(1) A prescription drug dispensed pursuant to an order must be labeled as follows:
(a) Drugs compounded and dispensed pursuant to a chart order for a patient in a hospital must bear a label containing the name of the outlet, the name and location of the patient, the identification of the drug, and, when applicable, any suitable control numbers, the expiration date, any warnings, and any precautionary statements.
(b) The symptom or purpose for which the drug is being prescribed must appear on the label, if, after being advised by the practitioner, the patient or the patient's authorized representative so requests. If the practitioner does not provide the symptom or purpose for which a drug is being prescribed, the pharmacist may fill the prescription order without contacting the practitioner, patient, or patient's representative.
(2) (a) Except as otherwise required by law, any drug dispensed pursuant to a prescription order must bear a label prepared and placed on or securely attached to the medicine container stating at least the name and address of the prescription drug outlet, the serial number and the date of the prescription or of its dispensing, the name of the drug dispensed unless otherwise requested by the practitioner, the name of the practitioner, the name of the patient, and, if stated in the prescription, the directions for use and cautionary statements, if any, contained in the prescription.
(b) Notwithstanding the labeling requirements described in subsection (2)(a) of this section, at the practitioner's request, a prescription label for mifepristone, misoprostol, or the generic alternatives to those prescriptions may include the name of the prescribing health-care practice instead of the name of the practitioner, provided the practitioner includes the name of the health-care practice on the paper or electronic form of the prescription.
(3) The board shall promulgate rules concerning the labeling requirements for a prescription drug that is dispensed to a patient for outpatient use and contains an opioid, except for an opioid prescribed for treatment of a substance use disorder or that is a partial opioid antagonist, which rules must include a warning to indicate risks such as overdose and addiction.
(4) (a) As used in this subsection (4), unless the context otherwise requires:
(I) Patient means a patient and a patient's caretaker.
(II) Patient's external accessible device means a commercially available computer, mobile phone, or other communications device that is able to receive electronic information transmitted from an external source and provide the electronic information in a form and format accessible to a patient.
(III) Prescription drug reader means an electronic device that is able to obtain information from an electronic label affixed to a container of a prescription drug and provide the information in an audio format accessible to the patient.
(b) On and after July 1, 2025, except as provided in subsections (4)(c) and (4)(d) of this section, when dispensing a prescription drug to a patient who notifies a pharmacy of difficulty seeing or reading standard printed labels on a prescription drug container, the pharmacy shall provide the patient with a method to access the prescription drug label information required pursuant to subsections (1) to (3) of this section by the patient's choice of:
(I) An electronic label affixed to the prescription drug container that transmits prescription drug label information, directions, and written instructions to a patient's external accessible device, including a patient's compatible prescription drug reader;
(II) A prescription drug reader provided to the patient at no cost;
(III) A prescription drug label in braille or large print; or
(IV) Any other method included in the best practices for access to prescription drug labeling information by the United States access board, or its successor organization.
(c) A pharmacy complies with subsection (4)(b) of this section if:
(I) The pharmacy offers a patient an alternative method to access a prescription drug label other than the methods specified in subsections (4)(b)(I) to (4)(b)(IV) of this section; and
(II) The board affirms that the alternative method offered to a patient pursuant to subsection (4)(c)(I) of this section is substantially similar to the method of access the patient requested and meets the needs of the patient.
(d) If a patient requests a method of access that the pharmacy has not yet been asked to provide to any other patient, the pharmacy must not take more than twenty-eight days to comply with subsection (4)(b) of this section. The pharmacy shall make reasonable efforts to ensure patient safety and access during the time it takes to provide the requested method of accessibility.
(e) Pharmacies shall make good faith, sustained, periodic, and reasonable efforts to inform the public that prescription drug label information is available in accessible formats for individuals who have difficulty seeing or reading standard printed labels on prescription drug containers.
(f) Pharmacies shall otherwise follow best practices as recommended by the United States access board, or its successor organization, for pharmacies in providing independent access to prescription drug label information.
(g) By January 1, 2025, the board shall adopt rules necessary to implement this subsection (4).
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1469, � 1, effective October 1; (3) added, (SB 19-228), ch. 276, p. 2610, � 17, effective October 1. L. 2021: (1)(b) amended, (SB 21-094), ch. 314, p. 1933, � 13, effective September 1. L. 2024: (4) added, (HB 24-1115), ch. 321, p. 2143, � 1, effective August 7. L. 2025: (2) amended, (SB 25-129), ch. 96, p. 436, � 2, effective April 24; (4)(c)(II) amended, (SB 25-300), ch. 428, p. 2442, � 13, effective August 6.
Editor's note: (1) This section is similar to former � 12-42.5-121 as it existed prior to 2019.
(2) Before its relocation in 2019, this section was amended in SB 19-228. 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 19-228, chapter 276, Session Laws of Colorado 2019.
