Colorado § 12-280-303 - Wholesaler registration requirements - rules.

§ 12-280-303. Wholesaler registration requirements - rules.

(1) A wholesaler that resides in this state must register with the board before engaging in the wholesale distribution of prescription drugs in this state. A wholesaler that does not reside in this state must be registered in this state prior to engaging in the wholesale distribution of prescription drugs in this state.

(2) (a) The board may adopt rules to approve an accreditation body to evaluate a wholesaler's operations to determine compliance with professional standards and any other applicable laws and to perform inspections of each facility and location where the wholesaler conducts wholesale distribution operations.

(b) An applicant for a registration shall pay any fee required by the accreditation body or the board and comply with any rules promulgated by the board.

(c) The board shall not issue or renew a registration to a wholesaler who does not comply with this part 3.

(3) (a) An applicant for a wholesaler registration shall provide to the board the following information, and any other information deemed appropriate by the board, on a form provided by the board:

(I) The name, full business address, and telephone number of the applicant;

(II) The trade and business names used by the applicant;

(III) The addresses, telephone numbers, and names of the contact persons for all facilities used by the applicant for the storage, handling, and distribution of prescription drugs;

(IV) The type of ownership or operation of the applicant;

(V) The names of the owner and the operator of the applicant, including:

(A) The name of each partner if the applicant is a partnership;

(B) The name and title of each officer and director, the name of the corporation, and the state of incorporation, if the applicant is a corporation;

(C) The name of the limited liability company, if the applicant is a limited liability company, and the name of the parent company, if any, and the state of incorporation or formation of both; or

(D) The name of the sole proprietor and the business entity if the applicant is a sole proprietorship;

(VI) A list of the licenses, registrations, or permits issued to the applicant by any other state that authorizes the applicant to purchase or possess prescription drugs; and

(VII) The name of the applicant's designated representative for the facility, the fingerprints of the designated representative, and a personal information statement for the designated representative that includes information as required by the board, including but not limited to the information in subsection (5) of this section.

(b) A registrant shall complete and return a form approved by the board at each renewal period. The board may suspend or revoke the registration of a wholesaler if the board determines that the wholesaler no longer qualifies for a registration.

(4) Prior to issuing a wholesaler registration to an applicant, the board, the regulatory oversight body from another state, or a board-approved accreditation body may conduct a physical inspection of the facility at the business address provided by the applicant. Nothing in this subsection (4) precludes the board from inspecting a wholesaler.

(5) The designated representative of an applicant for a wholesaler registration shall:

(a) Be at least twenty-one years of age;

(b) Have at least three years of full-time employment history with a pharmacy or a wholesaler in a capacity related to the dispensing and distribution of and the record keeping related to prescription drugs;

(c) Be employed by the applicant in a full-time managerial position;

(d) Be actively involved in and aware of the actual daily operation of the wholesaler;

(e) Be physically present at the facility of the applicant during regular business hours, except when the absence of the designated representative is authorized, including, but not limited to, sick leave and vacation leave;

(f) Serve in the capacity of a designated representative for only one applicant or wholesaler at a time, except where more than one registered wholesaler is co-located in the same facility and the wholesalers are members of an affiliated group as defined by section 1504 of the federal "Internal Revenue Code of 1986", as amended;

(g) Not have any convictions under federal, state, or local law relating to wholesale or retail prescription drug distribution or a controlled substance, as defined in section 18-18-102 (5);

(h) Not have any felony convictions pursuant to federal, state, or local law; and

(i) Update all of the information required in this part 3 whenever changes occur.

(6) A wholesaler shall obtain a registration for each facility it uses for the distribution of prescription drugs.

Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1490, § 1, effective October 1. L. 2021: (1), (2)(b), (2)(c), IP(3)(a), (3)(a)(VI), (3)(b), (4), IP(5), (5)(f), and (6) amended, (SB 21-094), ch. 314, p. 1941, § 27, effective September 1.

Editor's note: This section is similar to former § 12-42.5-303 as it existed prior to 2019.