Current through Register Vol. 35, No. 18, September 24, 2024
A.
Facilities. All facilities at which prescription drugs are stored,
warehoused, handled, held, offered, marketed, or displayed shall:
(1) be of suitable size and construction to
facilitate cleaning, maintenance, and proper operations;
(2) have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security;
(3) have a
quarantine area for storage of prescription drugs that are outdated, damaged,
deteriorated, misbranded, counterfeit or suspected of being counterfeit or
adulterated, suspect or illegitimate, otherwise unfit for distribution or
wholesale distribution or that are in immediate or sealed, secondary containers
that have been opened;
(4) be
maintained in a clean and orderly condition; and
(5) be free from infestation by insects,
rodents, birds, or vermin of any kind; and
(6) be a commercial location and not a
personal dwelling or residence; and
(7) provide for the secure and confidential
storage of information with restricted access and policies and procedures to
protect the integrity and confidentiality of the information; and
(8) provide and maintain appropriate
inventory controls in order to detect and document any theft, counterfeiting or
diversion of prescription drugs or devices; and
(9) controlled substances must be isolated
from non-controlled substance drugs and stored in a secure area in accordance
with DEA security requirements and standards.
B.
Security and
anti-counterfeiting. All facilities used for wholesale drug distribution
shall be secure from unauthorized entry.
(1)
Access from outside the premises shall be kept to a minimum and be
well-controlled.
(2) The outside
perimeter of the premises shall be well-lighted.
(3) Entry into areas where prescription drugs
are held shall be limited to authorized personnel.
(4) All facilities shall be equipped with an
alarm system to detect entry after hours.
(5) All facilities shall be equipped with a
security system that will provide suitable protection against theft and
diversion. When appropriate, the security system shall provide protection
against theft or diversion that is facilitated or hidden by tampering with
computers or electronic records.
(6) All facilities shall be equipped with a
security system that will provide suitable protection against, detect and
document any instances of theft, diversion or counterfeiting.
C.
Storage. All
prescription drugs shall be stored at appropriate temperatures and under
appropriate conditions in accordance with requirements, if any, in the labeling
of such drugs, or in compliance with standards in the current edition of an
official compendium, such as the USP-NF.
(1)
If no storage requirements are established for a prescription drug, the drug
may be held at "controlled" room temperature, as defined in an official
compendium, to help ensure that its identity, strength, quality and purity are
not adversely affected.
(2)
Appropriate manual, electromechanical, or electronic temperature and humidity
recording equipment, devices or logs shall be utilized to document proper
storage of prescription drugs.
D.
Examination of Materials.
(1) Upon receipt, each outside shipping
container shall be visually examined for identity and to prevent the acceptance
of contaminated prescription drugs or prescription drugs that are otherwise
unfit for distribution. This examination shall be adequate to reveal container
damage that would suggest possible contamination, adulteration, misbranding,
counterfeiting, contraband, suspected of being counterfeit or contraband, or
other damage to the contents.
(2)
Each outgoing shipment shall be carefully inspected for identity of the
prescription drug products and to ensure that there is no delivery of
prescription drugs that have been damaged in storage or held under improper
conditions.
F.
Theft or Loss: A wholesale distributor shall have and follow
diversion detection and prevention plan that includes prescription drugs.
Wholesale distributors shall report any theft, suspected theft, diversion or
other significant loss of any prescription drug or device to the board and
where applicable, to the DEA.
G.
Product tracing, product identifier, and verification: Wholesale
distributors licensed by the board shall comply with the requirements for
tracing products through the distribution system as defined in Sections 353 and
360eee, et seq., of the DSCSA,
21
U.S.C. 301, et seq., and successor FDA
regulations, with respect to the role of such wholesale distributor including
any requirements with respect to: transaction history, transaction information,
or transaction statement of a product as such product changes ownership in the
supply chain, or verification, investigation, disposition, notification, or
recordkeeping relating to such systems, including paper or electronic pedigree
systems or for tracking and tracing drugs throughout the distribution
system.
H.
Authorized trading
partners: The trading partners of a wholesale distributor may be only
authorized trading partners.
I.
Written policies and procedures. Wholesale drug distributors shall
establish, maintain, and adhere to written policies and procedures, which shall
be followed for the receipt, security, storage, inventory, and distribution of
prescription drugs, including policies and procedures for identifying,
recording and reporting losses or thefts, and for correcting all errors and
inaccuracies in inventories; wholesale drug distributors 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
wholesale distributors 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 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 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 cannot be used in counterfeiting
activities, including all necessary documentation, maintained for a minimum of
three years, and the appropriate witnessing of the destruction of any labels,
packaging, immediate containers or containers in accordance with all applicable
federal and state requirements;
(7)
a procedure for identifying, investigating and reporting significant
prescription drug inventory discrepancies involving counterfeit, suspect of
being counterfeit, contraband or suspect of being contraband, in the inventory
and reporting of such discrepancies within 10 business days to the board and
appropriate federal or state agency upon discovery of such
discrepancies;
(8) a procedure for
reporting criminal or suspected criminal activities involving the inventory of
prescription drug(s) to the board, FDA as required by the agency, and if
applicable, DEA, within three business days;
(9) a procedure that ensures all common
carriers contracted with or utilized by the wholesale distributor conduct a
criminal background check and drug screen of the employees whose
responsibilities include the known handling of prescription drugs;
(10) a procedure for conducting periodic
assessments of the security provisions of common carriers contracted with or
utilized by the wholesale distributor that at a minimum must specify that
vehicles must be secured by locks on all doors and windows when the driver is
not present, there shall be no unapproved stops during the delivery route and
that the vehicle must not be left running in the absence of the
driver;
(11) a procedure or set
procedures designated to address high-risk deliveries that may require the
common carriers contracted with or utilized by the wholesale distributor to
make deliveries only to highly-visible, well-lit locations during certain
prescribed time periods agreed upon with the customer and the use of varied
routing.
J.
Responsible persons. Wholesale drug distributors shall establish
and maintain lists of officers, directors, managers, and other persons in
charge of wholesale drug distribution, storage, and handling, including a
description of their duties and a summary of their qualifications.
K.
Compliance with federal, state, and
local law: Wholesale drug distributors shall operate in compliance with
applicable federal, state, and local laws and regulations.
(1) Wholesale drug distributors shall permit
board authorized personnel and authorized federal, state and local law
enforcement officials, to enter and inspect their premises and delivery
vehicles, and to audit their records and written operating procedures, at
reasonable times and in a reasonable manner, to the extent authorized by law,
and to confiscate prescription drugs and records to the extent authorized by
law or rules. Such officials shall be required to show appropriate
identification prior to being permitted access to wholesale drug distributors'
premises and delivery vehicles.
(2)
Wholesale drug distributors that deal in controlled substances shall register
with the board and with the DEA, and shall comply with all applicable state,
local and DEA regulations.
(3) A
wholesale distributor may distribute only to authorized trading partners.
Product shall be delivered only to the licensed address of the authorized
trading partner.
(4) Controlled
substances may only be distributed or delivered to persons in this state who
are registered by the board and the DEA to possess controlled
substances.
L.
Salvaging and reprocessing. Wholesale drug distributors shall be
subject to the provisions of any applicable federal, state, or local laws or
regulations that relate to prescription drug product salvaging or reprocessing
including Subsection I of 16.19.8.13 NMAC, (Written Policies and
Procedures).
