FDA WARNING_LETTER - Civic Center Pharmacy - July 15, 2008

On December 16, 2008, the FDA issued a Warning Letter to Civic Center Pharmacy following a July 15-16, 2008 inspection. The inspection revealed the firm compounds a hormone therapy drug containing estriol without an FDA-approved new drug application (NDA) or an FDA-sanctioned investigational new drug (IND) application.

The FDA asserts that compounded drugs are "new drugs" under the Federal Food, Drug, and Cosmetic Act (FDCA) and are generally prohibited from interstate commerce without approval. While FDA historically exercised enforcement discretion for traditional compounding, this discretion does not extend to drugs compounded with estriol, as it is not an active ingredient in any FDA-approved drug and lacks demonstrated safety and efficacy.

The estriol product is deemed a "new drug" under FDCA section 201(p) [21 U.S.C. § 321(p)] and its introduction into interstate commerce violates section 301(d) [21 U.S.C. § 331(d)] and 505 [21 U.S.C. § 355]. Furthermore, the drug is misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(1)] due to inadequate directions for use, violating sections 301(