

The partial filling of a prescription for a controlled substance
listed in Schedule III, IV, or V is permissible, provided that:
* * * * *
9. Section 1306.24 is revised to read as follows:

Sec. 1306.24 Labeling of substances and filing of prescriptions.

(a) The pharmacist filling a prescription for a controlled
substance listed in Schedule III, IV, or V shall affix to the package a
label showing the pharmacy name and address, the serial number and date
of initial filling, the name of the patient, the name of the
practitioner issuing the prescription, and directions for use and
cautionary statements, if any, contained in such prescription as
required by law.
(b) The requirements of paragraph (a) of this section do not apply
when a controlled substance listed in Schedule III, IV, or V is
prescribed for administration to an ultimate user who is
institutionalized: Provided, That:
(1) Not more than a 34-day supply or 100 dosage units, whichever is
less, of the controlled substance listed in Schedule III, IV, or V is
dispensed at one time;
(2) The controlled substance listed in Schedule III, IV, or V is
not in the possession of the ultimate user prior to administration;
(3) The institution maintains appropriate safeguards and records
the proper administration, control, dispensing, and storage of the
controlled substance listed in Schedule III, IV, or V; and
(4) The system employed by the pharmacist in filling a prescription
is adequate to identify the supplier, the product and the patient, and
to set forth the directions for use and cautionary statements, if any,
contained in the prescription or required by law.
(c) All prescriptions for controlled substances listed in Schedules
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this
chapter.

Sec. 1306.25 [Removed]

10. Section 1306.25 is removed.

[[Page 13966]]

Sec. 1306.26 [Redesignated as Sec. 1306.25 and amended]

11. Section 1306.26 is redesignated as Sec. 1306.25 and amended by
revising paragraphs (a) and (b) to read as follows:

Sec. 1306.25 Transfer between pharmacies of prescription information
for Schedules III, IV, and V controlled substances for refill purposes.

(a) The transfer of original prescription information for a
controlled substance listed in Schedules III, IV or V for the purpose
of refill dispensing is permissible between pharmacies on a one time
basis only. However, pharmacies electronically sharing a real-time, on-
line database may transfer up to the maximum refills permitted by law
and the prescriber's authorization. Transfers are subject to the
following requirements:
(1) The transfer is communicated directly between two licensed
pharmacists and the transferring pharmacist records the following
information:
(i) Write the word ``VOID'' on the face of the invalidated
prescription.
(ii) Record on the reverse of the invalidated prescription the
name, address and DEA registration number of the pharmacy to which it
was transferred and the name of the pharmacist receiving the
prescription information.
(iii) Record the date of the transfer and the name of the
pharmacist transferring the information.
(b) The pharmacist receiving the transferred prescription
information shall reduce to writing the following:
(1) Write the word ``transfer'' on the face of the transferred
prescription.
(2) Provide all information required to be on a prescription
pursuant to 21 CFR 1306.05 and include:
(i) Date of issuance of original prescription;
(ii) Original number of refills authorized on original
prescription;
(iii) Date of original dispensing;
(iv) Number of valid refills remaining and date(s) and locations of
previous refill(s);
(v) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription information was
transferred;
(vi) Name of pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA registration number and
prescription number from which the prescription was originally filled;
(3) The original and transferred prescription(s) must be maintained
for a period of two years from the date of last refill.
* * * * *

Sec. Undesignated center heading and Sec. 1306.31 [Removed]

12. The undesignated heading preceding Sec. 1306.31 and
Sec. 1306.31 are removed.

Sec. 1306.32 [Redesignated as Sec. 1306.26 and amended]

13. Sec. 1306.32 is redesignated as Sec. 1306.26 and the
introductory text and paragraph (a) revised to read as follows:

Sec. 1306.26 Dispensing without prescription.

