Okla. Admin. Code § 535:20-6-6

Current through Vol. 41, No. 19, June 17, 2024

Section 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.

(d) 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.

(e) The PIC shall be present and practicing at the outsourcing facility for which he holds the PIC position no less than 20 hour per week during the outsourcing facility's ordinary course of business. In the event the outsourcing facility's normal hours of business are less than 40 hour per week the PIC shall be present and practicing at least 50 percent of the normal business hours.

(f) A PIC shall work sufficient hours in the outsourcing facility to exercise control and meet the responsibilities of the PIC.

(g) A non-resident outsourcing facility registrant may request, in writing, that the Board allow additional time for a new pharmacist-in-charge to obtain an Oklahoma license in emergency or urgent situations. If the Board determines circumstances warrant it, the Board may grant up to a 90-day extension.

(h) 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.

(i) 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.

Okla. Admin. Code § 535:20-6-6

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

Amended by Oklahoma Register, Volume 38, Issue 24, September 1, 2021, eff. 9/11/2021

Amended by Oklahoma Register, Volume 39, Issue 24, September 1, 2022, eff. 9/11/2022