Regulations last checked for updates: May 18, 2024

Title 21 - Food and Drugs last revised: May 15, 2024
§ 1310.11 - Reinstatement of exemption for drug products distributed under the Food, Drug and Cosmetic Act.

(a) The Administrator has reinstated the exemption for the drug products listed in paragraph (e) of this section from application of sections 302, 303, 310, 1007, and 1008 of the Act (21 U.S.C. 822-823,830,and,to,c,and.

(b) No reinstated exemption granted pursuant to 1310.10 affects the criminal liability for illegal possession or distribution of listed chemicals contained in the exempt drug product.

(c) Changes in exempt drug product compositions: Any change in the quantitative or qualitative composition, trade name or other designation of an exempt drug product listed in paragraph (d) requires a new application for reinstatement of the exemption.

(d) The following drug products, in the form and quantity listed in the application submitted (indicated as the “date”) are designated as reinstated exempt drug products for the purposes set forth in this section:

Exempt Drug Products

Supplier Product name Form Date
[Reserved]
[60 FR 32462, June 22, 1995]
authority: 21 U.S.C. 802,827,830,871
source: 54 FR 31665, Aug. 1, 1989, unless otherwise noted.
cite as: 21 CFR 1310.11