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.
https://www.usp.org/sites/default/files/usp/document/about/public-policy/usp-covid19-handrub.pdf
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Eagle consultants and scientists are helping compounding facilities implement successful quality systems. Our team has over 200 years of combined experience in the FDA-regulated pharmaceutical industry and can provide guidance in establishing the systems and processes that will help facilities producing compounded medications meet and exceed regulatory expectations. Follow the link below to learn more about our consulting services.
- 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
