2023 Colorado Revised Statutes › Title 12 - PROFESSIONS AND OCCUPATIONS (§§ 12-1-101 — 12-315-310) › HEALTH CARE PROFESSIONS AND OCCUPATIONS (§§ 12-170-101 — 12-315-310) › Article 280 - PHARMACISTS, PHARMACY BUSINESSES, AND PHARMACEUTICALS (§§ 12-280-101 — 12-280-604) › Part 1 - GENERAL PROVISIONS (§§ 12-280-101 — 12-280-143) › Section 12-280-124 - [Effective 8/7/2024] Labeling - rules - definitions

(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)
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.
(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 state board of pharmacy affirms that the alternative method offered to a patient pursuant to subsection (4)(e)(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).
Amended by 2024 Ch. 321,§ 1, eff. 8/7/2024.
Amended by 2021 Ch. 314, § 13, eff. 9/1/2021.
Amended by 2019 Ch. 276, § 17, eff. 10/1/2019.
Renumbered from C.R.S. §
12-42.5-121
and amended by 2019 Ch. 136, § 1, eff. 10/1/2019.
Amended by 2019 Ch. 276, § 4, eff. 5/23/2019.
(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.
2024 Ch. 321, was passed without a safety clause. See Colo. Const. art. V, § 1(3).
This section is set out more than once due to postponed, multiple, or conflicting amendments.