Okla. Admin. Code § 535:20-3-3

Current through Vol. 42, No. 4, November 1, 2024

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.

Okla. Admin. Code § 535:20-3-3

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 by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015