Topical antiseptic products: hand sanitizers compliance – US FDA (Consumer)
The US Food and Drug Administration (FDA) regulates over-the-counter (OTC) consumer antiseptic products such as hand sanitizers used as antiseptic rubs, and antibacterial soaps intended to be used with water and rinsed off after use.
While the monograph for OTC Consumer and Health Care Antiseptic Products is an ongoing review of antiseptic active ingredients, FDA issued a final rule on the safety and effectiveness of consumer hand sanitizers in 2019 deferring action on three active ingredients. These ingredients are benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol. Using these three ingredients in consumer hand sanitizers within the specified concentrations does not require the producer to undergo the FDA’s rigorous New Drug Application (NDA) process. Under the OTC monograph system, the registrant of a compliant OTC product bypasses the NDA process and can use the FDA’s automated drug registration and listing system for establishment registrations and drug product listings. While this means that efficacy and safety data does not need to be submitted with the application, manufacturers are still required to have this data on file should FDA request it.
Consequently, all formulations that include an ingredient other than benzalkonium chloride, alcohol, or isopropyl alcohol will require a NDA or ANDA (Abbreviated New Drug Application).
Only OTC consumer antiseptic products containing the active ingredients in certain concentrations are allowed to make antimicrobial hand sanitizing claims.
Health care antiseptics are regulated separately from consumer antiseptics. Because the risk of infection varies in different health care settings, FDA bases these evaluations on intended use and related claims of safety and effectiveness.
TSG can help
TSG Consulting’s regulatory specialists help companies determine if their product qualifies for review under the OTC Drug Review and Monograph process. We can:
- Assist with labeling requirements for antibacterial hand soaps and sanitizing hand rubs
- Coordinate with the FDA for OTC Monograph drug registration and listing
- Develop and review the product claims and labeling
- Provide guidance on testing requirements
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
Frequently asked questions
Per FDA, “OTC drug monographs are a kind of ‘recipe book’ covering acceptable ingredients, doses, formulations, and labeling.” Many of these monographs can be found in section 300 of the Code of Federal Regulations. To review the rulemaking history for OTC Topical Antimicrobial Drug Products click here.
TSG is experienced in interpreting the final ruling of the OTC Monograph, supporting clients in ensuring that their hand sanitizer products are compliant.
Yes, per Section 510 of the FD&C Act, firms that manufacture, prepare, propagate compound, or process drugs in the US or offer for import into the US are required to register with the FDA. At the time of registration, all domestic and foreign firms are required to list all drug products with the FDA.
In the US, hand sanitizers cannot make specific claims against any virus or bacteria; therefore you cannot make any claims against SARS-CoV-2. You can make a general claim such as “reduces disease causing microorganisms”.