HHS Changes Guidelines for Buprenorphine Administration
As of January 2021, the U.S. Department of Health and Human Services (HHS) changed the practice guidelines for the administration of the prescription drug buprenorphine used for treating opioid use disorder. These changes were enacted to make it easier for physicians to administer buprenorphine as part of an effort to address the ongoing opioid epidemic. This notice supersedes the process outlined in 21 CFR 823(G) and removes the previous requirement to obtain a separate Drug Enforcement Administration (DEA) number for prescribing this drug.
Key Takeaways
This change removes the requirement for a prescriber to have a Narcotics Addiction DEA Number (NADEAN) to prescribe medications for drug addiction or detoxification treatment. It also affects the following buprenorphine-containing medications identified by HHS for opioid addiction treatment:
- Generic buprenorphine/naloxone sublingual tablets
- Buprenorphine sublingual tablets (Subutex)
- Buprenorphine/naloxone sublingual films (Suboxone)
- Buprenorphine/naloxone) sublingual tablets (Zubsolv)
- Buprenorphine/naloxone buccal film (Bunavail)
- Buprenorphine implants (Probuphine)
- Buprenorphine extended-release injection (Sublocade)
The HHS notice limits these exceptions to physicians, implements a 30-patient limit (prescribers limited to no more than 30 patients for these specific current addiction prescriptions) and requires marking the prescription with the letter “X.”
Recertification Requirement
Application providers seeking to implement the new prescribing procedures must undergo DEA-required re-audits of their e-prescribing application. Per 21 CFR 1311.300, the application provider of an electronic prescription application must undergo a third-party audit whenever a functionality related to controlled substance prescription requirements is altered or every two years, whichever occurs first.
To register for recertification, please visit: https://www.drummondgroup.com/compliance/pharma-supply-chain/dea-epcs/epcs-registration/
New GHB Medication
When prescribing medications that contain Gammahydroxybutyric Acid (GHB), DEA requires prescribers note the patient’s medical need on the prescription. Xywav, a new medication containing GHB, has been approved by the FDA for narcolepsy therapy and EPCS applications must update their controls to ensure the medical need is being included.
Xywav joins Xyrem and the generic Sodium Oxybate as drugs which require the medical need to be indicated in the diagnosis or prescriber note field. Application vendors should implement the necessary controls to ensure the application requires medical need for Xywav prescriptions. Please note recertification is not required for this change.
Upcoming EPCS Deadlines
- July 1, 2021: Mandatory ePrescribing of controlled substances in Colorado and Kansas
- Jan. 1, 2022: Federal enforcement for ePrescribing of controlled substances covered under Medicare Part D