Section 170. Requirements of a pedigree

A. For distributions of prescription drugs that require a pedigree in accordance with § 54.1-3307 of the Code of Virginia and 18VAC110-50-160, the pedigree shall list all distributions starting with the sale by a manufacturer through acquisition and sale by any wholesale distributor until final sale to a pharmacy or other person authorized to administer or dispense the prescription drug.

B. When required by law and regulation to provide a pedigree, a wholesale distributor shall provide an authenticated pedigree for drugs sold or returned to another wholesale distributor before or at the time the drug is shipped to such wholesale distributor.

C. The pedigree shall minimally include the following information on a prescription drug for which a pedigree is required:

1. The trade or generic name of the drug;

2. The dosage form and strength, the container size, number of containers, and lot number;

3. The name of the manufacturer of the finished drug product;

4. Each transaction in which the drug is shipped or received by a manufacturer or wholesale distributor showing the following:

a. The business name and address of each entity involved in the chain of the drug's physical custody;

b. Telephone number and other contact information needed to authenticate the pedigree;

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

d. The dates of the transactions to include shipping dates when a seller ships the product and the receiving dates when a purchaser receives the product.

5. A statement of certification that the information contained in the pedigree is true and accurate and the name and signature of the individual certifying the authenticity of the pedigree at the time of shipment of the drug.

D. The requirement for a pedigree shall be effective February 20, 2009.

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.