Current through Register Vol. 35, No. 18, September 24, 2024
A.
Compliance with federal, state, and local law. A repackager shall
operate in compliance with applicable federal, state, and local laws and
regulations.
(1) A repackager shall comply
with 16.19.9 NMAC, including operation in compliance with the Federal Food,
Drug, and Cosmetic Act; Good Manufacturing Practices,
21 U.S.C.
321,
351,
352,
355,
360b,
371,
374; 42 U.S.C. 216,
262, 263a, 264; and 21 C.F.R. Parts 210 and 211.
(2) A repackager shall permit board
authorized personnel and authorized federal, state and local law enforcement
officials, to enter and inspect its premises and delivery vehicles, and to
audit its 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.
(3) Inventories, records
and written operating procedures shall be made available for inspection and
photocopying by authorized inspectors employed by the board for a period of
three years following disposition of the drugs.
(4) Repackagers 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.
(5) A repackager may distribute only to
authorized trading partners. Product shall be delivered only to the licensed
address of the authorized trading partner.
(6) 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.
(7) Product tracing, product identifier, and
verification: Repackagers 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 repackager 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.
(8) Authorized trading
partners: The trading partners of a repackager may be only authorized trading
partners.
B.
Shipment. A repackager shall ship product only to the address
listed on the licensee's license.
C.
Theft or loss. A repackager
shall have and follow diversion detection and prevention plan that includes all
prescription drugs. A repackagers 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.
D.
Written policies and
procedures. Repackagers 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; repackagers 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 FDA 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 repackagers
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 repackager 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 repackager 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;
E.
Responsible persons.
Repackagers shall establish and maintain lists of officers, directors,
managers, and other persons in charge of operations, storage, and handling,
including a description of their duties and a summary of their
qualifications.
F.
Salvaging
and reprocessing. Repackagers 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 D of
16.19.8.23 NMAC.
