450.01(20)
(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:
450.01(20)(b)
(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).
450.01(21)
(21) "Prescription order" means an order transmitted orally, electronically or in writing by a practitioner for a drug or device for a particular patient.
450.01(21e)
(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:
450.01(21e)(a)
(a) An action by a pharmacist with respect to a prescription drug that the pharmacist is dispensing.
450.01(21e)(b)
(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.
450.01(21m)
(21m) "Repackager" means a person that repackages.
450.01(21s)
(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.
450.01(22)
(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.
450.01(23)
(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:
450.01(23)(b)
(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.
450.01(23)(c)
(c) The distribution of prescription drug samples, if the distribution is permitted under
21 USC 353 (d).
450.01(23)(d)
(d) Drug returns, when conducted by a hospital, health care entity, or charitable institution as provided in
21 CFR 203.23.
450.01(23)(e)
(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.
450.01(23)(f)
(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.
450.01(23)(g)
(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.
450.01(23)(h)
(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.
450.01(23)(i)
(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.
450.01(23)(L)
(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.
450.01(23)(m)
(m) The return of a prescription drug, if the return is authorized by the law of this state.
450.01(24)
(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, 3rd party logistics providers, retail pharmacies that conduct wholesale distribution, and chain pharmacy warehouses that conduct wholesale distribution.
450.01 Annotation
Vitamins not intended for use in the diagnosis, cure, investigation, treatment, or prevention of diseases are not drugs under this section. 66 Atty. Gen. 137.
450.02
450.02
Pharmacy examining board. 450.02(1)
(1) The department shall keep a record of the proceedings and a register of the names and places of practice or business of pharmacies, manufacturers, distributors and other persons licensed under this chapter, and the books, registers and records of the department shall be prima facie evidence of the matters recorded.
450.02(2)
(2) The board shall adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under
s. 450.05.
450.02(2g)(a)(a) The pharmacy examining board shall, after consultation with the medical examining board and the board of nursing, promulgate rules that establish criteria for approving courses under
ss. 450.035 (1r) and
(2) and
450.085 (1).
450.02(2g)(b)
(b) The board shall promulgate rules that establish requirements and procedures for the administration of a drug product or device, as defined in
s. 450.035 (1g), by a pharmacist under
s. 450.035 (1r). Notwithstanding
s. 15.08 (5) (b), the board may promulgate rules under this paragraph only if the rules are identical to rules recommended by the pharmacist advisory council. The board may amend or repeal rules promulgated under this paragraph only upon the recommendation of the pharmacist advisory council.
450.02(2m)
(2m) The board shall periodically prepare and distribute letters, bulletins or other types of notice to pharmacists that identify the courses that are approved for purposes of
ss. 450.035 (1r) and
(2) and
450.085 (1).
450.02(3)
(3) The board may promulgate rules:
450.02(3)(a)
(a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
450.02(3)(b)
(b) Establishing security standards for pharmacies.
450.02(3)(c)
(c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug.
450.02(3)(d)
(d) Necessary for the administration and enforcement of this chapter and
ch. 961.
450.02(3)(e)
(e) Establishing minimum standards for the practice of pharmacy.
450.02(3)(f)
(f) Establishing procedures for identifying pharmacists impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists in obtaining treatment.
450.02(3m)(a)(a) The board or its designee may grant a variance to a requirement of this chapter or to a rule promulgated by the board if all of the following are true:
450.02(3m)(a)1.
1. The board or its designee determines that a natural or man-made disaster or emergency exists or has occurred.
450.02(3m)(a)3.
3. The board or its designee determines that the variance is necessary to protect the public health, safety, or welfare.
450.02(3m)(am)
(am) If a member of the board disagrees with a decision made by a designee under
par. (a), the board chairperson shall call a meeting of the board as soon as practicable to review the decision. The board may affirm or modify the designee's decision.
450.02(3m)(b)
(b) A variance granted under
par. (a) shall be for a stated term not to exceed 90 days, except that the board or its designee may extend the variance upon request by a pharmacist if it determines that an extension is necessary to protect the public health, safety, or welfare.
450.02(4)
(4) The board may not promulgate a rule which does any of the following:
450.02(4)(a)
(a) Limits to a pharmacist the authority to sell or in any way interferes with the sale of nonnarcotic nonprescription drugs that are prepackaged for consumer use and labeled in compliance with all applicable state and federal laws.
450.02 Cross-reference
Cross-reference: See also
Phar, Wis. adm. code.
450.025
450.025
Pharmacist advisory council. The pharmacist advisory council shall recommend rules for promulgation by the board under
s. 450.02 (2g) (b) and may recommend the amendment or repeal of any rules promulgated under
s. 450.02 (2g) (b). A unanimous vote of the members of the pharmacist advisory council is required for the council to make a recommendation under this section.
450.025 History
History: 1997 a. 68;
1997 a. 237 s.
727m.
450.03
450.03
Pharmacist; licensure. 450.03(1)
(1) No person may engage in the practice of pharmacy or use the title "pharmacist" or sell, give away or barter drugs unless the person is licensed as a pharmacist by the board. This subsection does not apply to:
450.03(1)(b)
(b) The sale of any nonprescription drug product, in an original unbroken package, which complies with
21 USC 301 to
392.
