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© 2000-2022. Parexel International Corporation.
275 Grove St., Suite 101C, Newton, MA 02466
+1 617 454 9300
2520 Meridian Parkway, Research Triangle Park, Suite 200, Durham, NC 27713
+1 919 544 3170
© 2000-2022. Parexel International Corporation.
BY Kevin Nolan, Senior Consultant - 3.26.20 -
In Summary
The FDA is moving quickly to implement temporary Guidance to provide flexibility to those pharmacies and compounding centers to produce sanitizing solutions required to meet institutional and consumer demands. However, the current enforcement environment and regulatory actions against compounders may impact their ability to meet this demand, as they are focused on manufacturing critically needed drug products and/or are remediating current Regulatory enforcement activities (DOJ Consent Decree, etc.) that have impacted production and future viability of these firms.
The current COVID-19 healthcare impact and demand for surgical supplies, PPEs and sanitizing solutions has overrun the capacity of the domestic and global manufacturing capacity. There is a current need and demand for household and clinical access to sanitizing solutions that can be easily deployed and are familiar to the public with respect to packaging and portability. Recently in the virtual, printed and televised press, numerous companies have been augmenting their production processes and product workstreams to produce alcohol-based hand sanitizers. The manufacturers vary from local distilleries1 to larger pharmaceutical compounding centers with additional capacity.
The varied and diverse nature of these manufacturers, their facility controls and capabilities to consistency produce a product that will meet a standard of manufacturing. This was likely the impetus for the FDA to create and implement a temporary Guidance deployed without a commentary period.
The following talking points provide a high-level synopsis of the temporary Guidance:
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) March 2020
References
1. “Hand Sanitizer From Craft Distillery Could Be Useful Trend”; https://www.forbes.com/sites/larryolmsted/2020/03/17/hand-sanitizer-from-craft-distillery-could-be-useful-trend/#56a5c46a18d8
2. https://www.gpo.gov/fdsys/pkg/FR-1994-06-17/html/94-14503.htm. WHO’s recommendations, titled “Guide to Local Production: WHO-recommended Handrub Formulations,” are available at https://www.who.int/gpsc/5may/Guide_to_Local_Production.pdf.
The current COVID-19 healthcare impact and demand for surgical supplies, PPEs and sanitizing solutions has overrun the capacity of the domestic and global manufacturing capacity.
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