Colorado § 12-280-133.5 - Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - rules.

§ 12-280-133.5. Nonresident 503B outsourcing facility - registration - requirements - denial, revocation, or suspension - rules.

(1) A nonresident 503B outsourcing facility shall not conduct the business of distributing compounded prescription drugs in this state without first registering with the board as a nonresident 503B outsourcing facility. A nonresident 503B outsourcing facility shall apply for a nonresident 503B outsourcing facility registration on a form furnished by the board and shall submit the following to the board with the application:

(a) Proof that the facility is actively registered with the FDA as a 503B outsourcing facility and is actively licensed, permitted, or registered in the state in which it is a resident;

(b) The location, names, and titles of all principal entity officers and the name of the pharmacist in charge of the operations of the facility;

(c) Verification that the facility complies with all lawful directions and requests for information from the FDA and from the regulatory or licensing agency of the state in which it is licensed, permitted, or registered, as well as with all requests for information made by the board pursuant to this section;

(d) A copy of the most recent inspection report resulting from an inspection conducted by the FDA; and

(e) Any other information the board deems necessary to carry out the purpose of this section.

(2) A nonresident 503B outsourcing facility shall:

(a) Maintain at all times a valid, unexpired license, permit, or registration to operate the 503B outsourcing facility in compliance with the laws of the state in which it is a resident; and

(b) Comply with the requirements of the "Federal Food, Drug, and Cosmetic Act", 21 U.S.C. sec. 301 et seq., as amended, or the DQSA or with FDA regulations implementing either act.

(3) The board may deny, revoke, or suspend a nonresident 503B outsourcing facility registration if:

(a) The facility fails to comply with this section or with any rule promulgated by the board;

(b) The FDA has revoked or refused to renew the nonresident 503B outsourcing facility's FDA registration for failing to comply with the requirements of the "Federal Food, Drug, and Cosmetic Act", 21 U.S.C. sec. 301 et seq., as amended, the DQSA, or FDA regulations implementing either act or the facility's FDA registration has expired or is no longer active; or

(c) The state in which the nonresident 503B outsourcing facility resides has revoked or refused to renew the facility's license, permit, or registration for failing to comply with the laws of that state or the facility's license, permit, or registration in another state has expired or is no longer active.

(4) The board may adopt rules as necessary to implement this section.

Source: L. 2021: Entire section added, (SB 21-094), ch. 314, p. 1935, § 18, effective September 1.