FDA 483 - Professional Pharmacy Services - July 18, 2016

On January 2, 2018, the FDA issued a Form 483 to Professional Pharmacy Services, Inc. dba Good Day Pharmacy, located at 2033 Boise Avenue, Loveland, CO. The inspection, conducted from July 11-18, 2016, revealed that drug products produced by the firm failed to meet the conditions for exemption under section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA).

Key violations included: 1. **Lack of Valid Prescriptions:** The firm did not receive valid prescriptions for individually-identified patients for a portion of the drug products produced, a condition for 503A exemption. This renders the compounded drugs ineligible for exemptions from CGMP, adequate directions for use labeling, and FDA approval. 2. **Misbranding:** Ineligible drug products were deemed misbranded under section 502(f)(1) of the FDCA because adequate directions for use could not be written for layman use, as they are intended for conditions not amenable to self-diagnosis. This constitutes a prohibited act under section 301(k) of the FDCA. 3. **Use of Non-Compliant Bulk Drug Substance:** In May 2016, the firm compounded drug products using hyaluronic acid sodium salt, which is not subject to an applicable USP or NF monograph, is not a component of an