Authority for Practitioners To Dispense or Prescribe Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment

AGENCY:

Drug Enforcement Administration (DEA), Justice.

ACTION:

Final rule.

SUMMARY:

DEA is amending its regulations to allow qualified practitioners not otherwise registered as a narcotic treatment program to dispense and prescribe to narcotic dependent persons Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. This Final Rule is in response to amendments to the Controlled Substances Act by the Drug Addiction Treatment Act of 2000 (DATA) that are designed to expand and improve treatment of narcotic addiction. This Final Rule is intended to accomplish the goals of DATA while preventing the diversion of Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for maintenance/detoxification treatment.

DATES:

Effective Date: July 25, 2005.

FOR FURTHER INFORMATION CONTACT:

Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Technical Modification Regarding This Final Rule

In its Notice of Proposed Rulemaking (NPRM) proposing amendment of the regulations to implement the Drug Addiction Treatment Act of 2000, DEA proposed a new § 1301.27 of Title 21 of the Code of Federal regulations. Subsequent to publication of that NPRM, DEA published a Final Rule entitled “Preventing the Accumulation of Surplus Controlled Substances at Long Term Care Facilities” (70 FR 25462, May 13, 2005; Docket No. DEA-240, RIN 1117-AA75) which amended Title 21 by adding a new § 1301.27. Therefore, amendments regarding the Drug Addiction Treatment Act of 2000 which were proposed to be included in new § 1301.27 are being finalized at § 1301.28.

Background

On October 17, 2000, Congress passed the Drug Addiction Treatment Act of 2000 (DATA), amending the Controlled Substances Act (CSA) to establish “waiver authority for physicians who dispense or prescribe certain narcotic drugs for maintenance treatment or detoxification treatment” (Pub. L. 106-310, title XXXV; 114 Stat. 1222). Prior to DATA, the Controlled Substances Act and DEA regulations required practitioners who wanted to conduct maintenance or detoxification treatment using narcotic controlled drugs to be registered as a Narcotic Treatment Program (NTP) in addition to the practitioner's personal registration. The separate NTP registration authorized the practitioner to dispense or administer, but not prescribe, narcotic drugs.

With passage of DATA, DEA published a notice of proposed rulemaking (68 FR 37429, June 24, 2003) to amend the regulations affecting maintenance and detoxification treatment for narcotic treatment by establishing an exemption from the separate registration requirement.

This Final Rule will permit the following:

(1) Qualifying physicians to dispense and prescribe Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration (FDA) specifically for use in maintenance or detoxification treatment.

(2) Narcotic dependent patients to have one-on-one consultations with a practitioner in a private practice setting.

(3) Pharmacies to fill prescriptions for Schedule III, IV, and V narcotic controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment.

(4) Practitioners to offer maintenance and detoxification treatment to a limited number of patients in their private practices without having a second registration as a NTP.

The exemption and other amendments established by this Final Rule apply to individual practitioners working in traditional NTPs as well as any other practice setting. This rule does not affect the existing prohibition against prescribing any Schedule II narcotic controlled drugs for maintenance or detoxification treatment.

Conditions for Qualifying for an Exemption Under Section 1301.28

A practitioner who wishes to qualify for the exemption in new § 1301.28 must submit a notification of intent to dispense or prescribe narcotic controlled drugs to opiate-dependent patients to the U.S. Department of Health and Human Services (DHHS). In the notification the practitioner must certify that all of the 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 DHHS has established criteria to be used for determining whether a practitioner is a “qualifying physician.”

(2) The practitioner has the capacity to refer the patients, to whom the practitioner will provide specifically approved narcotic drugs or combinations of narcotic drugs, for appropriate counseling and other appropriate ancillary services.

(3) The total number of patients treated for opiate dependence by the practitioner who is not a member of a group practice will not exceed 30 at any one time, unless modified by regulation by the Secretary of DHHS.

(4) If the practitioner is a member of a group practice, the total number of patients treated for opiate dependence by the group practice of which the practitioner is a member will not exceed 30 at any one time, unless modified by regulation by the Secretary of DHHS.

The Schedule III, IV or V narcotic drugs or combination of narcotic drugs dispensed or prescribed by the practitioner must meet the following two conditions:

(1) The drugs are approved by FDA specifically for use in maintenance treatment or detoxification treatment.

(2) The drugs have not been the subject of an adverse determination by DHHS that their use requires additional standards respecting the qualifications of practitioners or the quantities of the drugs that may be provided for unsupervised use.

