2016 Colorado Revised Statutes
Title 12 - Professions and Occupations
Health Care
Article 42.5 - Pharmacists, Pharmacy Businesses, and Pharmaceuticals
Part 1 - General Provisions
§ 12-42.5-118. 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, C.R.S., 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 such 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 12-64-103 (15.5); 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 12-42.5-117 (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 in accordance with rules adopted by the board.

(5) (a) A registered prescription drug or licensed hospital other outlet may:

(I) Make a casual sale or loan of or give a drug to another registered outlet or to a wholesaler of drugs;

(II) Sell or give a drug 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) In the case of a county or district public health agency that operates registered other outlets, one registered other outlet may make a casual sale of a drug to another registered other outlet if:

(I) The drug is sold in the original sealed container in which it was originally received from the wholesaler;

(II) A casual sale is not made to a registered other outlet that is not owned or operated by that county or district public health agency; and

(III) The amount sold does not exceed the ten percent limit established by section 12-42.5-102 (6).

(c) Pursuant to section 17-1-113.1, C.R.S., 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 except section 12-42.5-126.

(b) (I) The board shall promulgate rules authorizing a prescription drug outlet located in this state to compound drugs for office use by a practitioner or for use by a hospital located in this state. The rules must limit the amount of drugs a prescription drug outlet may compound and distribute to a practitioner or hospital pursuant to this paragraph (b) to no more than ten percent of the total number of drug dosage units dispensed and distributed on an annual basis by the outlet.

(II) (A) The ten percent limitation set forth in subparagraph (I) of this paragraph (b) applies to a compounded drug for veterinary use that a prescription drug outlet distributes in Colorado.

(B) For purposes of this subparagraph (II), a "prescription drug outlet" includes a nonresident pharmacy outlet registered or licensed pursuant to this article 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 40 of this title or a physician licensed pursuant to article 36 of this title 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 federal food and drug administration as a drug or device, as long as the activity is within the scope of practice of the optometrist pursuant to article 40 of this title or the scope of practice of the physician pursuant to article 36 of this title.

(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) Any hospital employee or agent authorized by law to administer or dispense medications may dispense a twenty-four-hour supply of drugs on the specific order of a practitioner to a registered emergency room patient.

(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 pharmacist 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 12-42.5-102 (17) (a), engaged in the practice of pharmacy within the curriculum of a school or college of pharmacy in accordance with section 12-42.5-102 (17) (a), may be supervised by a manufacturer registered pursuant to section 12-42.5-112 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) A compounding prescription drug outlet registered pursuant to section 12-42.5-117 (9) may dispense and distribute compounded drugs without limitation to practitioners or to prescription drug outlets under common ownership with the pharmacist who owns the compounding prescription drug outlet.

(b) The following may distribute compounded and prepackaged medications, without limitation, to pharmacies under common ownership of the entity:

(I) A prescription drug outlet owned and operated by a hospital that is accredited by the joint commission on accreditation of healthcare organizations or a successor organization;

(II) A prescription drug outlet operated by a health maintenance organization, as defined in section 10-16-102, C.R.S.; 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 subparagraph (II) of this paragraph (c).

(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) A humane society or animal control agency that is registered with the board pursuant to section 12-42.5-117 (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; and

(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.

(b) A society or agency registered pursuant to section 12-42.5-117 (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 and with article 18 of title 18, C.R.S.