In order to assure the continuing availability of hand sanitizers throughout the COVID-19 pandemic, FDA issued a number of Temporary Guidance Documents aimed at increasing production of hand sanitizers by relaxing some of the basic requirements for OTC Drug products distributed within the USA. The major elements of FDA’s temporary policy for hand sanitizers were:
- Allowed manufacturers who were not drug manufacturers to produce alcohol-based hand sanitizers so long as the sanitizer conformed with the formulation and labeling requirements provided in the Temporary Guidances.
- Allowed for the use of non-pharmaceutical grade alcohols in the formulation of hand sanitizers, so long as the alcohol conformed with the specifications provided in the Temporary Guidances.
Allowed for the relaxation of basic GMP requirements including but not limited to an exemption from conducting stability testing and validation activities.
Although this Temporary Policy achieved its goal of increasing the production of hand sanitizers during the pandemic, it also opened the door to well-documented abuses such as sub-potent product batches, the use of disallowed formulations, and usage of alcohols containing high levels of contaminants.
Now that the COVID-19 pandemic has shown signs of subsiding, on October 12, 2021 FDA announced its intent to withdraw all of the Temporary Guidances for hand sanitizers which it had issued since March of 2020.
The Details of FDA’s Withdrawal of the Temporary Hand Sanitizer Guidances
- Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the Temporary Guidances must cease production of these products.
- After December 31, 2021, manufacturers wishing to continue producing hand sanitizer must comply with the Tentative Final Monograph for OTC Topical Antiseptics and all other requirements, including FDA’s Current Good Manufacturing Practice (cGMP) requirements.
- Hand sanitizers produced under the Temporary Guidances and manufactured before December 31, 2021 must no longer be sold to wholesalers and retailers by March 31, 2022.
CPT can assist in many ways.
If you have been manufacturing and/or distributing alcohol-based hand sanitizers under the Temporary Guidances and you wish to continue to do so, we can assist in your transition to a legal product which complies with the Tentative Final Monograph for OTC Topical Antiseptics and GMP requirements. Our Regulatory Consultants stand ready to guide you to the higher level of compliance that will be required after December 31, 2021. They can even conduct GMP audits of CMO’s on your behalf, so as to ensure that your product will be manufactured in a GMP-compliant environment. Our state-of-the-art Analytical Chemistry and Microbiology Labs can assist in the planning and conducting of raw material, product batch, and stability testing which had not been required under the Temporary Guidances.
Why not contact us today?