CSB 4.05 Electronic submission of dispensing data. CSB 4.06 Frequency of submissions. CSB 4.07 Correction of dispensing data. CSB 4.08 Exemptions from compiling and submitting dispensing data. CSB 4.09 Access to monitored prescription drug history reports and PDMP data about a patient. CSB 4.093 Monitored prescription drug history reports and audit trails about healthcare professionals. CSB 4.097 Deny, suspend, revoke or otherwise restrict or limit access. CSB 4.10 Requests for review. CSB 4.105 Practitioners’ requirement to review monitored prescription drug history reports. CSB 4.11 Methods of obtaining monitored prescription drug history reports. CSB 4.12 Use of PDMP data by the board and department. CSB 4.13 Confidentiality of PDMP records. CSB 4.14 Exchange of PDMP data. CSB 4.15 Disclosure of suspicious or critically dangerous conduct or practices. CSB 4.01CSB 4.01 Authority and scope. The rules in this chapter are adopted under authority in ss. 227.11 (2) (a) and 961.385, Stats., for the purpose of creating a prescription drug monitoring program to collect and disclose information relating to the prescribing and dispensing of monitored prescription drugs. CSB 4.02CSB 4.02 Definitions. As used in this chapter: CSB 4.02(1)(1) “Access” means to have the ability to view monitored prescription drug history reports, audit trails, and PDMP data as authorized by s. CSB 4.09. CSB 4.02(3m)(3m) “ASAP” means the American Society for Automation in Pharmacy. CSB 4.02 NoteNote: Contact: American Society for Automation in Pharmacy, 492 Norristown Road, Suite 160; Blue Bell, PA 19422; phone: (610) 825-7783; fax: (610) 825-7641; webpage: http://asapnet.org/index.html. CSB 4.02(3s)(3s) “Audit trail” means the log that contains information about each time the PDMP system discloses PDMP data, monitored prescription drug history reports, and prescribing metrics reports. CSB 4.02(4)(4) “Board” means the Controlled Substances Board. CSB 4.02(5)(5) “Controlled substance” means a drug, substance, analog, or precursor described in any of the following: CSB 4.02(5k)(5k) “DEA registration number” means the registration number issued to a dispenser or practitioner by the federal department of justice, drug enforcement administration. CSB 4.02(6)(6) “Department” means the department of safety and professional services. CSB 4.02 NoteNote: A site of remote dispensing authorized under s. 450.062, Stats., is under the supervision of a pharmacy. CSB 4.02(8)(b)(b) A practitioner who dispenses a monitored prescription drug. CSB 4.02(9)(9) “Dispenser delegate” means any of the following: CSB 4.02(9)(b)(b) An agent or employee of a practitioner who has been delegated the task of satisfying the data compilation and submission requirements of ss. CSB 4.04 and 4.05. CSB 4.02(11c)(11c) “Healthcare Professional” means a pharmacist, practitioner, registered nurse licensed under s. 441.06, Stats., substance abuse counselor, as defined in s. 440.88 (1) (b), Stats., or individual authorized under s. 457.02 (5m), Stats., to treat alcohol or substance dependency or abuse as a specialty. CSB 4.02(11r)(11r) “Managing pharmacist” means a pharmacist designated by the pharmacy owner to have responsibility for and direct control of pharmaceutical operations in a pharmacy. CSB 4.02(11w)(11w) “Medical coordinator” means a person who medically coordinates, directs, supervises, or establishes standard operating procedures for a healthcare professional. CSB 4.02(12)(a)(a) “Monitored prescription drug” means all of the following: CSB 4.02(12)(b)(b) “Monitored prescription drug” does not mean a controlled substance that by law may be dispensed without a prescription order. CSB 4.02(12m)(12m) “Monitored prescription drug history report” means all of the following information about a patient, patient address, practitioner, or dispenser compiled by the PDMP system and disclosed as authorized in ss. CSB 4.09 and 4.11: CSB 4.02(12m)(c)(c) Information submitted to the program by a healthcare professional. CSB 4.02(14e)(14e) “PDMP” means the Wisconsin prescription drug monitoring program. 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)(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(21)(21) “Program” means the prescription drug monitoring program established under this chapter. 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 HistoryHistory: 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 4.03CSB 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 HistoryHistory: 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 4.04CSB 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:
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