In this chapter: (1) “Administer” means the direct application of a vaccine or a prescribed drug or device, whether by injection, ingestion or any other means, to the body of a patient or research subject by any of the following: (a) A practitioner or his or her authorized agent. (b) A patient or research subject at the direction of a practitioner. (c) A pharmacist. (d) In the case of an opioid antagonist, any person. (1m) “Advanced practice nurse prescriber” means an advanced practice nurse who is certified under s. 441.16 (2). (17) “Practitioner” means a person licensed in this state to prescribe and administer drugs or licensed in another state and recognized by this state as a person authorized to prescribe and administer drugs. (18) “Prescribed drug or device” means any drug or device prescribed by a practitioner. (19) “Prescription” means a drug or device prescribed by a practitioner. (20) “Prescription drug” means all of the following, but does not include blood, blood components intended for transfusion, or biological products that are also medical devices: (a) A drug, drug product, or drug-containing preparation that is subject to 21 USC 353 (b) or 21 CFR 201.105. (b) A controlled substance included in schedules II to V of ch. 961, whether by statute or rule, except a substance that by law may be dispensed without the prescription order of a practitioner. Controlled substances are included within this definition for purposes of s. 450.11 (3) , (4) (a) , and (8) only and for violations thereof punishable under s. 450.11 (9). (21) “Prescription order” means an order transmitted orally, electronically or in writing by a practitioner for a drug or device for a particular patient and also includes a standing order issued under s. 441.18 (2) (a) 2. or 448.037 (2) (a) 2. (21c) “Remotely supervised pharmacy” means a pharmacy governed by s. 450.09 (2) (b). (21e) “Repackage” means to repack or otherwise change the container, wrapper, or label of a prescription drug, except that “repackage” does not include any of the following: (a) An action by a pharmacist or pharmacy technician with respect to a prescription drug that the pharmacist or pharmacy technician is dispensing. (b) An action by a pharmacist who receives a prescription drug or device that the pharmacist dispensed to a patient, if, after altering the packaging or labeling of the prescription drug or device, the pharmacist returns the prescription drug or device to the patient. (21m) “Repackager” means a person that repackages. (21p) “Standing order” means an order transmitted electronically or in writing by a practitioner for a drug or device for multiple patients or for one or more groups of patients. (21s) “Third-party logistics provider” means a person that contracts with a prescription drug manufacturer to provide or coordinate warehousing, distribution, or other services on behalf of the manufacturer but that does not take title to the manufacturer’s prescription drug or have general responsibility to direct the prescription drug’s sale or disposition. (22) “Vaccination protocol” means a written protocol agreed to by a physician, as defined in s. 448.01 (5), and a pharmacist that establishes procedures and record-keeping and reporting requirements for the administration of a vaccine by a pharmacist for a period specified in the protocol that may not exceed 2 years. (23) “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 USC 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. (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 or under 21 CFR 203.39. (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. (n) The operation or implementation of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a), or the possession or delivery of a household pharmaceutical item, as defined in s. 165.65 (1) (d), within the scope of a drug disposal program that is authorized under s. 165.65 (2) or (3) or is authorized under federal law. (o) The possession or delivery of a prescription drug within the scope of a written authorization under s. 450.115 (3). (p) The services of a 3rd-party logistics provider or out-ofstate 3rd-party logistics provider. (24) “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.
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