In a prepublication Federal Register (FR) notice (here), the “Food and Drug Administration (FDA or Agency) is announcing the withdrawal of three guidance documents titled ‘Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ ‘Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency,’ and ‘Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19),’ which were issued in March 2020 (and updated March 27, 2020, April 15, 2020, June 1, 2020, August 7, 2020, and February 10, 2021).” The Agency is taking this action because it believes that these temporary exemptions and policy changes to support the COVID-19 public health emergency are no longer required as there has been a decrease in the demand for hand sanitizer products, as well as a sufficient supply available to the public, hospitals, and healthcare workers.
The notice goes on to say, “Although the PHE is still ongoing and there currently is an increase in COVID‑19 cases, the data indicate that: (1) supply from traditional manufacturers has increased; (2) the demand for alcohol-based hand sanitizer that existed earlier in the pandemic has significantly decreased; and (3) most consumers and healthcare personnel are no longer having difficulty accessing alcohol-based hand sanitizer products.”
In addition, the FDA refers to the number of serious recalls of alcohol-based hand sanitizers that have occurred since the temporary guidances went into effect. The FDA has queried members of the healthcare community, including hospitals, and found that most (if not all) are no longer having trouble obtaining sufficient supplies through traditional manufacturers.
As the COVID-19 public health emergency continues, the Agency will continue to evaluate the emergency use authorizations (EUAs) and temporary policy issuances to ensure that those EUAs and policies are still required. The Agency also indicates, “[A]ccordingly, although the temporary policies are being withdrawn as described above, firms may continue to manufacture alcohol-based hand sanitizer products without an approved application, provided they comply with the applicable TFM and other applicable requirements, including current good manufacturing practice (CGMP) requirements under section 501(a)(2)(B) of the FD&C Act.”
