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 - Minimum required information for licensure
Universal Citation: OK Admin Code 535:20-3-4
Current through Vol. 42, No. 1, September 16, 2024
(a) A manufacturer applicant must submit a satisfactorily completed Board-approved application together with the required fee.
(1) New applicants shall provide, at
least, the following:
(A) Applicant's full
name, all trade or business names used, full business address and telephone
number;
(B) Type of ownership,
e.g. individual, partnership, limited liability company or
corporation;
(C) Name(s) of the
owner(s) of the applicant, including:
(i) if a
person, the name, address, Social Security number and date of birth;
(ii) if other than a person, the name,
address, and Social Security number and date of birth of each partner, limited
liability company member, or corporate officer and corporate director and the
federal employer identification number;
(iii) if a corporation, the State of
incorporation; and
(iv) if a
publicly traded corporation, the information in (a)(1)(C)(ii) is not required
for corporate officers and corporate directors.
(D) Names of designated representatives and
facility managers of the applicant, their Social Security numbers and dates of
birth;
(E) Evidence of criminal
background checks and fingerprinting of the applicant, if a person, and of all
of applicant's designated representatives and facility managers;
(F) Proof of licensure by the U.S. Secretary
of Health and Human Services, Food and Drug Administration, and, if applicable,
by the state where the applicant is located (home state); and,
(G) Upon the Board's written request, a list
of all manufacturers, wholesale distributors, third-party logistics providers
and dispensers for whom the manufacturer provides services at such facility.
(2) Renewal applicants
shall provide those items listed above.
(3) Any other information the Board deems
necessary to protect the public health and safety.
(b) The Board may use an outside agency, such as a National Association of Boards of Pharmacy (NABP), at its discretion, to inspect manufacturers.
Added at 9 Ok Reg 2145, eff 6-11-92; Amended at 10 Ok Reg 3175, eff 6-25-93; Amended at 18 Ok Reg 2749, eff 7-1-01; Amended at 25 Ok Reg 1772, eff 5-12-08 (emergency); Amended at 26 Ok Reg 2296, eff 7-1-09
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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