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Virginia Administrative Code (Last Updated: January 10, 2017) |
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Title 18. Professional and Occupational Licensing |
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Agency 110. Board of Pharmacy |
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Chapter 50. Regulations Governing Wholesale Distributors, Manufacturers, and Warehousers |
Section 10. Definitions
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Part I. General Provisions
In addition to words and terms defined in §§ 54.1-3300 and 54.1-3401 of the Code of Virginia, the following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:
"Authorized collector" means a registered manufacturer, wholesale distributor, or reverse distributor that is authorized by the U.S. Drug Enforcement Administration to receive drugs from an ultimate user, a person lawfully entitled to dispose of an ultimate user decedent's property, or a long-term care facility on behalf of an ultimate user who resides or has resided at that facility for the purpose of destruction.
"Authorized distributor of record" means a wholesale distributor with whom a manufacturer has entered into a written agreement under which such wholesale distributor is either authorized to distribute all of that manufacturer's prescription drug products, or only those products listed in the agreement, for such a period of time or number of shipments as specified in the agreement.
"Control number" means the unique identifying customer number assigned by the Virginia Department of Motor Vehicles to an individual when issuing a driver's license, learner's permit, or official identification card. This number is displayed on the driver's license or ID card in lieu of the social security number.
"DEA" means the U.S. Drug Enforcement Administration.
"Drop shipment" means the sale and distribution of a prescription drug in which a manufacturer, third-party logistics provider, or the manufacturer's exclusive distributor directly ships the prescription drug to a pharmacy, chain drug warehouse, or other person authorized to dispense or administer the prescription drug, and the pharmacy, chain drug warehouse or other authorized person is invoiced by a wholesale distributor that took title to the prescription drug during the shipping, but did not take physical possession of the prescription drug.
"Expiration date" means that date placed on a drug package by the manufacturer or repacker beyond which the product may not be dispensed or used.
"FDA" means the U.S. Food and Drug Administration.
"Manufacturer's exclusive distributor" means a distributor licensed by the board as a wholesale distributor or registered as a nonresident wholesale distributor who contracts with a manufacturer to provide or coordinate warehousing, distribution or other services on behalf of a manufacturer for a prescription drug and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to direct the sale or disposition of the prescription drug.
"Third-party logistics provider" means an entity licensed by the board as a wholesale distributor or registered as a nonresident wholesale distributor that contracts with a manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of a manufacturer for a prescription drug, but does not take title to the prescription drug and that only sells, distributes, or otherwise disposes of the prescription drug at the direction of the manufacturer.
"Ultimate user" means a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or a member of his household.
"USP-NF" means the United States Pharmacopeia-National Formulary.
Historical Notes
Derived from Volume 22, Issue 24, eff. September 6, 2006; amended, Volume 24, Issue 10, eff. February 20, 2008; Volume 32, Issue 12, eff. March 24, 2016.