[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1308.31]

[Page 93-94]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1308.31  Application for exemption of a nonnarcotic prescription product.

    (a) Any person seeking to have any compound, mixture, or preparation 
containing any nonnarcotic controlled substance listed in 
Sec. 1308.12(e), or in Sec. 1308.13 (b) or (c), or in Sec. 1308.14, or 
in Sec. 1308.15, exempted from application of all or any part of the Act 
pursuant to section 201(g)(3)(A), of the Act (21 U.S.C. 811(g)(3)(A). 
may apply to the Administrator, Drug Enforcement Administration, 
Washington, DC 20537, for such exemption.
    (b) An application for an exemption under this section shall contain 
the following information:
    (1) The complete quantitative composition of the dosage form.
    (2) Description of the unit dosage form together with complete 
labeling.
    (3) A summary of the pharmacology of the product including animal 
investigations and clinical evaluations and studies, with emphasis on 
the psychic and/or physiological dependence liability (this must be done 
for each of the active ingredients separately and for the combination 
product).
    (4) Details of synergisms and antagonisms among ingredients.
    (5) Deterrent effects of the noncontrolled ingredients.
    (6) Complete copies of all literature in support of claims.
    (7) Reported instances of abuse.
    (8) Reported and anticipated adverse effects.

[[Page 94]]

    (9) Number of dosage units produced for the past 2 years.
    (c) Within a reasonable period of time after the receipt of an 
application for an exemption under this section, the Administrator shall 
notify the applicant of his acceptance or non-acceptance 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 (b) of this section is lacking or is not set 
forth so as to be readily understood. If the applicant desires, he may 
amend the application to meet the requirements of paragraph (b) of this 
section. If accepted for filing, the Administrator shall publish in the 
Federal Register general notice of this proposed rulemaking in granting 
or denying the application. Such notice shall include a reference to the 
legal authority under which the rule is proposed, a statement of the 
proposed rule granting or denying an exemption, and, in the discretion 
of the Administrator, a summary of the subjects and issues involved. The 
Administrator shall permit any interested person to file written 
comments on or objections to the proposal and shall designate in the 
notice of proposed rule making the time during which such filings may be 
made. After consideration of the application and any comments on or 
objections to his proposed rulemaking, the Administrator shall issue and 
publish in the Federal Register his final order on the application, 
which shall set forth the findings of fact and conclusions of law upon 
which the order is based. This order shall specify the date on which it 
shall take effect, which shall not be less than 30 days from the date of 
publication in the Federal Register unless the Administrator finds that 
conditions of public health or safety necessitate an earlier effective 
date, in which event the Administrator shall specify in the order his 
findings as to such conditions.
    (d) The Administrator may revoke any exemption granted pursuant to 
section 201(g)(3)(A) of the Act (21 U.S.C. 811(g)(3)(A)) by following 
the procedures set forth in paragraph (c) of this section for handling 
an application for an exemption which has been accepted for filing.

[38 FR 8254, Mar. 30, 1973. Redesignated at 38 FR 26609, Sept. 24, 1973, 
as amended at 44 FR 18968, Mar. 30, 1979; 52 FR 9803, Mar. 27, 1987]