961.335(1)(c)3. 3. An individual who is designated and authorized to receive a permit under this section for a college or university department, research unit, or similar administrative organizational unit, and students, laboratory technicians, research specialists, or chemical analysts under his or her supervision, may, without an additional permit issued under this section, possess and use a controlled substance, for the purposes authorized in the permit received for the department or unit.
961.335(2) (2) A permit issued under this section shall be valid for one year from the date of issue.
961.335(3) (3) The fee for a permit under this section shall be an amount determined by the controlled substances board but shall not exceed $25. No fee may be charged for permits issued to employees of state agencies or institutions.
961.335(4) (4) Permits issued under this section shall be effective only for and shall specify:
961.335(4)(a) (a) The name and address of the permittee.
961.335(4)(b) (b) The nature of the project authorized by the permit.
961.335(4)(c) (c) The controlled substances to be used in the project, by name if included in schedule I, and by name or schedule if included in any other schedule.
961.335(4)(d) (d) Whether dispensing to human subjects is authorized.
961.335(5) (5) A permit shall be effective only for the person, substances and project specified on its face and for additional projects which derive directly from the stated project. Upon application, a valid permit may be amended to add a further activity or to add further substances or schedules to the project permitted thereunder. The fee for such amendment shall be determined by the controlled substances board but shall not exceed $5.
961.335(6) (6) Persons who possess a valid permit issued under this section are exempt from state prosecution for possession and distribution of controlled substances to the extent of the authorization.
961.335(7) (7) The controlled substances board may authorize persons engaged in research on the use and effects of controlled substances to withhold the names and other identifying characteristics of individuals who are the subjects of research. Persons who obtain this authorization are not compelled in any civil, criminal, administrative, legislative or other proceeding to identify or to identify to the board the individuals who are the subjects of research for which the authorization was obtained.
961.335(8) (8) The controlled substances board may promulgate rules relating to the granting of special use permits including, but not limited to, requirements for the keeping and disclosure of records other than those that may be withheld under sub. (7), submissions of protocols, filing of applications and suspension or revocation of permits.
961.335 Cross-reference Cross-reference: See also ch. CSB 3, Wis. adm. code.
961.335(9) (9) The controlled substances board may suspend or revoke a permit upon a finding that there is a violation of the rules of the board.
961.335 History History: 1971 c. 219; 1975 c. 110, 199; 1977 c. 26; 1995 a. 448 s. 233; Stats. 1995 s. 961.335; 2013 a. 198.
961.337 961.337 Drug disposal programs. Nothing in this chapter, or rules promulgated under this chapter, prohibits any of the following:
961.337(1) (1) The direct 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).
961.337(2) (2) The transfer by the ultimate user, or by another person that lawfully possesses the controlled substance or controlled substance analog, of a controlled substance or controlled substance analog to a drug disposal program that has been authorized under s. 165.65 (2) or (3) or is authorized under federal law, as defined in s. 165.65 (1) (a), and that accepts the controlled substance or controlled substance analog.
961.337 History History: 2013 a. 198.
961.34 961.34 Controlled substances therapeutic research.
961.34(1)(1) Upon the request of any practitioner, the controlled substances board shall aid the practitioner in applying for and processing an investigational drug permit for marijuana under 21 USC 355 (i). If the federal food and drug administration issues an investigational drug permit, the controlled substances board shall approve which pharmacies can distribute the marijuana to patients upon written prescription. Only pharmacies located within hospitals are eligible to receive the marijuana for distribution. The controlled substances board shall also approve which practitioners can write prescriptions for the marijuana.
961.34(2) (2)
961.34(2)(a)(a) Upon the request of any physician, the controlled substances board shall aid the physician in applying for and processing an investigational drug permit under 21 USC 355 (i) for cannabidiol as treatment for a seizure disorder. If the federal food and drug administration issues an investigational drug permit, the controlled substances board shall approve which pharmacies and physicians may dispense cannabidiol to patients.
961.34(2)(b) (b) If cannabidiol is removed from the list of controlled substances, or if cannabidiol is determined not to be a controlled substance, under schedule I of 21 USC 812 (c), the controlled substances board shall approve which pharmacies and physicians may dispense cannabidiol to patients as treatment for a seizure disorder.
