In this article, you will understand how to avoid FDA recall action for hand sanitizer and comply with FDA regulations for hand sanitizer. This article will be helpful for companies manufacturing and importing hand sanitizer into the USA.
Even though hand sanitizer containing OTC ingredients (Alcohol and benzalkonium chloride) does not require prior approval from the FDA, you must comply with certain FDA requirements.
Apart from general requirements, such as registration and listing, the product should comply with the FDA’s quality parameters. The FDA does not require companies to submit any testing reports for hand sanitizes. However, the FDA may test your products to confirm the presence of impurities and residual solvents. If any of the impurities are found above the acceptance level, then FDA shall take enforcement action.
Suppose the outcome of FDA testing confirms impurities such as methanol; FDA shall ask companies to recall the product currently distributed in the market. Companies are also responsible for notifying all their consignees affected by the product recall. Product recall notification can be done through a Press release, letter, telefax, telephone, e-mail, visit, etc.
Currently, the presence of methanol and 1-propanol is the reason for product recall.
The FDA strongly recommends testing the product for methanol content in a GMP compliant laboratory and is inspected by the FDA.
Potential Impurities may prevent the hand sanitizer and their acceptance criteria.
The firms using technical grade ethanol that does not meet USP or FCC should test their product for below-listed impurities.
Impurity Interim Limit published under the temporary policy
Methanol NMT 630 ppm
Benzene NMT 2 ppm
Acetaldehyde NMT 50 ppm
Acetal (1,1-diethoxyethane) NMT 50 ppm
Sum of all other impurities NMT 300 ppm
In case, the sum of impurities exceeds 3000 ppm, the firm should test below listed impurities.
Acetone NMT 4400 ppm
n-propanol (1-propanol) NMT 1000 ppm Ethyl acetate NMT 2200 ppm Sec-butanol (2-butanol) NMT 6200 ppm Iso-butanol (2-Methyl-1-propanol) NMT 21700 ppm n-butanol (1-butanol) NMT 1000 ppm iso-amyl alcohol (3-Methyl-1-butanol) NMT 4100 ppm Amyl alcohol NMT 4100 ppm
Failure to perform testing and maintaining propers records are violations of GMP (Good Manufacturing Practice). The FDA may place a firm under import alert for GMP compliance-related violations, which may adversely affect your company’s business in the long term.
Summary of FDA requirements for hand sanitizers
1 Compliance with temporary policy for hand sanitizers in terms of formulation, testing, and alcohol quality
2. Hand sanitizer marketed under OTC monograph should be 3.manufactured under GMP (Good Manufacturing Practice).
4. Compliance with FDA labeling requirements
Your US Agent plays a vital role in your business when it comes to regulatory compliance. The US Agent is responsible for communicating with foreign companies if there is any product recall or product-related regulatory issue.
FDAbasics offers US Agent and regulatory compliance services to companies to comply with FDA requirements. If you have any questions or need further assistance. Please write to us at firstname.lastname@example.org.