New Mexico Administrative Code
Title 16 - OCCUPATIONAL AND PROFESSIONAL LICENSING
Chapter 19 - PHARMACISTS
Part 8 - WHOLESALE PRESCRIPTION DRUG DISTRIBUTION
Section 16.19.8.17 - PERSONNEL

Universal Citation: 16 NM Admin Code 16.19.8.17

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

As a condition of receiving and retaining a third-party logistics provider license, the licensee shall require each person employed in any prescription drug third-party logistics activity to have education, training, and experience, or any combination thereof, sufficient for that person to perform the assigned functions in such a manner as to provide assurance that the drug product quality, safety and security will at all times be maintained by law. Each person that is issued an initial or renewal license as a third-party-logistics provider whether in state or out of state must designate in writing on a form required by the board a person for each facility to serve as the designated representatives of the third-party logistics provider.

A. To be certified as a designated representative a person must:

(1) submit an application on a form furnished by the board and provide information that includes:
(a) evidence of criminal background check and fingerprinting, the background check shall be sufficient to include all states residence since the person has been an adult;

(b) date of birth and social security number;

(c) occupations, positions of employment and offices held during the past seven years;

(d) whether the person during the past seven years has been enjoined, either temporarily or permanently, by a court of competent jurisdiction from violating and state or federal laws regulating the possession, control or wholesale distribution of prescription drugs or devices, together with details of such events;

(e) whether the person has been during the past seven years, the subject of any proceeding for the revocation of any professional or business license or any criminal violation and if so, the nature of the proceeding and the disposition of the proceeding;

(f) description of any involvement by the person with any business, including any investments, other than the ownership of stock in a publicly traded company or mutual fund during the past seven years, which manufactured, administered, prescribed, distributed or stored prescription drugs and devices in which such businesses were names as a party in a lawsuit;

(g) description of any criminal offense (not including minor traffic violations) of which the person, as an adult, was found guilty, regardless of whether adjudication of guilt was withheld or whether the person pled guilty or nolo contendere; if the person indicates that a criminal conviction is under appeal and submits a copy of the notice of appeal of the criminal offense, the applicant must, within 15 days after the disposition of the appeal, submit to the board a copy of the final written order of disposition;

(h) any other information the board deems relevant;

(2) may serve as the designated representative for only one third-party logistics provider at any one time, except where more than one licensed third-party logistics provider is co-located in the same facility and such third-party logistics providers are members of an affiliated group as defined in Section 1504 of the Internal Revenue Code;

(3) be actively involved in and aware of the actual daily operations and inventory control of the third-party logistics provider;
(a) employed full-time in a managerial position by the third-party logistics provider;

(b) physically present at the third-party logistics provider during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation or other authorized absence;

(c) aware of and knowledgeable about all policies and procedures pertaining to the operations of the third-party logistics provider.

B. The criminal and financial information collected pursuant to this section shall be made available only to the board, a third-party recognized by the board, and to state and federal law enforcement officials. The board and a third-party recognized by the board shall make provisions for protecting the confidentiality of the information collected under this section.

C. No third-party logistics provider shall have as an owner or designated representative anyone convicted of any felony violation of Subsection (i) or (k) of Section 301 or any violation of Section 1365 of title 18, United States Code relating to product tampering;

D. Each licensed third-party logistics provider located outside of this state that distributes prescription drugs into this state shall designate a registered agent in this state for service of process. Any licensed third-party logistics provider that does not so designate a registered agent shall be deemed to have designated the secretary of state of this state to be its true and lawful attorney, upon who may be served all legal processes in any action or proceeding against such licensed third-party logistics provider growing out of or arising from such drug distribution. A copy of any such service or process shall be mailed to such third-party logistics provider by the board by certified mail, return receipt requested, postage prepaid, at the address such licensed third-party logistics provider has designated on its application for licensure in this state. If any such third-party logistics provider is not licensed in this state, service on the secretary of state only shall be sufficient service.

E. A designated representative must complete training programs that address applicable state and federal laws and are provided by qualified in-house specialists, outside counsel or counseling specialists with capabilities to help ensure compliance.

Disclaimer: These regulations may not be the most recent version. New Mexico may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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