Wyoming Administrative Code › Agency 059 - Pharmacy, Board of › Sub-Agency 0001 - Pharmacy, Board of › Chapter 8 - WHOLESALE DISTRIBUTOR REGULATIONS › Section 8-5 - Licensing Requirement

Current through July 13, 2024
(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:
(A) Square footage;
(B) A general description of security and
				alarm systems;
(C) Terms of lease
				or ownership;
(D) Address;
				and
(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.