(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 280 or that meets the definition of other outlet as set forth in section 12-280-103 (32).
(2) The board shall establish, by rule, criteria, consistent with section 12-280-114 and with the public interest as set forth in section 12-280-101, 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 280 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 280 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 pharmacist care 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(9) Repealed.
(10) (a) 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) (a) 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 pharmacist care services to, residents of a long-term care facility.
(b) A pharmacy located in a hospice inpatient unit may register as a specialized prescription drug outlet if the pharmacy compounds drugs and devices and dispenses and delivers the drugs and devices, or provides pharmacist care services, to residents of the hospice inpatient unit.
(c) The board shall adopt rules as necessary to implement this subsection (11).
(12) (a) An animal shelter 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 an animal shelter or animal control agency to perform the activities described in section 12-280-120 (17).
(c) The board shall adopt rules as necessary to ensure strict compliance with this subsection (12) and section 12-280-120 (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), respectively.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1459, � 1, effective October 1. L. 2020: (1)(d) amended, (HB 20-1050), ch. 76, p. 313, � 2, effective September 14. L. 2021: (7) and (11) amended and (9) repealed, (SB 21-094), ch. 314, p. 1931, � 9, effective September 1. L. 2022: (11) amended, (HB 22-1246), ch. 454, p. 3257, � 1, effective August 10; (12)(a) and (12)(b) amended, (HB 22-1235), ch. 442, p. 3118, � 24, effective August 10.
Editor's note: This section is similar to former � 12-42.5-117 as it existed prior to 2019.
12-280-120. Compounding - dispensing - sale of drugs and devices - rules - definition. (1) Except as otherwise provided in this section or part 2 of article 80 of title 27, no drug, controlled substance, or device shall be sold, compounded, dispensed, given, received, or held in possession unless it is sold, compounded, dispensed, given, or received in accordance with this section.
(2) Except as provided in subsection (7) of this section, a manufacturer of drugs may sell or give any drug to:
(a) Any wholesaler of drugs;
(b) A licensed hospital;
(c) An other outlet;
(d) A registered prescription drug outlet; or
(e) Any practitioner authorized by law to prescribe the drugs.
(3) (a) A wholesaler may sell or give any drug or device to:
(I) Another wholesaler of drugs or devices;
(II) Any licensed hospital;
(III) A registered prescription drug outlet;
(IV) An other outlet; or
(V) Any practitioner authorized by law to prescribe the drugs or devices.
(b) A wholesaler may sell or deliver to a person responsible for the control of an animal a drug intended for veterinary use for that animal only if a licensed veterinarian has issued, prior to the sale or delivery, a written prescription order for the drug in the course of an existing, valid veterinarian-client-patient relationship as defined in section 12-315-104 (19); except that, if the prescription order is for a drug that is not a controlled substance or is a controlled substance listed on schedule III, IV, or V, the licensed veterinarian may issue an oral prescription order for that drug. If the licensed veterinarian issues an oral prescription order for a controlled substance listed on schedule III, IV, or V, the licensed veterinarian shall provide a written prescription to the wholesaler within three business days after issuing the oral order.
(4) Only a registered prescription drug outlet or other outlet registered pursuant to section 12-280-119 (1)(d) may compound or dispense a prescription. Initial interpretation and final evaluation, as defined by the board, may be conducted at a location other than a registered prescription drug outlet or other outlet registered pursuant to this article 280 in accordance with rules adopted by the board.
(5) (a) A registered prescription drug outlet or other outlet may:
(I) Make a casual sale of a drug in the manufacturer's sealed container to another registered outlet;
(II) Make a casual sale of a drug in the manufacturer's sealed container to a practitioner authorized by law to prescribe the drug;
(III) Supply an emergency kit or starter dose, as defined by the board by rule, to:
(A) Any facility approved by the board for receipt of an emergency kit;
(B) Any home health agency licensed by the department of public health and environment and approved by the board for receipt of an emergency kit;
(C) Any licensed hospice approved by the board for receipt of an emergency kit in compliance with subsection (12) of this section; and
(D) Any acute treatment unit licensed by the department of public health and environment and approved by the board for receipt of an emergency kit.
(b) Repealed.
(c) Pursuant to section 17-1-113.1, the department of corrections may transfer, deliver, or distribute to a corporation, individual, or other entity entitled to possess prescription drugs, other than a consumer, prescription drugs in an amount that is less than, equal to, or in excess of five percent of the total number of dosage units of drugs dispensed and distributed on an annual basis.
