Implementation of the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018: Dispensing and Administering Controlled Substances for Medication-Assisted Treatment

What it is

This is a final rule from the Drug Enforcement Administration (part of the Justice Department) that updates federal drug regulations (21 CFR parts 1300, 1301, and 1306). It finalizes parts of a 2020 interim rule and brings the rules in line with two laws — the SUPPORT Act of 2018 and the Restoring Hope for Mental Health and Well-Being Act of 2022 — that govern how controlled substances are used to treat opioid use disorder. It takes effect July 9, 2026.

What it changes

The rule removes the old “DATA-waiver” system, so there is no longer a federal cap on how many patients a practitioner can treat with maintenance or detox medication (the old limits of 30, 100, or 275 patients are gone), and DEA deletes regulation 21 CFR 1301.28. A separate “Narcotic Treatment Program” registration is now required only for Schedule II narcotics used for this treatment; Schedule III, IV, and V drugs no longer need the waiver. All practitioners (except those working solely as veterinarians) who apply for or renew a DEA registration to handle Schedule II–V controlled substances must complete a one-time training requirement, which applies to applications filed on or after June 27, 2023. The rule also lets a pharmacy deliver certain prescribed narcotics directly to a practitioner’s registered location for administration by injection or implant, and it extends the window to administer that medication to the named patient from 14 days to 45 days after the practitioner receives it. Practitioners and pharmacies must be authorized under their state’s law and must keep complete, accurate records of these drugs.

Who is affected

Practitioners who treat opioid use disorder — including physicians, nurse practitioners, and physician assistants — are affected, as are pharmacies that supply these medications and the patients receiving treatment. Prescribers face the new one-time training requirement but gain more flexibility, since the patient caps and waiver process are removed and pharmacies can now deliver injectable or implantable medication to their offices for administration.