450.03(1)(d)
(d) The delivery of complimentary samples of drug products or devices to a practitioner by a manufacturer or its agent acting in the usual course of business.
450.03(1)(e)
(e) Any person lawfully practicing within the scope of a license, permit, registration, certificate or certification granted to practice professional or practical nursing or nurse-midwifery under
ch. 441, to practice dentistry or dental hygiene under
ch. 447, to practice medicine and surgery under
ch. 448, to practice optometry under
ch. 449 or to practice veterinary medicine under
ch. 453, or as otherwise provided by statute.
450.03(1)(f)
(f) A person who has successfully completed his or her second year in, and is enrolled at, an accredited school of pharmacy and whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board.
450.03(1)(g)
(g) A person who has applied for a license under
s. 450.05 whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and during the period before which the board takes final action on the person's application.
450.03(2)
(2) The board shall issue a license as a pharmacist to any person who files satisfactory proof of qualifications under
s. 450.04 (3), passes the examination under
s. 450.04 and pays the fee specified in
s. 440.05 (1), except as provided under
s. 450.10.
450.03 Cross-reference
Cross-reference: See also chs.
Phar 2 and
17, Wis. adm. code.
450.035
450.035
Administration of drug products and devices; vaccines. 450.035(1g)(1g) In this section, "drug product or device" does not include a vaccine.
450.035(1r)
(1r) A pharmacist may not administer by injection a prescribed drug product or device unless he or she has successfully completed a course of study and training in injection technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board. A pharmacist may administer a prescribed drug product or device under this subsection only in the course of teaching self-administration techniques to a patient. A pharmacist who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under
s. 450.02 (2g) (b).
450.035(1t)
(1t) A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may not administer a prescribed drug product or device unless he or she has successfully completed a course of study and training in administration technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board. A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may administer a prescribed drug product or device under this subsection only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the American Council on Pharmaceutical Education or the board, and only in the course of teaching self-administration techniques to a patient. A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under
s. 450.02 (2g) (b).
450.035(2)
(2) A pharmacist may not administer a vaccine unless he or she has successfully completed 12 hours in a course of study and training, approved by the American Council on Pharmaceutical Education or the board, in vaccination storage, protocols, administration technique, emergency procedures and record keeping and has satisfied the requirements specified in
sub. (2t). A pharmacist may not administer a vaccine under this subsection to a person who is under the age of 6.
450.035(2g)
(2g) A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may not administer a vaccine unless he or she acts under the direct supervision of a pharmacist and he or she and the supervising pharmacist have successfully completed 12 hours in a course of study and training, approved by the American Council on Pharmaceutical Education or the board, in vaccination storage, protocols, administration technique, emergency procedures and record keeping and the supervising pharmacist has satisfied the requirements specified in
sub. (2t). A person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) may not administer a vaccine under this subsection to a person who is under the age of 18.
450.035(2m)
(2m) Except as provided in
sub. (1t) or
(2g), a pharmacist may not delegate to any person any administration of a prescribed drug product or device or vaccine under
sub. (1r) or
(2).
450.035(2t)
(2t) A pharmacist may not administer a vaccine under
sub. (2) or supervise a person administering a vaccine under
sub. (2g) unless the pharmacist satisfies each of the following:
450.035(2t)(a)
(a) The pharmacist has in effect liability insurance that covers the pharmacist and a person who administers a vaccine under
sub. (2g) against loss, expense and liability resulting from errors, omissions or neglect in the administration of vaccines in an amount that is not less than $1,000,000 for each occurrence and $2,000,000 for all occurrences in any one policy year.
450.035(2t)(b)
(b) The pharmacist maintains proof that he or she satisfies the requirement specified in
par. (a) and, upon request, provides copies of such proof to the department or the board.
450.035(3)
(3) A pharmacist or a person engaged in the practice of pharmacy under
s. 450.03 (1) (f) or
(g) who successfully completes a course of study and training specified in
sub. (1r),
(1t),
(2), or
(2g) shall maintain proof of completion and, upon request, provide copies of such proof to the department or the board.
450.04(1)(1) Examinations for licensure as a pharmacist shall be designed to determine whether an applicant is competent to engage in the practice of pharmacy.
450.04(2)
(2) Examinations shall be conducted at least semiannually.
450.04(3)
(3) Every candidate for examination for licensure as a pharmacist shall submit an application on a form provided by the department and pay the fee specified in
s. 440.05 (1) at least 30 days before the date of examination. Every candidate shall also submit proof to the board that he or she:
450.04(3)(a)
(a) Has received a professional degree from a pharmacy program approved by the board; and
450.04(3)(b)
(b) Has completed an internship in the practice of pharmacy or has practical experience acquired in another state which is comparable to that included in an internship and which is approved and verified by the board or by the agency which is the equivalent of the board in the state in which the practical experience was acquired.
450.04 Annotation
Post-examination review with applicants discussed. 68 Atty. Gen. 48.
