The Drug Enforcement Administration is proposing to increase regulatory controls on buprenorphine, a long-acting analgesic often used postsurgically in veterinary medicine, by upgrading it from a Schedule V narcotic to a Schedule III drug. The proposed action, based on a formal rescheduling recommendation by the Department of Health and Human Services and a Drug Enforcement Administration review, is aimed at discouraging illicit use of the drug.
Currently, little abuse of buprenorphine occurs in the United States, because it is available only in low doses and only in an injectable form. Officials have concerns, however, because data suggest that potential for abuse is high—narcotic users say the drug results in a morphine- or heroin-like experience. It is also likely that the drug will become available in new forms, including tablets, and evidence proves that abuse increases when a substance is available in a noninjectable form. When pentazocine became available in tablet form and butorphanol became available in a nasal form, for example, abuse of these drugs became widespread.
In addition, substantial abuse of buprenorphine has been reported in many countries where various forms of the drugs are available. The drug has been diverted from legitimate channels through theft, doctor shopping, and fraudulent prescriptions, and been abused via intravenous, sublingual, intranasal, and inhalation routes. In France, when the availability of high-dose sublingual tablets increased, diversion and abuse surged, resulting in over a hundred buprenorphine-related deaths.
The DEA hopes that reclassifying the drug will dissuade abuse. If the proposed rule is finalized, veterinarians' security and record-keeping obligations will not change, but those who divert the drug will face much stiffer penalties as a result of the Schedule III status.
For more information, review the announcement in the March 21, 2002 Federal Register, frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=02-6767-filed or contact Frank Sapienza, Chief of the Drug and Chemical Evaluation Section, DEA, at (202) 307-7183.