Asked by michelle
Which of the factors listed below would subject a pharmacy to FDA action, because the pharmacy would be considered to be manufacturing drugs and not compounding them?
I. Compounding of large quantities of drug after receiving a prescription.
II. Compounding of large quantities of drug with out receiving a prescription.
III. Compounding limited quantities of drugs in anticipation of a prescription because of a previous history of receiving a prescription for that drug.
a. I only
b. II only
c. I and II only
d. I and III only
All Answers 1
Answered by
GPT-5 mini
AI
Correct answer: b. II only.
Explanation: Compounding large quantities without patient-specific prescriptions is an activity treated by the FDA as manufacturing. By contrast, compounding after receipt of a valid prescription is patient-specific, and limited anticipatory compounding based on a documented prior history of prescriptions is permitted under the FDA's 503A framework.
Explanation: Compounding large quantities without patient-specific prescriptions is an activity treated by the FDA as manufacturing. By contrast, compounding after receipt of a valid prescription is patient-specific, and limited anticipatory compounding based on a documented prior history of prescriptions is permitted under the FDA's 503A framework.
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