Section 160. Susceptible drugs

Part IV. Pedigree Requirements

A. The list of drugs susceptible to counterfeiting for which a pedigree is required shall be all prescription drugs in Schedules II through VI, except that a pedigree is not required for those prescription drugs that do not leave the normal distribution channel or those that include one or more of the following additional distributions or variations to the normal distribution channel:

1. Distribution by a manufacturer's exclusive distributor;

2. Distribution by a third-party logistics provider;

3. Drop shipments;

4. Distributions to a veterinarian for veterinary use;

5. Distribution from an authorized distributor of record to one other authorized distributor of record to an office-based healthcare practitioner authorized by law to dispense or administer such drug to a patient; and

6. Distributions for emergency medical reasons, defined as those in which (i) a state of emergency has been declared by the Governor in accordance with § 54.1-3307.3 of the Code of Virginia, or (ii) there is a documented shortage of a drug, where the failure to acquire and dispense a prescription drug could result in imminent danger to patient health, and the wholesale distributor, in lieu of a pedigree, complies with the following requirements:

a. Obtains and maintains documentation from the manufacturer attesting to a shortage of the prescription drug and its non-availability through normal distribution channels;

b. Purchases the prescription drug only through an authorized distributor of record and maintains the name of such distributor;

c. Maintains a list of pharmacies or other authorized entities to which the prescription drug was distributed; and

d. Notifies the board within 24 hours of such a distribution.

B. Not less than annually, the board shall evaluate whether the list of susceptible drugs in subsection A of this section should be amended. The board may modify the list under its authority to adopt exempt regulations, pursuant to § 2.2-4006 of the Administrative Process Act, in accordance with the following process:

1. The board shall conduct a public hearing on any proposed amendments to subsection A of this section. Thirty days prior to conducting such hearing, the board shall give written notice of the date, time, and place of the hearing to all persons requesting to be notified of the hearings and publish proposed amendments to the list in the Virginia Register of Regulations.

2. During the public hearing, interested parties shall be given reasonable opportunity to be heard and present information prior to final adoption of any amendments. Final amendments of the list shall also be published, pursuant to § 2.2-4031 of the Code of Virginia, in the Virginia Register of Regulations.

3. Final amendments to the list of susceptible drugs shall become effective upon filing with the Registrar of Regulations.

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.