A controlled substance listed in Schedules II, III, IV, or V which
is not a prescription drug as determined under the Federal Food, Drug,
and Cosmetic Act, may be dispensed by a pharmacist without a
prescription to a purchaser at retail, provided that:
(a) Such dispensing is made only by a pharmacist (as defined in
part 1300 of this chapter), and not by a nonpharmacist employee even if
under the supervision of a pharmacist (although after the pharmacist
has fulfilled his professional and legal responsibilities set forth in
this section, the actual cash, credit transaction, or delivery, may be
completed by a nonpharmacist);
* * * * *
14. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

PART 1307--[AMENDED]

1. The authority citation for part 1307 continues to read as
follows:

Authority: 21 U.S.C. 821, 822(d), 871(b).

2. Section 1307.01 is revised to read as follows:

Sec. 1307.01 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
3. Section 1307.02 is revised to read as follows:

Sec. 1307.02 Application of State law and other Federal law.

Nothing in this chapter shall be construed as authorizing or
permitting any person to do any act which such person is not authorized
or permitted to do under other Federal laws or obligations under
international treaties, conventions or protocols, or under the law of
the State in which he/she desires to do such act nor shall compliance
with such parts be construed as compliance with other Federal or State
laws unless expressly provided in such other laws.
4. Section 1307.03 is revised to read as follows:

Sec. 1307.03 Exceptions to regulations.

Any person may apply for an exception to the application of any
provision of this chapter by filing a written request stating the
reasons for such exception. Requests shall be filed with the
Administrator, Drug Enforcement Administration, Department of Justice,
Washington, DC 20537. The Administrator may grant an exception in his
discretion, but in no case shall he/she be required to grant an
exception to any person which is otherwise required by law or the
regulations cited in this section.

Sec. 1307.12 [Removed]

5. Section 1307.12 is removed.

[[Page 13967]]

Sec. 1307.13 [Redesignated as Sec. 1307.12]

6. Section 1307.13 is redesignated as Sec. 1307.12.

Sec. 1307.14 [Removed]

7. Section 1307.14 is removed.

Sec. 1307.15 [Redesignated as Sec. 1307.13]

8. Section 1307.15 is redesignated as Sec. 1307.13.
9. Section 1307.21 is amended by revising paragraph (a) to read as
follows:

Sec. 1307.21 Procedure for disposing of controlled substances.

(a) Any person in possession of any controlled substance and
desiring or required to dispose of such substance may request
assistance from the Special Agent in Charge of the Administration in
the area in which the person is located for authority and instructions
to dispose of such substance. The request should be made as follows:
(1) If the person is a registrant, he/she shall list the controlled
substance or substances which he/she desires to dispose of on DEA Form
41, and submit three copies of that form to the Special Agent in Charge
in his/her area; or
(2) If the person is not a registrant, he/she shall submit to the
Special Agent in Charge a letter stating:
(i) The name and address of the person;
(ii) The name and quantity of each controlled substance to be
disposed of;
(iii) How the applicant obtained the substance, if known; and
(iv) The name, address, and registration number, if known, of the
person who possessed the controlled substances prior to the applicant,
if known.
* * * * *
10. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

PART 1308--[AMENDED]

1. The authority citation for part 1308 continues to read as
follows:

Authority: 21 U.S.C. 811, 812, 871(b).

2. Section 1308.02 is revised to read as follows:

Sec. 1308.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.

Sec. 1308.04 [Removed]

3. Section 1308.04 is removed.
4. Section 1308.24 is amended by removing the Exempt Chemical
Preparations Table and revising paragraphs (a) and (i) to read as
follows:

Sec. 1308.24 Exempt chemical preparations.

