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:

   1. (a) The pharmacist shall ensure that the flavoring agent is not more than 5 percent of the product’s total volume.
   2. (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.
   3. (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.
   4. (d) A prescription is required before a pharmacist may add flavoring to an over-the-counter product.
2. (2) Pharmaceutical compounding - sterile preparations. USP-NF general chapter 797, official as of November 1, 2023, is incorporated by reference into this chapter.
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.

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

   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.

History

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