Okla. Admin. Code § 535:20-3-4

Current through Vol. 42, No. 4, November 1, 2024

Section 535:20-3-4 - Minimum required information for licensure

(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.

Okla. Admin. Code § 535:20-3-4

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

Amended by Oklahoma Register, Volume 32, Issue 23, August 17, 2015, eff. 8/27/2015