(a) Every manufacturer, repackager, third party logistics provider, and wholesale distributor of prescription drugs for human use, wherever located, that provides services within this State shall be licensed by the Board and shall annually renew their license using an application provided by the Board. Manufacturers, repackagers, third party logistics providers and wholesale distributors cannot operate from a place of residence. Where wholesale distribution operations are conducted at more than one location, each such location shall be licensed by the Board.
(b) The Board shall require the following minimum information from each manufacturer, repackager, third party-logistics provider, and wholesale drug distributor as part of the initial licensing procedure and as part of any renewal of such license: - (i) All trade or business names used by the licensee (includes "is doing business as" and "formerly known as") which cannot be identical to the name used by another unrelated licensee to purchase/distribute prescription drugs in this State;
- (ii) Name(s) of the owner and operator of the licensee (if not the same person), including:
- (A) If a person: the name, business address, social security number, and date of birth;
- (B) If a partnership: the name, business address, and social security number and date of birth of each partner, and the name of the partnership and federal employer identification number;
- (C) If a corporation: the name, business address, social security number, date of birth, and title of each corporate officer and director; the corporate names, state of incorporation, federal employer identification number, and name of the parent company, if any; the name, business address, and social security number of each shareholder owning ten percent (10%) or more of the voting stock of the corporation, including over-the-counter (OTC) stock, unless the stock is traded on a major stock exchange and not OTC:
- (D) If a sole proprietorship: the full name, business address, social security number, and date of birth of the sole proprietor and the name and federal employer identification number of the business entity;
- (E) If a limited liability company: the name of each member, the name of each manager, the name of the limited liability company and federal employer identification number, and the name of the state in which the limited liability company was organized; and
- (F) Any other relevant information the Board requires.
- (iii) Name(s), business address(es), and telephone number(s) of the person(s) to serve as the designated representative(s) for each facility of the wholesale distributor that engages in the wholesale distribution of prescription drugs. The Board shall be notified of each change in designated representative within 30 days of the change. Fingerprints and a fifty dollar ($50.00) fee shall be submitted for each designated representative application for a criminal background check and with each application for change in designated representative;
- (iv) A list of all state and federal licenses, registrations, or permits, including the license, registration, or permit numbers issued to the wholesale distributor by any other state and federal authority that authorizes the wholesale distributor to purchase, possess, and wholesale distribute prescription drugs;
- (v) A list of all disciplinary actions by state and federal agencies against the entity as well as any such actions against principals, owners, directors or officers;
- (vi) A full description of each facility and warehouse, including all locations utilized for prescription drug storage or wholesale distribution. The description shall include the following:
- (B) A general description of security and alarm systems;
- (C) Terms of lease or ownership;
- (E) Temperature and humidity controls in accordance with this Chapter.
- (vii) A copy of the deed for the property on which the entity's establishment is located, if the property is owned by the entity; or a copy of the wholesale distributor's lease for the property on which the establishment is located which has an original term of not less than one (1) calendar year (if the establishment is not owned by the entity);
- (viii) Information regarding general and product liability insurance, including copies of relevant policies;
- (ix) A description of the entity's drug import and export activities; and
- (x) An electronic copy of the entity's written policies and procedures as required by this Chapter.
(c) The information collected pursuant to this Chapter shall be made available only to the Board, a third party recognized by the Board, and to state and federal law enforcement officials. The Board shall make provisions for protecting the confidentiality of the information collected under this section.
(d) All current wholesale distributor licensees and all applicants for licensure as a third party logistics provider or wholesale distributor must submit security in the amount of one hundred thousand dollars ($100,000.00) to the Board. The purpose of these funds will be to secure payment for any administrative penalty assessed by the Board, which remains unpaid thirty (30) days after the liability for the payment is final. A separate bond or other equivalent means of security is not required for each company's separate location or for affiliated companies/groups when such separate location or affiliated companies/groups are required to apply for or renew their wholesale distributor license with the Board. Acceptable forms of security include: - (i) "Surety" bond naming the board as the payee;
- (ii) Irrevocable letter of credit naming the board as the payee; or
- (iii) Funds deposited in a trust account or financial institution naming the board as the payee.
(e) The Board may waive the security requirement, if the wholesale distributor or third party logistics provider: - (i) Has previously obtained a comparable bond or other comparable security for the purposes of licensure in another state where they possess a valid license in good standing; or
- (ii) Is a publicly held company.
- (iii) Manufacturers and repackagers shall be exempt from securing a "surety" bond or other equivalent means of security acceptable to the Board or a third party recognized by the Board.
(f) Each facility licensed by the Board and all applicants for licensure must provide evidence of Verified-Accredited Wholesale Distributor (VAWD®) accreditation from the National Association of Boards of Pharmacy or from another third party recognized by the Board and must undergo the re-accreditation process periodically after initial accreditation. Manufacturing facilities are exempt from this requirement provided the manufacturing facilities are currently registered with the FDA in accordance with Section 510 of the Federal Act. - (i) Any applicant that is denied accreditation described under this section shall have the right of review of the accreditation body's decision, by:
- (A) The accreditation body; and
- (ii) The recognized accreditation body shall ensure that the proprietary information obtained during the accreditation process remains confidential and privileged.
- (iii) Individual or third party inspectors must demonstrate to the Board that they have received training or demonstrate familiarity with the inspection standards. A letter for certification from a training program, a notice from the inspector's employing third party organization, or other means recognized by the Board shall be accepted as meeting the requirement.
(g) The Board may license by reciprocity a manufacturer, repackager, third party logistics provider or wholesale distributor that is licensed under laws of another state if: - (i) The requirements of that state are deemed by the Board to be substantially equivalent; or
- (ii) The applicant is accredited by a third party recognized by the Board. An applicant that is accredited by a third party recognized and approved by the Board shall not be subject to duplicative requirements set by the Board.
(h) Where operations are conducted at more than one location by a single wholesale distributor, each location shall be licensed by the Board.
(i) Changes in any information required by this section shall be submitted to the Board within thirty (30) days after the change.
(j) All wholesale distributors shall publicly display or have readily available all licenses and the most recent inspection report.
(k) Information submitted by the wholesale distributor to the Board or a third party recognized by the Board that is considered trade secret or proprietary information, as defined under the state privacy and trade secret proprietary statutes, shall be maintained by the Board or a third party recognized by the Board as private or trade secret/proprietary information and be exempt from public disclosure.
(l) Any applicant denied licensure by the Board shall have the right of timely review and appeal as authorized by the Wyoming Administrative Procedure Act.
Amended, Eff. 10/31/2017.