[Federal Register Volume 59, Number 96 (Thursday, May 19, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12173]
[[Page Unknown]]
[Federal Register: May 19, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1306
Presriptions--Transmission by Facsimile
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The DEA amends its regulations to allow for the transmission
of controlled substance prescriptions between the prescriber and the
dispenser via facsimile. This change will facilitate the delivery of
medication in situations where medication needs change quickly and
physicians' orders need to be communicated rapidly.
EFFECTIVE DATE: May 19, 1994.
FOR FURTHER INFORMATION CONTACT:
G. Thomas Gitchel, Chief, Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement Administration, Washington, DC
20537, telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION: A notice of proposed rulemaking was
published in the Federal Register on September 23, 1993 (58 FR 49453).
This rule allows for the transmission of written prescriptions by a
practitioner to the dispensing pharmacy by facsimile. All conditions
specified under 21 CFR 1306.05 regarding the manner in which a
prescription must be prepared, shall apply to prescriptions generated
via facsimile.
By virtue of this rule, DEA recognizes the practice of transmitting
a Schedule II prescription from the prescriber to the pharmacy by means
of facsimile, but requires that the original written prescription be
presented and verified against the facsimile at the time the substances
are actually dispensed, and that the original document be properly
annotated and retained for filing. Two exceptions to this requirement
are granted.
The first exception involves pharmacies providing home infusion/
intravenous (I.V.) pain therapy. Prescriptions for home infusion/I.V.
pain therapy may be transmitted by the practitioner or the
practitioner's agent to the home infusion pharmacy by facsimile and
they may be considered ``written prescriptions'' as required by 21
U.S.C. 829(a). In other words, in the case of home (or hospice)
infusion/I.V. pain therapy, it is not necessary for the original
prescription to be delivered to the pharmacy either prior to or
subsequent to the delivery of the medication to the patient's home. The
facsimile copy of the prescription shall be retained as the original
document by the home infusion pharmacy and it must contain all
information required by 21 CFR 1306.05(a) including the date issued,
full name and address of the patient, name, address, DEA registration
number and signature of the practitioner.
The exception to the regulations for home infusion/I.V. therapy is
intended to facilitate the means by which home infusion pharmacies
obtain prescriptions for patients requiring the frequently modified
parenteral controlled release administration of narcotic substances,
but does not extend to the dispensing of oral dosage units of
controlled substances. By facilitating the process by which such
prescriptions are communicated, the need to treat them as ``emergency
prescriptions'' as defined by 21 CFR 1306.11(d), which presently
requires that a Schedule II emergency prescription be limited to an
amount for the duration of the emergency, will be substantially
eliminated. This exception will also facilitate the delivery of
medication to the terminally ill in non-hospital settings were
medication needs change quickly and physicians' orders need to be
communicated rapidly.
The second exception applies to Schedule II prescriptions written
for patients in Long Term Care Facilities (LTCF) which are filled by
and delivered to the facility by a pharmacy. A prescription for any
controlled substance in Schedule II written for a patient in a LTCF may
be transmitted by facsimile by the practitioner or the practitioner's
agent to the dispensing pharmacy and may be considered ``written
prescriptions'' as required by 21 U.S.C. 829(a). The facsimile copy of
the prescription shall be retained as the original document by the
dispensing pharmacy and it must contain all information required by 21
CFR 1306.05(a) including the date issued, full name and address of the
patient (the address shall indicate that the location is a LTCF), name,
address, DEA registration number and signature of the practitioner. By
facilitating the process by which prescriptions are communicated, the
need to treat them as ``emergency prescriptions'' as defined by 21 CFR
1306.11(d), which presently requires that a Schedule II emergency
prescription be limited to an amount for the duration of the emergency,
will be substantially eliminated. This exception will also facilitate
the delivery of medication to patients in LTCF settings where
medication needs change quickly and physicians' orders need to be
communicated rapidly.
Under current regulations, a pharmacist bears the responsibility
for ensuring that prescriptions for controlled substances have been
issued for a legitimate medical purpose by an individual practitioner
acting in the usual course of this professional practice pursuant to 21
CFR 1306.04(a). Orders purporting to be prescriptions, which are not
issued in the usual course of professional treatment, are not
considered prescriptions within the meaning and intent of the
Controlled Substances Act and a person who issues or fills such an
order shall be subject to penalties provided by law. That
responsibility applies equally to an order transmitted by facsimile.
Therefore, this rule should not constitute an increased potential for
the diversion of controlled substances. In exercising professional
judgment, a pharmacist must take adequate measures to guard against the
diversion of controlled substances through prescription forgeries. Some
measures to be considered in authenticating prescriptions received via
facsimile equipment would include maintenance of a practitioner's
facsimile number reference file, verification of the telephone number
of the originating facsimile equipment and/or telephone verification
with the practitioner's office that the prescription was both written
by the practitioner and transmitted by the practitioner or the
practitioner's agent. Although such measures parallel efforts currently
employed in verifying the authenticity of prescriptions transmitted by
traditional means, the requirement of this rule places an additional
responsibility on the pharmacist to take efforts to ensure that the
facsimile has been initiated by the prescriber.
