21 C.F.R. § 1308.31 Application for exemption of a nonnarcotic prescription product.
Title 21 - Food and Drugs
(a) Any person seeking to have any compound, mixture, or preparation containing any nonnarcotic controlled substance listed in §1308.12(e), or in §1308.13 (b) or (c), or in §1308.14, or in §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. (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 (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]
Title 21: Food and Drugs
PART 1308—SCHEDULES OF CONTROLLED SUBSTANCES
Exempted Prescription Products
§ 1308.31 Application for exemption of a nonnarcotic prescription product.