2016 Colorado Revised Statutes
Title 12 - Professions and Occupations
Health Care
Article 42.5 - Pharmacists, Pharmacy Businesses, and Pharmaceuticals
Part 1 - General Provisions
§ 12-42.5-117. Registration of facilities - rules

(1) All outlets with facilities in this state shall register with the board in one of the following classifications:

(a) Prescription drug outlet;

(b) Wholesale drug outlet;

(c) Manufacturing drug outlet;

(d) Any other outlet, as may be authorized by this article or that meets the definition of outlet as set forth in section 12-42.5-102 (25).

(2) The board shall establish, by rule, criteria, consistent with section 12-42.5-112 and with the public interest as set forth in section 12-42.5-101, that an outlet that has employees or personnel engaged in the practice of pharmacy must meet to qualify for registration in each classification.

(3) The board shall specify by rule the registration procedures applicants must follow, including the specifications for application for registration and the information needed.

(4) Registrations issued by the board pursuant to this section are transferable or assignable only pursuant to this article and rules established by the board.

(5) It is lawful for a person to sell and distribute nonprescription drugs. Any person engaged in the sale and distribution of nonprescription drugs is not improperly engaged in the practice of pharmacy, and the board shall not promulgate any rule pursuant to this article that permits the sale of nonprescription drugs only by a licensed pharmacist or only under the supervision of a licensed pharmacist or that would otherwise apply to or interfere with the sale and distribution of nonprescription drugs.

(6) The board shall accept the licensure or certification of nursing care facilities and intermediate care facilities required by the department of public health and environment as sufficient registration under this section.

(7) A separate registration is required under this section for any area outside the outlet that is not a satellite where pharmaceutical care and services are provided and for any area outside the outlet that is under different ownership from the outlet.

(8) No hospital outlet filling inpatient chart orders shall sell or otherwise transfer any portion of its prescription drug inventory to another registered outlet for sale or dispensing at retail. This subsection (8) does not limit any transfer of prescription drugs for the hospital's own use or limit the ability of a hospital outlet to engage in a casual sale.

(9) (a) Subject to paragraph (b) of this subsection (9), a prescription drug outlet may register as a compounding prescription drug outlet.

(b) The board shall not register a facility as a compounding prescription drug outlet unless:

(I) The facility has been accredited by a board-approved compounding accreditation entity to be within acceptable parameters to compound more than ten percent of the facility's total sales; and

(II) Ownership of the facility is vested solely in a pharmacist.

(c) To be approved by the board to accredit a compounding prescription drug outlet, a compounding accreditation entity shall be, at a minimum, a scientific organization with expertise in compounding medications.

(10) (a) On or after January 1, 2013, a satellite shall register as a hospital satellite pharmacy if the satellite:

(I) Is located in a facility that is under the same management and control as the building or site where the prescription drug outlet is located; and

(II) Has a different address than the prescription drug outlet.

(b) The board shall adopt rules as necessary to implement this subsection (10). At a minimum, the rules must set forth the manner in which a satellite is to apply for a hospital satellite pharmacy registration and the limits on the distance of satellites from the main prescription drug outlet.

(11) On or after January 1, 2013, a prescription drug outlet may register as a specialized prescription drug outlet if it engages in the compounding, dispensing, and delivery of drugs and devices to, or the provision of pharmaceutical care to residents of, a long-term care facility. The board shall adopt rules as necessary to implement this subsection (11).

(12) (a) A humane society that is duly registered with the secretary of state and has been in existence and in business for at least five years in this state as a nonprofit corporation, or an animal control agency that is operated by a unit of government, shall register with the board.

(b) The board may issue a limited license to a humane society or animal control agency to perform the activities described in section 12-42.5-118 (17).

(c) The board shall adopt rules as necessary to ensure strict compliance with this subsection (12) and section 12-42.5-118 (17) and, in conjunction with the state board of veterinary medicine, shall develop criteria for training individuals in the administration of the drug or combination of drugs.

(d) Nothing in this subsection (12) applies to a licensed veterinarian.

(13) A facility or outlet applying for a registration under this section shall have adequate and proper facilities for the handling and storage of controlled substances and shall maintain proper control over the controlled substances to ensure the controlled substances are not illegally dispensed or distributed.

(14) The board shall not issue a registration under this section to a manufacturer or distributor of marijuana or marijuana concentrate, as those terms are defined in section 27-80-203 (15) and (16), C.R.S., respectively.