United States: which exemptions to commercialise hand sanitizers and disinfectants?
Commercialising hand sanitizers in the United States during the pandemic
The United States have implemented a temporary guidance regarding the commercialisation of hand sanitizers in order to accelerate and facilitate it. To this effect, the American government declared a public health emergency linked to Covid-19 pandemic and hand sanitizer shortages. Hand sanitizers are considered over the counter drugs(OTC) in the US. They are therefore subject to requirements specific to this type of products.
This temporary guidance will stay in effect until the public health emergency is over, which is, for the time being, unclear. It can be used by companies which are not yet registered as drug manufacturers but wishing to produce hand rubs for the general public or health professionals (with the exception of surgical hand rubs).
Formulating sanitizers under the temporary guidance
The product formulation must comply with the WHO (World Health Organization) formula, meaning:
- Ethanol or Isopropanol
- Glycerol
- Hydrogene peroxide
- Sterile distilled water or boiled cold water
Other requirements for hand sanitizers in the US
These products will also need to comply with other requirements, including:
- Quality: the product must be prepared under sanitary conditions.
- Labelling: the labelling must comply with the guidance for hand sanitizers with ethanol or isopropyl alcohol.
- Registration and drug listing: companies must be careful to register their facilities and list their products.
- Batch control: each batch of finished products must be sampled in order to check the alcohol content with specific methods.
- Adverse event reporting
If you wish to know more, do not hesitate to register and receive the replay of our webinar on this subject.
Placing hard surface disinfectants on the American market
Hard surface disinfectants (including surface wipes) are considered antimicrobial pesticides in the United States. They are regulated by and must be register with the EPA (Environmental Protection Agency) and are subject to extremely strict rules.
An important amount of data must be provided before being granted a marketing authorisation for this type of product. The process is longer and costs more than simply placing hand sanitizers on the market. For instance, all the claims must be substantiated through tests which can cost up to $100,000.
This data must therefore be taken into account before placing this type of product on the market in the United States.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
Commercialising hand sanitizers in the United States during the pandemic
The United States have implemented a temporary guidance regarding the commercialisation of hand sanitizers in order to accelerate and facilitate it. To this effect, the American government declared a public health emergency linked to Covid-19 pandemic and hand sanitizer shortages. Hand sanitizers are considered over the counter drugs(OTC) in the US. They are therefore subject to requirements specific to this type of products.
This temporary guidance will stay in effect until the public health emergency is over, which is, for the time being, unclear. It can be used by companies which are not yet registered as drug manufacturers but wishing to produce hand rubs for the general public or health professionals (with the exception of surgical hand rubs).
Formulating sanitizers under the temporary guidance
The product formulation must comply with the WHO (World Health Organization) formula, meaning:
- Ethanol or Isopropanol
- Glycerol
- Hydrogene peroxide
- Sterile distilled water or boiled cold water
Other requirements for hand sanitizers in the US
These products will also need to comply with other requirements, including:
- Quality: the product must be prepared under sanitary conditions.
- Labelling: the labelling must comply with the guidance for hand sanitizers with ethanol or isopropyl alcohol.
- Registration and drug listing: companies must be careful to register their facilities and list their products.
- Batch control: each batch of finished products must be sampled in order to check the alcohol content with specific methods.
- Adverse event reporting
If you wish to know more, do not hesitate to register and receive the replay of our webinar on this subject.
Placing hard surface disinfectants on the American market
Hard surface disinfectants (including surface wipes) are considered antimicrobial pesticides in the United States. They are regulated by and must be register with the EPA (Environmental Protection Agency) and are subject to extremely strict rules.
An important amount of data must be provided before being granted a marketing authorisation for this type of product. The process is longer and costs more than simply placing hand sanitizers on the market. For instance, all the claims must be substantiated through tests which can cost up to $100,000.
This data must therefore be taken into account before placing this type of product on the market in the United States.
Wish to know more about biocidal products?
For more information, do not hesitate to contact Fang Zhou or one of our experts via our contact form, indicating the purpose of your inquiry.
