Colorado § 12-280-108 - Powers and duties - rules.

§ 12-280-108. Powers and duties - rules.

(1) The board shall:

(a) (I) Inspect, or direct inspectors who are licensed pharmacists to inspect, all outlets and investigate violations of this article 280.

(II) The board's authority under this subsection (1)(a) to inspect all outlets includes the authority, after conducting a risk-based assessment, as defined by the board by rule, to inspect an out-of-state pharmacy, a nonresident 503B outsourcing facility, or an out-of-state wholesaler.

(b) Prescribe forms and receive applications for licensure, certification, and registration and grant, renew, reactivate, and reinstate licenses, certifications, and registrations;

(c) Deny, suspend, or revoke licenses, certifications, or registrations;

(d) Apply to the courts for and obtain restraining orders and injunctions in accordance with section 12-20-406 to enjoin violations of the laws that the board is empowered to enforce;

(e) Administer examinations to, and determine the qualifications and fitness of, applicants for licensure, certification, or registration;

(f) Keep a record of:

(I) All licenses, certifications, registrations, and license, certification, and registration renewals, reactivations, and reinstatements for a reasonable period;

(II) All suspensions, revocations, and any other disciplinary actions; and

(III) Its own proceedings;

(g) Collect all fees prescribed by this article 280 and section 12-20-105;

(h) Fine registrants when consistent with the provisions of this article 280 and the rules adopted pursuant to this article 280;

(i) Conduct investigations, hold hearings, and take evidence in all matters relating to the exercise and performance of the powers and duties of the board in accordance with section 12-20-403;

(j) Review and approve or reject applications for participation in the pharmacy peer health assistance program pursuant to part 2 of this article 280 and perform any other functions that were performed by the rehabilitation evaluation committee prior to its repeal;

(k) Send a quarterly electronic newsletter to all licensees by email that details changes in state law, including changes outside of this article 280, that affect or are pertinent to the practice of pharmacy.

(2) The board has other duties, powers, and authority as may be necessary to enforce this article 280 and the rules adopted pursuant to this article 280.

(3) The board may:

(a) Adopt a seal to be used only in the manner the board prescribes;

(b) Promulgate rules governing the compounding of pharmaceutical products, which rules must address the following:

(I) Training and qualifications;

(II) Quality control;

(III) Internal operating procedures;

(IV) Procurement of compounding materials;

(V) Formulation, documentation, and testing requirements;

(VI) Equipment standards;

(VII) Facility standards; and

(VIII) A recall system.

(4) (a) (I) Whenever a duly authorized agent of the board finds or has probable cause to believe that, in any registered outlet, any drug, nonprescription drug, or device is adulterated or misbranded within the meaning of the "Colorado Food and Drug Act", part 4 of article 5 of title 25, the agent shall affix to the article a tag or other appropriate marking giving notice:

(A) That the article is, or is suspected of being, adulterated or misbranded;

(B) That the article has been detained or embargoed; and

(C) Warning all persons not to remove or dispose of the article by sale or otherwise until the board, its agent, or the court gives provision for removal or disposal.

(II) No person shall remove or dispose of an embargoed article by sale or otherwise without the permission of the board or its agent or, after summary proceedings have been instituted, without permission from the court.

(b) If the board or the court removes the embargo, neither the board nor the state is liable for damages because of the embargo if the court finds that there was probable cause for the embargo.

(c) When an agent finds that an article detained or embargoed under subsection (4)(a) of this section is adulterated or misbranded, the agent shall petition the judge of the district court in whose jurisdiction the article is detained or embargoed for an order for condemnation of the article. When the agent finds that an article so detained or embargoed is not adulterated or misbranded, he or she shall remove the tag or other marking.

(d) (I) If the court finds that a detained or embargoed article is adulterated or misbranded, except as provided in subsection (4)(d)(II) of this section, the court shall order the article, after entry of the decree, to be destroyed at the expense of the owner of the article under the supervision of the agent. The owner of the article or the owner's agent shall bear all court costs and fees, storage, and other proper expense.

(II) When the owner can correct the adulteration or misbranding by proper labeling or processing of the article, after entry of the decree and after the owner has paid the costs, fees, and expenses and has posted a good and sufficient bond, conditioned that the article be properly labeled or processed, the court may direct, by order, that the article be delivered to the owner for proper labeling or processing under the supervision of an agent. The owner shall pay the expense of the agent's supervision. The bond must be returned to the owner of the article once the board represents to the court that the article is no longer in violation of the embargo and that the owner has paid the expenses of supervision.

(e) It is the duty of the attorney general or the district attorney to whom the board reports any violation of this subsection (4) to institute appropriate proceedings in the proper courts without delay and to prosecute the matter in the manner required by law. Nothing in this subsection (4)(e) requires the board to report violations when the board believes the public interest will be adequately served in the circumstances by a suitable written notice or warning.

Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1448, § 1, effective October 1; (1)(b), (1)(c), (1)(e), and (1)(f)(I) amended, (HB 19-1242), ch. 434, p. 3749, § 3, effective October 1. L. 2021: (1)(a) and (1)(j) amended and (1)(k) added, (SB 21-094), ch. 314, p. 1929, § 6, effective September 1. L. 2024: (1)(k) amended, (SB 24-209), ch. 456, p. 3155, § 2, effective July 1.

Editor's note: This section is similar to former § 12-42.5-106 as it existed prior to 2019.

ANNOTATION

Annotator's note. The following annotations include cases decided under former provisions similar to this section.

Regulation of pharmacists and sale of drugs authorized by police power. The state has authority under the police power for the protection of the public health and welfare to regulate the practice of pharmacy and the sale of drugs, and to delegate to an administrative agency the power and authority to adopt rules and regulations and provide for their enforcement. Moore v. District Court, 184 Colo. 63, 518 P.2d 948 (1974).

Constitutionality of board's exercise of powers presumed valid. As an administrative agency statutorily created and endowed with specific enumerated powers and duties delegated pursuant to the police power of the state, the board's exercise of those powers within the scope of its authority is entitled to a presumption of validity and constitutionality. Moore v. District Court, 184 Colo. 63, 518 P.2d 948 (1974).

Presumption not lightly cast aside. The presumption of validity of the rules regularly promulgated by the board is not to be lightly cast aside by mere allegations in a complaint of unconstitutionality. Moore v. District Court, 184 Colo. 63, 518 P.2d 948 (1974).

Burden is upon party challenging constitutionality of board's rules to establish by a clear and convincing showing beyond a reasonable doubt the asserted invalidity. Moore v. District Court, 184 Colo. 63, 518 P.2d 948 (1974).

Board not required to issue notice before announcing final decision following changes in penalty. Changes, made by the state board of pharmacy in a hearing officer's penalty for pharmacist's violation of § 12-22-124, rendered without notice to the appellant or without any further hearings following a hearing officer's initial decision and order, were quasi-judicial in nature and thus neither § 12-22-124 nor due process principles required that the board issue any notice prior to announcing its final decision. Mitchell v. Klapper, 626 P.2d 1163 (Colo. App. 1980).