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 Annotation
Reefer Madness: Lighting Up in the Dairyland. Bailey. Wis. Law. Nov. 2014.
961.385
961.385
Prescription drug monitoring program. 961.385(1)(a)
(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:
Effective date note
NOTE: Par. (a) is shown as affected eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(a) “Administer" has the meaning given in s. 450.01 (1).
961.385(1)(ab)
(ab) “Agent" means an authorized person who acts on behalf of or at the direction of another person.
961.385(1)(ad)
(ad) “Business day" means any day on which the offices of the department of safety and professional services are open.
961.385(1)(ae)
(ae) “Deliver" or “delivery" means the actual, constructive, or attempted transfer of a monitored prescription drug from one person to another.
961.385(1)(af)
(af) “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.
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 or animal for whom a monitored prescription drug is prescribed or to whom a monitored prescription drug is dispensed or administered.
Effective date note
NOTE: Par. (aj) is shown as amended eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(aj) “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.
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)(b)
(b) “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.
Effective date note
NOTE: Par. (b) is shown as amended eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(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 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:
Effective date note
NOTE: Par. (a) (intro.) is shown as amended eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(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(2)(c)
(c) 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.
Effective date note
NOTE: Par. (c) is shown as affected eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(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)(cm)
(cm) Permit the board to disclose a record generated by the program to any of the following:
961.385(2)(cm)1.
1. A practitioner, pharmacist, registered nurse licensed under
s. 441.06, substance abuse counselor, as defined in
s. 440.88 (1) (b), or individual authorized under
s. 457.02 (5m) to treat alcohol or substance dependency or abuse as a specialty if any of the following is applicable:
961.385(2)(cm)1.a.
a. The practitioner, pharmacist, registered nurse, substance abuse counselor, or individual is directly treating or rendering assistance to the patient.
961.385(2)(cm)1.b.
b. The practitioner, pharmacist, registered nurse, substance abuse counselor, or individual is being consulted regarding the health of the patient by an individual who is directly treating or rendering assistance to the patient.
961.385(2)(cm)2.
2. A person who medically coordinates, directs, or supervises, or establishes standard operating procedures for, a practitioner, pharmacist, registered nurse, substance abuse counselor, or individual authorized under
s. 457.02 (5m) to treat alcohol or substance dependency or abuse as a specialty to whom records may be disclosed under
subd. 1., if the person is evaluating the job performance of the practitioner, pharmacist, registered nurse, substance abuse counselor, or individual, or is performing quality assessment and improvement activities, including outcomes evaluation or development of clinical guidelines, and if the disclosure does not contain personally identifiable information, as defined in
s. 19.62 (5), of a patient and is limited to only those records about the practitioner, pharmacist, registered nurse, substance abuse counselor, or individual the person medically coordinates, directs, or supervises, or for whom the person establishes standard operating procedures.
961.385(2)(cm)3.
3. Relevant state boards and agencies, relevant agencies of other states, relevant law enforcement agencies, as defined in
s. 165.77 (1) (b), and relevant prosecutorial units, as defined in
s. 978.001 (2), if any of the following is true:
961.385(2)(cm)3.a.
a. The state board or agency, agency of another state, law enforcement agency, or prosecutorial unit makes a written request for the record and is engaged in an active and specific investigation or prosecution of a violation of any state or federal law involving a monitored prescription drug, and the record being requested is reasonably related to that investigation or prosecution.
961.385(2)(cm)3.b.
b. The state board or agency, agency of another state, law enforcement agency, or prosecutorial unit makes a written request for the record and is monitoring the patient as part of a drug court, as defined in
s. 165.955 (1).
961.385(2)(cm)3.c.
c. The circumstances indicate 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 this
subd. 3. c.
961.385(2)(cm)4.
4. An agent of a practitioner or pharmacist if disclosure to the practitioner or pharmacist is authorized subject to
subd. 1.
961.385(2)(cs)1.1. Require a practitioner to review a patient's records under the program before the practitioner issues a prescription order for the patient. This subdivision does not apply after April 1, 2020 or 3 years after the 30th day after the date of publication in the Wisconsin Administrative Register of the notice under
2015 Wisconsin Act 266, section 17 (2g), whichever is later.
961.385(2)(cs)2.
2. The requirement under
subd. 1. that a practitioner review a patient's records under the program before the practitioner issues a prescription order for the patient does not apply if any of the following is true:
961.385(2)(cs)2.b.
b. The prescription order is for a number of doses that is intended to last the patient 3 days or less and is not subject to refill.
961.385(2)(cs)2.c.
c. The monitored prescription drug is lawfully administered to the patient.
961.385(2)(cs)2.d.
d. Due to emergency, it is not possible for the practitioner to review the patient's records under the program before the practitioner issues a prescription order for the patient.
961.385(2)(cs)2.e.
e. The practitioner is unable to review the patient's records under the program because the digital platform for the program is not operational or due to other technological failure if the practitioner reports that failure to the board.
961.385 Note
NOTE: Par. (cs) is shown as created by
2015 Wis. Act 266 effective on the 30th day after the date of publication in the Wisconsin Administrative Register of the notice under
2015 Wisconsin Act 266, section
17 (2g), or on April 1, 2017, whichever is later.
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.
Effective date note
NOTE: Par. (h) is shown as amended eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(h) Ensure that the program complies with s. 146.82 and 45 CFR part 164, subpart E.
961.385(2)(i)
(i) Disclose information submitted to the program by a law enforcement agency under
s. 961.37 (3) (a) to relevant practitioners, pharmacists, and others to whom the board may make disclosures under
par. (c).
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)(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 or pharmacist to obtain, before dispensing a monitored prescription drug to a patient, information about the patient that has been collected pursuant to the program established under
sub. (2).
Effective date note
NOTE: Par. (b) is shown as amended eff. 4-1-17 by
2015 Wis. Act 266. Prior to 4-1-17 it reads:
Effective date text
(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(5)(a)(a) Beginning with the 3rd calendar quarter of 2016, no later than 30 days after the end of each calendar quarter, the board shall conduct a review of the program under this section to evaluate the actual outcomes of the program compared with projected outcomes, as determined by the board. The board's review shall include an evaluation of all of the following:
961.385(5)(a)1.
1. The satisfaction with the program of pharmacists, pharmacies, practitioners, and other users of the program.
961.385(5)(a)2.
2. The program's impact on referrals of pharmacists, pharmacies, and practitioners to licensing or regulatory boards for discipline and to law enforcement agencies for investigation and possible prosecution.
961.385(5)(b)
(b) This subsection does not apply after October 30, 2020.
961.385(6)
(6) Beginning with the 3rd calendar quarter of 2016, no later than 30 days after the end of each calendar quarter, the board shall provide a report to the department of safety and professional services that includes all of the following:
961.385(6)(a)
(a) The results of the board's review under
sub. (5). This paragraph does not apply after October 30, 2020.
