STATE OF WISCONSIN
PHARMACY EXAMINING BOARD
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IN THE MATTER OF RULE-MAKING : PROPOSED ORDER OF THE
PROCEEDINGS BEFORE THE : PHARMACY EXAMINING BOARD
PHARMACY EXAMINING BOARD : ADOPTING RULES
: (CLEARINGHOUSE RULE )
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PROPOSED ORDER
An order of the Pharmacy Examining Board to repeal and recreate ch. Phar 8 relating to requirements for controlled substances. Analysis prepared by the Department of Safety and Professional Services.
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ANALYSIS
Statutes interpreted: s. 961.31, Stats. Explanation of agency authority:
Section 15.08 (5) (b) provides that the board “[s]hall promulgate rules for its own guidance and for the guidance of the trade or profession to which it pertains, and define and enforce professional conduct and unethical practices not inconsistent with the law relating to the particular trade or profession.” Section 450.02 (2) states that the board “shall adopt rules defining the active practice of pharmacy. The rules shall apply to all applicants for licensure under s. 450.05.” Section 450.02 (3) provides that “[t] board may promulgate rules: (a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.
(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).
