- (a) A wholesale operation shall maintain a written policy for handling recalls and withdrawals for products.
(b) Policies required by (a) above shall cover all recalls and withdrawals of prescription drug products due to:
- (1) Any voluntary action on the part of the manufacturer;
- (2) The direction of the Food and Drug Administration, or any other federal, state or local governmental agency; and
- (3) Replacement of existing merchandise with an improved product or new package design.
Source. #12007, eff 10-22-16 (formerly Ph 309.11)