Prior to selling a compounded drug product, what must a pharmacy do according to section 503A?

The requirement for a pharmacy to receive a prescription from a licensed practitioner before selling a compounded drug product is grounded in the regulations surrounding compounding under section 503A of the Federal Food, Drug, and Cosmetic Act. This section emphasizes that compounded medications should be prepared specifically for individual patients based on specific prescriptions from licensed healthcare professionals.

This stipulation is crucial as it ensures that the compounded products are tailored to meet the unique needs of patients, taking into account their medical conditions, allergies, and other factors that may not be addressed by commercially available medications. By requiring a prescription, the regulation promotes patient safety and therapeutic effectiveness, thereby maintaining the integrity of the pharmacy's compounding practices.

The other choices do not align with the core regulatory framework established by Section 503A, which focuses primarily on the patient-specific nature of compounded medications. Thus, receiving a prescription appropriately reflects the pharmacy's obligation to prioritize the individual patient’s health needs in the compounding process.