Section 13.02. Definitions.

  In this chapter:

(1)  "Blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing.

(2)  "Blood component" means that part of blood separated by physical or mechanical means.

(3)  "Controlled substance" has the meaning set forth in s. 961.01 (4) , Stats.

(3m)  "Department" means the department of safety and professional services.

(4)  "Device" has the meaning set forth in s. 450.01 (6) , Stats.

(5)  "Distribute" has the meaning set forth in s. 450.01 (8) , Stats.

(7)  "Drug sample" means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

(8)  "Facility" means a location where a wholesale distributor stores, handles, repackages, or offers for sale prescription drugs.

(9)  "Manufacturer" means a person licensed or approved by the federal food and drug administration to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" under the federal food and drug administration's regulations and interpreted guidance implementing the federal prescription drug marketing act.

(10)  "Prescription drug" has the meaning set forth in s. 450.01 (20) , Stats.

(11)  "Wholesale distribution" means distribution of a prescription drug to a person other than a consumer or patient, but does not include any of the following:

(a) Intracompany sales of prescription drugs which include any transaction or transfer between any division, subsidiary, parent, affiliated or related company under common ownership or control of a corporate entity or any transaction between co-licensees or a co-licensed product.

(b) The sale, purchase, distribution, trade, or transfer of a prescription drug or offer to sell, purchase, distribute, trade, or transfer a prescription drug for emergency medical reasons.

(c) The distribution of prescription drug samples, if the distribution is permitted under 21 CFR 353 (d).

(d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in 21 CFR 203.23 .

(e) Distributions to a practitioner for the purpose of general dispensing by the practitioner to his or her patients if all of the following apply:

1. The total number of dosage units of all prescription drugs distributed to practitioners by the pharmacy during each calendar year in which the pharmacy is licensed does not exceed 5% of the total number of dosage units of all prescription drugs distributed and dispensed by the pharmacy during the same calendar year.

2. The total number of dosage units of all controlled substances distributed to practitioners by the pharmacy during each calendar year in which the pharmacy is licensed does not exceed 5% of the total number of dosage units of all controlled substances distributed and dispensed by the pharmacy during the same calendar year.

(f) The sale, purchase, or trade of a drug, an offer to sell, purchase, or trade a drug, or the dispensing of a drug pursuant to a prescription.

(g) The sale, transfer, merger, or consolidation of all or part of the business of a pharmacy from or with another pharmacy, whether accomplished as a purchase and sale of stock or business assets.

(h) The sale, purchase, distribution, trade, or transfer of a prescription drug from one authorized distributor of record to one additional authorized distributor of record, if the manufacturer states in writing to the receiving authorized distributor of record that the manufacturer is unable to supply the drug and the supplying authorized distributor of record states in writing that the drug has previously been exclusively in the normal distribution channel.

(i) The delivery of, or offer to deliver, a prescription drug by a common carrier solely in the common carrier's usual course of business of transporting prescription drugs, if the common carrier does not store, warehouse, or take legal ownership of the drug.

(j) A transaction excluded from the definition of "wholesale distribution" under 21 CFR 203.3 (cc).

(k) The donation or distribution of a prescription drug under s. 255.056 , Stats.

(L) The transfer from a retail pharmacy or pharmacy warehouse of an expired, damaged, returned, or recalled prescription drug to the original manufacturer or original wholesale distributor or to a 3rd-party returns processor or reverse distributor.

(m) The return of a prescription drug, if the return is authorized by the law of this state.

(12)  "Wholesale distributor" means a person engaged in the wholesale distribution of prescription drugs, including manufacturers; repackagers; own-label distributors; private-label distributors; jobbers; brokers; warehouses, including manufacturers' and distributors' warehouses; manufacturers' exclusive distributors; manufacturers' authorized distributors of record; prescription drug wholesalers and distributors; independent wholesale prescription drug traders; 3rd-party logistics providers; retail pharmacies that conduct wholesale distribution; and chain pharmacy warehouses that conduct wholesale distribution.

History: Cr. Register, July, 1992, No. 439 , eff. 8-1-92; cr. (11) (f), Register, February, 1996, No. 482 , eff. 3-1-96; am. (3), Register, December, 1998, No. 516 , eff. 1-1-99; EmR0815 : emerg. cr. (3m), (11) (b) to (d) and (f) to (m), renum. (6) and (11) (f) to be (12) and (11) (e) and am. (12), am. (8), (9), (11) (intro.) and (a), r. (11) (b) to (e), eff. 6-1-08; CR 08-051 : cr. (3m), (11) (b) to (d) and (f) to (m), renum. (6) and (11) (f) to be (12) and (11) (e) and am. (12), am. (8), (9), (11) (intro.) and (a), r. (11) (b) to (e) Register November 2008 No. 635 , eff. 12-1-08; correction in (3m) made under s. 13.92 (4) (b) 6. , Stats., Register November 2011 No. 671 .