Practices and organizations offering MAT services must follow all Federal and State laws and regulations related to ordering, storage, administration, and dispensing of medications to treat opioid use disorder. Proper records should be maintained that reflect the program’s compliance with these laws.
The information provided in this Playbook regarding regulations is not intended to be a comprehensive discussion and these may change after publication. Practices should do their own due diligence to ensure compliance with all Federal, State, and local laws and consult with legal counsel when necessary.
Professional Licensure and Certification. Practices offering office-based treatment for opioid use disorders may be subject to additional regulations by State medical boards. These may vary by State, although the Federation of State Medical Boards developed a Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office (PDF—280 KB).
Physicians, nurse practitioners, and physician assistants who have received their Drug Addiction Treatment Act of 2000 (DATA 2000) waivers to prescribe buprenorphine should ensure ongoing compliance with all requirements associated with those waivers, including adhering to patient limits. Learn more about buprenorphine waiver management.
States may have additional laws or licensing requirements that restrict physicians assistants and nurse practitioners’ ability to prescribe medications to treat opioid use disorder. For example, they may impose limits on nonphysician prescribers, such as the ages of patients to whom these medications may be prescribed, duration of the prescriptions, supervisory requirements, and settings in which they may be prescribed.4
Code of Federal Regulations. The Diversion Control Division of the Drug Enforcement Agency (DEA) recommends providers who are authorized to prescribe, administer, and dispense approved schedule III-V controlled substances to treat opioid use disorder refer to the following sections of the Code of Federal Regulations5:
- Individuals required to keep records and file reports—21 CFR 1301.28(d)(3), 1304.03(c), 1304.03(d), 1304.22(c), and 1306.05(a)
- Maintenance of records, reports, and inventories—21 CFR 1304.04 and 1304.11
- Security—21 CFR 1301.71, 1301.75(b), and 1301.76
- Thefts involving controlled substance—21 CFR 1301.76(b)
- Disposal of controlled substances—21 CFR 1307.21
DEA Inspections. The DEA is responsible for ensuring prescribing providers are in compliance with regulations related to recordkeeping, security, and other requirements under the Controlled Substances Act. The DEA will hold routine, unannounced inspections to ensure providers are following all regulations related to recordkeeping and security. During an inspection, the DEA will look at records for patients being prescribed buprenorphine.6 Logs for DEA inspections should include patient names or identification numbers, dates of prescriptions, and details of the medication prescribed.6
Programs Dispensing Medications to Treat Opioid Use Disorder. The DEA also will conduct an audit to determine accountability of the controlled substance received and dispensed.6 This audit is considered one component of a larger DEA inspection process. Records should include the number of units and doses dispensed (with names and addresses of patients), dates medications were dispensed, and names of staff responsible for dispensing or administering the medications.7
Learn about record-related requirements and How To Prepare for a Visit From the DEA Regarding Buprenorphine Prescribing (PDF—390 KB). Providers Clinical Support System has also collected links to regulations to which DEA agents refer (PDF—100 KB) in the inspection process and a sample drug accountability record (PDF—150 KB) and buprenorphine prescription log (PDF—130 KB).