The following are answers to some frequently asked questions received by the Department of Regulation and Licensing. These questions and answers are general in nature and are provided as a public service. Licensees and applicants with specific questions should refer to the Wisconsin statutes and administrative code provisions which govern their profession. In any instance in which an answer may differ from the provisions of the statutes and administrative code provisions, the latter will govern.
Wholesale
Distributor Definitions
Application
FAQ's
Pseudoephedrine
Regulations
Q. When must a wholesale
prescription drug distributor or drug manufacturer be licensed to
do business in Wisconsin?
A.
- First,
note that Wisconsin only requires a license for wholesale drug distribution
for prescription drugs.
- No
license to distribute non prescription drugs or any type of devices
is necessary. Print this web page for your records verifying no
license is needed.
- Often,
distributors will contact the department to inquire whether the
drug that they distribute is a prescription drug. A distributor
should typically contact the manufacturer to obtain this information.
Business
Models and the Requirements for Licensure: The following
information is provided to business entities to be used as an aid
in determining whether or not they need a particular license to do
business in Wisconsin.
A. Drug Manufacturers
1. Drug
facilities which are located within the state of Wisconsin are required
to obtain a manufacturer's license from the Pharmacy Examining Board.
If the Wisconsin facility also distributes these drugs at wholesale
a distributor's license is not required at this time unless it is
required under federal law or regulation. (If the drugs are prescription
drugs or controlled substances.)
2. A corporate
headquarters located in this state, of a drug manufacturer, does not
need to be licensed as a manufacturer if the headquarters is not a
facility where manufacturing occurs.
3. The
pharmacy laws in this state do not prohibit a business arrangement
where a drug manufacturer retains title to prescription drugs distributed
to pharmacies until the medications are actually sold to a consumer
pursuant to a prescription order.
4. A wholesale
prescription drug distributor's license would not be required for
an out-of-state manufacturing facility if it engages in the wholesale
distribution of prescription drugs or devices in this state.
5 . Any
wholesale prescription drug distribution facility, except a manufacturer,
wherever located must be licensed as a distributor if it engages in
the wholesale distribution of prescription drugs in this state.
6.
"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.
(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) The sale of minimal quantities, as defined by the board in an
administrative rule, of prescription drugs by retail pharmacies
to licensed practitioners for office use. see Phar13.02 (11)(e).
(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.
(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.
"Wholesale distributor" means a person engaged in the
wholesale distribution of prescription drugs, including manufacturers,
re packagers, 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.
B. Wholesale Prescription
Drug Distributors
1.
A distributor's license does not authorize a facility to dispense
prescription drugs directly to patients pursuant to a prescriber's
prescription order. Dispensing directly to patients under a prescription
order requires a pharmacy license.
2. Out-of-state
or in-state wholesale distributors of prescription drugs are required
to obtain a distributor's license in Wisconsin for each facility from
which the prescription drugs are distributed.
