Question

Which of the following situations may require a pharmacy to register with the FDA, be subject to FDA inspections, and comply with CGMP?

a. Community pharmacist compounds large bulk quantities of inhaler solution and ships the product to
numerous out-of-state pharmacies for dispensing.
b. Hospital pharmacy repackages and relabels a drug product in unit-dose packaging for routine use for inpatients.
c. Community pharmacist compounds drugs in anticipation of prescription drug orders based on routine prescribing patterns.
d. a and b
e. a, b, and c

Answer 1

A pharmacy may need to register with the FDA, be subject to FDA inspections, and comply with CGMP if they engage in interstate commerce or alter a drug's packaging and labeling.

Step-by-step explanation:

The situation that may require a pharmacy to register with the FDA, be subject to FDA inspections, and comply with CGMP is option e, which includes both a and b.

In option a, when a community pharmacist compounds large bulk quantities of inhaler solution and ships the product to numerous out-of-state pharmacies for dispensing, they are engaged in interstate commerce. This requires them to register with the FDA and comply with the Current Good Manufacturing Practices (CGMP) regulations to ensure the quality and safety of the product.

In option b, when a hospital pharmacy repackages and relabels a drug product in unit-dose packaging for routine use for inpatients, they are altering the drug's packaging and labeling, which falls under the FDA's jurisdiction. Therefore, they need to register with the FDA and comply with CGMP.