Section Ph 2006.04 - Handling Recalls(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.N.H. Admin. Code § Ph 2006.04
Derived from Volume XXXVII Number 32, Filed August 10, 2017, Proposed by #12336, Effective 7/22/2017, Expires 7/22/2027.