12-280-125. Substitution of prescribed drugs and biological products authorized - when - conditions. (1) (a) A pharmacist filling a prescription order for a specific drug by brand or proprietary name may substitute an equivalent drug product if the substituted drug product is the same generic drug type and, in the pharmacist's professional judgment, the substituted drug product is therapeutically equivalent, is interchangeable with the prescribed drug, and is permitted to be moved in interstate commerce. A pharmacist making a substitution shall assume the same responsibility for selecting the dispensed drug product as he or she would incur in filling a prescription for a drug product prescribed by a generic name; except that the pharmacist is charged with notice and knowledge of the FDA list of approved drug substances and manufacturers that is published periodically.
(a.5) (I) A pharmacist filling a prescription order for a specific drug may substitute a drug in the same therapeutic class as long as the patient agrees to the substitution and the substitution is made to replace a drug that is on back order, to ensure formulary compliance with the patient's health insurance plan, or, in the case of an uninsured patient, to lower the cost to the patient for the drug while maintaining safety.
(II) This subsection (1)(a.5) does not authorize:
(A) The substitution of biological products, narrow therapeutic index drugs, or psychotropic drugs; or
(B) A substitution when the practitioner has indicated, in the manner described in subsection (2) of this section, that the pharmacist shall not substitute a drug in the same therapeutic class as the drug prescribed.
(b) (I) A pharmacist filling a prescription order for a specific biological product may substitute an interchangeable biological product for the prescribed biologic only if:
(A) The FDA has determined that the biological product to be substituted is interchangeable with the prescribed biological product; and
(B) The practitioner has not indicated, in the manner described in subsection (2) of this section, that the pharmacist shall not substitute an interchangeable biological product for the prescribed biological product.
(II) Within a reasonable time after dispensing a biological product, the dispensing pharmacist or his or her designee shall communicate to the prescribing practitioner the specific biological product dispensed to the patient, including the name and manufacturer of the biological product. The pharmacist or designee shall communicate the information to the prescribing practitioner by making an entry into an interoperable electronic medical records system, through electronic prescribing technology, or through a pharmacy record that the prescribing practitioner can access electronically. Otherwise, the pharmacist or his or her designee shall communicate to the prescribing practitioner the name and manufacturer of the biological product dispensed to the patient using facsimile, telephone, electronic transmission, or other prevailing means except when:
(A) There is no FDA-approved interchangeable biological product for the prescribed biological product; or
(B) A refill prescription is not changed from the biological product dispensed on the prior filling of the prescription.
(III) The pharmacy from which the biological product was dispensed must retain a written or electronic record of the dispensed biological product for at least two years after the substitution.
(IV) This subsection (1)(b) does not apply to the administration of vaccines and immunizations as outlined in board rules.
(2) (a) If, in the opinion of the practitioner, it is in the best interest of the patient that the pharmacist not substitute an equivalent drug, a drug in the same therapeutic class, or an interchangeable biological product for the specific drug or biological product the practitioner prescribed, the practitioner may convey this information to the pharmacist in any of the following manners:
(I) Initialing by hand or electronically a preprinted box that states dispense as written or DAW;
(II) Signing by hand or electronically a preprinted box stating do not substitute or dispense as written; or
(III) Orally, if the practitioner communicates the prescription orally to the pharmacist.
(b) The practitioner shall not transmit by facsimile his or her handwritten signature, nor preprint his or her initials, to indicate dispense as written.
(3) (a) If a pharmacist makes a substitution pursuant to subsection (1) of this section, the pharmacist shall communicate the substitution to the purchaser in writing and orally, label the container with the name of the drug or biological product dispensed, and indicate on the file copy of the prescription both the name of the prescribed drug or biological product and the name of the drug or biological product dispensed in lieu of the prescribed drug or prescribed biological product.
(b) The pharmacist is not required to communicate a substitution to patients in an inpatient setting or an outpatient infusion center.
(4) Except as provided in subsection (5) of this section, the pharmacist shall not substitute a drug or interchangeable biological product as provided in this section unless the drug or interchangeable biological product substituted costs the purchaser less than the drug or biological product prescribed. The prescription shall be priced for a drug, other than a biological product, as if it had been prescribed generically.
(5) If a prescription drug outlet does not have in stock the prescribed drug or biological product and the only equivalent drug, drug in the same therapeutic class, or interchangeable biological product in stock is higher priced, the pharmacist, with the consent of the purchaser, may substitute the higher priced drug or interchangeable biological product. This subsection (5) applies only to a prescription drug outlet located in a town, as defined in section 31-1-101 (13).
(6) The board shall maintain on its website a link to the FDA resource, if one is available, that identifies all biological products approved as interchangeable with specific biological products.
Source: L. 2019: Entire title R&RE with relocations, (HB 19-1172), ch. 136, p. 1470, � 1, effective October 1. L. 2021: (1)(a.5) added and IP(2)(a), (3)(b), and (5) amended, (SB 21-094), ch. 314, p. 1933, � 14, effective September 1.
Editor's note: This section is similar to former � 12-42.5-122 as it existed prior to 2019.