- (a) If Oklahoma is the state in which a prescription drug is manufactured or is the state from which or into which a prescription drug of a manufacturer is shipped, this prescription drug may not be manufactured in and/or shipped into or out of Oklahoma unless each facility of such manufacturer is licensed in Oklahoma. Such license shall be renewed annually by application and payment of renewal fees.
- (b) A manufacturer shall also be licensed as a manufacturer by the Secretary of the U.S. Department of Health and Human Services, Food and Drug Administration.
- (c) A manufacturer license is only valid for the name, ownership and location listed on the license. Changes of name, ownership or location require a new manufacturer license.
- (d) Changes in any information required for licensure must be reported to the Board, in writing, within ten (10) days (e.g. facility manager, designated representative, telephone number, etc.).
- (e) When manufacturer operations are conducted at more than one location, each location shall be licensed by the Board.
- (f) A manufacturer shall not operate from a place of residence.
- (g) The manufacturing facility shall be located apart and separate from any retail pharmacy licensed by the Board.
- (h) A manufacturer must publicly display all licenses and have readily available the most recent state and/or federal inspection reports.
Added at 9 Ok Reg 2145, eff 6-11-92
Amended at 18 Ok Reg 2749, eff 7-1-01
Amended at 25 Ok Reg 1772, eff 5-12-08 (emergency)
Amended at 26 Ok Reg 2296, eff 7-1-09
Amended at 32 Ok Reg 1233, eff 8-27-15