RAC US Exam Question No 44

Question No 44:

A company's supplier of the active drug substance for the company's OTC drug product informs the company that the supplier will be moving their production of the drug substance from the current plant to a new manufacturing plant in another state in 6 months. The supplier states that all manufacturing processes will remain the same and the specifications will not change. The company intends to qualify the change suitably. How should the company report the change to FDA?

A. The change only needs to be reported in an annual report because the company will qualify the change and the supplier said the process and specifications won't change.
B. The change should be reported in a pre-approval supplement (e.g., CBE, CBE-30 or full pre-approval supplement) because it is a change to the drug substance manufacturing location.
C. The change does not have to be reported because it is an OTC drug.
D. Not enough information.

Answer: D