The Drug Enforcement Administration issued a final rule that codifies sweeping changes to how practitioners can prescribe and administer medication-assisted treatment for opioid use disorder, effective July 9.
Here are seven things to know:
1. The DEA formally removed the DATA-waiver program from its regulations. As a result, any practitioner with a standard DEA registration and Schedule III authority may now prescribe buprenorphine for OUD — no separate waiver required.
2. Under the old framework, DATA-waived practitioners faced limits on how many OUD patients they could treat. With those limits now, eliminated, there is no federal cap on patient volume.
3. Any practitioner seeking a new or renewed DEA registration to dispense Schedule II–V controlled substances must meet one of the several conditions. Physicians must: hold board certification in addiction medicine or addiction psychiatry; complete not less than eight hours of training on opioid and substance use disorders from an approved organization; or have graduated in good standing from an accredited U.S. allopathic or osteopathic medical school within the five years immediately preceding their first DEA registration, from a curriculum that included equivalent training. Nonphysician practitioners must be legally authorized by their state to dispense the relevant controlled substances and must either complete not less than eight hours of equivalent training or meet the same recent-graduate condition. No qualified practitioner is required to complete the training more than once. This requirement applies to registrations submitted on or after June 27, 2023.
4. When a pharmacy delivers a Schedule III–V controlled substance to a practitioner for administration by injection or implantation, the practitioner now has 45 days — up from 14 — to administer it to the named patient. Insurance authorization delays and shipping time do not affect that window.
5. Practitioners who dispense Schedule II narcotics for maintenance or detoxification treatment must continue to register annually as a narcotic treatment program.
6. The DEA declined to formally list pharmacists as administering practitioners under the rule, citing intent that the provision covers only individually DEA-registered practitioners. State law also governs a pharmacist’s authority to administer.
7. The DEA’s economic analysis projected maximum annualized training costs of $368 million to $388 million at 3% and 7% discount rates, respectively. The rule will break even if the roughly 640,000 newly authorized practitioners in year one successfully treat just 3,047 OUD patients — a ratio of approximately 210 practitioners per patient treated.
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