Current through Register Vol. 35, No. 18, September 24, 2024
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prescription drugs that are outdated, damaged, deteriorated, misbranded,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.
