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ARCOS > ARCOS Registrant Bulletins > October 15, 2002 ARCOS Registrant BulletinPUBLISHED ON AN AS NEEDED BASIS FOR ARCOS REGISTRANTS
Automation of Reports and Consolidated Orders System This bulletin has been prepared by the Drug Enforcement Administration (DEA), Office of Diversion Control, ARCOS Unit, to assist participating ARCOS registrants with the preparation and submission of required DEA controlled substance transaction reports to ARCOS.
On October 7, 2002, the Deputy Administrator of The Drug Enforcement Administration (DEA) issued a final rule (67 FR 62354) to reschedule buprenorphine from a Schedule V narcotic to a Schedule III narcotic under the Controlled Substances Act (CSA). This final action imposes the regulatory controls and criminal sanctions of a Schedule III on those persons who handle buprenorphine or products containing buprenorphine.
As a result of the placement of buprenorphine into CSA Schedule III, manufacturers and distributors of products containing buprenorphine must report to ARCOS all on hand stocks of buprenorphine using a Transaction Code '1' (Schedule Change Inventory). Transaction Code '1' will establish existing stocks of buprenorphine inventory in ARCOS. Registrants must perform an inventory of buprenorphine stocks on or before December 1, 2002. Transaction Code '1' submissions are due with the December 2002 ARCOS reports. Manufacturers and distributors must also report all applicable ARCOS activity involving buprenorphine in accordance with Title 21, Code of Federal Regulations (21CFR) Section 1304.33.
The ARCOS Unit requests that manufacturers/labelers of buprenorphine products submit copies of commercial drug labels or labeling information to the ARCOS Unit for incorporation into the ARCOS National Drug Code (NDC) Dictionary. Labels must be provided to the ARCOS Unit prior to the use of a buprenorphine product NDC in an ARCOS transaction report. For further information, contact the ARCOS Unit at 202-307-8600.
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