(6) (a) A practitioner may personally compound and dispense for any patient under the practitioner's care any drug that the practitioner is authorized to prescribe and that the practitioner deems desirable or necessary in the treatment of any condition being treated by the practitioner, and the practitioner is exempt from all provisions of this article 280 except section 12-280-129.
(b) (I) A prescription drug outlet located in this state may compound and distribute drugs for veterinary use pursuant to section 12-280-121, but the amount of drugs the prescription drug outlet may compound and distribute for veterinary use must not exceed ten percent of the total number of drug dosage units dispensed and distributed on an annual basis by the outlet.
(II) As used in this subsection (6)(b), a prescription drug outlet includes a nonresident pharmacy outlet registered or licensed pursuant to this article 280 where prescriptions are compounded and dispensed, but only if the nonresident pharmacy outlet has provided the board with a copy of the most recent inspection of the nonresident pharmacy outlet by the agency that regulates pharmaceuticals in the state of residence and a copy of the most recent inspection received from a board-approved third-party entity that inspects pharmacy outlets, for which third-party inspection the nonresident pharmacy outlet shall obtain and pay for on an annual basis, and the board approves the inspection reports as satisfactorily demonstrating proof of compliance with the board's own inspection procedure and standards.
(c) Nothing in this section prohibits an optometrist licensed pursuant to article 275 of this title 12 or a physician licensed pursuant to article 240 of this title 12 from charging a fee for prescribing, adjusting, fitting, adapting, or dispensing drugs for ophthalmic purposes and ophthalmic devices, such as contact lenses, that are classified by the FDA as a drug or device, as long as the activity is within the scope of practice of the optometrist pursuant to article 275 of this title 12 or the scope of practice of the physician pursuant to article 240 of this title 12.
(7) Distribution of any sample may be made only upon written receipt from a practitioner, and the receipt must be given specifically for each drug or drug strength received.
(8) It is lawful for the vendor of any drug or device to repurchase the drug or device from the vendee to correct an error, to retire an outdated article, or for other good reason, under rules the board may adopt to protect consumers of drugs and devices against the possibility of obtaining unsafe or contaminated drugs or devices.
(9) A duly authorized agent or employee of an outlet registered by the board is not deemed to be in possession of a drug or device in violation of this section if he or she is in possession of the drug or device for the sole purpose of carrying out the authority granted by this section to his or her principal or employer.
(10) (a) (I) Any hospital employee or agent authorized by law to administer or dispense medications may dispense a seventy-two-hour supply of drugs on the specific order of a practitioner to a registered emergency room patient.
(II) Notwithstanding subsection (10)(a)(I) of this section, if the hospital employee or agent described in subsection (10)(a)(I) of this section is treating a registered emergency room patient for sexual assault, the hospital employee or agent may, in accordance with the guidelines of the federal centers for disease control and prevention, dispense between a seven-day and twenty-eight-day supply of drugs for prophylaxis of sexually transmitted infections to the patient.
(b) A hospital may dispense a prescription drug pursuant to a chart order for a hospitalized patient for use by the patient during a temporary leave from the hospital of less than seventy-two hours if the prescription drug:
(I) Is labeled in accordance with section 12-280-124 (1) and (2);
(II) Is administered by an authorized person;
(III) Is dispensed pursuant to a current, active order; and
(IV) Is limited to a seventy-two-hour supply or, if the temporary leave is for less than twenty-four hours, the quantity the patient requires during the temporary leave.
(11) The original, duplicate, or electronic or mechanical facsimile of a chart order by the physician or lawfully designated agent constitutes a valid authorization to a pharmacist or pharmacy intern to dispense to a hospitalized patient for administration the amounts of the drugs as will enable an authorized person to administer to the patient the drug ordered by the practitioner. The practitioner is responsible for verifying the accuracy of any chart order he or she transmitted to anyone other than a pharmacist or intern within forty-eight hours of the transmittal.
(12) Any facility approved by the board, any home health agency certified by the department of public health and environment and approved by the board, and any licensed hospice approved by the board may maintain emergency drugs provided and owned by a prescription drug outlet, consisting of drugs and quantities as established by the board.
(13) An intern under the direct and immediate supervision of a pharmacist may engage in the practice of pharmacy. An intern, as defined in section 12-280-103 (22)(a), engaged in the practice of pharmacy within the curriculum of a school or college of pharmacy in accordance with section 12-280-103 (22)(a), may be supervised by a manufacturer registered pursuant to section 12-280-114 or by another regulated individual as provided for in rules adopted by the board.
