Oklahoma Administrative Code
Title 535 - Oklahoma State Board of Pharmacy
Chapter 20 - Manufacturers, Repackagers, Outsourcing Facilities, Wholesalers, Third-Party Logistics Providers, Medical Gas Suppliers and Distributors, Durable Medical Equipment Suppliers (DME), and Combined DME and Medical Gas Distributors (MGD)
Subchapter 3 - Manufacturers
Section 535:20-3-4.1 - Minimum qualifications
Universal Citation: OK Admin Code 535:20-3-4.1
Current through Vol. 42, No. 1, September 16, 2024
(a) The Board shall consider, at a minimum, the following factors in determining the eligibility for and renewal of licensure of manufacturers:
(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 manufacturers;
(6) Any licensee who has no record of
manufacturing 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 manufacturer shall have and follow a 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.
Disclaimer: These regulations may not be the most recent version. Oklahoma may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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