N.M. Admin. Code § 16.19.8.18

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

Section 16.19.8.18 - MINIMUM STANDARDS FOR THIRD-PARTY LOGISTICS PROVIDERS

A.Reporting: Each facility of a third-party logistics provider shall comply with the FDA annual reporting requirements.

B.Storage practices, facilities: All third-party logistics provider facilities at which prescription drugs are stored, warehoused, handled, held, 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(3) have a quarantine area for storage of prescription drugs that are outdated, damaged, deteriorated, misbranded, counterfeit or suspected of being counterfeit or adulterated, suspect or illegitimate, otherwise unfit for distribution or 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.

C.Security and anti-counterfeiting: All facilities used for third-party logistics drug storage or 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.

D.Policies and procedures: Each third-party logistics provider must have written policies and procedures to:

(1) address receipt, security, storage, inventory, shipment, and distribution of a product;

(2) identify, record, and report confirmed significant losses, or thefts in the United States;

(3) correct errors and inaccuracies in inventories;

(4) provide support for manufacturer recalls;

(5) prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the facility, such as a strike, fire, or flood;

(6) ensure that any expired product is segregated from other products and returned to the manufacturer, repackager, or their agent, or destroyed;

(7) maintain the capability to trace the receipt and outbound distribution of a product, and supplies and records of inventory; and

(8) quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency;

E.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.

F.Inspection: Each third-party logistics provider facility located in New Mexico shall be inspected as a condition of initial licensure and periodically inspected to ensure compliance with board regulations.

G.Trading partner list: A third-party logistics provider must provide the board, upon a request by the board, a list of all product manufacturers, wholesale distributors, and dispensers for whom the third-party logistics provider provides services at such facility.

H.Compliance with federal, state, and local law: Third-party logistics providers shall operate in compliance with applicable federal, state, and local laws and regulations.

(1) Third-party logistics providers 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 third-party logistics providers' premises and delivery vehicles.

(2) Third-party logistics providers that deal in controlled substances shall register with the board as required, and with the DEA, and shall comply with all applicable state, local and DEA regulations.

(3) A third-party logistics provider may distribute only to authorized trading partners. Product shall be shipped only to the address listed on the licensee's license.

(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.

N.M. Admin. Code § 16.19.8.18

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