Regulations &
Codified CSA > CFR > Section 1304 > Section 1304.33
Section 1304.33 Reports to ARCOS.
(a) Reports generally. All reports required by this section shall be filed with the ARCOS Unit,
PO 28293, Central Station, Washington, DC 20005 on DEA Form 333, or on media which
contains the data required by DEA Form 333 and which is acceptable to the ARCOS Unit.
(b) Frequency of reports. Acquisition/Distribution transaction reports shall be filed every quarter
not later than the 15th day of the month succeeding the quarter for which it is submitted; except
that a registrant may be given permission to file more frequently (but not more frequently than
monthly), depending on the number of transactions being reported each time by that registrant.
Inventories shall provide data on the stocks of each reported controlled substance on hand as of
the close of business on December 31 of each year, indicating whether the substance is in storage
or in process of manufacturing. These reports shall be filed not later than January 15 of the
following year. Manufacturing transaction reports shall be filed annually for each calendar year
not later than January 15 of the following year, except that a registrant may be given permission
to file more frequently (but not more frequently than quarterly).
(c) Persons reporting. For controlled substances in Schedules I, II or narcotic controlled
substances in Schedule III and gamma- hydroxybutyric acid drug product controlled
substances in Schedule III, each person who is registered to manufacture in bulk or dosage form,
or to package, repackage, label or relabel, and each person who is registered to distribute shall
report acquisition/distribution transactions. In addition to reporting acquisition/distribution
transactions, each person who is registered to manufacture controlled substances in bulk or
dosage form shall report manufacturing transactions on controlled substances in Schedules I and
II, each narcotic controlled substance listed in Schedules III, IV, and V, and on each psychotropic
controlled substance listed in Schedules III and IV as identified in paragraph (d) of this section.
(d) Substances covered. (1) Manufacturing and acquisition/distribution transaction reports shall
include data on each controlled substance listed in Schedules I and II and on each narcotic
controlled substance listed in Schedule III (but not on any material, compound, mixture or
preparation containing a quantity of a substance having a stimulant effect on the central nervous
system, which material, compound, mixture or preparation is listed in Schedule III or on any
narcotic controlled substance listed in Schedule V), and
on gamma-hydroxybutyric acid drug products listed in Schedule III. Additionally, reports on manufacturing
transactions shall include the following psychotropic controlled substances listed in Schedules III
and IV:
(i) Schedule III
(A) Benzphetamine;
(B) Cyclobarbital;
(C) Methyprylon; and
(D) Phendimetrazine.
(ii) Schedule IV
(A) Barbital;
(B) Diethylpropion (Amfepramone);
(C) Ethchlorvynol;
(D) Ethinamate;
(E) Lefetamine (SPA);
(F) Mazindol;
(G) Meprobamate;
(H) Methylphenobarbital;
(I) Phenobarbital;
(J) Phentermine; and
(K) Pipradrol.
(2) Data shall be presented in such a manner as to identify the particular form,
strength, and trade name, if any, of the product containing the controlled substance
for which the report is being made. For this purpose, persons filing reports shall
utilize the National Drug Code Number assigned to the product under the National
Drug Code System of the Food and Drug Administration.
(e) Transactions reported. Acquisition/distribution transaction reports shall provide data on each
acquisition to inventory (identifying whether it is, e.g., by purchase or transfer, return from a
customer, or supply by the Federal Government) and each reduction from inventory (identifying
whether it is, e.g., by sale or transfer, theft, destruction or seizure by Government agencies).
Manufacturing reports shall provide data on material manufactured, manufacture from other
material, use in manufacturing other material and use in producing dosage forms.
(f) Exceptions. A registered institutional practitioner who repackages or relabels exclusively for
distribution or who distributes exclusively to (for dispensing by) agents, employees, or affiliated
institutional practitioners of the registrant may be exempted from filing reports under this section
by applying to the ARCOS Unit of the Administration.
(Approved by the Office of Management and Budget under control number 1117-0003)
[62 FR 13962, Mar. 24, 1997]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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