In light of the hand sanitizer shortage during the coronavirus (COVID-19) emergency, many companies have been trying to find alternative sources of product, especially employers in healthcare and essential service sectors where employees are still present or interacting with consumers. In response, the US Food and Drug Administration (FDA) issued guidance on March 20 for the manufacture of hand sanitizers by companies not previously registered to make over-the-counter (OTC) drugs.
Issues for Manufacturing Hand Sanitizer Under the New Policy
FDA agreed that it would allow companies that have not previously been registered to make OTC drug products to make hand sanitizer under the following conditions:
- The company registers as a drug manufacturer and lists the products. Once facilities are registered and products are listed, companies do not need to wait for further FDA communication before commencing product manufacturing and distribution.
- The company only uses specific US Pharmacopoeia (USP)-grade antimicrobial active ingredients and excipients, including
- Alcohol – ethanol, USP, or Food Chemical Codex (FCC) grade (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20; or
- Isopropyl Alcohol (75%, v/v) in an aqueous solution
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v)
- Sterile distilled water or boiled cold water
- No other active drug ingredients are added to the hand sanitizer.
- Manufacturing occurs under sanitary conditions and with equipment fit for purpose.
- Documentation of procedures used for the manufacturing process is maintained for each batch with critical steps and controls identified.
- The firm uses the most accurate method of analysis available at the site for verification of alcohol content in samples of the finished drug product before each batch is released for distribution. Methods can include gas chromatography (GC), alcoholmeter, hydrometer, or other chemical analysis of at least equivalent accuracy. The sample tested can be performed on in-process material before filling into the final containers to be distributed. Note—this analytical activity can be outsourced to laboratories if the manufacturer does not have in-house capabilities, but product should not be released until adequate test results are available.
- The product is labeled in accordance with the temporary guidelines, including use of drug facts panel and identification of the alcohol content.
- Firms should also ensure that they have an internal process for accepting and submitting adverse event reports to FDA.
Issues for Purchasing Hand Sanitizer Products Made Under the New Policy
Companies purchasing hand sanitizers can do the following:
- Consider obtaining a guaranty from the supplier that the product is not adulterated or misbranded under the current FDA guidance.
- Request certificates of analysis and certificates of conformance from manufacturers.
- Request further test results or records for manufactured batches if there is any question about the facility or the effectiveness of a particular batch of product.
- If there are adverse events from use of hand sanitizer product, report them immediately to the manufacturer.
Note that FDA released separate guidance for manufacture of hand sanitizers by pharmacy compounders that is different than the above guidance, and relies on the quality systems that most compounders already use in compounding drug products.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact Kathleen Sanzo or Jacqueline Berman.