Nebraska Administrative Code
Topic - HEALTH AND HUMAN SERVICES SYSTEM
Title 172 - PROFESSIONAL AND OCCUPATIONAL LICENSURE
Chapter 131 - WHOLESALE DRUG DISTRIBUTORS
Section 172-131-002 - DEFINITIONS

Universal Citation: 172 NE Admin Rules and Regs ch 131 ยง 002

Current through September 17, 2024

Definitions set out in the Wholesale Drug Distributor Licensing Act, 21 Code of Federal Regulations (CFR) Part 205, and the following apply to this chapter.

002.01 ATTEST OR ATTESTATION. An affirmation that the individual declares that all statements on the application are true and complete.

002.02 AUTHENTICATE. To affirmatively verify that each transaction listed on the pedigree and any other accompanying documentation has occurred.

002.03 CO-LICENSEE. A pharmaceutical manufacturer that has entered into an agreement with another pharmaceutical manufacturer to engage in a business activity or occupation related to the manufacture or distribution of a prescription drug.

002.04 COMMON CARRIER. An entity that provides transportation or delivery of prescription drugs without storing, warehousing, or taking legal ownership of such drugs.

002.05 DESIGNATED REPRESENTATIVE. An individual designated by the wholesale drug distributor who will serve as the responsible individual of the daily operations of the wholesale drug distributor.

002.06 DROP SHIPMENT. The sale, by a manufacturer, that manufacturer's co-licensee, that manufacturer's third party logistics provider, or that manufacturer's exclusive distributor of the manufacturer's prescription drug, to a wholesale drug distributor whereby the wholesale drug distributor takes title to but not possession of such prescription drug and the wholesale drug distributor invoices the pharmacy, the chain pharmacy warehouse, or other designated persons authorized by law to dispense, administer or distribute such drug and the pharmacy, chain pharmacy warehouse, or other designated persons authorized by law to dispense, administer or distribute such drug, receives delivery of the prescription drug directly from the manufacturer, that manufacturer's co-licensee, that manufacturer's third party logistics provider, or that manufacturer's exclusive distributor, of such prescription drug. Drop shipments must be part of the "normal distribution chain".

002.07 EXCLUSIVE DISTRIBUTOR. An entity that:

(A) Contracts with a manufacturer to provide or coordinate warehousing, wholesale drug distribution, or other services on behalf of a manufacturer 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 manufacturer's prescription drug; and

(B) Is licensed as a wholesale drug distributor under this chapter.

002.08 NATIONALLY RECOGNIZED ACCREDITATION PROGRAM. An accreditation program that conforms to the standards required for accreditation by the Verified-Accredited Wholesale Distributors (VAWD) program, established and operated by the National Association of Boards of Pharmacy (NABP), and is approved by the Board.

002.09 NORMAL DISTRIBUTION CHAIN. Defined by Neb. Rev. Stat. § 71-7439 and this chapter.

(A) From a manufacturer or co-licensee to a wholesale drug distributor, to a pharmacy buying cooperative warehouse, to a pharmacy that is a member or member owner of such pharmacy buying cooperative warehouse, and then to a patient or a patient's agent;

(B) From a manufacturer or co-licensee to a pharmacy buying cooperative warehouse, to a pharmacy that is a member or member owner of such pharmacy buying cooperative warehouse, and then to a patient or a patient's agent;

(C) From a manufacturer or co-licensee, to a third party logistics provider or an exclusive distributor, to a wholesale drug distributor, to a pharmacy, and then to a patient or a patient's agent;

(D) From a manufacturer or co-licensee to a third party logistics provider or an exclusive distributor, to a wholesale drug distributor, to a pharmacy, to a health care practitioner, health care practitioner facility, or hospital, and then to a patient or a patient's agent;

(E) From a manufacturer or co-licensee to a third party logistics provider or an exclusive distributor, to a pharmacy, to a health care practitioner, health care practitioner facility, or hospital, and then to a patient or a patient's agent;

(F) From a manufacturer or co-licensee to a third party logistics provider or an exclusive distributor, to a wholesale drug distributor, to a chain pharmacy warehouse, to a pharmacy affiliated with the chain pharmacy warehouse, and then to a patient or a patient's agent;

(G) From a manufacturer or co-licensee to a third party logistics provider or an exclusive distributor, to a chain pharmacy warehouse, to a pharmacy affiliated with the chain pharmacy warehouse, and then to a patient or a patient's agent; or

(H) From a manufacturer or co-licensee either through drop shipment or directly to a pharmacy, health care practitioner, health care practitioner facility, hospital, chain pharmacy warehouse, or other designated persons authorized by law to dispense, administer or distribute such drug, and then to a patient or a patient's agent.

002.10 PHARMACY BUYING COOPERATIVE WAREHOUSE. A permanent physical location that acts as a central warehouse for prescription drugs and from which sales of such drugs are made to an exclusive group of pharmacies that are members or member owners of the buying cooperative operating the warehouse and must be licensed as a wholesaler.

002.11 REVERSE DISTRIBUTOR. A person whose primary function is to act as an agent for a pharmacy, wholesaler, manufacturer, or other entity by receiving, inventorying, and managing the disposition of outdated, expired, or otherwise non-saleable medications.

002.12 THIRD PARTY LOGISTICS PROVIDER. An entity that

(A) Provides or coordinates warehousing, drug distribution, or other services on behalf of a manufacturer, but does not take title to the prescription drug or have general responsibility to direct the prescription drug's sale or disposition.

002.13 WHOLESALE DRUG DISTRIBUTION. Wholesale drug distribution is defined in Neb. Rev. Stat. § 71-7444 and also to exclude the sale, transfer, merger, or consolidation of all or part of the business of a retail pharmacy or pharmacies from or with another retail pharmacy or pharmacies, whether accomplished as a purchase and sale of stock or business assets, in accordance with this chapter.

Disclaimer: These regulations may not be the most recent version. Nebraska may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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