- (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.
Statutory/Other Authority
ORS 475.035 & 689.205
History
PB 1-1994, f. & cert. ef. 2-2-94
1PB 2-1980, f. & ef. 4-3-80