(1) A school or college of pharmacy that is approved by the board as a school or college of pharmacy from which graduation is required in order for the graduate of the school or college of pharmacy to apply for a license as a pharmacist must meet the requirements set forth by the board.
(2) The board may utilize the facilities, reports, requirements, and recommendations of any recognized accrediting organization in determining the requirements for a school or college of pharmacy.
(3) The board shall maintain a list of approved schools or colleges.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1452, � 1, effective October 1.
Editor's note: This section is similar to former � 12-42.5-111 as it existed prior to 2019.
12-280-114. Licensure, certification, or registration - applicability - applications - licensure and certification requirements - rules. (1) This article 280 applies to all persons in this state engaged in the practice of pharmacy and to all outlets in this state engaged in the manufacture, dispensing, production, sale, and distribution of drugs, devices, and other materials used in the treatment of injury, illness, and disease.
(2) (a) Every applicant for a license or certification under this article 280 must read and write the English language, or if the applicant is a partnership, each member of the partnership must read and write the English language. If the applicant is a Colorado corporation, the corporation must be in good standing, and if the applicant is a foreign corporation, it must be qualified to do business in this state.
(b) The board shall issue the appropriate registration to each manufacturer and wholesaler that meets the requirements of this article 280 unless the board determines that the issuance of the registration would be inconsistent with the public interest. In determining the public interest, the board shall consider the following factors:
(I) Maintenance of effective controls against diversion of controlled substances into illegitimate medical, scientific, or industrial channels;
(II) Compliance with applicable state and local laws;
(III) Any conviction of the applicant under any federal or state law relating to a controlled substance;
(IV) Past experience in the manufacture or distribution of controlled substances and the existence in the applicant's establishment of effective controls against diversion;
(V) Any false or fraudulent information in an application filed under this part 1;
(VI) Suspension or revocation of the applicant's federal registration to manufacture, distribute, or dispense a controlled substance as authorized by federal law; and
(VII) Any other factors relevant to and consistent with the public peace, health, and safety.
(c) The board shall issue a certification to an applicant to practice as a pharmacy technician who satisfies the requirements of this article 280, this section, and section 12-280-115.5.
(3) Every applicant for a license, certification, or registration under this article 280 shall make written application in the manner and form prescribed by the board, setting forth the applicant's name and address, the applicant's qualifications for the license, certification, or registration, and other information required by the board. The applicant shall submit with the application the required fee, and, if the applicant is required to take an examination, the applicant shall appear for examination at the time and place fixed by the board.
(4) (a) (I) An applicant who has graduated from a school or college of pharmacy approved by the board may take an examination before the board.
(II) The examination must be designed fairly to test the applicant's knowledge of pharmacy and other related subjects and must be in a form approved by the board. The examination cannot be administered orally.
(III) An applicant for licensure by examination shall have completed an internship as prescribed by the board.
(b) A person who produces evidence satisfactory to the board that the person has graduated and obtained a degree from a school of pharmacy outside the United States and has passed a foreign graduate equivalency test given or approved by the board may apply to take the examination set forth in subsection (4)(a) of this section.
(5) Every applicant for licensure as a pharmacist, whether by examination, transfer of license, reactivation, or reinstatement, shall take a jurisprudence examination approved by the board that tests the applicant's knowledge of the laws of this state.
(6) No applicant shall exercise the privileges of licensure, certification, or registration until the board grants the license, certification, or registration.
(7) The board may require any applicant for licensure or certification to display written or oral competency in English. The board may utilize a standardized test to determine language proficiency.
(8) A person licensed by examination and in good standing in another state may apply for a license transfer pursuant to the occupational credential portability program.
(9) The board shall adopt rules as necessary to ensure that any person who manufactures drugs and any wholesaler of drugs possesses the minimum qualifications required for wholesale drug distributors pursuant to the federal Prescription Drug Marketing Act of 1987, 21 U.S.C. sec. 353, as amended.
(10) Issuance of a license or registration under this section and section 12-280-119 does not entitle a licensee or registered facility or outlet to wholesale, manufacture, distribute, dispense, or professionally use controlled substances beyond the scope of the licensee's or registrant's federal registration.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1453, � 1, effective October 1; (2)(a), (3), (6), and (7) amended and (2)(c) added, (HB 19-1242), ch. 434, p. 3749, � 5, effective October 1. L. 2020: (8) amended, (HB 20-1326), ch. 126, p. 545, � 39, effective June 25.
Editor's note: This section is similar to former � 12-42.5-112 as it existed prior to 2019.
Cross references: For the short title (Red Tape Reduction Act) and the legislative declaration in HB 20-1326, see sections 1 and 2 of chapter 126, Session Laws of Colorado 2020.
12-280-115. Exemptions from licensure - hospital residency programs - home renal dialysis - research companies. (1) The board is authorized to approve hospital residency programs in the practice of pharmacy. Persons accepted into an approved hospital residency program who are licensed to practice pharmacy in another state are exempt from the licensing requirements of this article 280 so long as their practice is limited to participation in the residency program.
