[Title 21 CFR 1308.33]
[Code of Federal Regulations (annual edition) - April 1, 2002 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter II - DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE]
[Part 1308 - SCHEDULES OF CONTROLLED SUBSTANCES]
[Sec. 1308.33 - Exemption of certain anabolic steroid products; application.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS92002-04-012002-04-01false1308.33Sec. 1308.33FOOD AND DRUGSDRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICESCHEDULES OF CONTROLLED SUBSTANCES
Sec. 1308.33  Exemption of certain anabolic steroid products; application.

    (a) The Administrator, upon the recommendation of the Secretary of 
Health and Human Services, may, by regulation, exempt from the 
application of all or any part of the Act any compound, mixture, or 
preparation containing an anabolic steroid as defined in part 1300 of 
this chapter if, because of its concentration, preparation, mixture or 
delivery system, it has no significant potential for abuse (Pub. L. 101-
647 section 1903(a)).
    (b) Any person seeking to have any compound, mixture, or preparation 
containing an anabolic steroid as defined in part 1300 of this chapter 
exempted from the application of all or any part of the Act, pursuant to 
paragraph (a) of this section, may apply to the Administrator, Drug 
Enforcement Administration, Department of Justice, Washington, DC 20537.
    (c) An application for an exemption under this section shall be 
submitted in triplicate and contain the following information:
    (1) The name and address of the applicant;
    (2) The name of the product;
    (3) The chemical structural formula or description for any anabolic 
steroid contained in the product;
    (4) The complete description of dosage and quantitative composition 
of the dosage form;
    (5) A description of the delivery system, if applicable;
    (6) The indications and conditions for use in which species, 
including whether or not this product is a prescription drug;
    (7) Information to facilitate identification of the dosage form, 
such as shape, color, coating, and scoring;
    (8) The label and labeling of the immediate container and the 
commercial containers, if any, of the product;
    (9) The units in which the dosage form is ordinarily available; and
    (10) The facts which the applicant believes justify:

[[Page 96]]

    (i) A determination that the product has no significant potential 
for abuse and
    (ii) a granting of an exemption under this section.
    (d) Within a reasonable period of time after the receipt of the 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or nonacceptance of the 
application, and if not accepted, the reason therefor. The Administrator 
need not accept an application for filing if any of the requirements 
prescribed in paragraph (c) of this section is lacking or is not set 
forth so as to be readily understood. The applicant may amend the 
application to meet the requirements of paragraph (c) of this section. 
If accepted for filing, the Administrator will request from the 
Secretary for Health and Human Services his recommendation, as to 
whether such product which contains an anabolic steroid should be 
considered for exemption from certain portions of the Controlled 
Substances Act. On receipt of the recommendation of the Secretary, the 
Administrator shall make a determination as to whether the evidence 
submitted or otherwise available sufficiently establishes that the 
product possesses no significant potential for abuse. The Administrator 
shall issue and publish in the Federal Register his order on the 
application, which shall include a reference to the legal authority 
under which the order is issued, and the findings of fact and 
conclusions of law upon which the order is based. This order shall 
specify the date on which it will take effect. The Administrator shall 
permit any interested person to file written comments on or objections 
to the order within 60 days of the date of publication of his order in 
the Federal Register. If any such comments or objections raise 
significant issues regarding any finding of fact or conclusion of law 
upon which the order is based, the Administrator shall immediately 
suspend the effectiveness of the order until he may reconsider the 
application in light of the comments and objections filed. Thereafter, 
the Administrator shall reinstate, revoke, or amend his original order 
as he determines appropriate.
    (e) The Administrator may revoke any exemption granted pursuant to 
section 1903(a) of Public Law 101-647 by following the procedures set 
forth in paragraph (d) of this section for handling an application for 
an exemption which has been accepted for filing.

[56 FR 42936, Aug. 30, 1991; 57 FR 10815, Mar. 31, 1992, as amended at 
62 FR 13968, Mar. 24, 1997]