(a) The chemical preparations and mixtures approved pursuant to
Sec. 1308.23 are exempt from application of sections 302, 303, 305,
306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823,
825-829, 952-954) and Sec. 1301.74 of this chapter, to the extent
described in paragraphs (b) to (h) of this section. Substances set
forth in paragraph (j) of this section shall be exempt from the
application of sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of
the Act (21 U.S.C. 825-829, 952-954) and Secs. 1301.71--1301.73 and
1301.74 (a), (b), (d), (e) and (f) of this chapter to the extent as
hereinafter may be provided.
* * * * *
(i) A listing of exempt chemical preparations may be obtained by
submitting a written request to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration, Washington, DC 20537.
* * * * *
5. In Sec. 1308.26(a) the Table of Excluded Veterinary Anabolic
Steroid Implant Products is removed. As revised, Sec. 1308.26(a) reads
as follows:

Sec. 1308.26 Excluded veterinary anabolic steroid implant products.

(a) Products containing an anabolic steroid, that are expressly
intended for administration through implants to cattle or other
nonhuman species and which have been approved by the Secretary of
Health and Human Services for such administration are excluded from all
schedules pursuant to section 102(41)(B)(I) of the Act (21 U.S.C.
802(41)(B)(I)). A listing of the excluded products may be obtained by
submitting a written request to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration, Washington DC 20537.
* * * * *
6. In Sec. 1308.32 the Table of Exempted Prescription Products is
removed. As revised, Section 1308.32 reads as follows:

Sec. 1308.32 Exempted prescription products.

The compounds, mixtures, or preparations that contain a nonnarcotic
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13 (b)
or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of
Exempted Prescription Products have been exempted by the Administrator
from the application of sections 302 through 305, 307 through 309, 1002
through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and
Secs. 1301.13, 1301.22, and Secs. 1301.71 through 1301.76 of this
chapter for administrative purposes only. An exception to the above is
that those products containing butalbital shall not be exempt from the
requirement of 21 U.S.C. 952-954 concerning importation, exportation,
transshipment and in-transit shipment of controlled substances. Any
deviation from the quantitative composition of any of the listed drugs
shall require a petition of exemption in order for the product to be
exempted. A listing of the Exempted Prescription Products may be
obtained by submitting a written request to the Drug and Chemical
Evaluation Section, Drug Enforcement Administration, Washington, DC
20537.
7. In Sec. 1308.34 the Table of Exempt Anabolic Steroid Products is
removed. As revised, Sec. 1308.34 reads as follows:

Sec. 1308.34 Exempt anabolic steroid products.

The list of compounds, mixtures, or preparations that contain an
anabolic steroid that have been exempted by the Administrator from
application of sections 302 through 309 and 1002 through 1004 of the
Act (21 U.S.C. 822-829 and 952-954) and Secs. 1301.13, 1301.22, and
1301.71 through 1301.76 of this chapter for administrative purposes
only may be obtained by submitting a written request to the Drug and
Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537.

[[Page 13968]]

8. Sec. 1308.42 is revised to read as follows:

Sec. 1308.42 Purpose of hearing.

If requested by any interested person after proceedings are
initiated pursuant to Sec. 1308.43, the Administrator shall hold a
hearing for the purpose of receiving factual evidence and expert
opinion regarding the issues involved in the issuance, amendment or
repeal of a rule issuable pursuant to section 201(a) of the Act (21
U.S.C. 811(a)). Extensive argument should not be offered into evidence
but rather presented in opening or closing statements of counsel or in
memoranda or proposed findings of fact and conclusions of law.
Additional information relating to hearings to include waivers or
modification of rules, request for hearing, burden of proof, time and
place, and final order are set forth in Part 1316 of this chapter.

Section 1308.43 [Removed]

9. Section 1308.43 is removed.

Sec. 1308.44 [Redesignated as Sec. 1308.43 and amended]

10. Section 1308.44 is redesignated as Sec. 1308.43 and the
citation ``1308.45'' in paragraph (f) is revised to read ``1308.44'':

Sec. 1308.45 [Redesignated as Sec. 1308.44 and amended]

11. Section 1308.45 is redesignated as Sec. 1308.44 and the
citation in paragraph (e) ``1308.48'' is revised to read ``1308.45''.