(2) This article 280 does not apply to the sale or delivery of a dialysis solution if all of the following conditions are met:
(a) The sale or delivery is made directly by the manufacturer to a person with chronic kidney failure or to the designee of the person;
(b) The sale or delivery is for the purpose of self-administration by the person pursuant to an order by a physician lawfully practicing in this state; and
(c) The solution is sold or delivered in original packages, properly labeled, and unadulterated in accordance with the requirements of the Colorado Food and Drug Act, part 4 of article 5 of title 25, and the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. sec. 301 et seq., as amended.
(3) A manufacturer that must obtain a prescription drug or device solely for use in its research, development, or testing procedures and that does not further distribute the drug or device may apply to the board for a waiver of registration pursuant to this subsection (3). The board may grant a waiver if the manufacturer submits to the board the name of the drug or device it requires and an affidavit certifying that the drug or device will only be used for necessary research, development, or testing procedures and will not be further distributed. A waiver granted pursuant to this subsection (3) does not apply to a controlled substance, as defined in section 18-18-102 (5), or in federal law.
(4) An employee of a facility, as defined in section 25-1.5-301, who is administering and monitoring medications to persons under the care or jurisdiction of the facility pursuant to part 3 of article 1.5 of title 25 need not be licensed by the board to lawfully possess controlled substances under this article 280.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1455, � 1, effective October 1.
Editor's note: This section is similar to former � 12-42.5-113 as it existed prior to 2019.
12-280-115.5. Certification of pharmacy technicians - requirements - provisional certification - criminal history record check - rules. (1) On or after March 30, 2020, a person shall not engage in the practice as a pharmacy technician unless the person has obtained a certification or provisional certification from the board in accordance with this section.
(2) In addition to any other requirements specified in section 12-280-114 or this article 280, to be certified as a pharmacy technician, an applicant must:
(a) Provide proof satisfactory to the board that the applicant has obtained and maintains in good standing certification as a pharmacy technician from a certifying organization; and
(b) (I) Submit to a criminal history record check in the form and manner as determined by the board by rule; or
(II) Provide proof satisfactory to the board that the applicant submitted to a criminal history record check as a condition of employment at a pharmacy or other outlet, as required by the applicant's current employer, as a condition of participating in a course of study for or with a certifying organization, or in connection with obtaining certification from a certifying organization.
(3) (a) If an applicant for certification as a pharmacy technician has not satisfied the requirements of subsection (2)(a) of this section at the time of application to the board, the board may grant the applicant a provisional certification upon satisfaction of all other requirements for certification specified in this section and section 12-280-114.
(b) (I) Except as provided in subsection (3)(b)(II) of this section, a provisional certification is valid for not more than eighteen months after the date of issuance and is not renewable. If a person who is granted a provisional certification pursuant to this subsection (3) fails to satisfy the requirements of subsection (2)(a) of this section within eighteen months after the date the provisional certification is issued or within an extended period granted by the board pursuant to subsection (3)(b)(II) of this section, the provisional certification expires and the person shall not practice as a pharmacy technician until the person applies for and receives a certification in accordance with subsection (2) of this section.
(II) The board shall adopt rules to establish a process for a provisional certificant to apply for a hardship extension to extend the validity of the provisional certification beyond eighteen months. The board shall establish criteria for qualifying for a hardship extension based on:
(A) The negative effects on access to care in the community served by the provisional certificant or the employer of the provisional certificant;
(B) Financial hardship; or
(C) Health circumstances.
(c) A person whose provisional certification expires is not precluded from applying to the board for certification as a pharmacy technician in accordance with subsection (2) of this section.
Source: L. 2019: Entire section added, (HB 19-1242), ch. 434, p. 3750, � 6, effective October 1.
12-280-116. Expiration and renewal of licenses, certifications, or registrations. (1) All licenses, certifications, and registrations issued pursuant to this article 280, except provisional certifications issued pursuant to section 12-280-115.5 (3), are subject to the renewal, expiration, reinstatement, and delinquency fee provisions specified in section 12-20-202 (1) and (2). Any person whose license, certification, or registration expires is subject to the penalties provided in this article 280 or section 12-20-202 (1).
(2) A pharmacist who fails to renew his or her license or a pharmacy technician who fails to renew his or her certification issued pursuant to section 12-280-115.5 (2) on or before the applicable renewal time may have the license or certification, as applicable, reinstated in accordance with section 12-20-202 (2) for the remainder of the current renewal period by filing a proper application, satisfying the board that the pharmacist or pharmacy technician, as applicable, is fully qualified to practice, and paying the reinstatement fee as provided in section 12-280-112 (1)(e) and (1)(t) and all delinquent fees.
(3) Except for good cause shown, the board shall not grant a license to a pharmacy intern more than two years after the applicant has ceased to be an enrolled student in a college or school of pharmacy approved by the board.
(4) On and after July 1, 2023, as a condition of renewal of a license, each pharmacist shall attest that the pharmacist is in compliance with section 12-280-403 (2)(a) and that the pharmacist is aware of the penalties for noncompliance with that section.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1455, � 1, effective October 1; (1) and (2) amended, (HB 19-1242), ch. 434, p. 3751, � 7, effective October 1. L. 2022: (4) added, (HB 22-1115), ch. 397, p. 2826, � 6, effective August 10.
Editor's note: This section is similar to former � 12-42.5-114 as it existed prior to 2019.