EmR2102 Rule Text

Chapter Phar 7 provides standards for the practice of pharmacy.

Plain language analysis:

The emergency rule allows compounding personnel to use the pharmacist’s professional judgment regarding the condition of personal protective equipment and its suitability for re-use.

Summary of, and comparison with, existing or proposed federal statutes and regulations:

None.

Comparison with rules in adjacent states:

Illinois:

Rules of the Illinois Department of Financial and Professional Regulation specify the standards for pharmaceutical compounding (68 Ill. Adm. Code 1330.640). The standards, including standards for the re-use of personal protective equipment, are as set forth in the 2019 edition of the U.S. Pharmacopeia (USP) Compounding Compendium. On May 6, 2020, the USP added recommendations to its standards to, in response to stakeholder input, allow reuse of certain garb or personal protective equipment (USP Response to Shortages of Garb and Personal Protective Equipment (PPE) for Low- and Medium-Risk Sterile Compounding During COVID-19 Pandemic).

Iowa:

Rules of the Iowa Board of Pharmacy specify the standards for sterile pharmaceutical compounding (657 IAC 20.4). The standards, including standards for the re-use of personal protective equipment, are as set forth in the current revision of the U.S. Pharmacopeia (USP) Chapter 797 standards. On May 6, 2020, the USP added recommendations to its standards to, in response to stakeholder input, allow reuse of certain garb or personal protective equipment (USP Response to Shortages of Garb and Personal Protective Equipment (PPE) for Low- and Medium-Risk Sterile Compounding During COVID-19 Pandemic).

Michigan:

Michigan law requires a pharmacy that provides compounding services to be licensed as a pharmacy and authorized to provide compounding services (MCL 333.17748a). The pharmacy must be accredited by the Pharmacy Compounding Accreditation Board and be in compliance with U.S. Pharmacopeia standards. On May 6, 2020, the USP added recommendations to its standards to, in response to stakeholder input, allow reuse of certain garb or personal protective equipment (USP Response to Shortages of Garb and Personal Protective Equipment (PPE) for Low- and Medium-Risk Sterile Compounding During COVID-19 Pandemic).

Minnesota:

Rules of the Minnesota Board of Pharmacy require pharmacies compounding sterile drug preparations to follow United States Pharmacopeia, chapter 797 standards, including standards for the re-use of personal protective equipment (Minnesota Rules, part 6800.3300). On May 6, 2020, the USP added recommendations to its standards to, in response to stakeholder input, allow reuse of certain garb or personal protective equipment (USP Response to Shortages of Garb and Personal Protective Equipment (PPE) for Low- and Medium-Risk Sterile Compounding During COVID-19 Pandemic).

Summary of factual data and analytical methodologies:

The Pharmacy Examining Board recognizes that, due to the COVID-19 public health emergency, there remains a shortage of personal protective equipment. As a result, the Board has determined that preservation of public health and safety necessitates an emergency rule that allows compounding personnel to use the pharmacist’s professional judgment regarding the condition of personal protective equipment and its suitability for re-use.

Analysis and supporting documents used to determine effect on small business or in preparation of economic impact analysis:

As the emergency rule would allow compounding personnel to use the pharmacist’s professional judgment regarding the condition of personal protective equipment and its suitability for re-use, there is no anticipated effect on small business.

Fiscal estimate:

This emergency rule will not have a fiscal impact.

Effect on small business:

The emergency rule does not have an economic impact on small businesses, as defined in s. 227.114 (1), Stats. The Department’s Regulatory Review Coordinator may be contacted by email at [e-mail], or by calling [phone].

Agency contact person:

Dale Kleven, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366; telephone [phone]; email at [e-mail].

Place where comments are to be submitted and deadline for submission:

Comments may be submitted to Dale Kleven, Administrative Rules Coordinator, Department of Safety and Professional Services, Division of Policy Development, P.O. Box 8366, Madison, Wisconsin 53708-8366, or by email to [e-mail]. Comments must be submitted by the date and time at which the public hearing on this emergency rule is conducted. Information as to the place, date, and time of the public hearing will be published on the Legislature’s website and in the Wisconsin Administrative Register.

------------------------------------------------------------------------------------------------------------

TEXT OF RULE

Section 1. Phar 15.32 (5) is amended to read:

  Phar 15.32 (5) When compounding personnel exit the buffer or segregated compounding area, a gown may be removed and retained in the ante area or segregated compounding area if not visibly soiled, to be worn again during the same work shift. Coveralls, shoe covers, hair and facial hair covers, face masks, eye shields, and gloves shall be replaced with new ones before re−entering the compounding area unless, in the professional judgement of the pharmacist, the items are suitable for re-use.

Section 2. Effective date. The rules adopted in this order shall take effect upon publication in the official state newspaper, pursuant to s. 227.22 (2) (c), Stats.

------------------------------------------------------------------------------------------------------------

(END OF TEXT OF RULE)

------------------------------------------------------------------------------------------------------------

Dated _________________   Agency __________________________________

            Chairperson

          Pharmacy Examining Board