Agency Response To Notification and the Issuance of an Identification Number

When DHHS receives a notification of intent to dispense or prescribe narcotic controlled drugs for maintenance or detoxification treatment it will forward a copy of the notification to DEA. From the date DHHS receives the notification it will have up to 45 days to review the practitioner's qualifications and make a determination as to whether the practitioner meets all of the requirements for the exemption. While DHHS is conducting its determination, DEA will conduct its own review to determine if the practitioner has the appropriate DEA registration in accordance with 21 U.S.C. 823(f).

Once DHHS 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(f), 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 DHHS before the conclusion of the 45-day review period, or (2) the 45-day review period has concluded and no DHHS determination has been received.

If HHS denies certification to a practitioner or withdraws a 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 § 1301.28(d) the practitioner is required to include the identification number on all records when dispensing and on all prescriptions when prescribing Schedule III, IV, or V narcotic controlled drugs for use in maintenance or detoxification treatment.

Exception to the 45-Day Review Period

The practitioner does not have to wait for receipt of an identification number from DEA if the practitioner is in compliance with § 1301.28(e). The practitioner can 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 § 1301.28(b).

(2) The practitioner reasonably believes that the conditions specified in § 1301.28(b) and (c), regarding the practitioner and the narcotic drugs, have been met.

(3) The practitioner reasonably believes that prescribing or dispensing the narcotic drugs would facilitate the treatment of an individual patient.

(4) The practitioner has notified both DHHS and DEA of the intent to do so.

(5) DHHS has not notified the registrant that he or she is not a qualifying physician.

(6) The practitioner has the appropriate DEA registration under 21 CFR 1301.13.

The practitioner may satisfy the fourth requirement by including within the notification required by § 1301.28(b) a statement of his or her intent to immediately commence prescribing or dispensing. If DHHS refuses to certify a practitioner or withdraws a 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.

Violation of Section 1301.28(b)

If a practitioner dispenses or prescribes Schedule III, IV, or V narcotic drugs in violation of any of the conditions specified in § 1301.28(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 dependent persons Schedule III, IV, and V narcotic controlled drugs approved by the FDA specifically for use in maintenance or detoxification treatment.

Practitioners in Traditional NTPs Treated the Same as Practitioners in Other Practice Settings

This Final Rule affects practitioners working in traditional NTPs the same as any other practitioners. Prior to this final rule, practitioners, whether in a traditional NTP or any other setting, were not permitted to prescribe Schedule III, IV, and V narcotic controlled drugs for use in maintenance or detoxification treatment. This Final Rule applies to any “qualifying physician,” working in a NTP or other setting, who wants to dispense or prescribe Schedule III, IV, and V narcotic controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment. However, as discussed further below, since narcotic treatment programs are not permitted to prescribe controlled substances, if a physician working at a narcotic treatment program wishes to prescribe Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment, then the physician must register separately as an individual practitioner with DEA and obtain a waiver pursuant to 21 CFR 1301.28 to conduct such treatment. The practitioner would not issue such prescriptions under the narcotic treatment program's DEA registration.

Additional Requirements

Section 1306.05(a) requires the practitioner to include on the prescription the identification number (issued under § 1301.28(d)) or written notice that the practitioner is acting under the good faith exception of § 1301.28(e). These prescriptions will be subject to all of the existing requirements of part 1306 that apply to prescriptions for controlled substances. 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 as of, 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 existing 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 substances 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 drugs, have been amended by this Final Rule. This Final Rule amends § 1306.04(c) to permit prescriptions for Schedule III, IV, and V narcotic controlled drugs approved by FDA specifically for maintenance or detoxification treatment by practitioners who are in compliance with § 1301.28.

Section 1306.07(a) permits the administering and dispensing (but not prescribing) of narcotic drugs for detoxification or maintenance treatment only by practitioners who are separately registered as a Narcotic Treatment Program. This Final Rule adds paragraph (d) to § 1306.07 to permit a practitioner to administer or dispense (including prescribe) any Schedule III, IV, or V narcotic controlled drug approved by FDA specifically for use in maintenance or detoxification treatment if the practitioner is in compliance with § 1301.28. This Final Rule also revises § 1306.07(a) to improve the clarity of the language, as discussed in the Public Comments on the NPRM section below.

Refills

DEA regulations allow practitioners to authorize refills for Schedule III, IV, or V controlled substance prescriptions. Prescriptions for Schedule III, IV, and V controlled substances 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 drugs for use in maintenance or detoxification treatment are subject to all relevant State and Federal requirements that apply to prescriptions for controlled drugs.

Other Relevant Requirements Not Affected by the Final Rule

Practitioners who administer or dispense (other than by prescription) Schedule III, IV, or V narcotic drugs approved by FDA specifically for maintenance or detoxification treatment must maintain records and provide security for the controlled drugs in their possession. Records required to be maintained include inventories, records of receipt, reports of theft or loss, destruction of controlled drugs, and records of dispensing. These records must be maintained for two years.

