N.M. Admin. Code § 16.19.8.17 - PERSONNEL
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.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.