(14) A manufacturer or wholesaler of prescription drugs shall not sell or give any prescription drug, as provided in subsections (2) and (3) of this section, to a licensed hospital or registered outlet or to any practitioner unless the prescription drug stock container bears a label containing the name and place of business of the manufacturer of the finished dosage form of the drug and, if different from the manufacturer, the name and place of business of the packer or distributor.
(15) (a) Repealed.
(b) The following may distribute prepackaged medications, without limitation, to pharmacies and other outlets under common ownership of the entity:
(I) A prescription drug outlet owned and operated by a hospital that is accredited by the Joint Commission or a successor organization;
(II) A prescription drug outlet operated by a health maintenance organization, as defined in section 10-16-102; and
(III) The Colorado department of corrections.
(c) (I) A prescription drug outlet shall not compound drugs that are commercially available except as provided in subsection (15)(c)(II) of this section.
(II) A pharmacist may compound a commercially available drug if the compounded drug is significantly different from the commercially available drug or if use of the compounded drug is in the best medical interest of the patient, based upon the practitioner's drug order, including the removal of a dye that causes an allergic reaction. If the pharmacist compounds a drug in lieu of a commercially available product, the pharmacist shall notify the patient of that fact.
(16) A prescription drug outlet may allow a licensed pharmacist to remove immunizations and vaccines from the prescription drug outlet for the purpose of administration by a licensed pharmacist, or an intern under the supervision of a pharmacist certified in immunization, pursuant to rules promulgated by the board. The board shall promulgate rules regarding the storage, transportation, and record keeping of immunizations and vaccines that are administered off site.
(17) (a) An animal shelter or animal control agency that is registered with the board pursuant to section 12-280-119 (12) is authorized to:
(I) Purchase, possess, and administer sodium pentobarbital, or sodium pentobarbital in combination with other prescription drugs that are medically recognized for euthanasia, to euthanize injured, sick, homeless, or unwanted pets and animals;
(II) Purchase, possess, and administer drugs commonly used for the chemical capture of animals for control purposes or to sedate or immobilize pet animals immediately prior to euthanasia; and
(III) Purchase and possess vaccines and administer vaccines in accordance with applicable laws.
(b) An animal shelter or animal control agency registered pursuant to section 12-280-119 (12) shall not permit a person to administer scheduled controlled substances, sodium pentobarbital, or sodium pentobarbital in combination with other noncontrolled prescription drugs that are medically recognized for euthanasia unless the person has demonstrated adequate knowledge of the potential hazards and proper techniques to be used in administering the drug or combination of drugs.
(18) Persons registered as required under this part 1, or otherwise licensed or registered as required by federal law, may possess, manufacture, distribute, dispense, or administer controlled substances only to the extent authorized by their registrations or federal registrations or licenses and in conformity with this article 280 and with article 18 of title 18.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1461, � 1, effective October 1. L. 2020: IP(5)(a), (5)(a)(I), and (5)(a)(II) amended and (5)(b) repealed, (HB 20-1050), ch. 76, p. 313, � 3, effective September 14. L. 2021: (6)(b), (10), and IP(15)(b) amended and (15)(a) repealed, (SB 21-094), ch. 314, p. 1931, � 10, effective September 1. L. 2022: (10)(a) amended, (HB 22-1309), ch. 248, p. 1832, � 1, effective May 26; IP(17)(a) and (17)(b) amended and (17)(a)(III) added, (HB 22-1235), ch. 442, p. 3118, � 25, effective August 10.
Editor's note: This section is similar to former � 12-42.5-118 as it existed prior to 2019.
12-280-121. Compounding drugs for office use by a veterinarian - rules - definitions. (1) A registered prescription drug outlet may compound and distribute a drug to a licensed veterinarian so that the veterinarian may maintain the drug as part of the veterinarian's office stock.
(2) (a) A veterinarian may dispense a compounded drug maintained as part of the veterinarian's office stock pursuant to subsection (1) of this section only if:
(I) The compounded drug is necessary for the treatment of an animal patient's emergency condition; and
(II) As determined by the veterinarian, the veterinarian cannot access, in a timely manner, the compounded drug through a registered prescription drug outlet.
(b) A veterinarian shall not dispense a compounded drug pursuant to this section in an amount greater than the amount required to treat an animal patient's emergency condition for five days.
