Nebraska Statutes 71-7456. Pedigree; contents
(1) The pedigree required under section 71-7455 shall include all necessary identifying information concerning each sale or other transfer in the chain of distribution of the prescription drug from the manufacturer, through acquisition and sale by any wholesale drug distributor or repackager, until final sale to a pharmacy or other person dispensing or administering such drug, including, but not limited to:
Terms Used In Nebraska Statutes 71-7456
- Department: means the Department of Health and Human Services. See Nebraska Statutes 71-7434
- Manufacturer: means any entity engaged in manufacturing, preparing, propagating, processing, packaging, repackaging, or labeling a prescription drug. See Nebraska Statutes 71-7438
- Pedigree: means a written or electronic documentation of every transfer of a prescription drug as provided in sections 71-7455 and 71-7456. See Nebraska Statutes 71-7440
- Person: shall include bodies politic and corporate, societies, communities, the public generally, individuals, partnerships, limited liability companies, joint-stock companies, and associations. See Nebraska Statutes 49-801
- 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
- Repackager: means a person who repackages. See Nebraska Statutes 71-7443
- 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
(a) Name of the prescription drug;
(b) Dosage form and strength of the prescription drug;
(c) Size of the container;
(d) Number of containers;
(e) Lot number of the prescription drug;
(f) Name of the original manufacturer of the finished dosage form of the prescription drug;
(g) Name, address, telephone number, and if available, the email address of each owner of the prescription drug and each wholesale drug distributor who does not take title to the prescription drug;
(h) Name and address of each location from which the prescription drug was shipped if different from the owner’s;
(i) Transaction dates;
(j) Certification that each recipient has authenticated the pedigree;
(k) Name of any repackager, if applicable; and
(l) Name and address of person certifying the delivery.
(2) Each paper or electronic pedigree shall be maintained by the purchaser and the wholesale drug distributor for three years from the date of sale or transfer and available for inspection or use upon request of law enforcement or an authorized agent of the department.