The onset of the public health crisis caused by the spread of the coronavirus (COVID-19) has led to a global shortage of hand sanitizer. Businesses attempting to cope with new challenges presented by COVID-19 may be interested in retooling current manufacturing or other processes to begin developing hand sanitizer for external distribution or even internal use. In support of these efforts, the federal Food and Drug Administration (FDA) has issued guidance for both companies that are not currently authorized by the FDA to manufacture hand sanitizer companies and pharmacists in state-licensed, federal, or registered outsourcing facilities compounders that may be interested in producing hand sanitizer. Companies that adhere to this guidance and maintain sufficient documentation should be able to manufacture hand sanitizer for external distribution or internal use without enforcement exposure from the FDA.
According to the guidance, the FDA will not bring any action during the pendency of the public health crisis associated with COVID-19 against a company or compounder that produces hand sanitizer in accordance with certain requirements. These requirements, although slightly different for companies and compounders, detail the formula and process that must be used to ensure that hand sanitizer is properly made. According to the FDA guidance, only those companies and compounders that comply with all of the requirements detailed in the guidance will be shielded from FDA enforcement throughout the duration of the COVID-19 public health crisis.
As the central focus of the guidance documents, the FDA provides the formula and the percentage of different ingredients that must be used by companies or compounders to develop hand sanitizer. These ingredients, which must be United States Pharmacopoeia (USP) grade ingredients, and their percentage in the final product formulation include:
- Alcohol (ethanol) (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. In addition to USP grade, alcohol used by companies may also be Food Chemical Code (FCC) grade.
or Isopropyl Alcohol (75%, v/v) in an aqueous solution;
- Glycerol (1.45% v/v);
- Hydrogen peroxide (0.125% v/v); and
- Sterile distilled water or boiled cold water.
Companies or compounders may not include any other inactive or active ingredients other than those enumerated above because that may impact the quality or potency of the product.
In addition to the formula, the guidance also requires companies and compounders to pay particular attention to the amount of the ethanol or isopropyl active ingredient in the final product to ensure accuracy. Under this requirement, companies are required to keep a “simple record” of the controls taken to ensure that each batch of produced hand sanitizer complies with the formula prescribed by the FDA. Additionally, the guidance requires compounders and companies to prepare hand sanitizer under sanitary conditions and that equipment used during the preparation of the product is well maintained. For compounders, the FDA requires the preparation of the hand sanitizer to be done under “conditions routinely used by the compounder to compound similar nonsterile drugs.”
After production, both companies and compounders alike are required to appropriately label all of the produced hand sanitizer. The FDA has provided specific labels that correspond to the type of hand sanitizer and its intended use. These labels can be viewed here.
For companies, there are two additional requirements that must be followed under the guidance. First, companies must be able to implement and use the “most accurate method of analysis available for verification of alcohol content in samples of the finished drug product before each batch is released for distribution.” These methods may include, but are not limited to, gas chromatography, alcoholometer, or other chemical analysis of at least equivalent accuracy. Second, companies interested in manufacturing hand sanitizer must also register their facility and list the products being temporarily produced in the FDA Drug Registration and Listing System (DRLS). The DRLS can be found here. After completing the registration and listing, companies will receive automatic confirmation from the FDA and will be able to immediately begin manufacturing and distributing hand sanitizer products.
For any questions related to the FDA’s guidance or properly registering a company on the DRLS, please contact Rob Browne.