Okla. Admin. Code § 535:20-5-3.1

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

Section 535:20-5-3.1 - Repackager licensing requirement

(a) If Oklahoma is the state in which a prescription drug is repackaged or is the state from which or into which a prescription drug of a repackager is shipped, this prescription drug may not be repackaged and/or shipped into or out of Oklahoma unless each facility of such repackager is licensed in Oklahoma. Such license shall be renewed annually by application and payment of renewal fees.

(b) A repackager shall also be licensed as a repackager by the Secretary of the U.S. Department of Health and Human Services, Food and Drug Administration.

(c) A repackager license is only valid for the name, ownership and location listed on the license. Changes of name, ownership or location require a new repackager 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 repackager operations are conducted at more than one location, each location shall be licensed by the Board.

(f) A repackager shall not operate from a place of residence.

(g) The repackaging facility shall be located apart and separate from any retail pharmacy licensed by the Board.

(h) A repackager must publicly display all licenses and have readily available the most recent state and/or federal inspection reports.

Okla. Admin. Code § 535:20-5-3.1

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