[Federal Register Volume 62, Number 27 (Monday, February 10, 1997)]
[Rules and Regulations]
[Pages 5914-5917]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-3086]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1309, 1310, and 1313
[DEA Number 154I]
RIN 1117-AA42
Comprehensive Methamphetamine Control Act of 1996; Possession of
List I Chemicals, Definitions, Record Retention, and Temporary
Exemption From Chemical Registration for Distributors of Combination
Ephedrine Products
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Interim rule with request for comments.
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SUMMARY: DEA is amending its regulations to incorporate certain
amendments of the Controlled Substances Act (CSA) made by the
Comprehensive Methamphetamine Control Act of 1996 (MCA) and to provide
temporary exemption from registration for persons who distribute
combination ephedrine drug products. The MCA amends the CSA with
respect to: possession of listed chemicals following suspension or
revocation of registration; the record retention requirements for List
I chemical transactions; certain definitions; and establishes the
requirement that, effective October 3, 1996, persons that distribute
combination ephedrine products shall be subject to the chemical
registration requirement. To avoid interruption in the legitimate
distribution of combination ephedrine products, DEA is amending its
regulations to provide certain temporary exemptions from the
registration requirement pending promulgation of final regulations.
DATES: Effective February 10, 1997. Written comments or objections must
be submitted on or before April 11, 1997.
ADDRESSES: Comments and objections should be submitted in quintuplicate
to the Deputy Assistant Administrator, Office of Diversion Control,
Drug Enforcement Administration, Washington, D.C. 20537, Attention: DEA
Federal Register Representative/CCR.
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: The Comprehensive Methamphetamine Control
Act of 1996 was enacted on October 3, 1996. Among its provisions, the
MCA contained revisions of the Controlled Substances Act (CSA) with
respect to possession of listed chemicals following revocation or
suspension of registration, the record retention requirements for
transactions involving List I chemicals and tableting or encapsulating
machines, and definitions, of ``regulated transaction'', ``retail
distributor'', and ``combination ephedrine product''. To accommodate
the amendments made by the MCA, DEA is making the following changes to
Title 21, Code of Federal Regulations (CFR):
21 CFR 1309.43 Suspension or Revocation of Registration
The MCA amends Section 404 of the CSA (21 U.S.C. 844) to make it
unlawful for any person to knowingly or intentionally possess any list
I chemical obtained under the authority of a registration or an
exemption from registration granted by the Administrator by regulation,
if that registration or exemption has been revoked or suspended. The
revised language also makes it illegal to possess list I chemicals
obtained under the authority of a registration or an exemption granted
by regulation by the Administrator, if the registration has expired or
if the registrant has ceased to do business as originally intended
under that registration.
To reflect the amendments in the law, DEA is revising 21 CFR
1309.43, to include seizure and forfeiture instructions. Persons whose
registrations or exemptions have been revoked or suspended shall be
required, upon service of the notice of revocation or suspension, to
surrender all List I
[[Page 5915]]
chemicals in their possession obtained under the authority of a
registration or an exemption from registration granted by the
Administrator by regulation, to the nearest office of the
Administration or authorized agent of the Administration, or place such
List I chemicals under seal as described in 21 U.S.C. 824(f). When the
suspension or revocation is limited to certain chemicals, the
registrant shall surrender those chemicals affected by the revocation
or suspension as indicated above.
21 CFR 1309.02, 1310.01 & 1313.02 Definitions
The definition of ``retail distributor'' found in Sec. 1309.02(f)
has been amended by the MCA. As defined by the MCA, the term refers to
persons, such as grocery stores, general merchandise stores, drug
stores, etc., that engage in sales of pseudoephedrine,
phenylpropanolamine, and combination ephedrine drug products almost
exclusively to individuals for personal use in face-to-face
transactions. The new definition will apply to all retail distributors
of regulated drug products, including single entity ephedrine products.
