FDA/DEA Stops X-Waiver requirement for OUD treatment using Buprenorphine

This is the official notification that was received by waiver holders.  Most NPs either took the waiver training that was offered through a CE education opportunity within their states or the used the on-line SAMHSA program.  The recent federal omnibus bill (Consolidated Appropriations Act, 2023) removed the federal requirement for practitioners to have an X-waiver to prescribe medications, like buprenorphine, for the treatment of opioid use disorder. 

Effective immediately, SAMHSA has stopped accepting waiver applications and the DEA has now removed the X waiver from existing DEA licenses. Going forward, all prescriptions for buprenorphine will only require a standard DEA registration number. Also, there are no longer any limits or caps on the number of patients a prescriber may treat. There is a separate provision in the omnibus legislation related to new training requirements for DEA registration that will become effective in June 2023.  We don't yet know what that education will be.

Here is the online announcement from the DEA:  https://www.deadiversion.usdoj.gov/pubs/docs/

Dear Registrants:

On December 29, 2022, with the signing of the Consolidated Appropriations Act of 2023 (the Act), Congress eliminated the "DATA-Waiver Program."

DEA fully supports this significant policy reform. In this moment, when the United States is suffering tens of thousands of opioid-related drug poisoning deaths every year, the DEA's top priority is doing everything in our power to save lives. Medication for opioid use disorder helps those who are fighting to overcome opioid use disorder by sustaining recovery and preventing overdoses. At DEA, our goal is simple: we want medication for opioid use disorder to be readily and safely available to anyone in the country who needs it. The elimination of the X-Waiver will increase access to buprenorphine for those in need.

All DEA registrants should be aware of the following:

• A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
• Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
• There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
• The Act does not impact existing state laws or regulations that may be applicable.

Separately, the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023.

The DEA and SAMHSA are actively working to provide further guidance and DEA will follow up with additional information on these requirements shortly. Importantly, these new requirements do not impact the changes related to elimination of the DATA-Waiver Program described above.

Sincerely,

Anne Milgram
Administrator

For information regarding DEA's Diversion Control Division, please visit https://www.DEAdiversion.usdoj.gov. Please contact the Diversion Control Division Policy Section at ODLP@dea.gov if you seek additional assistance regarding this or any other matter.