Wisconsin Administrative Code › Pharmacy Examining Board › Chapter Phar 13 - Distributor Requirements › Section Phar 13.02 - Definitions

Current through June 24, 2024
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.