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Talk to a SpecialistTalk to a SpecialistRight Value Drug Stores, LLC dba Carie Boyd Pharmaceuticals, an outsourcing facility registered to compound drugs under section 503B of the Federal Food, Drug, and Cosmetic Act, produced drug products that failed to meet the conditions necessary to qualify for exemptions from drug approval requirements and other regulatory provisions. During an FDA inspection conducted from May 28 to June 21, 2024, investigators identified serious deficiencies in the facility's manufacturing practices that put patients at risk, resulting in issuance of a Form FDA 483 on June 21, 2024. The company's compounded drug products violated the FDCA by not meeting the requirements for outsourcing facility status under section 503B.