N.M. Admin. Code § 16.19.35.13

Current through Register Vol. 35, No. 23, December 10, 2024

Section 16.19.35.13 - WRITTEN POLICIES AND PROCEDURES

A. Drug warehouses shall establish, maintain and adhere to written policies and procedures which shall be followed:

(1) for the receipt, security, storage, inventory, and distribution of prescription drugs, including policies and procedures;

(2) for identifying, recording and reporting losses or thefts; and

(3) for correcting all errors and inaccuracies in inventories.

B. Drug warehouses shall include in their written policies and procedures the following:

(1) a procedure whereby the oldest approved stock of a prescription drug product is distributed first; the procedure may permit deviation from this requirement if such deviation is temporary and appropriate;

(2) a procedure to be followed for handling recalls and withdrawals of prescription drugs; such procedure shall be adequate to deal with recalls and withdrawals due to;

(a) any action initiated at the request of the food and drug administration or other federal, state or local law enforcement or other government agency, including the state licensing agency;

(b) any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or

(c) any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design;

(3) a procedure to ensure that drug warehouses prepare for, protect against, and handle any crisis that affects security or operation of any facility in the event of strike, fire, flood or other natural disaster or other situations of local, state, or national emergency;

(4) a procedure to ensure that any outdated prescription drugs shall be segregated from other drugs and either returned to the manufacturer or destroyed; this procedure shall provide for written documentation of the disposition of outdated prescription drugs; this documentation shall be maintained for three (3) years after

disposition of the outdated drugs;

(5) a procedure for the destruction of outdated prescription drugs in accordance with state and federal laws, including all necessary documentation, maintained for a minimum of three (3) years and the appropriate witnessing of the destruction of outdated prescription drugs in accordance with all applicable federal and state requirements;

(6) a procedure for the disposing and destruction of containers, labels and packaging to ensure that the containers, labels and packaging can not be used in counterfeiting activities, including all necessary documentation, maintained for a minimum of three (3) years and the appropriate witnessing of the destruction of any labels, packaging, immediate containers or containers in accordance with all federal and state requirements;

(7) a procedure for reporting criminal or suspected criminal activities involving the inventory of prescription drugs to the board, FDA as required by the agency and if applicable, DEA, within three (3) business days.

N.M. Admin. Code § 16.19.35.13

16.19.35.13 NMAC - N, 11-15-10