2026 Revised Sterile Compounding Rule

Effective 7/30/2026, Board rule 20 CSR 2220-2.200 Sterile Compounding has been amended to adopt USP Chapter 797 Pharmaceutical Compounding - Sterile Preparations (2023). Compliance with USP Chapter 797 is now required for all Class H Sterile Compounding pharmacy permit holders. The Board's previous sterile compounding rule is no longer applicable and all previous rule references to the 2008/2013 version of USP Chapter 797 have been removed.

The Board has published a 2026 Sterile Compounding Guidance Document with additional information on rule changes and additional Missouri requirements to/variances from USP Chapter 797. See the following additional compliance resources:

• 2026 Revised Rule 20 CSR 2220-2.200 (Sterile Compounding)
• 20 CSR 2220-2.400 (Compounding Standards of Practice) *Not revised but contains additional compounding requirements for all compounding pharmacies
• 2026 Board Sterile Compounding Webinars (available on-demand)
• USP Official Chapter 797 Site

Questions?

Submit an "Ask an Inspection" question on the Board's website or by scanning the below QR code. Questions received before 12 noon, Monday - Thursday, will receive a same day reply (excluding holidays/office closures):

Questions can also be submitted via e-mail: MissouriBOP@pr.mo.gov or by calling (573) 751-0091 (e-mail is preferred).