(3) A licensed veterinarian shall not administer or dispense a compounded drug maintained for office stock pursuant to this section or for office use pursuant to section 12-280-120 (6)(b) without a valid veterinarian-client-patient relationship in place at the time of administering the compounded drug to an animal patient or dispensing the compounded drug to a client.
(4) To compound and distribute a controlled substance pursuant to this section or section 12-280-120 (6)(b), a registered prescription drug outlet shall possess a valid manufacturing registration from the federal drug enforcement administration.
(5) As used in this section, unless the context otherwise requires:
(a) Client has the same meaning as set forth in section 12-315-104 (4).
(b) Office stock means the storage of a compounded drug:
(I) That was distributed or sold by a registered prescription drug outlet to a veterinarian;
(II) Without a specific animal patient indicated to receive the compounded drug; and
(III) That the veterinarian may subsequently administer to an animal patient or dispense to a client.
(c) (I) Prescription drug outlet means any:
(A) Resident or nonresident pharmacy outlet registered or licensed pursuant to this article 280 where prescriptions are compounded and dispensed; or
(B) Federally owned and operated pharmacy registered with the federal drug enforcement administration.
(II) Notwithstanding subsection (5)(c)(I) of this section, prescription drug outlet does not include a nonresident pharmacy outlet unless the nonresident pharmacy outlet has provided the board with a copy of the most recent inspection of the nonresident pharmacy by the agency that regulates pharmaceuticals in the state of residence and a copy of the most recent inspection received from a board-approved third-party entity that inspects pharmacy outlets, for which third-party inspection the nonresident pharmacy outlet shall obtain and pay for on an annual basis, and the board approves the inspection reports as satisfactorily demonstrating proof of compliance with the board's own inspection procedure and standards.
(6) The board may promulgate rules as necessary concerning compounded veterinary pharmaceuticals pursuant to this section and section 12-280-120 (6)(b).
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1465, � 1, effective October 1. L. 2021: (3), (4), and (6) amended, (SB 21-094), ch. 314, p. 1933, � 11, effective September 1.
Editor's note: This section is similar to former � 12-42.5-118.5 as it existed prior to 2019.
12-280-122. Limited authority to delegate activities constituting practice of pharmacy to pharmacy interns or pharmacy technicians - definition. (1) A pharmacist may supervise up to six persons who are either pharmacy interns or pharmacy technicians, of whom no more than two may be pharmacy interns. If three or more pharmacy technicians are on duty, the majority must be fully certified by the board in accordance with section 12-280-115.5 (2), and any pharmacy technician on duty who is not certified pursuant to section 12-280-115.5 (2) must have a provisional certification issued pursuant to section 12-280-115.5 (3).
(2) The pharmacy shall retain documentation verifying the training for review by the pharmacist responsible for the final check on prescriptions filled by the pharmacy technician and shall make the documentation available for inspection by the board.
(3) The supervision ratio specified in subsection (1) of this section does not include other ancillary personnel who may be in the prescription drug outlet but who are not performing duties described in section 12-280-103 (39)(b) that are delegated to the interns or duties described in section 12-280-103 (38.5)(a) that are delegated to the pharmacy technicians.
(4) (a) The provisions of subsection (1) of this section apply to a central fill pharmacy; except that a pharmacist may supervise up to eight persons who are either pharmacy interns or pharmacy technicians, of whom no more than two may be pharmacy interns.
(b) As used in this subsection (4), central fill pharmacy means a pharmacy, other than a pharmacy located in a hospital licensed pursuant to section 25-1.5-103, that is not a public-facing pharmacy and that only acts as an agent of an originating pharmacy to fill or refill a prescription.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1467, � 1, effective October 1; (1) and (3) amended, (HB 19-1242), ch. 434, p. 3753, � 10, effective October 1. L. 2023: (1) amended and (4) added, (SB 23-162), ch. 148, p. 630, � 3, effective August 7.
Editor's note: This section is similar to former � 12-42.5-119 as it existed prior to 2019.
12-280-123. Prescription required - exception - dispensing opioid antagonists - selling nonprescription syringes and needles. (1) (a) Except as provided in sections 12-280-125.5 and 18-18-414 and subsections (2) and (3) of this section, an order is required prior to dispensing any prescription drug. Orders shall be readily retrievable within the appropriate statute of limitations.
