Chapter Phar 15

Chapter Phar 15

PHARMACEUTICAL COMPOUNDING, SAFE HANDLING OF HAZARDOUS DRUGS,
AND RADIOPHARMACEUTICALS

Phar 15.01   Definitions.

Phar 15.02   Incorporation of standards.

Phar 15.03   Compliance.

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Ch. Phar 15 Note Note: Chapter Phar 15 is shown as repealed and recreated by CR 16-085, effective November 1, 2018, Register April 2018 No. 748. Chapter Phar 15 as it existed on September 30, 2025, was repealed and a new chapter Phar 15 was created effective October 1, 2025, Register September 2025 No. 837.

Phar 15.01 Phar 15.01 Definitions. In this chapter, “USP-NF” means the United States Pharmacopeia-National Formulary published by the United States Pharmacopeial Convention.

Phar 15.01 History History: CR 24-092: cr. Register September 2025 No. 837, eff. 10-1-25.

Phar 15.02 Phar 15.02 Incorporation of standards.

Phar 15.02(1) (1) Pharmaceutical compounding - nonsterile preparations. USP-NF general chapter 795, official as of November 1, 2023, is incorporated by reference into this chapter, subject to the exception that nonsterile compounding does not include the addition of nonallergenic, therapeutically inert flavoring agents to a conventionally manufactured drug product. The pharmacist shall also comply with the following requirements when adding flavoring agents to a drug product:

Phar 15.02(1)(a) (a) The pharmacist shall ensure that the flavoring agent is not more than 5 percent of the product’s total volume.

Phar 15.02(1)(b) (b) The pharmacist shall label the flavored drug with a beyond-use date no greater than 14 days past the date the flavoring agent is added if the drug is required to be stored in a refrigerator. A different beyond-use date or alternate storage conditions may be indicated if such variation is supported by peer-reviewed medical literature or manufacturer’s recommendations. The pharmacist shall electronically or manually document that a flavoring agent was added to a drug.

Phar 15.02(1)(c) (c) The pharmacist shall document the addition of flavoring as part of the prescription record. The documentation shall include the type of flavoring agent, manufacturer, lot number, and expiration date.

Phar 15.02(1)(d) (d) A prescription is required before a pharmacist may add flavoring to an over-the-counter product.

Phar 15.02(2) (2) Pharmaceutical compounding - sterile preparations. USP-NF general chapter 797, official as of November 1, 2023, is incorporated by reference into this chapter.

Phar 15.02(3) (3) Safe handling of hazardous drugs. USP-NF general chapter 800, official as of July 1, 2020, is incorporated by reference into this chapter.

Phar 15.02(4) (4) Radiopharmaceuticals. USP-NF general chapter 825, official as of January 1, 2024, is incorporated by reference into this chapter.

Phar 15.02 Note Note: Copies of the above standards are on file in the office of the legislative reference bureau. A copy of the USP-NF can be purchased from the United States Pharmacopeial Convention at https://usp.org.

Phar 15.02 History History: CR 24-092: cr. Register September 2025 No. 837, eff. 10-1-25.

Phar 15.03 Phar 15.03 Compliance.

Phar 15.03(1) (1) Unprofessional conduct. Noncompliance with ch. Phar 15 shall be considered a violation of s. Phar 10.03 and may result in disciplinary action by the board against a credential holder.

Phar 15.03(2) (2) Differing requirements.

Phar 15.03(2)(a) (a) Where any board rule in this chapter differs from a requirement within a standard referenced in this chapter, the board rule shall govern.

Phar 15.03(2)(b) (b) Except as provided in par. (a), where a provision of this chapter prescribes a general requirement and another provision of this chapter prescribes a specific or more detailed requirement regarding the same subject, the specific or more detailed requirement shall govern.

Phar 15.03(2)(c) (c) Except as provided in pars. (a) and (b), where different sections of this chapter specify conflicting requirements. The most restrictive requirement, as determined by the board, shall govern.

Phar 15.03 History History: CR 24-092: cr. Register September 2025 No. 837, eff. 10-1-25.