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Talk to a SpecialistTalk to a SpecialistMatthew 7:25 Inc dba Thrive Pharmacy, a compounding pharmacy in Jacksonville, Florida, failed to meet the conditions of Section 503A of the Federal Food, Drug, and Cosmetic Act for exemption from current good manufacturing practice (CGMP) and other regulatory requirements when producing compounded drug products, including buprenorphine and buprenorphine-containing troches. The FDA investigator found that the pharmacy did not obtain valid prescriptions for individually-identified patients for a portion of the drug products it produced, which is a mandatory condition for Section 503A exemptions. The company had already initiated a voluntary recall in March 2020 of three buprenorphine troche products due to subpotency, indicating underlying quality control deficiencies in the compounding process.