961.34 History History: 1981 c. 193; 1983 a. 189 s. 329 (18); 1985 a. 146 s. 8; 1995 a. 448 ss. 16 to 19; Stats. 1995 s. 961.34; 2013 a. 267.
961.34 Annotation Reefer Madness: Lighting Up in the Dairyland. Bailey. Wis. Law. Nov. 2014.
961.36 961.36 Controlled substances board duties relating to diversion control and prevention, compliance with controlled substances law and advice and assistance.
961.36(1)(1) The controlled substances board shall regularly prepare and make available to state regulatory, licensing and law enforcement agencies descriptive and analytic reports on the potential for diversion and actual patterns and trends of distribution, diversion and abuse within the state of certain controlled substances the board selects that are listed in s. 961.16, 961.18, 961.20 or 961.22.
961.36(1m) (1m) At the request of the department of safety and professional services or a board, examining board or affiliated credentialing board in the department of safety and professional services, the controlled substances board shall provide advice and assistance in matters related to the controlled substances law to the department or to the board, examining board or affiliated credentialing board in the department making the request for advice or assistance.
961.36(2) (2) The controlled substances board shall enter into written agreements with local, state and federal agencies to improve the identification of sources of diversion and to improve enforcement of and compliance with this chapter and other laws and regulations pertaining to unlawful conduct involving controlled substances. An agreement must specify the roles and responsibilities of each agency that has information or authority to identify, prevent or control drug diversion and drug abuse. The board shall convene periodic meetings to coordinate a state diversion prevention and control program. The board shall assist and promote cooperation and exchange of information among agencies and with other states and the federal government.
961.36(3) (3) The controlled substances board shall evaluate the outcome of its program under this section and shall annually submit a report to the chief clerk of each house of the legislature, for distribution to the legislature under s. 13.172 (3), on its findings with respect to its effect on distribution and abuse of controlled substances, including recommendations for improving control and prevention of the diversion of controlled substances.
961.36 History History: 1981 c. 200; 1987 a. 186; 1995 a. 305 ss. 2, 3; 1995 a. 448 s. 234; Stats. 1995 s. 961.36; 1997 a. 35 s. 339; 2011 a. 32.
961.38 961.38 Prescriptions.
961.38(1g)(1g) In this section, "medical treatment" includes dispensing or administering a narcotic drug for pain, including intractable pain.
961.38(1n) (1n) A pharmacy or physician approved under s. 961.34 (2) (a) or (b) may dispense cannabidiol in a form without a psychoactive effect as a treatment for a seizure disorder or any physician may provide an individual with a hard copy of a letter or other official documentation stating that the individual possesses cannabidiol to treat a seizure disorder if the cannabidiol is in a form without a psychoactive effect.
961.38(1r) (1r) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, no controlled substance included in schedule II may be dispensed without the written hard copy or electronic prescription of a practitioner.
961.38(2) (2) In emergency situations, as defined by rule of the pharmacy examining board, schedule II drugs may be dispensed upon an oral prescription of a practitioner, reduced promptly to a written hard copy or electronic record and filed by the pharmacy. Prescriptions shall be retained in conformity with rules of the pharmacy examining board promulgated under s. 961.31. No prescription for a schedule II substance may be refilled.
961.38(3) (3) Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a controlled substance included in schedule III or IV, which is a prescription drug, shall not be dispensed without a written, oral or electronic prescription of a practitioner. The prescription shall not be filled or refilled except as designated on the prescription and in any case not more than 6 months after the date thereof, nor may it be refilled more than 5 times, unless renewed by the practitioner.
961.38(4) (4) A substance included in schedule V may be distributed or dispensed only for a medical purpose, including medical treatment or authorized research.
961.38(4g) (4g) A practitioner may dispense or deliver a controlled substance to or for an individual or animal only for medical treatment or authorized research in the ordinary course of that practitioner's profession.
961.38(4r) (4r) A pharmacist is immune from any civil or criminal liability and from discipline under s. 450.10 for any act taken by the pharmacist in reliance on a reasonable belief that an order purporting to be a prescription was issued by a practitioner in the usual course of professional treatment or in authorized research.
