Labeling - rules.

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(1) A prescription drug dispensed pursuant to an order must be labeled as follows:

  1. Drugs compounded and dispensed pursuant to a chart order for a patient in a hospitalmust 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.

  2. (I) If the prescription is for an anabolic steroid, the purpose for which the anabolicsteroid is being prescribed must appear on the label.

(II) If the prescription is for any drug other than an anabolic steroid, 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, unless the prescription is for an anabolic steroid.

  1. Except as otherwise required by law, any drug dispensed pursuant to a prescriptionorder 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.

  2. 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.

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.

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.


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