Secs. 1308.46 and 1308.47 [Removed]

12. Sections 1308.46 and 1308.47 are removed.

Secs. 1308.48-1308.50 [Redesignated as Secs. 1308.45-1308.47]

13. Sections 1308.48 through 1308.50 are redesignated as
Secs. Sections 1308.45 through 1308.47.

Section 1308.51 [Removed]

14. Section 1308.51 is removed.

Sec. 1308.52 [Redesignated as Sec. 1308.49 and corrected]

15. Section 1308.52 is redesignated as Sec. 1308.49 and the
typographical error ``withott'' in the introductory text is corrected
to read ``without''.
16. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

PART 1309--[AMENDED]

1. The authority citation for part 1309 continues to read as
follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877,
958.

2. Section 1309.02 is revised to read as follows:

Sec. 1309.02 Definitions.

Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.

Secs. 1309.53 and 1309.57 [Removed] and

Secs. 1309.54-1309.56 [Redesignated as Secs. 1309.53-1309.55]

3. Sections 1309.53 and 1309.57 are removed and Secs. 1309.54
through 1309.56 are redesignated as Secs. 1309.53 through 1309.55.
4. In addition to the amendments set forth above, DEA is removing
the words ``Sec. 1310.01(f)(1)(iv) and adding in their place the words
``Sec. 1300.01(b)(28)(i)(D)'' in the following places:
(a) Section 1309.02(g)
(b) Section 1309.21 (a) and (b)
(c) Section 1309.25 (a) and (b); and
(d) Section 1309.71(a)(2).

PART 1310--[AMENDED]

1. The authority citation for part 1310 continues to read as
follows:

Authority: 21 U.S.C. 802, 830, 871(b).

2. Section 1310.01 is revised to read as follows:

Sec. 1310.01 Definitions.

Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

Sec. 1310.05 [Amended]

3. Section 1310.05(c) is amended by removing the words ``as defined
in Sec. 1310.01(i)'' and ``as defined in Sec. 1310.01(j)''

Sec. 1310.08 [Amended]

4. Section 1310.08 introductory text is amended by removing the
words ``contained in 21 CFR 1310.01(f) and 1313.02(d)''

Sec. 1310.09 [Removed]

5. Section 1310.09 is removed.
6. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

[[Page 13969]]

PART 1311--[REMOVED AND RESERVED]

Part 1311 is removed and reserved.

PART 1312--[AMENDED]

1. The authority citation for part 1312 continues to read as
follows:

Authority: 21 U.S.C. 952, 953, 954, 957, 958.

2. Section 1312.02 is revised to read as follows:

Sec. 1312.02 Definitions.

Any term contained in this part shall have the definition set forth
in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.
3. Part 1312 is amended to remove the words, ``1405 I Street, NW''
and ``1405 Eye Street, NW.'', in the following sections:
(a) 1312.12(a);
(b) 1312.16(b);
(c) 1312.18(b);
(d) 1312.19(b);
(e) 1312.22(a);
(f) 1312.24(a);
(g) 1312.27(a);
(h) 1312.27(b)(5)(iv);
(i) 1312.28(d);
(j) 1312.31(b); and
(k) 1312.32(a).
4. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

