21 C.F.R. § 1310.15 Exempt drug products containing ephedrine and therapeutically significant quantities of another active medicinal ingredient.
Title 21 - Food and Drugs
(a) The drug products containing ephedrine and therapeutically significant quantities of another active medicinal ingredient listed in paragraph (e) of this section have been exempted by the Administrator from application of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822–3, 830, and 957–8) to the extent described in paragraphs (b), (c), and (d) of this section. (b) No exemption granted pursuant to 1310.14 affects the criminal liability for illegal possession or distribution of listed chemicals contained in the exempt drug product. (c) Changes in drug product compositions: Any change in the quantitative or qualitative composition of an exempt drug product listed in paragraph (d) requires a new application for exemption. (d) In addition to the drug products listed in the compendium set forth in §1310.01(b)(28)(i)(D)(1), the following drug products, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as exempt drug products for the purposes set forth in this section: [60 FR 32463, June 22, 1995, as amended at 62 FR 13968, Mar. 24, 1997]
Title 21: Food and Drugs
PART 1310—RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
§ 1310.15 Exempt drug products containing ephedrine and therapeutically significant quantities of another active medicinal ingredient.
Exempt Drug Products Containing Ephedrine and Therapeutically Significant Quantities of Another Active Medicinal Ingredient---------------------------------------------------------------------------------------------------------------- Supplier Product name Form Date----------------------------------------------------------------------------------------------------------------[Reserved]...........................----------------------------------------------------------------------------------------------------------------
