Source: https://www.federalregister.gov/documents/2003/06/24/03-15787/authority-for-practitioners-to-dispense-or-prescribe-approved-narcotic-opioid-controlled-substances
Timestamp: 2017-09-24 01:44:18
Document Index: 61784348

Matched Legal Cases: ['§\u20091301', '§\u20091301', '§\u20091301', 'ART 1301', 'ART 1306', '§\u20091301', '§\u20091306', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091306', '§\u20091301', '§\u20091301', 'art 1306', '§\u20091306', '§\u20091306', '§\u20091304', '§\u20091306', '§\u20091306', '§\u20091301', '§\u20091306', '§\u20091301', '§\u20091306', '§\u20091306', '§\u20091301', '§\u20091306', '§\u20091306', '§\u20091306', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u2009823', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301', '§\u20091301']

Federal Register :: Authority for Practitioners To Dispense or Prescribe Approved Narcotic (Opioid) Controlled Substances for Maintenance or Detoxification Treatment
A Proposed Rule by the Drug Enforcement Administration on 06/24/2003
Written comments must be postmarked on or before September 22, 2003.
37429-37434 (6 pages)
Docket No. DEA-202P
What Are the Conditions for Qualifying for the Proposed § 1301.27 Exemption From Separate Registration for Practitioners Dispensing or Prescribing Schedule III, IV, and V Narcotic Drugs Approved by FDA Specifically for Use in Maintenance or Detoxification Treatment?
What Will Happen After the Practitioner Submits to HHS the Notification Under Proposed § 1301.27 of Intent To Dispense or Prescribe Narcotic Drugs?
What Happens if a Practitioner Dispenses or Prescribes Schedule III, IV, or V Narcotic (Opioid) Drugs in Violation of One of the Conditions in Proposed § 1301.27(b)?
What Additional Requirements Would Apply When a “Qualifying Physician” Writes a Prescription for Schedule III, IV, and V Narcotic (Opioid) Drugs Approved by FDA Specifically for Maintenance or Detoxification Treatment?
PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES—[AMENDED]
PART 1306—PRESCRIPTIONS—[AMENDED]
https://www.federalregister.gov/d/03-15787 https://www.federalregister.gov/d/03-15787
DEA proposes to amend its regulations to allow qualified practitioners to dispense and prescribe to narcotic (opioid) dependent persons Schedule III, IV, and V narcotic (opioid) controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. These practitioners would not need to obtain a separate DEA registration as a narcotic treatment program to legally dispense or prescribe these drugs. Such practitioners, however, must be deemed “qualifying physicians” by the Secretary, Department of Health and Human Services. This notice of proposed rulemaking is in response to the recent amendments to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000 (DATA), title XXXV of the Children's Health Act of 2000 (Pub. L. 106-310), that are designed to expand and improve treatment of opioid addiction. The proposed regulations are intended to accomplish the goals of DATA while preventing the diversion of Schedule III, IV, and V narcotic (opioid) controlled drugs approved by the Food and Drug Administration specifically for maintenance/detoxification treatment.
Proposed § 1301.27 would establish an exemption from the separate registration requirement for qualified Start Printed Page 37430practitioners dispensing or prescribing Schedule III, IV, and V narcotic (opioid) controlled drugs approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment (see also proposed amendments to §§ 1306.04(c) and 1306.07). This NPRM would allow “qualifying physicians,” whether they are already registered as NTPs or not, to dispense and prescribe Schedule III, IV, and V narcotic (opioid) controlled drugs or combinations of controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment. (On October 8, 2002, FDA approved two products containing buprenorphine, subutex and suboxone, Schedule III controlled drugs, for use in maintenance and detoxification treatment.) Under this proposed rule, practitioners permitted to dispense and prescribe Schedule III, IV, and V narcotic (opioid) controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment would not be required to have separate DEA registrations as NTPs. DEA is taking this proposed action in conjunction with the Department of Health and Human Services' (HHS) adoption of the concept of Office-Based Opioid Treatment. Proponents believe that the changes proposed here would provide greater access to narcotic (opioid) addiction treatment, and permit expanded treatment services. This action also responds to the recent amendment to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000. This proposed rule would not affect the existing prohibition against prescribing any Schedule II narcotic (opioid) controlled drugs for maintenance or detoxification treatment.
During the late 1960s and the early 1970s, drug substitution therapy for addiction treatment using methadone was introduced as a medical modality and was considered “research,” that is, still outside the scope of “medical treatment.” At that time, medical and legal standards governing the use of methadone in addiction treatment programs did not exist. In effect, there were no clear means for differentiating legitimate treatment efforts using the drug as part of a comprehensive program of treatment services from bogus clinics or unethical practitioners distributing methadone to addicts under the guise of treatment. As a result the diversion of methadone was occurring on a large-scale basis.
