450.073 Wholesale distributors; pedigree.

245 words·~1 min read·/wi/chapter-450/450-073

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(1)A wholesale distributor shall establish and maintain a pedigree for each prescription drug that leaves, or has ever left, the normal distribution channel. Before a wholesale distribution of a prescription drug leaves the normal distribution channel, a wholesale distributor shall provide a copy of the pedigree to the person receiving the drug. This section does not apply to a retail pharmacy or pharmacy intracompany warehouse unless the pharmacy or pharmacy intracompany warehouse engages in the wholesale distribution of prescription drugs.

(2)A pedigree shall contain all necessary identifying information concerning each sale in the chain of the distribution of the prescription drug from the manufacturer of the prescription drug or the manufacturers 3rd-party logistics provider, colicensed product partner, or exclusive distributor until final sale or distribution to a pharmacy or a person dispensing or distributing the prescription drug. The pedigree shall include all of the following:

(a)The name, address, telephone number, and, if available, electronic mail address of each recipient or distributor of the prescription drug in the chain of distribution, until the final sale or distribution described in sub.

(2)(intro.) .

(b)The name and address of each facility from which the prescription drug was distributed, if different from the address provided in par.

(a).

(c)The date of each distribution.

(d)A certification that every recipient has authenticated the pedigree before distribution of the prescription drug to the next point in the chain of distribution.