The U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) has issued a temporary policy that allows entities that are not currently registered drug manufacturers, such as ethanol producers, to produce alcohol to be used in hand-sanitizers.
According to the FDA:
“Because of the public health emergency posed by COVID-19, FDA 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 for consumer use and for use as health care personnel hand rubs for the duration of the public health emergency declared by the Secretary of HHS on January 31, 2020, provided the following circumstances are present:
- To meet component quality requirements for hand sanitizer production, the alcohol manufactured as an API meets at a minimum the United States Pharmacopoeia (USP) or Food Chemical Codex (FCC) grade requirements for purity, that is, not less than 94.9% ethanol by volume.
- Any water used to adjust the finished ethanol content in the alcohol API is sterile (e.g., boiling the water, distillation, or reverse osmosis).
- The alcohol is denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR parts 20 and 21, using the formulas in Appendix C of this document. This is critical because there have been reports of adverse events, including deaths, from unintentional ingestion of hand sanitizer, particularly in young children. The alcohol may be denatured at the point of production by the alcohol production firm or the point of manufacture or compounding of the hand sanitizer, but the alcohol intended for incorporation into a finished product must be labeled accurately as “denatured” or “undenatured” accordingly.
Beyond alcohol, water, and denaturants (if added at the point of production), the alcohol production firm does not add other ingredients. Different or additional ingredients in the API may impact the quality and potency of the finished hand sanitizer product.
The alcohol production firm ensures the ethanol content in the finished API before being denatured is at least 94.9% by volume (see United States Pharmacopeia National Formulary [USP-NF] or Food Chemical Codex [FCC])). If the alcohol is to be distributed to another firm for producing the hand sanitizer, it is labeled with the ethanol content determined by an appropriate test so that the hand sanitizer can be reliably produced at the intended labeled strength. A simple record should be used to document key steps and controls.
- The alcohol is prepared under sanitary conditions and equipment used is well maintained and fit for this purpose.
- The alcohol production firm uses the most accurate method of analysis available at the site for verification of ethanol content in a sample before each batch is released for distribution or for use in producing the hand sanitizer. Methods can include gas chromatography (GC), specific gravity (e.g., alcoholmeter, hydrometer, pycnometer, or gravity density meter), or another test that is at least as accurate. The sample tested can be from the final API before packaging (if distributed as an API) or before actual use in producing the hand sanitizer.
- The alcohol API, if distributed to other producers, is labeled consistent with the attached labeling in Appendices A and B (Labeling for Undenatured/Denatured Alcohol to be used for incorporation into hand sanitizers).
- Alcohol production firms register their facility and list these products in the FDA Drug Registration and Listing System (DRLS, https://www.fda.gov/drugs/guidancecompliance-regulatory-information/drug-registration-and-listing-system-drls-andedrls). Upon completion of registration and listing, firms receive automatic confirmation from FDA and do not need to wait for further communication from FDA before they begin to manufacture and distribute these products. FDA relies on registration and listing information to help manage drug shortages, monitor safety issues that may arise with product distributed to the public, and manage product recalls, among other important FDA public safety activities. Our help desk is standing by to assist with facilitating this process and can be contacted by sending an email to: firstname.lastname@example.org.”