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.
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 email@example.com.
1FDA (March 2020) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) retrieved on 04/01/2020 from https://www.fda.gov/media/136289/download
2FDA (March 2020) Temporary Policy for Manufacture of Alcohol for Incorporation Into AlcoholBased Hand Sanitizer Products During the Public Health Emergency (COVID-19) retrieved on 04/082020 from https://www.fda.gov/media/136390/download