Mich. Admin. Code R. 338.582 - Prescription drug labeling and dispensing

Rule 82.

(1) All labeling of prescription drugs must comply with the requirements of the code and sections 351 to 399f of the Federal Food, Drug, and Cosmetic Act, 21 USC 351 to 399f.

(2) All containers in which prescription medication is dispensed must bear a label that 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 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 pharmacy shall notify the purchaser and the prescription label must 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 must indicate the name of the brand prescribed followed by the generic name of the drug dispensed. 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 must be noted on the prescription.

(5) This rule does not apply to pharmacy services provided in a medical institution.

Notes

Mich. Admin. Code R. 338.582

2020 AACS; 2022 MR 4, Eff. 2/22/2022