(b) Establishing security standards for pharmacies.
…
(d) Necessary for the administration and enforcement of this chapter and ch. 961. (e) Establishing minimum standards for the practice of pharmacy.”
Section 961.31 gives the Pharmacy Examining Board authority to “promulgate rules relating to the manufacture, distribution and dispensing of controlled substances within this state.” Related statute or rule: N/A
Plain language analysis:
This rule project revises ch. Phar 8 to reduce regulatory burdens on pharmacies, while maintaining public safety. The rule project simplifies recordkeeping requirements for controlled substances, removes restrictions on receipt of prescriptions via facsimile machine, partial dispensing, renewals, labeling, and emergency kits in long-term care facilities. Summary of, and comparison with, existing or proposed federal regulation:
The practice of pharmacy is not regulated by the federal government and Wisconsin has its own controlled substances schedules. However, the federal government does regulate federally controlled substances and the vast majority of Wisconsin controlled substances are also federally controlled substances. Title 21 CFR Chapter II governs federally scheduled controlled substances, including: registration of manufacturers, distributors and dispensers of controlled substances; prescriptions; orders for schedule I and II controlled substances; requirements for electronic orders and prescriptions; and disposal.
Comparison with rules in adjacent states:
Illinois: Statutes outlining Illinois’ Pharmacy Practice Act are found under 225 ILCS 85 and codified under IL 68/1330 for the Pharmacy Practice. Specifically, IL 68/1330.600 to 68/1330.800 outlines requirements for pharmacy standards and pharmacy operations. Illinois law requires a pharmacist to report theft or loss of controlled substances to the board at the same time it is reported to the DEA (IL 68/1330.710). Illinois administrative rule requires that inventory of controlled substances be done annually, with an exact count for Schedule II drugs and an approximation for Schedule III and IV. Illinois also requires that a record of all written prescription orders received and verbal prescriptions filled, compounded or dispensed for controlled substances be retained for at least 5 years (IAC 3100.360). Illinois also allows a pharmacist to fill an oral prescription for a Schedule II controlled substance where immediate administration is necessary for proper treatment, no appropriate alternative treatment is available, and it is not possible for the prescriber to provide a written prescription. There does not appear to be a requirement that the prescriber follow up with a written prescription (IAC 3100.400).
Iowa: The Iowa Pharmacy Board requires a pharmacy to maintain controlled substance records for at least 2 years and to segregate Schedule I and II drug records from other controlled substance records (Iowa Admin. Code 657-10.36). Iowa also requires that pharmacies keep a perpetual inventory of all Schedule II drugs on hand (Iowa Admin. Code 657-10.18). Iowa only requires a pharmacist to report theft or loss of controlled substances to the Pharmacy Board if there is reason to believe that the theft was committed by a pharmacy board licensee, otherwise it is sufficient to merely report to the DEA (Iowa Admin. Code 657-10.21). Iowa also allows a pharmacist to fill an oral prescription for a Schedule II controlled substance where immediate administration is necessary for proper treatment, no appropriate alternative treatment is available, and it is not possible for the prescriber to provide a written prescription. Like Wisconsin, the prescriber must provide a written prescription within 7 days (Iowa Admin. Code 657-10.26).
Michigan: Michigan requires theft or diversion of a controlled substance to be reported to the DEA within 10 days. There does not appear to be a separate requirement to report it to the Pharmacy Board (Mich. R 338.3141). Inventory must be taken of all controlled substances at least annually (Mich. R 338.3151 and 338.3152). Controlled substance records must be retained for at least 5 years, with the first 3 in hard copy form and in the last 2 may be kept electronically. Michigan also allows a pharmacist to fill an oral prescription for a Schedule II controlled substance where immediate administration is necessary for proper treatment, no appropriate alternative treatment is available, and it is not possible for the prescriber to provide a written prescription. Like Wisconsin, the prescriber must provide a written prescription within 7 days (Michigan R 338.3164 and 338.3165).
Minnesota: Minnesota requires a perpetual inventory of Schedule II substances which must be reconciled monthly (Minn. Admin. Code 6800.4600). Pharmacists must report loss or theft of controlled substances to the DEA immediately. There is no requirement that a separate report be made to the state (Minn. Admin. Code 6800.4800). All prescription information must be maintained for at least 2 years (Minn. Admin. Code 6800.3100).
Summary of factual data and analytical methodologies:
The Pharmacy Examining Board completed a comprehensive review of ch. Phar 8, Requirements for Controlled Substances, in order to identify and make revisions to ensure the chapters are statutorily compliant with state and federal law and are current with professional standards and practices. The board also evaluated ch. Phar 8 for ways to reduce the regulatory impact on pharmacies without negatively impacting public safety. Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:
The proposed rules were posted for a period of 14 days to solicit public comment on economic impact, including how the proposed rules may affect businesses, local government units, and individuals. No comments were received.
Fiscal Estimate and Economic Impact Analysis:
A fiscal estimate and economic impact analysis are attached.
Effect on small business:
These proposed rules do not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats.
Agency contact person:
Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8306; phone (608) 267-7139; email at DSPSAdminRules@wisconsin.gov. Place where comments are to be submitted and deadline for submission:
Comments may be submitted to Nilajah Hardin, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, WI 53708-8366, or by email to DSPSAdminRules@wisconsin.gov. Comments must be received at or before the public hearing to be held on October 20, 2021 at 9:00 a.m. to be included in the record of rule-making proceedings. ---------------------------------------------------------------------------------------------------------------------
TEXT OF RULE
Section 1. Chapter Phar 8 is repealed and recreated to read:
REQUIREMENTS FOR CONTROLLED SUBSTANCES
Phar 8.01 Federal registration and compliance with federal, state, and local laws and regulations. (1) FEDERAL REGISTRATION REQUIRED. To possess, manufacture, distribute, dispense, or conduct research with controlled substances in this state, pharmacies and pharmacists shall register with the drug enforcement administration as required under federal law.
