535:20-6-6 - Personnel

535:20-6-6. Personnel

(a) Outsourcing facilities shall establish and maintain for Board inspection a list of each partner, limited liability company member or corporate officer and corporate director, as well as designated representatives and facility managers, including a description of their duties and a summary of their qualifications.

(b) Each outsourcing facility shall designate, in writing on a Board-approved form, a person to serve as the designated facility manager of the outsourcing facility for each location licensed.

(c) Each outsourcing facility shall designate, in writing on a Board-approved form, a person to serve as the PIC who is a pharmacist licensed by the Board. No pharmacist may serve as the PIC for more than one outsourcing facility and/or pharmacy at a time unless they are located at the same physical address and are dually licensed with the Board.

(d) No outsourcing facility shall have as an owner, designated representative, facility manager, or pharmacist-in-charge anyone convicted of any felony for conduct relating to compounding prescription drugs, any felony for violation of 21 U.S.C. § 331(i) or (k) or any felony for violation of 18 U.S.C. § 1365 relating to product tampering. No outsourcing facility shall have as an owner, designated representative, facility manager or pharmacist-in-charge anyone who has violated federal or state requirements for licensure that presents a threat of serious adverse health consequences or death to humans.

(Adopted by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015 Amended by Oklahoma Register, Volume 34, Issue 24, September 1, 2017, eff. 9/11/2017)

The following state regulations pages link to this page.