DEA received 26 comments on the proposed rule. Of these, seven
support the proposed rule as written and 19 support the proposed rule
with clarification or minor change. Commentors expressed concern in the
following general areas. Seven comments were concerned with the problem
of allowing the facsimile prescription to be dispensed only by a
``consulting'' pharmacy as proposed in 21 CFR 1306.11(f) and suggested
that other categories of pharmacies also be allowed to dispense
controlled substances based upon facsimile prescriptions. Six submitted
alternatives: (1) Consulting or provider pharmacy, (2) provider
pharmacy, (3) dispensing or provider pharmacy, (4) pharmacy with which
the facility has a contract or agreement, (5) pharmacy dispensing
medications to the facility and (6) providing pharmacy.
DEA has changed ``consulting'' pharmacy to ``dispensing'' pharmacy
in the final rule. It was found that many facilities utilize more than
one pharmacy on a regular basis. Although some state laws require that
each facility must have a consultant pharmacist, the individual may not
be affiliated with the pharmacy actually dispensing medications.
Restricting the process to consulting pharmacies would not facilitate
the process for those facilities whose dispensing pharmacy and
consulting pharmacy are different.
DEA received three comments on the definition of LTCF. One
commentor suggested including facilities such as nursing homes or
facilities, residential care facilities and mental and correctional
institutions in the definition. Another commentor suggested including
the term ``or hospice setting''. The third commentor suggested
including skilled nursing homes, personal care homes and adult care
facilities as closed system environments in the definition. DEA
maintains that the existing definition of lTCF, currently found in 21
CFR 1306.02(e), adequately addresses the facilities that should be
included. The definition includes a nursing home, retirement care,
mental care or other facility or institution which provides extended
health care to resident patients.
One commentor pointed out a lack of consistency concerning the use
of the terms physician, practitioner, prescriber, and prescribing
practitioner throughout the proposed rule. It was further suggested
that DEA standardize or clarify the term prescribing practitioner by
mentioning physicians and mid-level practitioners.
DEA acknowledges the inconsistency. The term practitioner will be
used in the final rule. Pursuant to 21 U.S.C. 823(f), DEA registers
practitioners which includes Mid-Level Practitioners (MLPs) if the
applicant is authorized to dispense controlled substances by the state
in which he/she practices. No further clarification is warranted. This
term is defined in 21 U.S.C. 802(21) and 21 CFR 1304.02 (d) and is
consistently used throughout the statutes and regulations of Title 21
of the Controlled Substances Act.
Two commentors suggest adding information on the prescription prior
to faxing such as: ``faxed to'' to void the prescription for reuse.
This was considered prior to publishing the proposed rule. While DEA
agrees with and encourages this practice as a deterrent to sending the
same document several times, the ease of getting around the requirement
does not justify its addition to the rule. If such information were
required but was not transmitted in the facsimile, the dispensing
pharmacist would be forced to seek the information before dispensing
the controlled substance, thus adding delay to the process, which is
contrary to the intent of the regulation.
Four comments concern the Schedule II restriction of only allowing
oral prescription under emergency situations pursuant to the conditions
set forth in 21 CFR 1306.11(d). Two commentors state that no schedule
II's should be faxed. Two commentors disagree with the Schedule II
restriction, one of these two commentors suggests that the prescription
could be delivered within 5 days after the faxed original.
Since Schedule II controlled substances have the highest potential
for abuse, extra care and diligence must be employed with these
substances. The diversity in the comments received, both positive and
negative, reflect the dichotomy between availability and adequate
controls. Having studied the comments, DEA feels that the original
proposal struck an appropriate balance for Schedule II prescriptions
and provides the necessary controls while still allowing for the rapid
delivery of the controlled substances.
Three comments address the issue of what administration methods
should be permitted for purposes of the proposed definition of ``home
infusion pharmacy'' and of the proposed exception which allows a
Schedule II facsimile to serve as the original written prescription
pursuant to 21 CFR 1306.02(h) and 1306.11(e). One commentor suggests
including intramuscular and oral dosage unit. A second commentor
suggests allowing oral dosage unit dispensing in the same manner as
Schedule III and IV prescriptions. The third commentor suggests oral
dosage unit for terminally ill regardless of the care setting.
Dispensing of oral dosage forms for the terminally ill has been
previously addressed in 21 CFR 1306.13. However, intramuscular has been
added to the final rule. DEA was advised by health care professionals
that intramuscular administration is one form of administration
utilized when repeated doses are required.
Four comments addressed the issue of expanding the term prescriber
to include a prescriber's ``agent'' for purposes of defining who is
allowed to transmit a facsimile prescription under 21 CFR 1306.11(a).
Two suggest using ``practitioner's agent'' instead. Two suggest
including ``prescriber'' or ``agent''. DEA agrees with the commentors
that the proposal unintentionally implied that every practitioner would
have to personally fax the prescription. Therefore, the language has
been amended to include the faxing by the practitioner's agent.
