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21 C.F.R. § 1310.14   Exemption of drug products containing ephedrine and therapeutically significant quantities of another active medicinal ingredient.

Title 21: Food and Drugs
PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES

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§ 1310.14   Exemption of drug products containing ephedrine and therapeutically significant quantities of another active medicinal ingredient.

(a) Any manufacturer of a drug product containing ephedrine in combination with another active medicinal ingredient, the product formulation of which is not listed in the compendiums set forth in §1310.01(b)(28)(i)(D)(1), may request that the Administrator exempt the product as one which contains ephedrine together with a therapeutically significant quantity of another active medicinal ingredient.

(b) An application for an exemption under this section shall contain the following information:

(1) The name and address of the applicant;

(2) The exact trade name of the drug product for which exemption is sought;

(3) The complete quantitative and qualitative composition of the drug product;

(4) A brief statement of the facts which the applicant believes justify the granting of an exemption under this section; and

(5) Certification by the applicant that the product may be lawfully marketed or distributed under the Food, Drug, and Cosmetic Act.

(6) The identification of any information on the application which is considered by the applicant to be a trade secret or confidential and entitled to protection under U.S. laws restricting the public disclosure of such information by government employees.

(c) The Administrator may require the applicant to submit such additional documents or written statements of fact relevant to the application which he deems necessary for determining if the application should be granted.

(d) Within a reasonable period of time after the receipt of a completed application for an exemption under this section, the Administrator shall notify the applicant of acceptance or non-acceptance of the application. If the application is not accepted, an explanation will be provided. The Administrator is not required to accept an application if any of the information required in paragraph (b) of this section or requested pursuant to paragraph (c) of this section is lacking or not readily understood. The applicant may, however, amend the application to meet the requirements of paragraphs (b) and (c) of this section. If the application is accepted for filing, the Administrator shall issue and publish in the Federal Register an order on the application, which shall include a reference to the legal authority under which the order is based. This order shall specify the date on which it shall take effect. The Administrator shall permit any interested person to file written comments on or objections to the order. If any comments or objections raise significant issues regarding any findings of fact or 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 the original order as deemed appropriate.

[60 FR 32462, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]