N.M. Admin. Code § 16.19.8.23

Current through Register Vol. 35, No. 19, October 8, 2024

Section 16.19.8.23 - REPACKAGER MINIMUM STANDARDS

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.

N.M. Admin. Code § 16.19.8.23

Adopted by New Mexico Register, Volume XXVIII, Issue 22, November 28, 2017, eff. 11/28/2017