The MCA also amends the definition of ``regulated transaction'' to
make all ephedrine products and certain drug products containing
pseudoephedrine and phenylpropanolamine subject to regulation. However,
because the provisions relating to pseudoephedrine and
phenylpropanolamine products will not become effective until October 3,
1997, the definition of ``regulated transaction'', as found in 21 CFR
1310.01(f) and 1313.02(d), is being amended only with respect to
ephedrine products at this time. The MCA also defines ``combination
ephedrine product''; that definition, together with the appropriate
guidelines clarifying the specific criteria established by the
definition, has been added to Secs. 1309.02 and 1310.01.
As a result of the amendment to the definition of ``regulated
transaction'', persons who distribute, import, or export combination
ephedrine products are now subject to the chemical registration,
recordkeeping, and reporting requirements. As noted later in this
document, DEA is establishing certain temporary exemptions from the
registration requirement pending promulgation of regulations, subject
to notice and comment, relating to the control of combination ephedrine
products.
21 CFR 1310.02 Substances Covered and 21 CFR 1310.04 Maintenance of
Records
The MCA amends Section 802(34) of the CSA to correct the spelling
of ``Isosafrole'' and ``hydriodic acid'' and Section 830(a) to modify
the record retention period from the current 4 years to 2 years for all
transactions involving a listed chemical or a tableting or
encapsulating machine. The corresponding amendments are being made in
the regulations. With respect to the change in the record retention
period, the new language of the law does not distinguish between
records created before and after the change in the retention
requirement. Thus, effective October 3, 1996, a regulated person's
records must only contain records of those regulated transactions that
occurred within the past two years; records of transactions that are
more than two years old are no longer required.
Temporary Exemptions From Registration Pending Promulgation, With
Notice and Comment, of Regulations
As noted earlier, combination ephedrine products became subject to
the CSA's chemical registration, recordkeeping, and reporting
provisions effective October 3, 1996. Under this new requirement, any
person who distributes, imports, or exports combination ephedrine
products must first obtain a DEA registration. Because implementation
of this provision will require amendment to DEA's regulations, DEA is
establishing temporary exemptions from the registration requirement for
persons handling combination ephedrine products, to allow for
continuation of legitimate commerce in the products. In addition, the
existing exemptions from chemical registration for persons registered
with DEA to handle controlled substances, which is contained in 21 CFR
1309.25 and for distributors of prescription drug products, which is
contained in 21 CFR 1309.28, are continued for combination ephedrine
products.
The first new exemption applies to retail distributors of
combination ephedrine products. A single transaction limit of 24 grams
has been established by the MCA for combination ephedrine products in
retail distributions. Consistent with previous proposals regarding the
regulation of retail distributions of drug products that contain List I
chemicals, DEA is temporarily exempting retail distributors from the
registration requirement. This interim rule is subject to public
comment. Under this exemption, retail distributors will not be required
to obtain a registration if they engage exclusively in distributions of
combination ephedrine products below the 24 gram limit in a single
transaction for legitimate medical use either directly to walk-in
customers or in face-to-face transactions by direct sales. This
exemption is set out in the new section 21 CFR 1309.29. Retail
distributors that operate under this exemption are reminded that they
will be subject to civil penalties for violations of the 24 gram single
transaction limit, as set out in Section 401(f)(2) of the MCA.
The second exemption applies to those persons (other than retail
distributors, as described above, or persons subject to the existing
exemptions regarding CSA registrants and prescription drug products)
who are required to obtain a registration. Any such person who submits
an application for registration for activities involving combination
ephedrine products on or before May 12, 1997 will be exempt from the
registration requirement for their lawful activities with combination
ephedrine products until the Administration has taken final action with
respect to that application. This exemption is set out in 21 CFR
1310.09.
DEA recognizes that, unlike the second exemption, which provides a
general benefit to all affected persons, the first exemption is limited
in its benefit. Therefore, while the regulatory changes in this interim
rule take effect upon publication, the notice is open for public
comment or objection until May 12, 1997. Further, the exemptions are
temporary and may be subject to change, based on the comments or
objections received.
