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Talk to a SpecialistTalk to a SpecialistPharmaceutical Care Solutions dba Pharmacy Solutions, a compounding pharmacy in Ann Arbor, Michigan, produced drug products that failed to meet the conditions required for exemption under Section 503A of the Federal Food, Drug, and Cosmetic Act. During an FDA inspection from January 15-24, 2020, investigators found evidence that the company's compounded drugs did not comply with current good manufacturing practice (CGMP) requirements, adequate labeling standards, and FDA approval provisions. The violations indicated the pharmacy produced adulterated drug products by not properly meeting the statutory conditions necessary to qualify for compounding exemptions, including potential issues with bulk drug substance sourcing and composition standards.