Section Ph 1002.06 - Written Policies and Procedures(a) Written policies and procedures shall be developed by management personnel to assure that the manufacturer and wholesale drug distributor prepares for, protects against, and handles crisis situations that affect the security or operation of the facility. Such crises shall include fires, floods, or other natural disasters, and situations of local, state or national emergency.(b) Written policies and procedures described in (a) above shall also provide for: (1) The management and correction of all errors or inaccuracies in inventories;(2) The assurance that any outdated stock, or any stock with an expiration date that, in the wholesale drug distributor's view, does not allow sufficient time for repacking or resale, shall be prepared for return to the manufacturer or otherwise destroyed;(3) The control over the shipping and receiving of all stock within the operation; and(4) A process for storage and disposal of hazardous drugs.(c) Policies and procedures will be reviewed on a regular basis.(d) A copy of the policies and procedures, or sections thereof, shall be made available to the board upon request.(e) All manufacturers, wholesalers and distributors shall notify the board when it initiates a class I recall based on an FDA inspection.N.H. Admin. Code § Ph 1002.06
Derived From Volume XXXVI Number 45, Filed November 10, 2016, Proposed by #12007, Effective 10/22/2016, Expires 10/22/2026.