The Deputy Assistant Administrator for the Office of Diversion
Control hereby certifies that this interim rulemaking will not have a
significant economic impact upon a substantial number of entities whose
interests must be considered under the Regulatory Flexibility Act, 5
U.S.C. 601 et seq. This interim rulemaking is an administrative action
to make the regulations consistent with the law and to avoid
interruption of legitimate commerce by granting temporary exemptions
from registration pending promulgation, through notice and comment, of
the regulations necessary to implement the provisions of the MCA
pertaining to combination ephedrine products. Further, since this is a
temporary action which provides affected persons with a means to comply
with the law pending promulgation of regulations implementing the MCA,
this action is
[[Page 5916]]
not a significant regulatory action and therefore has not been reviewed
by the Office of Management and Budget pursuant to Executive Order
12866. Consideration of the significance and impact of the new
requirements of the MCA will be addressed as part of a future proposed
rulemaking by DEA proposing regulations to implement the MCA.
This action has been analyzed in accordance with the principles and
criteria in Executive Order 12612, and it has been determined that this
interim rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.
List of Subjects
21 CFR Part 1309
Administrative practice and procedure, Drug traffic control, List I
and List II chemicals, Security measures.
21 CFR 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
21 CFR Part 1313
Drug traffic control, Exports, Imports, list I and List II
chemicals, Transshipment and in-transit shipments.
For the reasons set out above, 21 CFR Parts 1309, 1310, and 1313
are to be amended as follows:
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS
AND EXPORTERS OF LIST I CHEMICALS
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 1309.29 is added to read as follows:
Sec. 1309.29 Exemption of retail distributors of combination ephedrine
drug products.
The requirement of registration is waived for any retail
distributor whose activities with respect to List I chemicals are
restricted to the distribution of below-threshold quantities of a
combination ephedrine drug product in a single transaction to an
individual for legitimate medical use. The threshold for a distribution
of a combination ephedrine drug product in a single transaction to an
individual for legitimate medical use is 24 grams of ephedrine base.
2. Section 1309.43 is amended by revising paragraph (d) and adding
a new paragraph (e) to read as follows:
Sec. 1309.43 Suspension or revocation of registration.
* * * * *
(d) Upon service of the order of the Administrator suspending or
revoking registration, the registrant shall immediately deliver his or
her Certificate of Registration to the nearest office of the
Administration. Also, upon service of the order of the Administrator
revoking or suspending registration, the registrant shall, as
instructed by the Administrator:
(1) Deliver all List I chemicals in his or her possession that were
obtained under the authority of a registration or an exemption from
registration granted by the Administrator by regulation, to the nearest
office of the Administration or to authorized agents of the
Administration; or
(2) Place all such List I chemicals in his or her possession under
seal as described in section 304(f) of the Act (21 U.S.C. 824(f)).
(e) In the event that revocation or suspension is limited to a
particular chemical or chemicals, 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 for the new
Certificate of Registration. The registrant shall deliver the old
Certificate of Registration to the nearest office of the
Administration. Also, upon service of the order of the Administrator
revoking or suspending registration with respect to a particular
chemical or chemicals, 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 chemical
or chemicals in his or her possession that were obtained under the
authority of a registration or an exemption from registration granted
by the Administrator by regulation, which are affected by the
revocation or suspension; or
(2) Place all of such chemicals under seal as described in section
304(f) of the Act (21 U.S.C. 824(f)).
3. Section 1309.44 is amended by revising paragraph (b) to read as
follows:
Sec. 1309.44 Suspension of registration pending final order.
* * * * *
(b) Upon service of the order of immediate suspension, the
registrant shall promptly return his Certificate of Registration to the
nearest office of the Administration. Also, upon service of the order
of immediate suspension, 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 chemical
or chemicals in his or her possession that were obtained under the
authority of a registration or an exemption from registration granted
by the Administrator by regulation, which are affected by the
revocation or suspension; or
(2) Place all of such chemicals under seal as described in section
304(f) of the Act (21 U.S.C. 824(f)).
* * * * *
4. Section 1309.62 is to be amended by revising the existing text
and redesignating it as paragraph (a) and adding a new paragraph (b) to
read as follows:
Sec. 1309.62 Termination of registration.
(a) 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 cases legal existence or
discontinues business or professional practice shall promptly notify
the Special Agent in Charge of the Administration in the area in which
the person is located of such fact and seek authority and instructions
to dispose of any List I chemicals obtained under the authority of that
registration.
