N.M. Admin. Code § 16.19.8.20

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

Section 16.19.8.20 - MINIMUM REQUIRED INFORMATION FOR REPACKAGER LICENSURE

A. Every repackager who engages in the distribution of product shall be licensed with the board by submitting an application and providing information required by the board on an application approved by the board, including:

(1) applicant's full name; 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, third-party logistics provider, or repackager licensed by the board; full business address and telephone number;

(2) type of ownership, e.g. individual, partnership, limited liability company or corporation;

(3) name(s) of the owner(s) of the applicant, including;

(a) if a person, the name, address, social security number or FEIN, and date of birth;

(b) if other than a person, the name, address, social security number and date of birth of each partner, limited liability company member, or corporate officer and corporate director and the federal employer identification number;

(c) if a corporation, the state of incorporation; and

(d) if a publicly traded corporation, the information in Subparagraph (b) of this paragraph is not required for corporate officers and corporate directors.

(e) any other relevant information that the board requires;

(4) name(s), business address(es), telephone number(s) of a person(s) to serve as the designated representative(s) for each facility of the repackager that engages in the distribution of drugs;

(5) proof of valid registration as a drug establishment with the FDA;

(6) a list of all state and federal licenses, registrations or permits, including the license, registration or permit numbers issued to the repackager by any other state and federal authority that authorizes the repackager to purchase, possess, repackage and distribute drugs;

(7) a list of all disciplinary actions or any other sanction by state and federal agencies against the repackager as well as any such actions against principals, owners, directors or officers;

(8) a full description of each facility and warehouse located in New Mexico, 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;

(9) a description of the repackager's drug import and export activities;

(10) a copy of the repackager's written policies and procedures as required in Subsection D of 16.19.8.23 NMAC;

(11) a facility located outside of New Mexico shall submit a copy of a current satisfactory inspection report issued by the FDA, or State licensing authority, or by a third-party inspection service approved by the FDA or the state authority licensing such repackager, or by the board.

(12) the information collected pursuant to Paragraphs (8) and (10) of this subsection shall be made available only to the board, and to state and federal law enforcement officials; the board shall make provisions for protecting the confidentiality of the information collected under this section.

(13) renewal applications shall be on a form furnished by the board.

B. Every repackager shall submit a reasonable fee to be determined by the board.

C. Each facility located in New Mexico that engages in repackaging must undergo an inspection by the board for the purpose of inspecting the repackaging facility and operations prior to initial licensure.

D. All repackagers must publicly 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 within 30 days of such change unless otherwise noted.

F. Information submitted by the repackager to the board that is considered trade secret or proprietary information as defined under this states privacy and trade secret/proprietary statutes shall be maintained by the board as private or trade secret proprietary information and be exempt from public disclosure.

G. The board shall have the authority to recognize a third-party to inspect repackagers.

H. The board may license by reciprocity, a repackager that is licensed under the laws of another state if:

(1) the applicant submits documentation of a current satisfactory inspection conducted by the FDA, or state licensing authority, or by a third-party inspection service approved by the FDA or the state authority licensing such repackager, or by the board; and

(2) the requirements of that state are deemed by the board to be substantially equivalent.

N.M. Admin. Code § 16.19.8.20

Adopted by New Mexico Register, Volume XXVIII, Issue 22, November 28, 2017, eff. 11/28/2017, Amended by New Mexico Register, Volume XXXIV, Issue 19, October 10, 2023, eff. 10/10/2023