Chapter CSB 4

CSB 4.02(15) (15) “PDMP data” means the information compiled and analyzed by the PDMP system from dispensing data submitted to it by dispensers.

CSB 4.02(15b) (15b) “PDMP system” means the web-based application, analytics platform, and all related hardware and software that facilitates the submission of dispensing data and the access to and disclosure of PDMP data, monitored prescription drug history reports, audit trails, and prescribing metrics reports.

CSB 4.02(15e) (15e) “Personally identifiable information” means information that can be associated with a particular person through one or more identifiers or other information or circumstances.

CSB 4.02(15g) (15g) “Pharmacist” has the meaning given in s. 961.385 (1) (aL), Stats. For the purposes of this program, the board recognizes a pharmacist licensed by another state that engages in the practice of pharmacy within the contiguous borders of this state or who practices at a pharmacy licensed under s. 450.065, Stats. as a person authorized to engage in the practice of pharmacy.

CSB 4.02(15r) (15r) “Pharmacist delegate” means an agent of a pharmacist to whom the pharmacist has delegated the task of accessing monitored prescription drug history reports.

CSB 4.02(16) (16) “Pharmacy” has the meaning given in s. 961.385 (1) (an), Stats., including a pharmacy that chooses to solely dispense to animal patients.

CSB 4.02(17) (17) “Practitioner” has the meaning given in s. 961.385 (1) (ar), Stats. For the purposes of this program, the board recognizes a practitioner licensed by another state that engages in the practice of their credentialed profession within the contiguous borders of this state as a person authorized to prescribe and administer drugs.

CSB 4.02(18) (18) “Practitioner delegate” means an agent of a practitioner to whom the practitioner has delegated the task of accessing monitored prescription drug history reports.

CSB 4.02(18m) (18m) “Prescribing metrics report” means all of the following information about a practitioner compiled by the PDMP system and disclosed as authorized in s. CSB 4.09:

CSB 4.02(18m)(a) (a) PDMP data.

CSB 4.02(18m)(b) (b) Audit trails.

CSB 4.02(18m)(c) (c) Reports submitted to the program pursuant to s. 961.37, Stats., about a patient to whom the practitioner has issued a prescription order.

CSB 4.02(18m)(d) (d) Information from the analytics platform.

CSB 4.02(19) (19) “Prescription” has the meaning given in s. 450.01 (19), Stats.

CSB 4.02(20) (20) “Prescription order” has the meaning given in s. 961.385 (1) (b), Stats.

CSB 4.02(21) (21) “Program” means the prescription drug monitoring program established under this chapter.

CSB 4.02(21m) (21m) “Prosecutorial unit” has the meaning given in s. 978.001 (2), Stats.

CSB 4.02(23) (23) “Zero report” means a report that indicates that a dispenser has not dispensed a monitored prescription drug since the previous submission of dispensing data or a zero report.

CSB 4.02 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction in (5) (b) made under s. 13.92 (4) (b) 7., Stats., Register October 2012 No. 682; CR 13-065: cr. (3m), (13e), am. (16), (17), r. (22) Register February 2014 No. 698, eff. 3-1-14; (13e) renum. to (14e) under s. 13.92 (4) (b) 1., Stats., Register February 2014 No. 698; correction in (17) made under s. 13.92 (4) (b) 7., Stats., Register February 2014 No. 698; CR 14-003: am. (8) (a), renum. (9) to (9) (intro.) and am., cr. (9) (a), (b), (11g), (11r), am. (15) (intro.), cr. (15g), (15r), am. (17) Register August 2014 No. 704, eff. 9-1-14; correction in (3), (9) (b), (10), (12) (a) 1., 2., (15) (b), (15g), (17), (20) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; CR 15-101: am. (4) Register June 2016 No. 726, eff. 7-1-16; EmR1706: emerg. am. (1), (2), cr. (2m), (3s), (4m), (5m), am. (7), cr. (11c), (11n), am. (11r), cr. (11w), am. (12) (a) 1., cr. (12m), am. (13), r. (14), cons. and renum. (15) (intro.) and (a) to (15) and am., r. (15) (b), cr. (15b), (15e), am. (15g), (15r), (16), (17), (18), cr. (18m), (21m), eff. 4-1-17; CR 17-028: am. (1), (2), cr. (2m), (3s), (4m), (5m), am. (7), cr. (11c), (11n), am. (11r), cr. (11w), am. (12) (a) 1., cr. (12m), am. (13), r. (14), cons. and renum. (15) (intro.) and (a) to (15) and am., r. (15) (b), cr. (15b), (15e), am. (15g), (15r), (16), (17), (18), cr. (18m), (21m) Register December 2017 No. 744, eff. 1-1-18; (5k) renumbered from CSB 4.04 (1) (a) under s. 13.92 (4) (b) 1., Stats., Register August 2021 No. 788.

