A permit issued under this section shall be valid for one year from the date of issue.
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.
Permits issued under this section shall be effective only for and shall specify:
The nature of the project authorized by the permit.
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, except that, for any permit issued to a state crime laboratory, the permit is effective for any controlled substance whether or not the name or schedule is specified.
Whether dispensing to human subjects is authorized.
A permit shall be effective only for the person, project, and, except as provided in sub. (4) (c)
, substances 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.
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.
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.
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.
See also ch. CSB 3
, Wis. adm. code.
The controlled substances board may suspend or revoke a permit upon a finding that there is a violation of the rules of the board.
Drug disposal programs.
Nothing in this chapter, or rules promulgated under this chapter, prohibits any of the following:
The direct operation or implementation of a drug disposal program that is authorized under s. 165.65 (2)
or is authorized under federal law, as defined in s. 165.65 (1) (a)
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 is authorized under federal law, as defined in s. 165.65 (1) (a)
, and that accepts the controlled substance or controlled substance analog.
History: 2013 a. 198
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.
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 medical condition.
Reefer Madness: Lighting Up in the Dairyland. Bailey. Wis. Law. Nov. 2014.
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
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.
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.
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.
History: 1981 c. 200
; 1987 a. 186
; 1995 a. 305
; 1995 a. 448
; Stats. 1995 s. 961.36; 1997 a. 35
; 2011 a. 32
Law enforcement duty. 961.37(1)(1)
A law enforcement officer shall report as provided in sub. (2)
if the law enforcement officer, while acting in an official capacity, does any of the following:
Encounters a situation in which the law enforcement officer reasonably suspects that a violation of this chapter involving a monitored prescription drug, as defined in s. 961.385 (1) (ag)
, is occurring or has occurred.
Encounters an individual who the law enforcement officer believes is undergoing or has immediately prior experienced an opioid-related drug overdose, as defined in s. 256.40 (1) (d)
, or a deceased individual who the law enforcement officer believes died as a result of using a narcotic drug.
Receives a report of a stolen controlled-substance prescription.
A law enforcement officer under sub. (1)
shall report to the law enforcement agency that employs him or her all of the following:
The name and date of birth of all of the following, if applicable:
The individual who is suspected of violating this chapter.
The individual who experienced an opioid-related drug overdose.
The individual who died as a result of using a narcotic drug.
The individual who filed the report of a stolen controlled-substance prescription.
The individual for whom a prescription drug related to an event under subd. 1.
, or 4.
The name of the prescribing practitioner, the prescription number, and the name of the drug as it appears on the prescription order or prescription medicine container if a prescription medicine container was in the vicinity of the suspected violation, drug overdose, or death or if a controlled-substance prescription was reported stolen.
The law enforcement agency receiving the report under sub. (2)
shall, except as provided under par. (b)
, submit notice of the suspected violation of this chapter, the opioid-related drug overdose, the death as a result of using a narcotic drug, or the report of a stolen controlled-substance prescription, and the information reported under sub. (2)
to the prescription drug monitoring program.
If a law enforcement agency determines that submitting any information under par. (a)
would interfere with an active criminal investigation, the law enforcement agency may postpone the action until the investigation concludes.
History: 2015 a. 268
In this section, “medical treatment" includes dispensing or administering a narcotic drug for pain, including intractable pain.
A pharmacy or physician approved under s. 961.34 (2)
may dispense cannabidiol products as a treatment for a medical condition.
A physician licensed under s. 448.04 (1) (a)
may issue an individual a certification, as defined in s. 961.32 (2m) (a)
, stating that the individual possesses a cannabidiol product to treat a medical condition.
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.
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.
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.
A substance included in schedule V may be distributed or dispensed only for a medical purpose, including medical treatment or authorized research.
Except when dispensed directly by a practitioner, other than a pharmacy, to an ultimate user, a substance specified in s. 961.22 (2)
shall not be dispensed without a written, oral, or electronic prescription of a practitioner.
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.
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.
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.
Reefer Madness: Lighting Up in the Dairyland. Bailey. Wis. Law. Nov. 2014.
Prescription drug monitoring program. 961.385(1)(a)
“Administer" means the direct application of a monitored prescription drug, whether by injection, ingestion, or any other means, to the body of a patient by any of the following:
“Agent" means an authorized person who acts on behalf of or at the direction of another person.
“Business day" means any day on which the offices of the department of safety and professional services are open.
“Deliver" or “delivery" means the actual, constructive, or attempted transfer of a monitored prescription drug from one person to another.
“Dispense" means to deliver a monitored prescription drug pursuant to the lawful prescription order of a practitioner, including the compounding, packaging, or labeling necessary to prepare the monitored prescription drug for delivery.
“Monitored prescription drug" means a substance identified in s. 961.16
, or 961.22
or a drug identified by the board by rule as having a substantial potential for abuse.
“Patient" means an individual or animal for whom a monitored prescription drug is prescribed or to whom a monitored prescription drug is dispensed or administered.
“Pharmacist" means a person licensed by the pharmacy examining board under s. 450.03
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.
“Prescription order" means an order transmitted orally, electronically, or in writing by a practitioner or a veterinarian licensed under ch. 89
for a monitored prescription drug for a particular patient.
The board shall establish by rule a program for monitoring the dispensing of monitored prescription drugs. The program shall do all of the following:
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 no later than 11:59 p.m. of the next business day after the monitored prescription drug is dispensed, except that the program may not require the generation of a record in any of the following circumstances:
A monitored prescription drug is administered directly to a patient.
A monitored prescription drug is compounded, packaged, or labeled in preparation for delivery but is not delivered.
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.
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.
Specify the persons to whom a record may be disclosed and the circumstances under which the disclosure may occur. Except as otherwise provided under this section, the rule promulgated under this paragraph shall comply with s. 146.82
Permit the board to disclose a record generated by the program to any of the following:
A practitioner, pharmacist, registered nurse licensed under s. 441.06
, or substance abuse counselor, as defined in s. 440.88 (1) (b)
, or an individual licensed under s. 457.08 (4)
, or 457.14 (1) (d)
who treats alcohol or substance dependency or abuse as a specialty, if any of the following is applicable:
The practitioner, pharmacist, registered nurse, substance abuse counselor, or individual is directly treating or rendering assistance to the patient.