----------------------------------------------------------------------------------------------------------------
Section Remove Add
----------------------------------------------------------------------------------------------------------------
1312.12(a)....................... Drug Control Section.......... Drug Operations Section
1312.14(a)....................... Drug Control Section.......... Drug Operations Section
1312.16(b)....................... Drug Control Section.......... Drug Operations Section
1312.17.......................... 304........................... 1304
1312.18(b)....................... Drug Control Section.......... Drug Operations Section
1312.18(c)....................... (or BND)......................
1312.19(a)....................... Drug Control Section.......... Drug Operations Section
1312.19(b)....................... Drug Control Section.......... Drug Operations Section
1312.22(a)....................... Drug Control Section.......... Drug Operations Section
1312.24(a)....................... Bureau........................ Administration
1312.24(a)....................... Drug Control Section.......... Drug Operations Section
1312.25.......................... Drug Control Section.......... Drug Operations Section
1312.27(a)....................... regirtered.................... registered
1312.27(a)....................... Drug Control Section.......... Drug Operations Section
1312.27(b)(5)(iii)............... inital........................ initial
1312.27(b)(5)(iv)................ Drug Control Section.......... Drug Operations Section
1312.28(d)....................... Drug Control Section.......... Drug Operations Section
1312.28(d)....................... 1327.27(b)(4)................. 1312.27(b)(4)
1312.31(b)....................... Drug Control Section.......... Drug Operations Section
1312.32(a)....................... Drug Control Section.......... Drug Operations Section
----------------------------------------------------------------------------------------------------------------

PART 1313--[AMENDED]

1. The authority citation for part 1313 continues to read as
follows:

Authority: 21 U.S.C. 802, 830, 871(b), 971.

2. Section 1313.02 is revised to read as follows:

Sec. 1313.02 Definitions.

Any term used in this part shall have the definition set forth in
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.

Sec. 1313.15 [Amended]

3. Section 1313.15(a) is amended by removing the words
``Sec. 1313.02(i)'' and replacing them with the words
``Sec. 1300.02(b)(13)''

Sec. 1313.21 [Amended]

4. Section 1313.21(c)(1) is amended by removing the words
``Sec. 1313.02(j)'' and replacing them with the words
``Sec. 1300.02(b)(12)''

Sec. 1313.24 [Amended]

5. Section 1313.24(a) is amended by removing the words
``Sec. 1313.02(j)'' and replacing them with the words
``Sec. 1300.02(b)(12)''

PART 1316--[AMENDED]

1. The authority citation for part 1316 continues to read as
follows:

Authority: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.

2. Section 1316.02 is amended by revising paragraph (g) to read as
follows:

Sec. 1316.02 Definitions.

* * * * *
(g) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this
chapter.
3. Section 1316.13 is amended by revising the text to read as
follows:

Sec. 1316.13 Frequency of administrative inspections.

Except where circumstances otherwise dictate, it is the intent of
the Administration to inspect all manufacturers of controlled
substances listed in Schedules I and II and distributors of controlled
substances listed in Schedule I once each year. Distributors of
controlled substances listed in Schedules II through V and
manufacturers of controlled substances listed in Schedules III through
V shall be inspected as circumstances may require, based in part on the
registrant's history of compliance with the requirements of this
chapter and maintenance of effective controls and procedures to guard
against the diversion of controlled substances.
4. Section 1316.42 is amended by revising paragraph (h) to read as
follows:

Sec. 1316.42 Definitions.

* * * * *
(h) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this
chapter.
5. Section 1316.71 is amended by revising paragraph (f) to read as
follows:

Sec. 1316.71 Definitions.

* * * * *
(f) Any term not defined in this part shall have the definition set
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this
chapter.
6. In addition to the amendments set forth above, DEA is amending
each section indicated in the left column by removing the words
indicated in the middle column and adding the words in the right
column:

[[Page 13970]]

Dated: February 26, 1997.
James Milford,
Acting Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 97-7036 Filed 3-21-97; 8:45 am]
BILLING CODE 4410-09-P

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Document Information

Effective Date:: 3/28/1997
Published:: 03/24/1997
Department:: Drug Enforcement Administration
Entry Type:: Rule
Action:: Final rule.
Document Number:: 97-7036
Dates:: March 28, 1997.
Pages:: 13938-13970 (33 pages)
Docket Numbers:: DEA Number 139F
PDF File:: 97-7036.pdf
CFR: (155): 21 CFR 1310.02(b); 21 CFR 1300.02(b)(12); 21 CFR 1304.22(c); 21 CFR 1308.11(d); 21 CFR 1308.12(e); More ...