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Colorado Revised Statutes Title 12. Professions and Occupations § 12-280-124. Labeling--rules

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(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.

Cite this article: - Colorado Revised Statutes Title 12. Professions and Occupations § 12-280-124. Labeling--rules - last updated January 01, 2019 |

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