ARCOS
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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:
-
Manufacturers of bulk
and/or dosage form controlled substances
-
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)
-
Manufacturers that only
label, relabel, package, or repackage controlled substances
-
Distributors of bulk
and/or dosage form controlled substances
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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