FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency. The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities in finished products, as well as sources and specifications for the use of the permitted ingredients.
The Agency notes that the revisions were made based on queries from firms that are not registered or licensed drug manufacturers, or licensed state pharmacies and outsource compounders. With the issuance of these updated guidances, the burden on these entities for assuring compliance with the emergency permissions appears to be increased.
The three guidance documents are:
- Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) (here)
- Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry (here)
- Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (here)
It is not clear how the Agency will police the hand sanitizer market to assure compliance with these guidances as there are literally hundreds, if not thousands of entrants into this space, in response to the supply shortage and demand created by the COVID-19 public health emergency.