Today treatment experts view addiction as a medical condition, which should be treated as a chronic disease, and believe that drug replacement therapy is a viable form of medical treatment for opioid dependent individuals. On October 17, 2000, Congress passed DATA, amending the Controlled Substances Act to establish “waiver authority for physicians who dispense or prescribe certain narcotic (opioid) drugs for maintenance treatment or detoxification treatment” (Pub. L. 106-310, title XXXV; 116 Stat. 1222). When the DATA bill was introduced in the United States Senate, it was described as follows:
Start Printed Page 37431
There are two main sets of conditions involved in the proposed exemption: Conditions with respect to the practitioner and conditions with respect to the Schedule III, IV, or V narcotic (opioid) drugs approved by FDA specifically for use in maintenance or detoxification treatment. To qualify for the proposed exemption, a practitioner would have to submit notification to HHS stating his or her intent to dispense or prescribe narcotic (opioid) controlled drugs to opiate-dependent patients and certifying that all of following are true:
(1) The practitioner is a “qualifying physician.” A practitioner is a “qualifying physician” if he or she is licensed under State law and has specific medical certification, training or experience in maintenance or detoxification treatment. The Secretary of HHS will establish criteria to be used for determining whether a practitioner is a “qualifying physician.”
Once HHS has made its determination, it will send the findings to DEA. If DEA determines that the practitioner has the appropriate DEA registration in accordance with 21 U.S.C. 823(a) and if there are no adverse determinations, then DEA will issue the practitioner an identification number as soon as either of the following conditions occurs: (1) DEA receives the positive determination from HHS before the conclusion of the 45 day review period, or (2) the 45 day review period has concluded and no determination by HHS has been received. If HHS refuses to certify a practitioner or withdraws such certification once it is issued, then DEA will not issue the practitioner an identification number, or will withdraw the identification number if one has been issued. Under proposed § 1301.27(d) the practitioner would be required to include the identification number on all records when dispensing and on all prescriptions when prescribing Schedule III, IV or V narcotic (opioid) controlled drugs for use in maintenance or detoxification treatment.
The practitioner would not have to wait if the practitioner was in compliance with proposed § 1301.27(e). As proposed, the practitioner could begin dispensing or prescribing during the 45-day review period if all of the following requirements are met:
(1) The practitioner has submitted, in good faith, a written notification under § 1301.27(b).
(2) The practitioner reasonably believes that the conditions specified in §§ 1301.27(b) and (c), regarding the practitioner and the narcotic (opioid) drugs, have been met.
The practitioner would be able to satisfy the fourth requirement by including within the notification required by proposed § 1301.27(b) a statement of his or her intent to immediately commence prescribing or dispensing. If HHS refuses to certify a practitioner or withdraws such certification once it is issued, then DEA will not issue the practitioner an identification number, or will withdraw the identification number if one has been issued.
If a practitioner dispenses or prescribes Schedule III, IV, or V narcotic (opioid) drugs in violation of any of the conditions specified in proposed § 1301.27(b), then DEA may revoke the practitioner's DEA registration in accordance with § 1301.36.
Due to the potential for diversion and in an effort to verify compliance with these regulations, DEA intends to conduct at least two regulatory investigations per field office per year of practitioners dispensing and prescribing to narcotic (opioid) dependent persons Schedule III, IV, and V narcotic (opioid) controlled drugs approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment.
The proposed regulation would affect practitioners working in traditional NTPs the same as any other practitioners. If a “qualifying physician” working in a NTP wants to dispense or Start Printed Page 37432prescribe Schedule III, IV, and V narcotic (opioid) controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment, then he or she would have to comply with the proposed regulations.
Proposed changes to § 1306.05(a) require the practitioner to include on the prescription the identification number (issued under proposed § 1301.27(d)) or written notice that the practitioner is acting under the good faith exception of proposed § 1301.27(e). These prescriptions would be subject to all of the existing requirements of Part 1306 that apply to prescriptions for controlled drugs. To be valid, a prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of his or her professional practice (§ 1306.04(a)). The prescription must be dated and signed on the day issued, must contain the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the name, address, and registration number of the practitioner (§ 1306.05(a)).
Under current law practitioners are not normally required to keep records of prescriptions issued. However, DEA regulations (§ 1304.03(c)) do require records to be kept by practitioners prescribing controlled drugs listed in any schedule for maintenance or detoxification treatment of an individual.
For conformity §§ 1306.04, Purpose of issue of prescription, and 1306.07, Administering or dispensing of narcotic (opioid) controlled drugs, would also be amended by this NPRM. Section 1306.04(c) currently prohibits the issuance of prescriptions for narcotic (opioid) drugs listed in any schedule for “detoxification treatment” or “maintenance treatment.” Under this NPRM, the prohibition against prescriptions in § 1306.04(c) would be amended to permit prescriptions for Schedule III, IV, and V narcotic (opioid) controlled drugs approved by FDA specifically for maintenance or detoxification treatment by practitioners who are in compliance with proposed § 1301.27.
