[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]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1306

 

Presriptions--Transmission by Facsimile

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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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