Links: FDA & USP Guides on Compounding of Hand Sanitizer
To address shortages of hand sanitizer due to the rapidly evolving COVID-19 pandemic, the FDA issued a guidance document on compounding and labeling alcohol-based hand sanitizer, which can be accessed here:
The FDA guidance document provides two formulations that compounders can follow to prepare alcohol-based hand sanitizers.
In addition, the USP Compounding Expert Committee (CMP EC) released an updated document with three formulations for compounding alcohol-based hand sanitizers on 3/25/2020 to address substitutions in light of ingredient shortages. Visit the link below to learn more about the new recommendations provided by the USP CMP EC.
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- Antimicrobial Effectiveness | USP 795 & 797 Revisions - July 18, 2023
- 2023 PDA/FDA Joint Regulatory Conference, 09/18 – 09/20 - July 11, 2023
- APC: Compounders on Capitol Hill, 09/19 – 09/20 - July 11, 2023