Rules - Prior to 1998
[Federal Register Volume 59, Number 96 (Thursday, May 19, 1994)]
[Unknown Section] [Page 0]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 94-12173]
[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:
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.
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(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.
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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).
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(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).
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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.
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(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.
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5. Section 1306.31 is amended by revising paragraph (c) as follows:
Controlled Substances Listed in Schedule V
Sec. 1306.31 Requirement of prescription.
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(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
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