18 Va. Admin. Code § 110-50-140

Current through Register Vol. 40, No. 22, June 17, 2024

Section 18VAC110-50-140 - Due diligence

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.

18 Va. Admin. Code § 110-50-140

Derived from Virginia Register Volume 22, Issue 24, eff. September 6, 2006; Amended, Virginia Register Volume 33, Issue 19, eff. 6/29/2017.

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