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Michigan Administrative Code (Last Updated: November 16, 2016) |
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Department LR. Licensing and Regulatory Affairs |
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Bureau of Professional Licensing |
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Chapter Board of Pharmacy – General Rules |
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Part 1. GENERAL PROVISIONS |
Section 338.479. Prescription drug labeling and dispensing.
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(1) All labeling of prescription drugs shall comply with the requirements of the code and the federal food, drug, and cosmetic act, 21 U.S.C. §301 et seq.
(2) All containers in which prescription medication is dispensed shall bear a label which contains, at a minimum, all of the following information:
(a) Pharmacy name and address.
(b) Prescription number.
(c) Patient's name.
(d) Date the prescription was most recently dispensed.
(e) Prescriber's name.
(f) Directions for use.
(g) The name of the medication and the strength, unless the prescriber indicates "do not label."
(h) The quantity dispensed, if applicable.
(i) The name of the manufacturer or supplier of the drug if the drug has no brand name, unless the prescriber indicates “do not label.”
(3) If a drug is dispensed that is not the brand prescribed, the purchaser shall be notified and the prescription label shall indicate both the name of the brand prescribed and the name of the brand dispensed. If the dispensed drug does not have a brand name, the prescription label shall indicate the name of the brand prescribed followed by the generic name of the drug dispensed or the reference "G.Eq.," "generic," or "generic equivalent" in the case of multi-ingredient products. This subrule does not apply if the prescriber indicates "do not label."
(4) If drug product selection takes place, the brand name or the name of the manufacturer or supplier of the drug dispensed shall be noted on the prescription.
(5) This rule does not apply to inpatient medical institution service. History: 1979 AC; 1980 AACS; 2013 AACS.