Section 180. Authentication of a pedigree

A. Each person who is engaged in the wholesale distribution of a drug, who is provided a pedigree as specified in 18VAC110-50-160 and attempts to further distribute that drug, shall affirmatively verify before any distribution of a prescription drug that each transaction listed on the pedigree has occurred.

B. Upon request of a wholesale distributor who is attempting to authenticate a pedigree for a drug as specified in 18VAC110-50-160, any manufacturer or wholesale distributor listed on the pedigree shall provide requested information in a timely manner, only for those applicable transactions outside the normal chain of distribution conducted by that manufacturer or wholesale distributor, to include the following:

1. Dates of receipt or shipment of the drug as well as the name, address, and other contact information of those entities from whom they received the drug or to whom they shipped the drug;

2. Lot number;

3. Sales invoice number or other unique shipping document numbers that identify each transaction; and

4. Name of the person who is providing the requested information.

C. The wholesale distributor shall record the above information and maintain the information in accordance with 18VAC110-20-190.

D. If a wholesale distributor that is attempting to authenticate the distribution of a drug back to a manufacturer is unable to authenticate each distribution, the wholesale distributor shall quarantine the drug and report to the board and the FDA within three business days after completing the attempted authentication.

Historical Notes

Derived from Volume 24, Issue 10, eff. February 20, 2008.

Statutory Authority

§§ 54.1-2400 and 54.1-3307 of the Code of Virginia.