The Food and Drug Administration (FDA) has now issued three Guidance’s pertaining to processes and formulas for compounding of alcohol-based hand sanitizers during the COVID-19 public health emergency:
- Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)– Enabling entities that are not currently registered drug manufacturers the ability to temporarily register as over the counter (OTC) drug manufacturers and prepare alcohol-based hand sanitizers during the COVID-19 public health emergency
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency– Enabling pharmacies and registered outsourcing facilities to temporarily compound certain alcohol-based hand sanitizers
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)– Enabling alcohol production firms (e.g. distillers/ breweries) to temporarily produce alcohol for incorporation into alcohol-based hand sanitizers during the COVID-19 public health emergency[1]
Various pharmacy organizations had written to FDA regarding supply issues experienced by pharmacies in obtaining alcohol required in the formulas. FDA is now allowing food-grade (Food Chemical Codex) alcohol (ethyl alcohol- not less than 94.9% by volume) for compounding and is expanding such compounding to non-pharmacy firms. The food grade alcohol must be rendered denatured to prevent ingestion. FDA is continuing to evaluate other formulas and those wishing to use different formulas or denaturants are encouraged to contact FDA at COVID-19-hand-sanitizers@fda.hhs.gov. Additionally, any pharmacy that produces hand sanitizer must follow state and local recordkeeping and labeling requirements. For example, in the state of Connecticut, pharmacists must obtain customer contact information which must be retained by the pharmacy for 3 years (in case of recall) and made available to the Department of Consumer Protection.
During the COVID-19 public health emergency, entities that are not currently registered drug manufacturers can register as over the counter (OTC) drug manufacturers to make alcohol-based hand sanitizers. Pharmacies and hospital pharmacies that regularly engage in dispensing prescription drugs (as well as practitioners licensed to prescribe or administer drugs) and “do not manufacture, repack, relabel, or salvage drugs other than in the regular course of their business of dispensing or selling drugs at retail” are exempt. On April 6, 2020, FDA clarified its policy regarding interstate distribution of hand sanitizers compounded by pharmacies and referred to several of its policies include its shortage list as well as an unfinished MOU regarding limits. FDA policy is evolving on this issue. Additionally, some states have temporarily waived interstate distribution requirements.
Please contact a Frier Levitt attorney for assistance in navigating this.
[1] Additionally, the Alcohol and Tobacco Tax and Trade Bureau (TTB) temporarily waived their requirement for prior authorization and formula approval for permittees and further allows the transfer of ethanol to certain other entities to use in hand sanitizers.
