TITLE 16 OCCUPATIONAL AND PROFESSIONAL
LICENSING
CHAPTER 19 PHARMACISTS
PART 35 DRUG WAREHOUSE
16.19.35.1 ISSUING AGENCY: Regulation and Licensing Department - Board of Pharmacy.
[16.19.35.1 NMAC - N,
11-15-10]
16.19.35.2 SCOPE: This section applies to all licensed clinics, hospitals and pharmacies.
[16.19.35.2 NMAC - N,
11-15-10]
16.19.35.3 STATUTORY
AUTHORITY: Section 61-11-6(A)(6) NMSA 1978 authorizes
the board of pharmacy to provide for the licensing of all places where
dangerous drugs are stored or administered and for the inspection of their
facilities and activities. Section
61-11-14(B)(10) NMSA 1978 authorizes the board to issue limited drug permits
for home care services.
[16.19.35.3 NMAC - N,
11-15-10]
16.19.35.4 DURATION: Permanent.
[16.19.35.4 NMAC - N,
11-15-10]
16.19.35.5 EFFECTIVE
DATE: November 15, 2010, unless a different date is
cited at the end of a section.
[16.19.35.5 NMAC -
N, 11-15-10]
16.19.35.6 OBJECTIVE: The
objective of Part 35 of Chapter 19 is to establish standards for the safe and
competent storage of pharmaceutical products in facilities located off-site
from the licensed clinic, hospital or pharmacy.
[16.19.35.6 NMAC -
N, 11-15-10]
16.19.35.7 DEFINITIONS: “Drug
warehouse” means an off-site physical storage location of a clinic, hospital or
pharmacy currently licensed by the New Mexico board of pharmacy. Dangerous drugs may be stored for the use of
the licensed clinic, hospital or pharmacy.
[16.19.35.7 NMAC -
N, 11-15-10]
16.19.35.8 FACILITIES:
A. All facilities at which prescription drugs are stored 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
prescriptions that are outdated, damaged, deteriorated, misbranded, counterfeit
or suspected of being counterfeit or adulterated, otherwise unfit for use;
(4) be maintained in a clean and orderly
condition;
(5) be free from infestation by insects,
rodents, birds, or vermin of any kind;
(6) be a commercial location and not a
personal dwelling or residence;
(7) provide and maintain appropriate inventory
controls in order to detect and document any theft, counterfeiting or diversion
of prescription drugs or devices.
B. Controlled substances must be isolated from
non-controlled substance drugs and stored in a secure area in accordance with
DEA security requirements and standards.
[16.19.35.8 NMAC -
N, 11-15-10]
16.19.35.9 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 United States pharmacopeia-national formulary
(USP/NF).
A. If no 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.
B. Appropriate manual, electromechanical, or electronic
temperature and humidity recording equipment, devices or logs shall be utilized
to document proper storage of prescription drugs.
C. The record keeping requirements in Subsection F of
16.19.8.13 NMAC shall be followed for all stored prescription drugs.
[16.19.35.9 NMAC -
N, 11-15-10]
16.19.35.10 SECURITY:
A. All facilities used for drug warehouses shall be secure from unauthorized
entry and;
(1) access from outside the premises shall be
kept to a minimum and 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.
B. 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 and;
(1) all facilities shall be equipped with an
alarm system to detect entry after hours;
(2) all facilities shall be equipped with a
security system that will provide suitable protection against theft and
diversion;
(3) the security system shall provide
protection against theft or diversion that is facilitated or hidden by
tampering with computers or electronic records.
[16.19.35.10 NMAC -
N, 11-15-10]
16.19.35.11 EXAMINATION
OF MATERIALS:
A. 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.
B. 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.
C. Upon receipt, a drug warehouse must review records
for the acquisition of prescription drugs or devices for accuracy and completeness.
[16.19.35.11 NMAC -
N, 11-15-10]
16.19.35.12 RECORD
KEEPING:
A. Drug warehouses shall establish and maintain inventories and records of
all transactions regarding receipt and distribution of other disposition of
prescription drugs. These records shall
be maintained at the clinic, hospital or pharmacy and must include the
following information:
(1) the identity and quantity of the drugs
received and distributed or disposed of; and
(2)
the dates of receipt and distribution or other disposition of the drugs;
(3) the name, location and license number of
the business, health care practitioner or other entity appropriately licensed
to possess, dispense, distribute, administer or destroy prescription drugs.
B. Inventories and records shall be made available for
inspection and photocopying by authorized inspectors employed by the board and
authorized federal, state or local law enforcement agency officials for a
retention period of three (3) years following disposition of the drugs.
C. Registrants must petition the board for a waiver in
order to store the required records at an alternate location. The registrant must provide the board in
writing, of the address (mailing and street), telephone number, and the name
and title of the person designated by the registrant as the custodian of the
records. Any changes of custodian or
location of records must be reported in writing to the board within fifteen
(15) actual days. Any records approved
by waiver to be stored at an alternate location must be available within two
(2) working days of a request by authorized board personnel or officials of a
federal, state or local law enforcement agency.
D. Drug warehouses shall report any theft, suspected
theft, diversion or other significant loss of any prescription drug or device
to the board and FDA and where applicable to the DEA.
[16.19.35.12 NMAC -
N, 11-15-10]
16.19.35.13 WRITTEN
POLICIES AND PROCEDURES:
A. Drug warehouses shall establish, maintain and adhere to written policies
and procedures which shall be followed:
(1) for
the receipt, security, storage, inventory, and distribution of prescription
drugs, including policies and procedures;
(2) for identifying, recording and reporting
losses or thefts; and
(3) for
correcting all errors and inaccuracies in inventories.
B. Drug warehouses 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 drug warehouses
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 (3) 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 (3) 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 can not be used in counterfeiting activities, including all
necessary documentation, maintained for a minimum of three (3) years and the
appropriate witnessing of the destruction of any labels, packaging, immediate
containers or containers in accordance with all federal and state requirements;
(7) a procedure for reporting criminal or
suspected criminal activities involving the inventory of prescription drugs to
the board, FDA as required by the agency and if applicable, DEA, within three
(3) business days.
[16.19.35.13 NMAC -
N, 11-15-10]
16.19.35.14 RESPONSIBLE
PERSONS: Drug warehouses shall establish and maintain
lists of officers, directors, managers and other persons in charge of drug
warehouse storage and handling, including a description of their duties and a
summary of their qualifications.
[16.19.35.14 NMAC -
N, 11-15-10]
16.19.35.15 COMPLIANCE
WITH FEDERAL, STATE AND LOCAL LAW: Drug warehouses shall operate in compliance
with applicable federal, state and local laws and regulations.
A. Drug warehouses shall permit board authorized personnel and authorized federal, state and local law enforcement officials to enter and inspect their premises, 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. Such officials shall be required to show appropriate identification prior to being permitted access to wholesale drug distributors' premises and delivery vehicles.
B. Drug warehouses that deal in controlled substances shall register with the board and the DEA and shall comply with all applicable state, local and DEA regulations.
