Mich. Admin. Code 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.
Notes
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