(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.
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
(7) Vehicle shall be
registered annually; registration shall expire annually on July 1, of each
(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.
If so required, the vehicle shall be registered with the federal Food and Drug
(10) The vehicle
shall not display insignia or device to indicate that drugs are stored within
or represent it as a pharmacy.