(b) A pharmacist who receives an order for a controlled substance that is included in schedule II, III, or IV from a podiatrist, dentist, physician, physician assistant, advanced practice registered nurse, certified midwife, or optometrist, which order is not transmitted electronically to the pharmacist, is not required to verify the applicability of an exception to electronic prescribing of controlled substances under section 12-30-111 and may dispense the controlled substance pursuant to a written, oral, or facsimile-transmitted order that is otherwise valid and consistent with the requirements of current law.
(c) (I) A pharmacist who dispenses a prescription order for a prescription drug that is an opioid shall inform the individual of the potential dangers of a high dose of an opioid, as described by the federal centers for disease control and prevention in the United States department of health and human services, and offer to dispense to the individual to whom the opioid is being dispensed, on at least an annual basis, an opioid antagonist approved by the FDA for the reversal of an opioid overdose if:
(A) The individual is, at the same time, prescribed a benzodiazepine, a sedative hypnotic drug, carisoprodol, tramadol, or gabapentin; or
(B) The opioid prescription is at or in excess of ninety morphine milligram equivalent, as described in the guidelines of the federal centers for disease control and prevention.
(II) Notwithstanding section 12-30-110 (2)(a), if an individual to whom an opioid is being dispensed chooses to accept the pharmacist's offer for an opioid antagonist, the pharmacist shall counsel the individual on how to use the opioid antagonist in the event of an overdose. The pharmacist shall notify the individual of available generic and brand-name opioid antagonists.
(III) This subsection (1)(c) does not apply to a pharmacist dispensing a prescription medication to:
(A) A patient who is in hospice or palliative care; and
(B) A resident in a veterans community living center, as defined in section 26-12-102 (7).
(2) A pharmacist may refill a prescription order for any prescription drug without the practitioner's authorization when all reasonable efforts to contact the practitioner have failed and when, in the pharmacist's professional judgment, continuation of the medication is necessary for the patient's health, safety, and welfare. The prescription refill may only be in an amount sufficient to maintain the patient until the practitioner can be contacted, but in no event may a refill under this subsection (2) continue medication beyond seventy-two hours. However, if the practitioner states on the prescription that no emergency filling of the prescription is permitted, then the pharmacist shall not issue any medication that is not authorized by the prescription. Neither a prescription drug outlet nor a pharmacist is liable as a result of refusing to refill a prescription pursuant to this subsection (2).
(3) A pharmacist may prescribe and dispense an opioid antagonist in accordance with section 12-30-110.
(4) A pharmacist or pharmacy technician may sell a nonprescription syringe or needle to any person.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1467, � 1, effective October 1; (1) amended, (HB 19-1077), ch. 40, p. 138, � 5, effective October 1; (1) amended, (SB 19-079), ch. 86, p. 320, � 24, effective October 1. L. 2020: (1)(c) and (4) added, (HB 20-1065), ch. 287, pp. 1419, 1421, �� 3, 8, effective September 14. L. 2021: (3) amended, (SB 21-094), ch. 314, p. 1933, � 12, effective September 1; (1)(c) amended, (SB 21-011), ch. 207, p. 1081, � 1, effective September 7. L. 2023: (1)(b) amended, (SB 23-167), ch. 261, p. 1545, � 49, effective May 25. L. 2024: IP(1)(c)(I), (1)(c)(II), and (3) amended, (HB 24-1037), ch. 458, p. 3169, � 14, effective June 6.
Editor's note: (1) This section is similar to former � 12-42.5-120 as it existed prior to 2019; except that � 12-42.5-120 (3)(d) was relocated to � 12-30-110 (1)(b), (2)(b), and (4)(b).
(2) (a) Before its relocation in 2019, this section was amended in HB 19-1077. Those amendments were superseded by the repeal and reenactment of this title 12, effective October 1, 2019. For those amendments to the former section in effect from March 21, 2019, to October 1, 2019, see HB 19-1077, chapter 40, Session Laws of Colorado 2019.
(b) Before its relocation in 2019, this section was amended in SB 19-079. Those amendments were superseded by the repeal and reenactment of this title 12, effective October 1, 2019. For those amendments to the former section in effect from August 2, 2019, to October 1, 2019, see SB 19-079, chapter 86, Session Laws of Colorado 2019.
(c) Before its relocation in 2019, this section was amended in SB 19-227. Those amendments were superseded by the repeal and reenactment of this title 12, effective October 1, 2019. For those amendments to the former section in effect from May 23, 2019, to October 1, 2019, see SB 19-227, chapter 273, Session Laws of Colorado 2019.
(3) Amendments to subsection (1) by HB 19-1077 and SB 19-079 were harmonized.