Under section 503A of the federal Food, Drug and Cosmetic Act, what should pharmacies maintain records of?

Pharmacies must maintain records of calculations for limited quantities of compounded drug products under section 503A of the federal Food, Drug, and Cosmetic Act. This requirement is crucial because 503A outlines the regulations surrounding the compounding of medications to ensure safety and efficacy. Specifically, it emphasizes the importance of accurate preparation and formulation procedures, which involves carefully documenting how much of each ingredient is needed for a compounded prescription.

Maintaining such records helps to ensure that pharmacies follow proper protocols when compounding medications, which can significantly affect patient outcomes. Ensuring precise calculations is vital in preventing dosage errors and maintaining the integrity of the compounded product. This regulation is in place to protect patients and maintain the standards of pharmaceutical practice.