Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD)
Subchapter 3 - Manufacturers
Section 535:20-3-3 - Manufacturer licensing requirements

(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.