The regulations also require practitioners to safeguard controlled drugs (§ 1301.75(b)). The Schedule III, IV, or V narcotic controlled drugs approved by FDA specifically for maintenance or detoxification treatment must be stored in a securely locked, substantially constructed cabinet.

Regulations on prescribing allow the use of a written prescription signed by a practitioner, or a facsimile of a written prescription signed by a practitioner, transmitted by the practitioner, or the practitioner's agent, to the 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)).

Public Comments on the NPRM

DEA received six comments in response to the proposed rule. Commenters included community health centers, hospitals, an industry association, and the Center for Substance Abuse Treatment of the Department of Health and Human Services (CSAT). While the commenters supported the general intent of the rule, they also requested changes to certain aspects of the rule. The following discussion summarizes the issues raised by commenters and DEA's response to these issues.

Practitioners Other Than Physicians

Three commenters requested that the rule be modified to permit mid-level practitioners, including physician assistants, nurse practitioners and, where states permit, pharmacists, who meet the appropriate training and certification criteria to be deemed “qualifying physicians” and, thus, to be able to prescribe Schedule III, IV and V narcotic controlled drugs for maintenance or detoxification treatment.

DEA Response: The final rule has not been modified to allow mid-level practitioners, such as pharmacists, nurse practitioners, and physician assistants to prescribe Schedule III, IV, and V substances for substance abuse treatment. In DATA Congress specified that physicians may prescribe these substances. This final rule is also consistent with the rules and policies of CSAT.

30 Patient Limit

One commenter expressed concern regarding the 30 patient limit, stating that it was difficult to treat all patients served by the facility without experiencing problems with this limit.

DEA Response: The 30 patient limit is specifically referenced in the law (21 U.S.C. 823(g)(2)(iii) and (iv)) where it is referred to as the “applicable number”. The law specifically grants the Secretary of Health and Human Services the authority to change, by regulation, the applicable number. DEA does not have authority regarding the 30 patient limit, and, thus, is leaving the regulations unchanged.

Pharmacist Responsibilities

One commenter was concerned that pharmacists have the necessary information to ensure that a physician has made the good faith effort to obtain an identification number. The commenter also questioned whether the pharmacist is responsible for ensuring that only one patient is treated by the physician prior to receipt of the identification number. The commenter requested that DEA clarify in the final rule that pharmacists are not responsible for ensuring the “one patient” rule other than patients that the pharmacy serves.

Further, the same commenter questioned how the pharmacist will know if a physician goes over the 30 patient limit, and requested DEA clarify whether pharmacists would be responsible for enforcing this limit.

DEA Response: Pharmacists only need to be sure that the practitioner either has received an identification number or is claiming the good faith exception. Pharmacists are not responsible for ensuring that only one patient is treated by the practitioner prior to receipt of the identification number. The language in § 1301.28(e)(3) has been revised in the Final Rule to make this clear.

Pharmacists are also not covered by the 30-patient rule. Pharmacists are not required to investigate the validity of the practitioners' good faith claim nor their compliance with the 30-patient rule.

DEA wishes to note, however, that if a pharmacy becomes aware of circumstances in which it has reason to believe that a qualifying physician is violating either the good faith exception or the limit regarding the applicable number of patients which a qualifying physician is permitted to treat, DEA would expect the pharmacy to report this information to DEA as a matter of public interest.

The individual practitioner (physician) is responsible for compliance with the requirements of § 1301.28. The practitioner must submit to DHHS a separate notification letter for each patient the practitioner plans to treat under § 1301.28(e).

Physicians With Waivers

CSAT stated that it has received several inquiries from physicians with “waivers” who intend to treat patients in NTPs as well as other settings, including “drug-free” treatment programs. CSAT requested that the final rule should clarify that physicians with waivers do not need to register as NTPs to dispense buprenorphine products under the conditions set forth in DATA.

DEA Response: Individual practitioners with waivers do not need to register as NTPs to dispense buprenorphine products under the conditions set forth in DATA. These practitioners may treat patients in NTPs or other settings just as any other practitioner would in accordance with this Final Rule. Practitioners also must comply with all state requirements related to buprenorphine products, which may be more than DEA requirements.

DEA wishes to reiterate that narcotic treatment programs may administer or dispense directly, but not prescribe, narcotic drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment to narcotic dependent persons for maintenance or detoxification treatment. Thus, narcotic treatment programs may administer or dispense directly Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment. Narcotic treatment programs are not limited in the number of patients to whom they may administer or dispense directly these controlled substances. Such controlled substances, however, may not be prescribed. If a physician working at a narcotic treatment program wishes to prescribe Schedule III, IV, and V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment, then the physician must register separately as an individual practitioner with DEA and obtain a waiver pursuant to 21 CFR 1301.28 to conduct such treatment. The practitioner would not issue such prescriptions under the narcotic treatment program's DEA registration.