CSB 4.03 CSB 4.03 Drugs that have a substantial potential for abuse. Pursuant to s. 961.385 (1) (ag), Stats., the board has identified all of the following drugs as having a substantial potential for abuse:

CSB 4.03(1) (1) A controlled substance identified in schedule II, III, IV or V in the federal controlled substances act, 21 USC 812 (b) (2) to (b) (5) and (c), as changed and updated by 21 CFR 1308.

CSB 4.03(2) (2) Gabapentin.

CSB 4.03 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; correction in (2) made under s. 13.92 (4) (b) 7., Stats., Register October 2012 No. 682; CR 13-065: am. (intro.) Register February 2014 No. 698, eff. 3-1-14; correction in (intro.) made under s. 13.92 (4) (b) 7., Stats., Register February 2014 No. 698; correction in (intro.) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; CR 15-101: r. (3) Register June 2016 No. 726, eff. 7-1-16; EmR1706: emerg. r. (2), eff. 4-1-17; CR 17-028: r. (2) Register December 2017 No. 744, eff. 1-1-18; CR 20-080: cr. (2) Register August 2021 No. 788, eff. 9-1-21.

CSB 4.04 CSB 4.04 Compilation of dispensing data.

CSB 4.04(1) (1) As used in this section, “NDC number” means national drug code number, the universal product identifier used in the U.S. to identify a specific drug product.

CSB 4.04(2) (2) Subject to s. CSB 4.08, a dispenser shall compile dispensing data that contains all of the following information each time the dispenser dispenses a monitored prescription drug:

CSB 4.04(2)(a) (a) The dispenser’s full name.

CSB 4.04(2)(b) (b) The dispenser’s DEA registration number.

CSB 4.04(2)(c) (c) The date dispensed.

CSB 4.04(2)(d) (d) The prescription number.

CSB 4.04(2)(e) (e) The NDC number of the monitored prescription drug.

CSB 4.04(2)(f) (f) The quantity dispensed.

CSB 4.04(2)(g) (g) The estimated number of days of drug therapy.

CSB 4.04(2)(gb) (gb) The drug dosage units.

CSB 4.04(2)(gd) (gd) The partial fill indicator.

CSB 4.04(2)(ge) (ge) The classification code for payment type.

CSB 4.04(2)(gm) (gm) The number of refills authorized by the prescriber.

CSB 4.04(2)(gs) (gs) The refill number of the prescription.

CSB 4.04(2)(h) (h) The practitioner’s full name.

CSB 4.04(2)(i) (i) The practitioner’s DEA registration number.

CSB 4.04(2)(j) (j) The date prescribed.

CSB 4.04(2)(L) (L) The patient’s full name or if the patient is an animal, the animal’s name and the owner’s last name.

CSB 4.04(2)(m) (m) The patient’s address, or if the patient is an animal, patient’s owner’s address, including street address, city, state, and ZIP code.

CSB 4.04(2)(n) (n) The patient’s date of birth, or if the patient is an animal, patient’s owner’s date of birth.

CSB 4.04(2)(o) (o) The patient’s gender.

CSB 4.04(2)(p) (p) The name recorded under s. 450.11 (1b) (bm), Stats.

CSB 4.04(4) (4) The board may refer a dispenser and dispenser delegate that fail to compile dispensing data as required by sub. (2) to the appropriate licensing or regulatory board for discipline.

