UNATHORIZED BUPREN COMPOUNDING IN US
In a CSAT letter dated 3 April the Director warns that "certain pharmacies may be compounding and selling buprenorphine and buprenorphine/naloxone combination products in various strengths, colors, and flavors."
CSAT states that the only buprenorphine and buprenorphine/naloxone products that are authorized are Subutex and Suboxone, produced by Reckitt Benckiser Pharmaceutical (RBPI) Other formulations "present potentially serious public health and safety issues," and that "the use of unapproved buprenorphine products circumvents the public health purpose of the [RBPI] Risk Management Program." It is not clear what physicians are to do about this problem. Even more perplexing is why DEA seems to be uninvolved. Even if there were no safety issues or circumvention of Risk Management protocols, one would think that DEA would nevertheless move swiftly and decisively against the pharmacies imnvolved.