(1) In facilities licensed by the Montana Department of Public Health and Human Services where United States pharmacopeia storage requirements are assured, unit-dosed legend drugs, with the exception of controlled substances, no longer needed by the patient for whom they were prescribed, may be transferred to a provisional permitted pharmacy for relabeling and dispensing free of charge to patients who are uninsured, indigent or have insufficient funds to obtain needed prescription drugs. Prescription medications may be dispensed pursuant to a valid prescription order. A usual and customary dispensing fee may be charged at the pharmacist's discretion.
(2) The pharmacist-in-charge of the provisional permitted pharmacy shall be responsible for determining the suitability of the legend drug for use. Medications must be unopened in sealed, unaltered unit dose containers that meet USP standards for light, moisture and air permeation. No product in which drug integrity cannot be assured shall be accepted for redispensing by the pharmacist.
(3) A redispensed prescription medication must be assigned the expiration date stated on the unit dose packaging. Medications packaged in unit dose form within a pharmacy must be given an expiration date of one year or actual date of expiration of the medication, whichever comes first, and must not be repackaged.
(4) No medication can be redistributed more than once.
(5) Only authorized personnel shall carry out the physical transfer of medication in either facility, pursuant to established policies and procedures.
(6) The patient's name and other identifying marks must be obliterated from packaging prior to transfer. The drug name, strength, lot number and expiration date must remain clearly visible on the packaging.
(7) An inventory list of drugs transferred, including expiration dates, must accompany the drugs, and must be maintained in the provisional permitted pharmacy for a period of two years.
(8) Policies and procedures to document safe storage and transfer of unneeded medications must be written and adhered to by the facilities involved, and must be available for inspection by an authorized representative of the Montana Board of Pharmacy or Department of Public Health and Human Services.