Section 1306.07(a) currently permits the administering and dispensing (but not prescribing) of narcotic (opioid) drugs for detoxification or maintenance treatment only by practitioners who are separately registered as a Narcotic Treatment Program. This proposed rule would add paragraph (d) to § 1306.07 to permit a practitioner to administer or dispense (including prescribe) any Schedule III, IV, or V narcotic (opioid) controlled drug approved by FDA specifically for use in maintenance or detoxification treatment if the practitioner is in compliance with proposed § 1301.27. This NPRM would also revise § 1306.07(a) to improve the clarity of the language, but not to change the drug of the paragraph.
DEA regulations allow practitioners to authorize refills for Schedule III, IV, or V controlled drug prescriptions. Prescriptions for Schedule III, IV and V controlled drugs are subject to the requirements in §§ 1306.22 and 1306.23, regarding the refilling and partial filling of prescriptions. In addition, practitioners prescribing Schedule III, IV, or V narcotic (opioid) drugs for use in maintenance or detoxification treatment would be subject to all relevant state and federal requirements that apply to prescriptions for controlled drugs.
The regulations also require practitioners to safeguard controlled drugs (§ 1301.75(b)). The Schedule III, IV, or V narcotic (opioid) controlled drugs approved by FDA specifically for maintenance or detoxification treatment must be stored in a securely locked, substantially constructed cabinet.
Current regulations on prescribing permit the use of a written prescription signed by a practitioner. Current regulations also permit a practitioner, or the practitioner's agent, to transmit a facsimile of a written signed prescription to a pharmacy (§ 1306.21). In addition, a practitioner may telephone the pharmacy with an oral prescription. The pharmacist must immediately reduce the oral prescription to writing, including all information required in § 1306.05, except for the signature of the practitioner (§ 1306.21(a)).
This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have Federalism implications warranting the application of Executive Order 13132. Start Printed Page 37433
Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic (opioid) controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment.
(a) A practitioner may dispense or prescribe Schedule III, IV, or V narcotic (opioid) controlled drugs or combinations of narcotic (opioid) controlled drugs which have been approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment without obtaining the separate registration required by § 1301.13(e) so long as all of the following conditions are met:
(i) The practitioner is registered under § 1301.13 and is a “qualifying physician” as defined in section 303(g)(2)(G) of the Act (21 U.S.C. 823(g)(2)(G)).
(i) Notification as required under subparagraph (1) of this paragraph must be provided in writing, and must state the name of the practitioner and the registration number of the practitioner issued under § 1301.13.
(ii) If the practitioner is a member of a group practice, the names of the other practitioners in the group and the registration numbers issued to the other practitioners under § 1301.13 shall be provided.
(1) The drugs or combination of drugs have been approved for use in “detoxification treatment” or “maintenance treatment” under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.
(d) After receiving the notification submitted under paragraph (b) of this section, the Secretary of Health and Human Services will forward a copy of the notification to the Administrator. The Secretary of Health and Human Services will have 45 days from the date of receipt of the notification to make a determination of whether the practitioner involved meets all requirements for a waiver under § 823(g)(2)(B) of the Act (21 U.S.C. 823(g)(2)(B)). HHS will notify DEA of its determination regarding the practitioner. If the practitioner has the appropriate registration under § 1301.13 of this chapter, then the Administrator will issue the practitioner an identification number as soon as one of the following conditions occurs:
(1) The Administrator receives a positive determination from the Secretary of Health and Human Services before the conclusion of the 45-day review period, or
(1) The practitioner has submitted a notification under paragraph (b) of this section in good faith to the Secretary of Health and Human Services. Start Printed Page 37434
(6) The practitioner has the appropriate registration under § 1301.13 of this chapter. If HHS refuses to certify a practitioner or withdraws such certification once it is issued, then DEA will not issue the practitioner an identification number, or will withdraw the identification number if one has been issued.
(f) If a practitioner dispenses or prescribes Schedule III, IV, or V narcotic (opioid) drugs approved by FDA specifically for maintenance or detoxification treatment in violation of any of the conditions specified in § 1301.27(b) or (c), the Administrator may revoke the practitioner's registration in accordance with § 1301.36.
(c) A prescription may not be issued for “detoxification treatment” or “maintenance treatment,” unless the prescription is for a Schedule III, IV, or V narcotic (opioid) drug approved by FDA specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in § 1301.27 of this chapter.
(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and registration number of the practitioner. In addition, a prescription for a Schedule III, IV, or V narcotic (opioid) drug approved by FDA specifically for “detoxification treatment” or “maintenance treatment” must include the identification number issued by the Administration under § 1301.27(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of § 1301.27(e). 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.
Administering or dispensing of narcotic (opioid) drugs.
(d) A practitioner may administer or dispense (including prescribe) any Schedule III, IV or V narcotic (opioid) drug specifically approved by the Food and Drug Administration for use in maintenance or detoxification treatment to a narcotic (opioid) dependent person if the practitioner complies with the requirements of § 1301.27 of this chapter.