C.R.S. Section 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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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)

Intentionally left blank —Ed.

(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: Section 12-280-120 — Compounding - dispensing - sale of drugs and devices - rules - definition, https://leg.colorado.gov/sites/default/files/images/olls/crs2023-title-12.pdf (accessed Oct. 20, 2023).

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C.R.S. Section 12-280-120 Compounding

(1)

(2)

(a)

(b)

(c)

(d)

(e)

(3)

(a)

(I)

(II)

(III)

(IV)

(V)

(b)

(4)

(5)

(a)

(I)

(II)

(III)

(A)

(B)

(C)

(D)

(b)

(c)

(6)

(a)

(b)

(I)

(II)

(c)

(7)

(8)

(9)

(II)

(b)

(I)

(II)

(III)

(IV)

(11)

(12)

(13)

(14)

(15)

(a)

(b)

(I)

(II)

(III)

(c)

(I)

(II)

(16)

(17)

(a)

(I)

(II)

(III)

(b)

(18)

C.R.S. Section 12-280-120
Compounding