CSB 4.04 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 13-065: am. (1) (b), (e), (3) (b), (d), (i), (k) Register February 2014 No. 698, eff. 3-1-14; CR 14-003: am. (title), renum. (2) to (2) (intro.) and am., cr. (2) (ge), (gm), (gs), renum. (3) (a) to (g) and (h) to (j) to (2) (a) to (g) and (h) to (j), r. (3) (k), renum. (3) (L) to (o) to (2) (L) to (o) and am. (L) to (n), am. (4) Register August 2014 No. 704, eff. 9-1-14; correction in (2) (intro.) made under s. 35.17, Stats., and in (4) made under s. 13.92 (4) (b) 7., Stats., Register August 2014 No. 704; correction in (2) (intro.) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; CR 15-070: cr. (2) (p) Register April 2016 No. 724, eff. 4-9-17; numbering correction in (2) (p) under s. 13.92 (4) (b) 1. Register April 2016 No. 724; republished to correct CR 15-070: cr. (2) (p) effective date Register May 2016 No. 725; EmR1706: emerg. r. (1) (b), (d), (e), am. (2) (b), (e), (i), (4), eff. 4-1-17; CR 17-028: r. (1) (b), (d), (e), am. (2) (b), (e), (i), (4) Register December 2017 No. 744, eff. 1-1-18; CR 19-156: cr. (2) (gb), (gd) Register August 2020 No. 776, eff. 9-1-20; (1) (a) renumbered to CSB 4.02 (5k), and (1) (intro.) and (c) consolidated and renumberd to (1) under s. 13.92 (4) (b) 1., Stats., correction in (1) made under s. 35.17, Stats., Register August 2021 No. 788.

CSB 4.05 CSB 4.05 Electronic submission of dispensing data.

CSB 4.05(1) (1) Unless exempt under s. CSB 4.08, a dispenser shall electronically submit dispensing data to the PDMP in any of the following ways:

CSB 4.05(1)(a) (a) As a file that complies with the data standards identified in version 4 and release 2 of ASAP implementation guide for prescription monitoring programs.

CSB 4.05(1)(b) (b) Using the prescription record entry functions of the PDMP system.

CSB 4.05 Note Note: The guide for dispensers which specifies the data standards in version 4 release 2 of the ASAP implementation guide for prescription monitoring programs and other electronic formats identified by the board may be obtained online at https://pdmp.wi.gov or obtained at no charge from the Department of Safety and Professional Services, 1400 East Washington Avenue, P.O. Box 8366, Madison, WI 53708.

CSB 4.05(4) (4) The board may refer a dispenser and dispenser delegate that fail to submit dispensing data as required by sub. (1) to the appropriate licensing or regulatory board for discipline.

CSB 4.05 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 13-065: am. (2) Register February 2014 No. 698, eff. 3-1-14; CR 14-003: am. (1), (4) Register August 2014 No. 704, eff. 9-1-14; correction in (intro.) made under s. 13.92 (4) (b) 7., Stats., Register September 2015 No. 717; EmR1706: emerg. renum. (1) to (1) (intro.), cr. (1) (a), (b), r. (2), (3), r. and recr. (4), eff. 4-1-17; CR 17-028: renum. (1) to (1) (intro.), cr. (1) (a), (b), r. (2), (3), r. and recr. (4) Register December 2017 No. 744, eff. 1-1-18.

CSB 4.06 CSB 4.06 Frequency of submissions.

CSB 4.06(1) (1) A dispenser shall submit dispensing data to the PDMP no later than 11:59 p.m. of the next business day after the monitored prescription drug is dispensed.

CSB 4.06(2) (2) If a dispenser does not dispense a monitored prescription drug on a business day, the dispenser shall submit no later than 11:59 p.m. of the next business day a zero report to the PDMP that accounts for each business day on which the dispenser did not dispense a monitored prescription drug.

CSB 4.06(3) (3) If a dispenser is not able to submit dispensing data zero report before 11:59 p.m. of the next business day as required by subs. (1) or (2), the board may grant an emergency waiver to a dispenser who satisfies all of the following conditions:

CSB 4.06(3)(a) (a) The dispenser is not able to submit dispensing data or a zero report because of circumstances beyond its control.

CSB 4.06(3)(b) (b) The dispenser files with the board a written application for an emergency waiver on a form provided by the board prior to the required submission of dispensing data or zero report.

CSB 4.06 Note Note: The application for an emergency waiver may be obtained online at www.dsps.wi.gov or obtained at no charge from the Department of Safety and Professional Services, 1400 East Washington Avenue, P.O. Box 8366, Madison, WI 53708.

CSB 4.06(4) (4) Unless otherwise specified by the board, an emergency waiver granted under sub. (3) shall only be effective for 7 days.

CSB 4.06(5) (5) The board may refer a dispenser and dispenser delegate that fail to submit dispensing data or a zero report as required by subs. (1) and (2), or be granted an emergency waiver under sub. (3), or a dispenser and a dispenser delegate that submit false information to the PDMP to the appropriate licensing or regulatory board for discipline.

