FDA Enforcement on Compounding Pharmacies Continue


Enforcement activity on compounding pharmacies continues to mount with FDA warning letters posted this week from FDA inspections at two pharmacies. Thirteen warning letters to pharmacies were issued in 2013.  The pharmacies receiving the most recent warning letters include Total Pharmacy Services and Olympia Pharmacy.
Observations include:
• Compounding drugs without a valid individual prescription.
• Compounding a drug that is not the subject of USP or NF or FDA-Approved drug.
• Sterile products that are prepared, packed, or held under insanitary conditions.

In addition, FDA investigators also noted CGMP violations at both facilities, causing the drug products for which you have not obtained valid prescriptions for individually-identified patients to be adulterated under Section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)]. The violations include, for example:

• Both Firms: failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
• Both Firms: failed to ensure manufacturing personnel wear clothing appropriate to protect drug product from contamination (21 CFR 211.28(a)).
• Both Firms: failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
• Both Firms: failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).
• Both Firms: did not have, for each batch of drug product purporting to be sterile and/or pyrogen-free, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product (21 CFR 211.167(a)).
• Total Pharmacy Services: Your firm did not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).
• Olympia Pharmacy: Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to product aseptic conditions [21 CFR 211.42(c)(10)(v)].
• Olympia Pharmacy: Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas [21 CFR 211.42(c)(10)(iv)].