(a) Each person that is issued an initial or renewal license as a manufacturer, repackager, third party logistics provider or wholesale distributor of prescription drugs for human use, 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 representative.
(b) To be certified as a designated representative, a person shall: - (i) Submit an application on a form furnished by the Board and provide information that includes:
- (A) Fingerprint cards and fee for a criminal background check;
- (B) Date and place of birth;
- (C) Occupations, positions of employment, and offices held during the past seven (7) years;
- (D) Principal business and address of any business corporation, or other organization in which each such office of the person was held or in which each such occupation or position of employment was carried on;
- (E) Whether the person, during the past seven (7) years, has been enjoined, either temporarily or permanently, by a court of competent jurisdiction for violating any federal or state law regulating the possession, control or wholesale distribution of prescription drugs, together with details of such events;
- (F) A 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 (7) years, which manufactured, administered, prescribed, wholesale distributed, or stored prescription drugs in which such businesses were named as a party in a lawsuit;
- (G) A description of any felony criminal offense, or any offense (misdemeanor or felony) involving moral turpitude, or any offense related to the qualifications, functions or duties of that person in connection with the operation of the entity, of which the person, as an adult, was found guilty, regardless of whether adjudication of guilty 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 thirty (30) days after the disposition of the appeal, submit a copy of the final written order of disposition to the Board; and
- (H) A passport type and size of photograph of the person taken within the previous year.
- (ii) Have a minimum of two (2) years of verifiable full-time managerial or supervisory experience in a pharmacy or entity or another state where the person's responsibilities included but were not limited to recordkeeping, storage, and shipment of prescription drugs;
- (iii) Serve as the designated representative for only one location at any one time, except where more than one licensed entity is co-located in the facility and such entities are members of an affiliated group, as defined in Section 1504 of the Internal Revenue Code;
- (iv) Be actively involved in and aware of the actual daily operations of the entity as follows:
- (A) Be employed full-time in a managerial position by the entity;
- (B) Be physically present at the location during normal business hours, except for time periods when absent due to illness, family illness or death, scheduled vacation, or other authorized absence; and
- (C) Be aware of, and knowledgeable about, all policies and procedures pertaining to the operations of the entity.
(c) The information collected pursuant to this Chapter 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.
059-8 Wyo. Code R. § 8-12
Amended, Eff. 10/31/2017.