(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; retail pharmacies that conduct
wholesale distribution; and chain pharmacy warehouses that conduct wholesale
distribution.
