W. Va. Code R. § 15-5-4 - Minimum Required Information For Wholesale Drug Distributor or Third-Party Logistics Provider Licensure, and Manufacturer Permit; Applications and Renewals

4.1. A wholesale drug distributor or third-party logistics provider, and a manufacturer, including prescription drug manufacturers and outsourcing facilities, as part of the initial licensing procedure and as part of any renewal of license, shall provide on the application form as required by the Board:

4.1.1. The name, full business address, and telephone number of the licensee;

4.1.2. All trade or business names used by the licensee;

4.1.3. Addresses, telephone numbers, and the names of contact persons for the facility used by the licensee for the storage, handling, and distribution of prescription drugs;

4.1.4. The type of ownership or operation (i.e. partnership, corporation, or sole proprietorship) and

4.1.5. The name of the owner and/or operator of the licensee, including:

4.1.5.a. If a person, the name of the person;

4.1.5.b. If a partnership, the name of each partner, and the name of the partnership;

4.1.5.c. If a corporation, the name and title of each corporate officer and director, the corporate names, and the name of the state of incorporation, and the name of the parent company, if any;

4.1.5.d. If a sole proprietorship, the full name of the sole proprietor and the name of the business entity.

4.2. Where operations are conducted at more than one location by a single wholesale drug distributor, third-party logistics provider, or manufacturer, each location shall be licensed or permitted by the Board. However, the Board may provide for a single license or permit for a business entity operating more than one facility within this state, or for a parent entity with divisions, subsidiaries, and/or affiliate companies within this state when operations are conducted at more than one location and there exists joint ownership and control among all entities.

4.3. A wholesale drug distributor, third-party logistics provider, or manufacturer shall submit changes in any of the information required by this section to the Board within thirty days after the change.

4.4. Applicants for an original wholesale drug distributor license or third-party logistics provider license shall pay an application fee of Seven Hundred Fifty Dollars which shall be submitted along with a satisfactory application for licensure. Each applicant for a wholesale drug distributor or third-party logistics provider license located in this state where prescription drugs will be handled, stored, or kept must complete an inspection satisfactory to the Board. Each applicant for a wholesale drug distributor or third-party logistics provider license located outside of this state must be properly licensed as such in that state or United States territory, of, if no such licensure is granted by that state or territory, then with the Federal Food and Drug Administration, and must supply proof of that authorization along with its application.

4.5. Applicants for an original manufacturer permit shall pay an application fee of Five Hundred Dollars which shall be submitted along with a satisfactory application for a permit. Each applicant for a manufacturer permit must be authorized to operate as a manufacturer with the Federal Food and Drug Administration, and must supply proof of that authorization along with its application. The manufacturer must supply proof of satisfactory inspection by the FDA within the previous 5-year period, or pay an additional fee of Four Hundred Dollars for inspection by the Board.

4.6. A wholesale drug distributor and third-party logistics provider license shall expire on June 30, of each calendar year. Applications for renewal of wholesale drug distributor and third-party logistics provider licenses shall be provided to each licensee at least thirty days before the first day of July of each calendar year by the Board. The notification may be sent electronically to an e-mail or be mailed to the last known address of the licensee. The fee for renewal is Seven Hundred Fifty Dollars.

4.6.1. If a completed application for renewal is not received in the Board office on or before June 30 of the year in which it expires, the license is expired. Renewal applications received after June 30 shall require the payment of a late fee in the amount of One Hundred Fifty Dollars in addition to the application fee of Seven Hundred Dollars, for a total amount of Nine Hundred Dollars.

4.6.2. If a completed application for renewal is not received in the Board office before the first day of August each year, then, in order to renew, the licensee shall pay a reinstatement fee of two hundred fifty dollars, and pay the required renewal fee of Seven Hundred Fifty Dollars, for a total amount of One Thousand Dollars.

4.7. A manufacturer permit shall expire on June 30, of each calendar year. An application for renewal of a manufacturer permit shall be provided to each licensee at least thirty days before the first day of July of each calendar year by the Board. The notification may be sent electronically to an e-mail or be mailed to the last known address of the licensee. The fee for the annual renewal is Five Hundred Dollars.

4.7.1. If a completed application for renewal is not received in the Board office on or before June 30 of the year in which it expires, the permit shall expire. Renewal applications received after June 30 shall require the payment of a late fee in the amount of One Hundred Fifty Dollars in addition to the application fee of Five Hundred Dollars, for a total amount of Six Hundred Fifty Dollars.

4.7.2. If an application for renewal is not received in the Board office before the first day of August each year, then, in order to, the manufacturer must supply proof of inspection by the FDA within the previous 5-year period, and the permittee shall pay a reinstatement fee of Two Hundred Fifty dollars, in addition to the application fee of Five Hundred Dollars, for a total amount of Seven Hundred Fifty Dollars.

4.8. Licenses and permits issued under this section are not transferable, and become immediately expire upon change of ownership.

Notes

W. Va. Code R. § 15-5-4