961.38(5) (5) No practitioner shall prescribe, orally, electronically or in writing, or take without a prescription a controlled substance included in schedule I, II, III or IV for the practitioner's own personal use.
961.38 History History: 1971 c. 219; 1975 c. 190, 421; 1977 c. 203; 1995 a. 448 ss. 235 to 240, 483 to 485; Stats. 1995 s. 961.38; 1997 a. 27; 2011 a. 159; 2013 a. 267.
961.38 Annotation Reefer Madness: Lighting Up in the Dairyland. Bailey. Wis. Law. Nov. 2014.
961.385 961.385 Prescription drug monitoring program.
961.385(1) (1) In this section:
961.385(1)(a) (a) "Administer" has the meaning given in s. 450.01 (1).
961.385(1)(ac) (ac) "Board" means the controlled substances board.
961.385(1)(ag) (ag) "Monitored prescription drug" means a substance identified in s. 961.16, 961.18, 961.20, or 961.22 or a drug identified by the board by rule as having a substantial potential for abuse.
961.385(1)(aj) (aj) "Patient" means an individual for whom a monitored prescription drug is prescribed or to whom a monitored prescription drug is dispensed or administered.
961.385(1)(aL) (aL) "Pharmacist" means a person licensed by the pharmacy examining board under s. 450.03 or 450.05 or licensed in another state and recognized by this state as a person authorized to engage in the practice of pharmacy in the state in which the person is licensed.
961.385(1)(an) (an) "Pharmacy" means a place of practice licensed under s. 450.06 or 450.065.
961.385(1)(ar) (ar) "Practitioner" has the meaning given in s. 450.01 (17) but does not include a veterinarian licensed under ch. 89.
961.385(1)(b) (b) "Prescription order" means an order transmitted orally, electronically, or in writing by a practitioner for a monitored prescription drug for a particular patient.
961.385(2) (2) The board shall establish by rule a program for monitoring the dispensing of monitored prescription drugs. The program shall do all of the following:
961.385(2)(a) (a) Require a pharmacy or a practitioner to generate a record documenting each dispensing of a monitored prescription drug at the pharmacy or, if the monitored prescription drug is not dispensed at a pharmacy, by the practitioner and to submit the record to the board, except that the program may not require the generation of a record in any of the following circumstances:
961.385(2)(a)1. 1. A monitored prescription drug is administered directly to a patient.
961.385(2)(a)2. 2. A monitored prescription drug is compounded, packaged, or labeled in preparation for delivery but is not delivered.
961.385(2)(a)3. 3. The prescription order is for a monitored prescription drug that is a substance listed in the schedule in s. 961.22 and is not a narcotic drug, and the prescription order is for a number of doses that is intended to last the patient 7 days or less.
961.385(2)(b) (b) Identify specific data elements to be contained in a record documenting the dispensing of a monitored prescription drug, including the method of payment and, subject to sub. (2m), the name recorded under s. 450.11 (1b) (bm). In identifying specific data elements, the board shall consider data elements identified by similar programs in other states and shall ensure, to the extent possible, that records generated by the program are easily shared with other states.
961.385 Note NOTE: Par. (b), as renumbered from s. 450.19 (2) (b) by 2015 Wis. Act 55, is shown as affected by 2013 Wis. Acts 124 and 199 and as merged by the legislative reference bureau under s. 13.92 (2) (i).
961.385(2)(c) (c) Specify the persons to whom a record may be disclosed and the circumstances under which the disclosure may occur. The rule promulgated under this paragraph shall comply with s. 146.82, except that the rule shall permit the board to disclose a record generated by the program to relevant state boards and agencies, relevant agencies of other states, and relevant law enforcement agencies, as defined in s. 165.77 (1) (b), including under circumstances indicating suspicious or critically dangerous conduct or practices of a pharmacy, pharmacist, practitioner, or patient. The board shall define what constitutes suspicious or critically dangerous conduct or practices for purposes of the rule promulgated under this paragraph.
961.385(2)(d) (d) Specify a secure electronic format for submittal of a record generated under the program and authorize the board to grant a pharmacy or practitioner a waiver of the specified format.
961.385(2)(e) (e) Specify a deadline for the submittal of a record to the board.
