Or. Admin. R. 855-060-0035 - Registration of Mobile Manufacturers

(1) A mobile manufacturer means a manufacturer who manufactures within a vehicle equipped to provide unit dose packaging and repackage capabilities operated by a currently licensed pharmacist in this state.
(2) Stock medication for packaging and repacking will be furnished by the purchaser and shall exclude controlled substances.
(3) The vehicle shall be secure against pilferage, maintained and operated in accordance with good manufacturing practices standards in this division.
(4) All unit dose packages must be labeled in conformity with ORS 689.005.
(5) Records shall be maintained of all package operations of receipt and disposition of drugs.
(6) The building in which this vehicle is stored shall be its permanent address and shall maintain security of vehicle.
(7) Vehicle shall be registered annually; registration shall expire annually on July 1, of each year.
(8) Applicant must show to the Board that he will be actively in charge of equipment in this vehicle at all times it is in operation.
(9) If so required, the vehicle shall be registered with the federal Food and Drug Administration.
(10) The vehicle shall not display insignia or device to indicate that drugs are stored within or represent it as a pharmacy.

Notes

Or. Admin. R. 855-060-0035
1PB 2-1980, f. & ef. 4-3-80; PB 1-1994, f. & cert. ef. 2-2-94

Stat. Auth.: ORS 475.035 & 689.205

Stats. Implemented:

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