Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such as hand sanitizers. Hand sanitizers were the first ones to go out of stock from stores. To account for this hand sanitizer shortage, FDA is asking for facilities with the ability to manufacture hand sanitizers to help during the outbreak...

1. Marketing Your Hand Sanitizer During the
COVID-19 Pandemic
By: Nikita Angane, MS
Health care facilities are facing shortages of medical equipment, drugs, PPEs and essentials such
as hand sanitizers. Hand sanitizers were the first ones to go out of stock from stores. To account
for this hand sanitizer shortage, FDA is asking for facilities with the ability to manufacture hand
sanitizers to help during the outbreak.
Certain chemicals, cosmetic and even breweries and distilleries are helping to curb the hand
sanitizers shortage. To help these new companies produce hand sanitizers that are safe and
effective, FDA released a temporary policy outlining the requirements that these firms should
comply with.
Hand sanitizers are regulated under the FDA as over the counter drugs. FDA stated in its
temporary policy that it does not intend to take any action against firms that1
 Manufacture hand sanitizers as per the recommended recipe by the World Health
Organization
 Register their establishment and list their product with the FDA
 Comply with FDA’s labeling requirements
 It is being prepared under sanitary conditions
FDA received several inquiries from alcohol manufacturers regarding its requirement for the
production of alcohol for incorporation into hand sanitizers. In response to their inquiries, FDA
released a guidance document outlining its temporary policy surrounding the production of
alcohol.
FDA states in the policy that it does not intend to take action against alcohol production firms
that manufacture alcohol (i.e., ethanol or ethyl alcohol) for use as the Active Pharmaceutical
Ingredient (API) in alcohol-based hand sanitizers as long as: 2
 The alcohol manufactured as an API is not less than 94.9% ethanol by volume.
 The alcohol is prepared under sanitary conditions and equipment used is well maintained
and fit for this purpose.
 Firms register their facility and list these products with the FDA.

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Through these temporary policies, FDA is trying to help the industry by providing all the
information manufactures would need to expedite the production of hand sanitizers. EMMA
International can take the load off you to get your product on the market fast. Call us today at
248-987-4497 or email us at info@emmainternational.com.
1FDA (March 2020) Temporary Policy for Preparation of Certain Alcohol -Based Hand Sanitizer Products Duringthe
Public Health Emergency (COVID-19) retrieved on 04/01/2020 from
https://www.fda.gov/media/136289/download
2 FDA (March 2020) Temporary Policy for Manufactureof Alcohol for Incorporation Into Alcohol Based Hand
Sanitizer Products Duringthe Public Health Emergency (COVID-19) retrieved on 04/082020 from
https://www.fda.gov/media/136390/download