when Subutex and Suboxone may be administered by a practitioner without the DATA 2000 waiver?
Under the Narcotic Addiction Treatment Act of 1974, all practitioners who use narcotic drugs for treating opiate addiction must obtain a separate registration under 21 U.S.C. Section 823(g)(1) or a DATA 2000 Waiver under 21 U.S.C. Section 823(g)(2). However, according to the Drug Enforcement Administration (DEA), an exception to the registration requirement, known as the “three-day rule” (Title 21, Code of Federal Regulations, Part 1306.07(b)), allows a practitioner who is not separately registered as a narcotic treatment program or certified as a “waivered DATA 2000 physician,” to administer (but not prescribe) narcotic drugs to a patient for the purpose of relieving acute withdrawal symptoms while arranging for the patient’s referral for treatment, under the following conditions: 1) not more than one day’s medication may be administered or given to a patient at one time? 2) this treatment may not be carried out for more than 72 hours? and 3) this 72hour period cannot be renewed or extended. The intent of 21 CFR 1306.07(b) is to provide practitioner flexibility in emergency situations where he or she may be confronted with a patient undergoing withdrawal. In such emergencies, it is impractical to require practitioners to obtain a separate registration. The 72-hour exception offers an opioid-dependent individual relief from experiencing acute withdrawal symptoms, while the physician arranges placement in a maintenance/detoxification treatment program.
This provision was established to augment, not to circumvent, the separate registration requirement. The three-day (72hour) emergency exception cannot be renewed or extended. Because this is a Drug Enforcement Administration (DEA) rule, for further details consult DEA. This information may be found at http://www.deadiversion.usdoj.
gov/drugreg/faq.htm More FAQ for the DEA by physicians about buprenorphine treatment. http://www.deadiversion.usdoj. gov/drugreg/faq.htm The National Alliance of Advocates for Buprenorphine Treatment www.naabt.org 71 Drug Enforcement Administration, Justice § 1306.07 and registration number of the practitioner. A practitioner may sign a prescription in the same manner as he would sign a check or legal document (e.g., J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written with ink or indelible pencil or typewriter and shall be manually signed by the practitioner. The prescriptions may be prepared by the secretary or agent for the signature of a practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law and regulations.
A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by these regulations. (b) An individual practitioner exempted from registration under § 1301.22(c) of this chapter shall include on all prescriptions issued by him or her the registration number of the hospital or other institution and the special internal code number assigned to him or her by the hospital or other institution as provided in § 1301.22(c) of this chapter, in lieu of the registration number of the practitioner required by this section. Each written prescription shall have the name of the physician stamped, typed, or handprinted on it, as well as the signature of the physician. (c) An official exempted from registration under § 1301.22(c) shall include on all prescriptions issued by him his branch of service or agency (e.g., ‘‘U.S. Army’’ or ‘‘Public Health Service’’) and his service identification number, in lieu of the registration number of the practitioner required by this section. The service identification number for a Public Health Service employee is his Social Security identification number. Each prescription shall have the name of the officer stamped, typed, or handprinted on it, as well as the signature of the officer. [36 FR 7799, Apr. 24, 1971, as amended at 36 FR 18733, Sept. 21, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 56 FR 25026, June 3, 1991; 60 FR 36641, July 18, 1995; 62 FR 13966, Mar. 24, 1997] § 1306.06 Persons entitled to fill prescriptions. A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner. § 1306.07 Administering or dispensing of narcotic drugs. (a) The administering or dispensing directly (but not prescribing) of narcotic drugs listed in any schedule to a narcotic drug dependent person for ‘‘detoxification treatment’’ or ‘‘maintenance treatment’’ as defined in section 102 of the Act (21 U.S.C. 802) shall be deemed to be within the meaning of the term ‘‘in the course of his professional practice or research’’ in section 308(e) and section 102(20) of the Act (21 U.S.C. 828 (e)): Provided, That the practitioner is separately registered with the Attorney General as required by section 303(g) of the Act (21 U.S.C. 823(g)) and then thereafter complies with the regulatory standards imposed relative to treatment qualification, security, records and unsupervised use of drugs pursuant to such Act. (b) Nothing in this section shall prohibit a physician who is not specifically registered to conduct a narcotic treatment program from administering (but not prescribing) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment.
Not more than one day’s medication may be administered to the person or for the person’s use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended. (c) This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or VerDate 112000 08:46 May 09, 2001 Jkt 194070 PO 00000 Frm 00071 Fmt 8010 Sfmt 8010 Y:\SGML\194070T.XXX pfrm13 PsN: 194070T 72 § 1306.11 21 CFR Ch. II (4–1–01 Edition) cure is possible or none has been found after reasonable efforts. [39 FR 37986, Oct. 25, 1974] CONTROLLED SUBSTANCES LISTED IN SCHEDULE II § 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 § 1304.04(h) of this chapter. (b) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his professional practice without a prescription, subject to § 1306.07. (c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user. (d) In the case of an emergency situation, as defined by the Secretary in § 290.10 of this title, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that: (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner); (2) The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in § 1306.05, except for the signature of the prescribing individual practitioner; (3) If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and (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 § 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 § 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 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 § 1304.04(h) of this chapter.