Nebraska Statutes 71-7439. Normal distribution chain, defined
(1) Normal distribution chain means the transfer of a prescription drug or the co-licensed product of the original manufacturer of the finished form of a prescription drug along a chain of custody directly from the manufacturer or co-licensee of such drug to a patient or ultimate consumer of such drug.
Terms Used In Nebraska Statutes 71-7439
- Chain pharmacy warehouse: means a facility utilized as a central warehouse for intracompany sales or transfers of prescription drugs or devices by two or more pharmacies operating under common ownership or common control. See Nebraska Statutes 71-7432
- Department: means the Department of Health and Human Services. See Nebraska Statutes 71-7434
- Facility: means a physical structure utilized by a wholesale drug distributor for the storage, handling, or repackaging of prescription drugs or the offering of prescription drugs for sale. See Nebraska Statutes 71-7437
- Manufacturer: means any entity engaged in manufacturing, preparing, propagating, processing, packaging, repackaging, or labeling a prescription drug. See Nebraska Statutes 71-7438
- Normal distribution chain: includes transfers of a prescription drug or co-licensed product:
(a) From a manufacturer or co-licensee to a wholesale drug distributor, to a pharmacy, and then to a patient or a patient's agent. See Nebraska Statutes 71-7439
- Prescription drug: means any human drug required by federal law or regulation to be dispensed only by prescription, including finished dosage forms and active ingredients subject to section 503(b) of the Federal Food, Drug, and Cosmetic Act, as such section existed on August 1, 2006. See Nebraska Statutes 71-7441
- Wholesale drug distributor: means any person or entity engaged in wholesale drug distribution in this state, including manufacturers, repackagers, own-label distributors, jobbers, private-label distributors, brokers, warehouses including manufacturer and distributor warehouses, chain pharmacy warehouses, and wholesale drug warehouses, wholesale medical gas distributors, independent wholesale drug traders, and retail pharmacies that engage in wholesale drug distribution in this state. See Nebraska Statutes 71-7445
(2) Normal distribution chain includes transfers of a prescription drug or co-licensed product:
(a) From a manufacturer or co-licensee to a wholesale drug distributor, to a pharmacy, and then to a patient or a patient’s agent;
(b) From a manufacturer or co-licensee 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;
(c) From a manufacturer or co-licensee 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;
(d) From a manufacturer or co-licensee 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
(e) Recognized in rules and regulations adopted and promulgated by the department.
(3) For purposes of this section, co-licensed products means prescription drugs that have been approved by the federal Food and Drug Administration and are the subject of an arrangement by which two or more parties have the right to engage in a business activity or occupation concerning such drugs.