New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 35 - DRUG WAREHOUSE
Section 16.19.35.13 - WRITTEN POLICIES AND PROCEDURES
Universal Citation: 16 NM Admin Code 16.19.35.13
Current through Register Vol. 35, No. 18, September 24, 2024
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to ensure that any outdated prescription drugs shall be segregated from other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shall provide for written documentation of the disposition of outdated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disposition of the outdated drugs;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outdated prescription drugs in accordance with state and federal laws,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years and the appropriate witnessing of the destruction of outdated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.
Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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