Virginia Administrative Code
Title 18 - PROFESSIONAL AND OCCUPATIONAL LICENSING
Agency 110 - BOARD OF PHARMACY
Chapter 50 - REGULATIONS GOVERNING WHOLESALE DISTRIBUTORS, MANUFACTURERS, THIRD-PARTY LOGISTICS PROVIDERS, AND WAREHOUSERS
Part II - Wholesale Distributors and Third-y Logistics Providers
Section 18VAC110-50-140 - Due diligence

Universal Citation: 8 VA Admin Code 110-50-140

Current through Register Vol. 41, No. 9, December 16, 2024

A. Prior to the initial purchase of prescription drugs from another wholesale distributor or third-party logistics provider not residing and licensed in Virginia, a wholesale distributor or third-party logistics provider shall obtain, and update annually, the following information from the selling wholesale distributor or third-party logistics provider:

1. A copy of the license to wholesale distribute or act as a third-party logistics provider from the resident state. If the resident state does not require licensure as a third-party logistics provider, documentation confirming active registration with the U.S. Food and Drug Administration is acceptable;

2. The most recent facility inspection report, if available;

3. A list of other names under which the wholesale distributor or third-party logistics provider is doing business, or was formerly known as;

4. A list of principals, directors, officers, or any shareholder who owns 10% or more of outstanding stock in any nonpublicly held corporation;

5. A list of all disciplinary actions by state and federal agencies;

6. A description, including the address, dimensions, and other relevant information, of each facility or warehouse used for drug storage and distribution or for the legal acts of a third-party logistics provider; and

7. A listing of any manufacturers for whom the wholesale distributor or third-party logistics provider is an authorized distributor of record.

B. If the selling wholesale distributor's or third-party logistics provider's facility has not been inspected by the resident board or the board's agent within three years of the contemplated purchase, the purchasing wholesale distributor or third-party logistics provider may conduct an inspection of the wholesale distributor's or third-party logistics provider's facility prior to the first purchase of drugs or devices from another wholesale distributor or third-party logistics provider to ensure compliance with applicable laws and regulations relating to the storage and handling of drugs or devices. A third party may be engaged to conduct the site inspection on behalf of the purchasing wholesale distributor or third-party logistics provider.

C. Prior to the first purchase of drugs from another wholesale distributor or third-party logistics provider not residing in and licensed in Virginia, the purchasing wholesale distributor or third-party logistics provider shall secure a national criminal background check of all of the wholesale distributor's or third-party logistics provider's owners, corporate officers, and the person named as the responsible party with the resident board or licensing agency.

Statutory Authority: §§ 54.1-2400 and 54.1-3307 of the Code of Virginia.

Disclaimer: These regulations may not be the most recent version. Virginia 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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