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Talk to a SpecialistTalk to a SpecialistBelmar Pharma Solutions, Drug Depot, LLC (dba APS Pharmacy) was cited for producing compounded drug products that failed to meet the exemption requirements under Section 503A of the Federal Food, Drug, and Cosmetic Act during an FDA inspection conducted June 6-17, 2022 in Palm Harbor, Florida. The facility's compounded drugs did not comply with conditions required for exemption from current good manufacturing practice (CGMP), adequate labeling requirements, and FDA approval prior to marketing. The violations stemmed from the company's failure to meet Section 503A requirements, including improper use of bulk drug substances that did not comply with United States Pharmacopeia (USP) or National Formulary (NF) monograph standards.