 |
Oklahoma Administrative Code (Last Updated: March 11, 2021) |
 |
TITLE 535. Oklahoma State Board of Pharmacy |
|
Chapter 20. Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third- Party Logistics Providers, and Medical Gas Suppliers and Distributors |
|
Subchapter 5. Repackagers |
SECTION 535:20-5-4.2. Minimum qualifications
Latest version.
- (a) The Board shall consider, at a minimum, the following factors in determining the eligibility for and renewal of licensure of repackagers:(1) Any finding by a law enforcement agency or regulatory agency that the applicant or any of its owners have violated any federal, state, or local laws or foreign laws;(2) Suspension, revocation or any other sanction against a license currently or previously held by the applicant or any of its owners for violations of state or federal laws;(3) Any finding that the applicant or any of its owners are guilty of or pleaded guilty or nolo contendere to violating federal, state, or local criminal laws;(4) The furnishing by the applicant of false or fraudulent material in any application;(5) Failure to maintain and/or make available to the Board or to federal, state, or local law enforcement officials those records required to be maintained by repackagers;(6) Any licensee who has no record of repackaging prescription drugs during routine inspection may have its subsequent renewal application referred to the Board for review and possible approval or disapproval, and such review may require the licensee to appear before the Board; and,(7) Any other factors or qualifications that the Board considers relevant to and consistent with the public health and safety.(b) A repackager shall have and follow diversion detection and prevention plan that includes all prescription drugs.(c) The Board shall have the right to deny a license to an applicant if it determines that granting such a license would not be consistent with the public health and safety.