(b) The Special Agent in Charge shall authorize and instruct the
person to dispose of the List I chemical in one of the following
manners:
(1) By transfer to person registered under the Act and authorized
to possess the substances;
(2) By delivery to an agent of the Administration or to the nearest
office of the Administration;
(3) By such other means as the Special Agent in Charge may
determine to assure that the substance does not become available to
unauthorized persons.
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
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 amended by revising paragraphs (f)(1)(iv)(A)
and (B) redesignating paragraphs (g) through (l) as paragraphs (h)
through (m), redesignating paragraph (m) as paragraph (o), and adding
new paragraphs (g) and (n) to read as follows:
Sec. 1310.01 Definitions.
* * * * *
(f) * * *
(1) * * *
[[Page 5917]]
(iv) * * *
(A) (1) the drug contains ephedrine or its salts, optical isomers,
or salts of optical isomers; or
(2) The Administrator has determined pursuant to the criteria in
1310.10 that 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
(B) 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.
* * * * *
(g) The term combination ephedrine product means a drug product
containing ephedrine or its salts, optical isomers, or salts of optical
isomers and therapeutically significant quantities of another active
medicinal ingredient. The term ``therapeutically significant
quantities'' shall apply if the product formulation (i.e., the
qualitative and quantitative composition of active ingredients within
the product) is listed in 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 listed in Sec. 1310.15 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 whether the active medicinal ingredients are
present in quantities considered therapeutically significant for
purposes of this paragraph.
* * * * *
(n) The term retail distributor means a grocery store, general
merchandise store, drug store, or other entity or person whose
activities as a distributor relating to drug products containing
pseudeophedrine, phenylpropanolamine, or ephedrine are limited almost
exclusively to sales for personal use, both in number of sales and
volume of sales, either directly to walk-in customers or in face-to-
face transactions by direct sales. For the purposes of this paragraph,
sale for personal use means the distribution of below-threshold
quantities in a single transaction to an individual for legitimate
medical use. Also for the purposes of this paragraph, a grocery store
is an entity within Standard Industrial Classification (SIC) code 5411,
a general merchandise store is an entity within SIC codes 5300 through
5399 and 5499, and a drug store is an entity within SIC code 5912.
* * * * *
3. Section 1310.02 is amended by revising paragraphs (a)(16) and
(a)(21) to read as follows:
Sec. 1310.02 Substances covered.
* * * * *
(a) * * *
(16) Isosafrole.................................................. 8704
* * * * *
(21) Hydriodic Acid.............................................. 6695
* * * * *
4. Section 1310.04 is amended by revising paragraph (a) to read as
follows:
Sec. 1310.04 Maintenance of records.
(a) Every record required to be kept subject to Sec. 1310.03 for a
List I chemical, a tableting machine, or an encapsulating machine shall
be kept by the regulated person for two years after the date of the
transaction.
* * * * *
5. Section 1310.09 is revised to read as follows:
Sec. 1310.09 Temporary exemption from registration.
Each person required by section 302 of the Act (21 U.S.C. 822) to
obtain a registration to distribute, import, or export an combination
ephedrine product is temporarily exempted from the registration
requirement, provided that the person submits a proper application for
registration on or before May 12, 1997. The exemption will remain in
effect for each person who has made such application until the
Administration has approved or denied that application. This exemption
applies only to registration; all other chemical control requirements
set forth in parts 1309, 1310, and 1313 of this chapter remain in full
force and effect.
PART 1313--IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL
CHEMICALS
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 amended by revising paragraphs (d)(1)(iv)(A)
and (B), to read as follows:
Sec. 1313.02 Definitions.
* * * * *
(d) * * *
(1) * * *
(iv) * * *
(A)(1) the drug contains ephedrine or its salts, optical isomers,
or salts of optical isomers; or
(2) The Administrator has determined pursuant to the criteria in
1310.10 that 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
(B) 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.
* * * * *
Dated: January 28, 1997.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 97-3086 Filed 2-7-97; 8:45 am]
BILLING CODE 4410-09-M