(2) CONTROLLED SUBSTANCES AUTHORIZATION UNDER FEDERAL REGISTRATION. As provided under s. 961.32 (1m) (a), Stats., pharmacies and pharmacists registered under federal law to manufacture, distribute, dispense, or conduct research with controlled substances may possess, manufacture, distribute, dispense, and conduct research with those substances in this state to the extent authorized by their federal registration and in conformity with the provisions of ch. 961, Stats. (3) COMPLIANCE WITH LAWS AND REGULATIONS. Failure to register with the drug enforcement administration or otherwise comply with applicable federal, state, and local laws and regulations relating to possessing, manufacturing, distributing, dispensing, or conducting research with controlled substances constitutes unprofessional conduct for purposes of s. 450.10, Stats. Phar 8.02 Purpose of issue of prescription order. Prescription orders for controlled substances shall be issued for a legitimate medical purpose by individual practitioners acting in the usual course of professional practice. Responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription.
Phar 8.03 Valid prescription requirements. (1) A pharmacist may not dispense controlled substances for a prescription the pharmacist knows, or reasonably should know, is not a valid prescription under applicable federal, state, and local laws and regulations.
(2) An order purporting to be a prescription order not issued in the usual course of professional treatment or in legitimate and authorized research is not a valid prescription order within the meaning and intent of ss. 450.01 (21) and 961.38, Stats. A prescription order issued by a practitioner to obtain controlled substances for the purpose of general dispensing or administration to patients by the practitioner is not valid. A pharmacist knowingly dispensing pursuant to such a purported order, as well as the practitioner issuing it, shall be subject to the penalties provided for violation of the provision of law relating to controlled substances. (3) As provided under s. 961.38 (4r), Stats., a pharmacist is immune from any civil or criminal liability and from discipline under s. 450.10, Stats., 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. Phar 8.04 Notification of suspicious orders for and theft or loss of controlled substances. A pharmacy or pharmacist shall notify the board of a suspicious order or series of orders for controlled substances or the theft or loss of controlled substances on the same day notification is required to be provided to the drug enforcement administration. Notification to the board shall include all information required to be provided in the notification to the drug enforcement administration.
Phar 8.05 Recordkeeping. Records required by the federal controlled substances act, ch. 961, Stats., and s. 450.11 (2), Stats., shall be maintained for at least 5 years from the date the drug was received, manufactured, distributed, or dispensed or, for a record that is subject to s. 961.385, Stats., until the name of a person to whom a drug is dispensed is delivered to the controlled substances board under s. 961.385, Stats., whichever is sooner. Records shall be readily retrievable, easily readable, and available for inspection by authorized persons for at least 5 years from the date of such record. An electronic recordkeeping system shall have the capability of producing a printout of records as required under this section. The pharmacist-in-charge shall oversee monthly inspections, maintenance, and reconciliation of all controlled substances, including maintaining a perpetual inventory for all Schedule II controlled substances.
Phar 8.06 Identification card requirement under s. 450.11 (1b), Stats. (1) DEFINITION. In this section and s. 450.11 (1b) (e) 3., Stats., “health care facility” means a facility, as defined in s. 647.01 (4), Stats.; any hospital, nursing home, community−based residential facility, county home, county infirmary, county hospital, county mental health complex, or other place licensed or approved by the department of health services under s. 49.70, 49.71, 49.72, 50.03, 50.032, 50.033, 50.034, 50.35, 51.08, or 51.09, Stats.; a facility under s. 45.50, 51.05, 51.06, 233.40, 233.41, 233.42, or 252.10, Stats.; and a hospice facility under s. 50.90 (1) (c), Stats. (2) IDENTIFICATION CARD REQUIREMENT. As provided under s. 450.11 (1b) (b) and (e), Stats., a controlled substance included in schedule II or III of ch. 961, Stats., may not be dispensed, and may not be delivered to a representative of the ultimate user, without an identification card belonging to the person to whom the drug is being dispensed or delivered. An identification card is not required if any of the following applies: (a) The drug is administered or dispensed directly to the ultimate user by a practitioner.
(b) The pharmacist or other person dispensing or delivering the drug has personal knowledge of the person to whom the drug is dispensed or delivered, and that the person is the ultimate user or the ultimate user’s authorized representative.
(c) The drug is delivered to a health care facility to be administered in the health care facility.
Phar 8.07 Dispensing schedule II controlled substances in emergency situations under s. 961.38 (2), Stats. (1) DEFINITION. For purposes of dispensing a schedule II controlled substance under s. 961.38 (2), Stats., “emergency situation" means a situation in which the prescribing practitioner determines all of the following: (a) Immediate administration of the schedule II controlled substance is necessary for proper treatment of the patient.
(b) No appropriate alternative treatment is available, including the administration of a drug that is not a schedule II controlled substance.
(c) It is not reasonably possible for the prescribing practitioner to provide a written prescription order to be presented to the pharmacist prior to dispensing.
(2) REQUIRED NOTIFICATION. A dispensing pharmacist shall notify the board of the failure of a prescribing practitioner to deliver a written prescription within 7 days after authorizing an emergency oral prescription for a schedule II controlled substance. The notification shall be provided to the board on the same day notification is required to be provided to the drug enforcement administration and shall include all information required to be provided in the notification to the drug enforcement administration.
