Question

According to the FDA Compliance Policy Guide, which of the following pharmacy activities does the FDA consider to be traditional pharmacy activity that is NOT subject to FDA enforcement?

a. Extemporaneously compounding medication on receipt of a valid prescription from a licensed practitioner for an individual patient.
b. Compounding a medication from components that have not been determined to meet official compendial requirements.
c. Compounding drugs for third parties who resell the drugs to individual patients.
d. Compounding drugs that have been withdrawn from the market due to safety concerns

Answer 1

The FDA considers extemporaneously compounding medication on receipt of a valid prescription from a licensed practitioner for an individual patient as a traditional pharmacy activity that is not subject to FDA enforcement.

Step-by-step explanation:

According to the FDA Compliance Policy Guide, the pharmacy activity that is considered traditional and not subject to FDA enforcement is extemporaneously compounding medication on receipt of a valid prescription from a licensed practitioner for an individual patient. This means that pharmacists are allowed to compound medications for individual patients based on a valid prescription. Compounding medications from components that have not met official compendial requirements, compounding drugs for third parties who resell the drugs to individual patients, and compounding drugs that have been withdrawn from the market due to safety concerns are all activities that are subject to FDA enforcement.