- (a) An outsourcing facility 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 compounded sterile products due to:
- (1) A voluntary action on the part of the compounder;
- (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 design.
Source. #12336, eff 7-22-17