Records

CSAT stated that since the CSA defines practitioners to include pharmacies, it was unclear from the NPRM (68 FR 37432) whether pharmacies are required to maintain records of dispensation.

DEA Response: In the preamble to the NPRM the use of the word practitioners was referring to the individual practitioners (physicians) who administer or dispense Schedule III, IV, or V narcotic drugs approved by the FDA specifically for maintenance or detoxification treatment. In addition, pharmacies are required to maintain records of all controlled substance dispensing.

Written Notification

CSAT requested that the Final Rule should clarify when a written notification is necessary. CSAT recommended allowing all forms of notification submission for “good faith” waivers.

DEA Response: The Final Rule has been modified to clarify the circumstances in which notification must be provided in writing. The requirement for written notification is contained in the law and DEA, therefore, has no authority to permit other forms of notification.

Issuance of an Order

CSAT questioned the requirement in § 1301.28(e)(5), that states that DEA will issue a practitioner an identification number if “the Secretary has not issued an order indicating that the registrant is not qualified under paragraph (d) of this section.” CSAT stated that the limited review period does not permit sufficient time to issue “an order” to each physician with incomplete or deficient notifications. CSAT believed it should be sufficient to inform physicians of deficiencies by phone, fax, or letter. CSAT recommended that the language be revised to reflect “the Secretary has not notified the registrant that they are not qualified under paragraph (d) of this section.”

DEA Response: The Final Rule has been modified to remove the language specifying that the Secretary must issue an order indicating that the registrant is not qualified. The revised language states that the Secretary has not notified the registrant that he or she is not qualified.

Administering or Dispensing of Narcotic Drugs

CSAT indicated that the language in § 1306.07(a) should clarify that qualifying physicians would only be able to administer or dispense directly those schedule III, IV, or V narcotic drugs that meet the legislated criteria under DATA. This would not include narcotic drugs listed in schedule II.

DEA Response: DEA agrees with this comment and has clarified the language of § 1306.07(a)(2) to remove the reference to § 1301.28 so that paragraph (a)(2) now states that the practitioner is in compliance with DEA regulations regarding treatment qualifications, security, records, and unsupervised use of the drugs.

Regulatory Certifications

Regulatory Flexibility Act

The Deputy Assistant Administrator, Office of Diversion Control, has reviewed this regulation and hereby certifies that it has been drafted in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)) and that it will not have a significant economic impact on a substantial number of small entities. This rule permits practitioners to prescribe Schedule III, IV, and V narcotic controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment without being separately registered with DEA as a NTP. Although virtually all entities affected would be small, the cost of determining eligibility and applying for a waiver is negligible. Further, the ability to prescribe Schedule III, IV and V narcotic controlled substances specifically approved by FDA for maintenance/detoxification treatment to narcotic dependent persons is not required; physicians choosing to conduct this treatment do so voluntarily and choose to apply for the waiver.

Executive Order 12866

The Deputy Assistant Administrator further certifies that this rule has been drafted in accordance with the principles in Executive Order 12866 Section 1(b). DEA has determined that this is not a significant rulemaking action. Therefore, this action has not been reviewed by the Office of Management and Budget. As noted above, this rule permits practitioners to prescribe Schedule III, IV, and V narcotic controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment without being separately registered with DEA as a NTP.

Executive Order 12988

This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

This rule 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.

Unfunded Mandates Reform Act of 1995

This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $115,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

Small Business Regulatory Enforcement Fairness Act of 1996

This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign based companies in domestic and export markets.

List of Subjects

21 CFR Part 1301

• Administrative practice and procedure
• Drug traffic control
• Security measures

21 CFR Part 1306

• Drug traffic control
• Prescription drugs

For the reasons set out above, 21 CFR Parts 1301 and 1306 are amended as follows:

PART 1301—REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

1. The authority citation for part 1301 continues to read as follows:

Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 951, 952, 953, 956, 957.

2. Part 1301 is amended by adding § 1301.28 to read as follows:

PART 1306—PRESCRIPTIONS

3. The authority citation for Part 1306 continues to read as follows:

Authority: 21 U.S.C. 821, 829, 871(b), unless otherwise noted.

4. Section 1306.04 is amended by revising paragraph (c) to read as follows:

5. Section 1306.05 is amended by revising paragraph (a) to read as follows:

6. Section 1306.07 is amended by revising the section heading and paragraph (a) and adding paragraph (d) to read as follows: