Current through Register Vol. 35, No. 18, September 24, 2024
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.
