FDA WARNING_LETTER - Village Pharmacy - June 22, 2016

On October 30, 2017, the FDA issued Warning Letter 17-NWJ-10 to Village Pharmacy, following an inspection from June 14-22, 2016. The inspection revealed that drug products, such as Hydroxyzine Pamoate 25 mg/ml Suspension, failed to meet Section 503A of the FDCA conditions for exemption from certain provisions.

A key violation was the failure to receive valid prescriptions for individually-identified patients for a portion of compounded drug products, rendering them ineligible for exemptions from new drug approval, adequate labeling, and CGMP requirements.

The ineligible drug products were deemed adulterated under Section 501(a)(2)(B) of the FDCA due to significant CGMP violations, including: 1. Failure to establish and follow an adequate written stability testing program (21 CFR 211.166(a)). 2. Lack of appropriate laboratory determination of satisfactory conformance to final specifications for each batch prior to release (21 CFR 211.165(a)). 3. Failure to adequately clean, maintain, and sanitize/sterilize equipment and utensils (21 CFR 211.67(a)).

Additionally, the ineligible drug products were misbranded under Section 502(f)(1) of the FDCA because they lacked adequate directions for use for laypersons.