§ 1310.15 - Exempt drug products containing ephedrine and therapeutically significant quantities of another active medicinal ingredient.

(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:

Exempt Drug Products Containing Ephedrine and Therapeutically Significant Quantities of Another Active Medicinal IngredientSupplierProduct nameFormDate[Reserved]