CSB 4.06 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 13-065: am. (1), (2), (3) (intro.), r. (4) to (6), (9), renum. (7) to (4) and am., renum. (8) to (5) Register February 2014 No. 698, eff. 3-1-14; CR 14-003: am. (2), (5) Register August 2014 No. 704, eff. 9-1-14; EmR1706: emerg. am. (1), (2), (3), (5), eff. 4-1-17; CR 17-028: am. (1), (2), (3), (5) Register December 2017 No. 744, eff. 1-1-18.

CSB 4.07 CSB 4.07 Correction of dispensing data.

CSB 4.07(1) (1) A dispenser shall electronically correct dispensing data in the PDMP system within 5 business days of discovering an omission, error, or inaccuracy in previously submitted dispensing data.

CSB 4.07(2) (2) The board may refer a dispenser and dispenser delegate that fail to correct dispensing data as required by sub. (1) to the appropriate licensing or regulatory board for discipline.

CSB 4.07 Note Note: The written notice to the board may be submitted through an account with the board, sent by electronic mail or sent by U.S. mail to the Department of Safety and Professional Services 1400 East Washington Avenue, P.O. Box 8366, Madison, WI 53708.

CSB 4.07 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. Register August 2014 No. 704, eff. 9-1-14; EmR1706: emerg. r. and recr. eff. 4-1-17; CR 17-028: r. and recr. Register December 2017 No. 744, eff. 1-1-18.

CSB 4.08 CSB 4.08 Exemptions from compiling and submitting dispensing data.

CSB 4.08(1) (1) The board shall exempt a dispenser from compiling and submitting dispensing data and from submitting a zero report as required under this chapter until the dispenser is required to renew its license, or until the dispenser dispenses a monitored prescription drug, if the dispenser satisfies all of the following conditions:

CSB 4.08(1)(a) (a) The dispenser provides evidence sufficient to the board that the dispenser does not dispense monitored prescription drugs.

CSB 4.08(1)(b) (b) The dispenser files with the board a written request for exemption on a form provided by the board.

CSB 4.08 Note Note: The application for an exemption may be obtained online at www.dsps.wi.gov or at no charge from the Department of Safety and Professional Services 1400 East Washington Avenue, P.O. Box 8366, Madison, WI 53708. A dispenser who is already exempt can renew his or her exemption as part of the licensure renewal process.

CSB 4.08(2) (2) A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is administered directly to a patient.

CSB 4.08(2m) (2m) A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is compounded, packaged, or labeled in preparation for delivery but is not delivered.

CSB 4.08(3) (3) A dispenser is not required to compile or submit dispensing data when the monitored prescription drug is a substance listed in the schedule in s. 961.22, Stats., and is not a narcotic drug, as defined in s. 961.01 (15), Stats., and is dispensed pursuant to a prescription order for a number of doses that is intended to last the patient 7 days or less.

CSB 4.08(4) (4) A dispenser who is not otherwise required to have a DEA registration number is not required to compile or submit dispensing data when dispensing Gabapentin.

CSB 4.08 History History: CR 12-009: cr. Register October 2012 No. 682, eff. 1-1-13; CR 14-003: am. (1) (a), cr. (3) Register August 2014 No. 704, eff. 9-1-14; CR 15-101: am. (1) Register June 2016 No. 726, eff. 7-1-16; EmR1706: emerg. cr. (2m), eff. 4-1-17; CR 17-028: cr. (2m) Register December 2017 No. 744, eff. 1-1-18; CR 20-080: cr. (4) Register August 2021 No. 788, eff. 9-1-21.

CSB 4.09 CSB 4.09 Access to monitored prescription drug history reports and PDMP data about a patient.

CSB 4.09(1) (1) Healthcare professionals may access monitored prescription drug history reports about a patient for any of the following reasons:

CSB 4.09(1)(a) (a) The healthcare professional is directly treating or rendering assistance to the patient.

CSB 4.09(1)(b) (b) The healthcare professional is being consulted regarding the health of the patient by an individual who is directly treating or rendering assistance to the patient.

CSB 4.09(1)(c) (c) Scientific research purposes if all of the following requirements are met:

CSB 4.09(1)(c)1. 1. The patient is a direct patient of the healthcare professional.

CSB 4.09(1)(c)2. 2. The healthcare professional has obtained informed consent from the patient to access monitored prescription drug history reports for scientific research purposes.

CSB 4.09(1)(d) (d) Purposes of conducting an overdose fatality review.

CSB 4.09(2) (2) Pharmacist delegates and practitioner delegates may access monitored prescription drug history reports about a patient for any of the following reasons: