SECTION 535:20-6-3. Outsourcing facility licensing requirement

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

(b)   An outsourcing facility shall also be licensed as an outsourcing facility by the Secretary of the U. S. Department of Health and Human Services, Food and Drug Administration.

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

(f)   An outsourcing facility shall not operate from a place of residence.

(g)   The outsourcing facility may be located in a facility where a retail pharmacy licensed by the Board is located.

(h)   An outsourcing facility which receives patient specific prescriptions and fills the prescriptions in Oklahoma or ships the filled prescriptions into Oklahoma shall also have an Oklahoma pharmacy or non-resident pharmacy license.

(i)   An outsourcing facility must publicly display all licenses and have readily available the most recent state and/or federal inspection reports.

[Source: Added at 32 Ok Reg 1233, eff 8-27-15]