Given the importance of hand hygiene in combatting the spread of COVID-19, FDA recently issued several sets of guidance for manufacturers wishing to produce hand sanitizers and certain ingredients used in their production. FDA anticipates that its temporary policies will encourage additional manufacturers to scale up production to increase supplies of these critical products.
FDA’s first guidance is perhaps the most significant, as it is designed to encourage production of hand sanitizer products by entities that are not currently licensed or registered drug manufacturers. Among other conditions described below, FDA’s policy permits the preparation of certain alcohol-based hand sanitizer products by firms for public distribution or for their own internal use, provided they register as over-the-counter (OTC) drug manufacturers.
The guidance document sets forth a number of requirements that firms must follow when preparing alcohol-based hand sanitizers:
- The hand sanitizer is manufactured using only the following U.S. Pharmacopoeia (USP) grade ingredients in final product formulations: alcohol (ethanol) or isopropyl alcohol; glycerol; hydrogen peroxide and sterile distilled water or boiled cold water.
FDA cautions that the manufacturer should not add other active or inactive ingredients, as different or additional ingredients may impact the quality and potency of the product.
Importantly, FDA recognized that certain ingredients used to manufacture alcohol-based hand sanitizers also may be in short supply. In response to these shortages, FDA also released additional guidance that allows for the temporary manufacturing of ethanol products by firms that manufacture alcohol for incorporation into alcohol-based hand sanitizer products. However, the policy does not extend to other types of active ingredients for incorporation into alcohol-based hand sanitizers, such as isopropyl alcohol.
- The manufacturer must ensure the ethanol or isopropyl alcohol active ingredient is correct and the correct amount of the active ingredient is used, according to FDA’s stated percentages. The manufacturer should use appropriate recordkeeping and controls to assure each batch matches the formula developed for the product.
- The hand sanitizer is prepared under sanitary conditions and equipment utilized is well maintained and fit for this purpose.
- The firm analyzes product on site to verify the alcohol content in samples of the finished product before each batch is released for distribution.
- The hand sanitizer is labeled in accordance with FDA standard labeling.
- A manufacturer must register its facility as an OTC manufacturer and list its products in the FDA Drug Registration and Listing System.
For new manufacturers, many of these requirements imposed by FDA may be unfamiliar, and we encourage interested parties to consult their legal advisors to ensure compliance with FDA requirements.
FDA’s second guidance addresses the temporary compounding of certain alcohol-based hand sanitizers by entities more familiar with manufacturing and distributing regulated drug products. This temporary policy sets forth requirements for pharmacists, licensed pharmacies and other human drug outsourcing facilities to prepare alcohol-based hand sanitizers for consumer use and for use as health care personnel hand rubs.
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