FDA recommends buprenorphine labeling clarification

The FDA announced recommended changes to the labeling for sublingual buprenorphine products, encouraging manufacturers to submit supplemental new drug applications to clarify that neither 16 nor 24 mg should be considered maximum daily doses for transmucosal buprenorphine products indicated for the treatment of opioid use disorder. This much needed clarification affirms the recommendations of consensus practice guidelines from ASAM, SAMHSA, and NCPA's own Pharmacy Access to Medication for Opioid Use Disorder Practice Guideline.