961.385(2)(f) (f) Permit the board to refer to the appropriate licensing or regulatory board for discipline, or the appropriate law enforcement agency for investigation and possible prosecution, a pharmacist, pharmacy, or practitioner that fails to comply with rules promulgated under this subsection, including by failure to generate a record that is required by the program.
961.385(2)(g) (g) Maximize the potential for funding the operation of the program with available federal funding sources.
961.385(2)(h) (h) Ensure that the program complies with s. 146.82 and 45 CFR part 164, subpart E.
961.385(2m) (2m)
961.385(2m)(a)(a) The rules promulgated under sub. (2) may not require that a record submitted to the board before 2 years after April 9, 2014, contain the name recorded under s. 450.11 (1b) (bm).
961.385(2m)(b) (b) After consultation with representatives of licensed pharmacists and pharmacies, and subject to the approval of the secretary of safety and professional services, the board may delay the requirement that a record submitted to the board contain the name recorded under s. 450.11 (1b) (bm) for an additional period beyond the date specified in par. (a).
961.385(3) (3)
961.385(3)(a)(a) A pharmacy, pharmacist, or practitioner is immune from civil or criminal liability or professional discipline arising from the pharmacy's, pharmacist's, or practitioner's compliance in good faith with this section or with rules promulgated under this section.
961.385(3)(b) (b) Nothing in this section may be construed to require a pharmacy, pharmacist, or practitioner to obtain, before prescribing or dispensing a monitored prescription drug to a patient, information about the patient that has been collected pursuant to the program established under sub. (2).
961.385(4) (4) Records generated under the program under this section are not subject to inspection or copying under s. 19.35.
961.385 History History: 2009 a. 362; 2011 a. 260 s. 81; 2013 a. 3, 20, 124, 199; 2015 a. 55; 2015 a. 55 ss. 4477, 4737f to 4731k; Stats. 2015 s. 961.385; s. 13.92 (2) (i).
961.385 Cross-reference Cross-reference: See also ch. Phar 18, Wis. adm. code.
961.39 961.39 Limitations on optometrists. An optometrist who is allowed under s. 449.18 (1) to use therapeutic pharmaceutical agents and under s. 449.18 (6) (am) 2. b. to dispense a contact lens that delivers a therapeutic pharmaceutical agent:
961.39(1) (1) May not prescribe, dispense, or administer a controlled substance included in schedule I or II.
961.39(2) (2) May prescribe, dispense, or administer only those controlled substances included in schedules III, IV, and V that are permitted for prescription or administration under the rules promulgated under s. 449.18 (6) (cm).
961.39(2m) (2m) Notwithstanding sub. (1), may prescribe, dispense, or administer any of the following, if permitted for prescription or administration under the rules promulgated under s. 449.18 (6) (cm):
961.39(2m)(a) (a) Not more than 300 milligrams of hydrocodone per 100 milliliters or per 100 grams or not more than 15 milligrams per dosage unit, with a four-fold or greater quantity of an isoquinoline alkaloid of opium.
961.39(2m)(b) (b) Not more than 300 milligrams of hydrocodone per 100 milliliters or per 100 grams or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.
961.39(3) (3) Shall include with each prescription order all of the following:
961.39(3)(a) (a) A statement that he or she is allowed under s. 449.18 (1) to use therapeutic pharmaceutical agents.
961.39(3)(b) (b) The indicated use of the controlled substance included in schedule III, IV, or V so prescribed or the indicated use of the controlled substance under sub. (2m) (a) or (b) so prescribed.
961.39(4) (4) May not dispense other than as provided under s. 449.18 (6) (am) 2.
961.39 History History: 1989 a. 31; 1995 a. 448 s. 241; Stats. 1995 s. 961.39; 2005 a. 297; 2009 a. 168; 2015 a. 34.
961.395 961.395 Limitation on advanced practice nurses.
961.395(1)(1) An advanced practice nurse who is certified under s. 441.16 may prescribe controlled substances only as permitted by the rules promulgated under s. 441.16 (3).
Loading...
Loading...
2013-14 Wisconsin Statutes updated through 2015 Wis. Act 60 and all Supreme Court Orders entered before August 26, 2015. Published and certified under s. 35.18. Changes effective after August 26, 2015 are designated by NOTES. (Published 8-26-15)