Quality CDMO, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your products, Sodium Sulfacetamide 10% Wash, Sodium Sulfacetamide 10% and Sulfur 5% Cleanser, Selenium Sulfide 2.25% Shampoo, Urea 40% Cream, and Salicylic Acid 5.9% Topical Cream are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, are considered new drugs as defined in section 201(p)(1) of the FD&C Act. Subject to certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Because no FDA-approved applications are in effect for your products pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, the introduction or delivery for introduction of these products into interstate commerce violates section 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).