[Title 21 CFR 1304.33]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1304 - RECORDS AND REPORTS OF REGISTRANTS]
[Sec. 1304.33 - Reports to ARCOS.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1304.33Sec. 1304.33FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICERECORDS AND REPORTS OF REGISTRANTS
Sec. 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

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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, 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). 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]