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REPORTING > ARCOS > ARCOS Registrant Handbook > Section 1.0 - ARCOS Overview

ARCOS Registrant Handbook

PART I: GENERAL INFORMATION
Section 1.0 - ARCOS Overview

1.1 WHAT IS ARCOS?

1.1.1 ARCOS Defined

The Automation of Reports and Consolidated Orders System (ARCOS) is the automated system developed by DEA to monitor selected controlled substances. ARCOS software enables the government to maintain a current and historical record of selected controlled substance inventories and transactions from the point of manufacture to the point of sale, distribution, or other disposition, and finally, to the dispensing (consumption) level.

1.1.2 Authority for ARCOS

Manufacturers and distributors must periodically report to DEA (ARCOS) their inventories of selected controlled substances and increases and decreases to the inventories of these substances. Reporting is mandated under the Code of Federal Regulations (CFR), 21 CFR 1304. A copy of the CFR can be purchased from the Government Printing Office. The address and phone number are:

U.S. Government Printing Office
Superintendent of Documents, Mail Stop: SSOP
Washington, D.C. 20402-9328
Phone: (202) 512-1800

1.2 ARCOS' RELATIONSHIP TO DRUG INVENTORY AUDIT

DEA has the capability to perform analyses on filled order form data (DEA Form 222), since ARCOS captures and stores this information. This increases the federal government's ability to detect potential diversion situations.

1.3 ARCOS' RELATIONSHIP TO UNITED NATIONS

DEA is responsible for fulfilling United Nations' treaty obligations which relate to the international control of certain narcotic drugs and psychotropic substances. ARCOS software provides automated consumption, manufacturing, and inventory data which serve as a basis for establishing the United States' estimates of medical and scientific needs and the establishment and maintenance of inventories. The United States submits these estimates annually to the United Nations' International Narcotics Control Board (INCB), in Vienna, Austria. The INCB uses the United States' estimates to determine worldwide estimates.

DEA also sets annual manufacturing and procurement quotas for Schedules I and II controlled substances under the United States Controlled Substances Act. These quotas cannot be exceeded during the calendar year for which they are given. DEA submits annually to the INCB statistics on the United States' consumption, manufacturing, and year-end inventories of the narcotic drugs and psychotropic substances which are controlled under the 1961 and 1971 Conventions.

1.4 REPORTING: WHO and WHAT

Manufacturers and distributors are required to report controlled substance inventories and transactions as follows:

  1. Manufacturers of bulk and/or dosage form controlled substances
    • Inventories
      • All controlled substances in Schedules I and II
      • All narcotic controlled substances in Schedule III
      • Selected psychotropic controlled substances in Schedules III and IV (see list in Section 6, Manufacturing Activities)
    • Acquisitions
      • All controlled substances in Schedules I and II
      • All narcotic controlled substances in Schedule III
    • Dispositions
      • All controlled substances in Schedules I and II
      • All narcotic controlled substances in Schedule III
    • Manufacturing Activities
  2. Manufacturers that only label, relabel, package, or repackage controlled substances
    • All controlled substances in Schedules I and II
    • All narcotic controlled substances in Schedule III
  3. Distributors of bulk and/or dosage form controlled substances
    • All controlled substances in Schedules I and II
    • All narcotic controlled substances in Schedule III

1.4.1 Submitting Report

DEA recommends that each ARCOS report be sent by UnitedStates Postal Service certified mail, along with a return receipt requestedcard, PS Form 3811, December1994 (green card). Irrespective of the delivery method, DEA (ARCOS) must receive the report by the 15th day of the month following the close of the reporting period.

Otherwise, your company could appear in a delinquent reporting status. If time constraints dictate a faster delivery method, overnight mail or a courier service may be used. Both the normal mailing address for DEA and the address for courier or overnight mail are located on the contact information page at the front of this handbook. Exhibit 1.1: Receipt Deadlines, illustrates the deadlines by which DEA (ARCOS) must receive the monthly or quarterly ARCOS reports.

SAMPLE DEA RECEIPT DEADLINES FOR ARCOS REPORTS
Reporting Period End Reporting Frequency Reporting Deadline
February 28th Monthly March 15th
September 30th Monthly October 15th
September 30th Quarterly October 15th

Exhibit 1.1: Receipt Deadlines

1.5 WHO MUST NOT REPORT?

Individuals, firms, or institutions that hold a DEA registration and are listed in Exhibit 1.2: Registrants Not Required to Report, must not report to DEA (ARCOS) their controlled substance inventories or transactions.

WHO MUST NOT REPORT TO ARCOS?
Practitioners
Pharmacies
Hospitals or Clinics
Teaching Institutions
Analytical Laboratories
Researchers
Narcotic Treatment Programs
Importers
Exporters

Exhibit 1.2: Registrants Not Required to Report

1.6 MULTIPLE REGISTRATIONS

DEA issues a separate registration to manufacturers and distributors of controlled substances for each location in which controlled substance activity occurs. Therefore, manufacturers and distributors may hold multiple registrations simultaneously. Each individual registration is identified by a unique registration number. Those firms holding multiple registrations need to make certain that the DEA registration number (reporting registrant number) used in reporting controlled substance transactions corresponds to the location where the activity occurred.

If a firm holds a DEA registration as a manufacturer and/or distributor of controlled substances and, in addition, holds a registration as an enterprise listed in Section 1.5, Who Must Not Report, the firm is only required to report to DEA (ARCOS) controlled substance transactions and inventories that pertain to its registration as a manufacturer and/or distributor.

Example:

A firm holds a registration as an importer of controlled substances and simultaneously holds a second registration as a distributor of controlled substances. Only the inventories and transactions of the distributor are reportable to DEA (ARCOS). Additionally, when reporting the distributor's inventories and transactions, the firm must be certain to use only the distributor's registration number as the reporting number.

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