ARCOS > ARCOS Registrant Bulletins > March 18, 2005

ARCOS Registrant Bulletin

Published on an as-needed basis for ARCOS registrants

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 January 4, 2005, the Drug Enforcement Administration issued a final rule (Federal Register: January 4, 2005, Vol. 70, No. 2) amending its regulations to include Schedule III GHB drug products as controlled substances that must be reported by manufacturers and distributors under the Automation of Reports and Consolidated Orders System (ARCOS). This final action, with an effective date of February 3, 2005, imposes the regulatory reporting requirements of Title 21, Code of Federal Regulations (21CFR) Section 1304.33 (and others) on those persons who handle CIII GHB drug products. A full discussion of this rule change is available on the DEA Office of Diversion Control’s web site at www.deadiverson.usdoj.gov and can be accessed by clicking the ‘Federal Register Notices’, ‘Rules’ 2005 buttons.

As a result of the new reporting requirements for GHB, manufacturers and distributors of drug products containing GHB must report to ARCOS all on hand stocks of GHB using a Transaction Code '1' (Schedule Change Inventory). Transaction Code '1' will establish existing stocks of GHB inventory in ARCOS. Registrants must perform an inventory of GHB stocks on or before May 15, 2005. Transaction Code '1' submissions are due with the May, or second quarter, 2005 ARCOS reports. Manufacturers and distributors must also report all applicable ARCOS activity involving GHB in accordance with Title 21, Code of Federal Regulations (21CFR) Section 1304.33.

The ARCOS Unit requests that manufacturers/labelers of GHB drug 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 GHB product NDC in an ARCOS transaction report.

For additional information, please contact the ARCOS Unit at (202)307-8600.

Effective Date: February 3, 2005