Mich. Admin. Code R. 338.3167

Current through Vol. 24-16, September 15, 2024

Section R. 338.3167 - Dispensing schedule 5 substances without prescriptions

Rule 67.

(1) A pharmacist may, without a prescription, dispense a controlled substance listed in schedule 5 that is not a prescription medication as determined under the FDCA, if all of the following provisions are met:

(a) The dispensing pharmacist determines the controlled substance is intended to be used for a medical purpose.

(b) Not more than 240 cc, 8 ounces, or 48 solid doses of a substance containing opium or more than 120 cc, 4 ounces, or 24 solid doses of another substance listed in schedule 5 are distributed at retail to the same purchaser in a 48-hour period.

(c) The purchaser is not younger than 18 years of age.

(d) The dispensing pharmacist requires a purchaser, not known to the pharmacist, to furnish suitable identification, including proof of age where appropriate.

(2) If a pharmacist dispenses a controlled substance listed in schedule 5 without a prescription, the pharmacist shall affix a label to the container that holds the substance that includes all the following:

(a) The date the controlled substance was dispensed.

(b) The pharmacist's name.

(c) The name and address of the pharmacy where the substance is dispensed.

(3) The pharmacist shall maintain a record of the dispensing without a prescription of controlled substances listed in schedule 5 with the following requirements:

(a) The record must be maintained for 5 years after the date of dispensing. After 2 years, an electronic duplicate of the original order may be made which becomes the original record.

(b) The record must be immediately retrievable and may be maintained in the same manner as required for schedule 5 prescription medication.

(c) The record must contain all of the following information:

(i) The name and address of the patient.

(ii) The name and address of the purchaser if different from the patient.

(iii) The name and quantity of substance purchased.

(iv) The date purchased.

(v) The name or initials of the pharmacist or pharmacy intern who dispensed the substance.

(vi) The medical purpose of the medication as determined by the pharmacist.

Mich. Admin. Code R. 338.3167

1979 AC; 1992 AACS; 1994 AACS; 2003 AACS; 2022 AACS; 2024 MR 10, Eff. 5/28/2024