N.M. Admin. Code § 16.19.35.16

Current through Register Vol. 35, No. 23, December 10, 2024

Section 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.

N.M. Admin. Code § 16.19.35.16

16.19.35.16 NMAC - N, 11-15-10