C. A licensed drug warehouse may distribute only to persons who are licensed to possess dangerous drugs.
D. 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.
[16.19.35.15 NMAC - N, 11-15-10]
16.19.35.16 MINIMUM REQUIRED INFORMATION FOR DRUG
WAREHOUSE LICENSURE:
A. Every clinic, hospital or pharmacy requiring off-site storage of drugs shall license with the board by application and provide information required by the board on an application approved by the board, including but not limited to:
(1) all trade or business names used by the licensee (includes “is doing business as” and “formerly known as”) which cannot be identical to the name used by another unrelated wholesale distributor licensed to purchase drugs or devices in the state;
(2) name(s) of the owner and operator of the licensee (if not the same person) including;
(a) if a person: the name, business address and date of birth;
(b) if a partnership: the name, business address, date of birth of each partner and the name of the partnership and federal employer identification number;
(c) if a corporation: the name, business address, date of birth, title of each corporate officer and director, the corporate names, the name of the state of incorporation, federal employer identification number, the name of the parent company, if any; the name and business address of each shareholder owning ten percent (10%) or more of the voting stock of the corporation, including over-the-counter (OTC) stock, unless the stock is traded on a major stock exchange and not OTC, publicly held corporations may request a waiver to the requirements of this Paragraph pursuant to 16.19.32 NMAC;
(d) if sole proprietorship: the full name, business address, date of birth of the sole proprietor and the name and federal employer identification number of the business entity;
(e) if a limited liability company: the name of each member, the name of each manager, the name of the limited liability company and federal employer identification number, the name of the state in which the limited liability company was originated;
(f) any other relevant information that the board requires;
(3) name(s), business address(es), telephone number(s) of a person(s) to serve as the designated representative(s) for each facility of the wholesale distributor that engages in the distribution of drugs and additional information as required in Subsection F of 16.19.8.13 NMAC;
(4) a list of all state and federal licenses, registrations or permits, including the license, registration or permit numbers issued to the wholesale drug distributor by any other state and federal authority that authorizes the wholesale distributor to purchase, possess and distribute drugs;
(5) a list of all disciplinary actions by state and federal agencies against the wholesale distributor as well as any such actions against principals, owners, directors or officers;
(6) a full description of each facility and warehouse, including all locations utilized for drug storage or distribution; the description must include the following:
(a) square footage;
(b) security and alarm system descriptions;
(c) terms of lease or ownership;
(d) address and;
(e) temperature and humidity controls;
(7) a copy of the drug warehouse written policies and procedures.
B. Every clinic, hospital or pharmacy who operates a drug warehouse shall submit a reasonable fee to be determined by the board.
C. Each drug warehouse must undergo an inspection by the board or a third party working on behalf of the board for the purpose of inspecting the warehouse operations prior to initial licensure and periodically thereafter in accordance with a schedule to be determined by the board.
D. All drug warehouses must display or have readily available all licenses and the most recent inspection report administered by the board.
E. Changes in any information in this section shall be submitted to the board or to the third party working on behalf of the boar within thirty (30) days of such change unless otherwise noted.
[16.19.35.16 NMAC - N, 11-15-10]
16.19.35.17 MINIMUM QUALIFICATIONS:
A. The board shall consider, at a minimum, the following factors in reviewing the qualifications of persons who engage in warehousing of prescription drugs within the state:
(1) any conviction of the applicant under any federal, state or local laws relating to drug samples, wholesale or retail drug distribution, or distribution of controlled substances;
(2) any felony convictions of the applicant under federal, state or local law;
(3) the applicant's past experience in the distribution of prescription drugs, including controlled substances;
(4) the furnishing by the applicant of false or fraudulent material in any application made in connection with prescription drug manufacturing or prescription drug distribution;
(5) suspension or revocation by federal, state, or local government of any license currently or previously held by the applicant for the manufacture or distribution of any drugs, including controlled substances;
(6) compliance with licensing requirements under previously granted licenses, if any;
(7) compliance with requirements to maintain or make available to the board or to federal, state, or local law enforcement officials those records required under this section; and
(8) any findings by the board that the applicant has violated or been disciplined by a regulatory agency in any state for violating and federal, state, or local laws relating to drug or device wholesale distribution;
(9) any other factors or qualifications the board considers relevant to and consistent with the public health and safety.
B. The board shall have the right to deny a license to an applicant if it determines that the granting of such a license would not be in the public interest. Public interest considerations shall be based upon factors and qualifications that are directly related to the protection of the public health and safety.
[16.19.35.17 NMAC - N, 11-15-10]
HISTORY OF 16.19.35 NMAC: [RESERVED]