One commentor suggests that due to fading of certain types of
facsimile paper DEA should allow copying. DEA is concerned about the
quality of the copy and its durability. It is the intent of this rule
that if a facsimile copy is retained as the original record it must
satisfy the same record-keeping requirements as an original paper
record. The facsimile copy must be maintained as a complete and
accurate record for the record-keeping time limit of two years pursuant
to 21 CFR 1304.04(a). A facsimile which can fade and deteriorate before
the record-keeping time limit is reached would not be acceptable as the
original record.
Two comments suggested that the phrase ``administer and dispense
(but not prescribe)'' be changed by deleting the prohibition against
prescribing by the institutional practitioner as proposed in
Secs. 1306.21(c) and 1306.31(c). The proposed regulations address the
situations where an individual practitioner or his agent (as opposed to
an institutional practitioner such as a hospital) transmits a written
instrument, a facsimile or an oral order. Hence, it would be confusing
to delete the phrase ``(but not prescribe)'' because it would indicate
that the institutional practitioner had the authority to prescribe
based upon a prescription already issued by an individual practitioner.
The current regulations do address the general circumstances under
which practitioners and exempted persons are allowed to dispense,
administer or prescribe in 21 CFR 1301.24. A proposal will be drafted
in the near future to amend Sec. 1301.24 which should clarify any
current ambiguities in Secs. 1306.21(c) and 1306.31(c).
One comment was received concerning an inconsistency in the use of
the phrases ``transmitted from'', ``transmitted directly by'', and
``transmitted by''. DEA realized that there was an inconsistency. In
section 1306.11, as proposed, ``transmitted from'' and ``transmitted
directly from'' were used and in Secs. 1306.21 and 1306.31, as
proposed, ``transmitted directly by'' was used. For clarity and
consistency ``transmitted by'' will be used for the final rule.
The Deputy Assistant Administrator, Office of Diversion Control,
hereby certifies that this rule will have no significant impact upon
entities whose interests must be considered under the Regulatory
Flexibility Act, 5 U.S.C. 601 et seq. This rule is not a significant
regulatory action and therefore has not been reviewed by the Office of
Management and Budget pursuant to Executive Order 12866.
This action has been analyzed in accordance with the principles and
criteria in Executive Order 12612 and it has been determined that the
rule does not have sufficient federalism implications to warrant the
preparation of a Federalism Assessment.
List of Subjects in 21 CFR 1306
Drug traffic control, Prescriptions.
For reasons set out above, 21 CFR 1306 is amended as follows:
PART 1306--[AMENDED]
1. The authority citation for Part 1306 continues to read as
follows:
Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.
2. Section 1306.02 is amended by redesignating the current
paragraph (h) as paragraph (i) and adding a new paragraph (h) to read
as follows:
Sec. 1306.02 Definitions.
* * * * *
(h) The term home infusion pharmacy means a pharmacy which
compounds solutions for direct administration to a patient in a private
residence, Long Term Care Facility or hospice setting by means of
parenteral, intravenous, intramuscular, subcutaneous or intraspinal
infusion.
* * * * *
3. Section 1306.11 is amended by revising paragraph (a) and by
adding new paragraphs (e) and (f) as follows:
Controlled Substances Listed in Schedule II
Sec. 1306.11 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance in
Schedule II, which is prescription drug as determined by 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 agency to a
pharmacy via facsimile equipment, provided 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) or (f) of this section. The original prescription shall
be maintained in accordance with Sec. 1304.04(h).
* * * * *
(e) A prescription prepared in accordance with Sec. 1306.05 written
for a 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 home infusion 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).
(f) A prescription prepared in accordance with Sec. 1304.05 written
for Schedule II substance for a resident of a Long Term Care Facility
may be transmitted by the practitioner or the practitioner's agent to
the dispensing pharmacy by facsimile. The facsimile serves as the
original written prescription for purposes of this paragraph (f) and it
shall be maintained in accordance with Sec. 1304.04(h).
* * * * *
4. Section 1306.21 is amended by revising paragraphs (a) and (c) as
follows:
Controlled Substances Listed in Schedules III and IV
Sec. 1306.21 Requirement of prescription.
(a) A pharmacist may dispense directly a controlled substance
listed in Schedule III or IV, 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.
* * * * *
(c) An institutional practitioner may administer or dispense
directly (but not prescribe) a controlled substance listed in Schedules
III or IV only pursuant to 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 Sec. 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.
* * * * *
5. Section 1306.31 is amended by revising paragraph (c) as follows:
Controlled Substances Listed in Schedule V
Sec. 1306.31 Requirement of prescription.
* * * * *
(c) An institutional practitioner may administer or dispense
directly (but not prescribe) a controlled substance listed in Schedule
V only pursuant to a written prescription signed by an individual
practitioner, or pursuant to a facsimile of a written prescription
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
Sec. 1306.05 except for the signature of the 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.
Dated: May 10, 1994.
Gene R. Haislip,
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration.
[FR Doc. 94-12173 Filed 5-18-94; 8:45 am]
BILLING CODE 4410-09-M
