Hand Sanitizer Testing

Screening Hand Sanitizers For Regulatory Compliance Testing

Due to the worldwide COVID-19 crisis, much attention is being focused on the use of hand sanitizers as part of one’s personal hygiene program in an attempt to safeguard health. As a result, the continuing manufacturing, testing and availability of these products is of paramount concern to consumers and to the United States Food & Drug Administration (FDA).

The Covid-19 pandemic had changed the regulations surrounding hand sanitizer products due to unmet demand. Now that manufacturers have been able to re-vamp production and the urgency for the products has decreased they are rolling back the emergency guidelines. It’s important to understand the next steps in the regulatory landscape to avoid recalls and financial loss.

Let CPT℠ assist in the protection of your “brand” and your reputation.

Since it has been clearly shown that there are illegal and in some instances, dangerous hand sanitizer products being offered for sale within the US during this COVID-19 crisis, every product owner should be concerned about the quality of the products that they purchase for distribution. CPT℠ can provide rapid screening of hand sanitizers with fast turnaround times. We can tell you if the product you have purchased or are considering to purchase is a legal product, free from disallowed ingredients. CPT℠’s state-of-the-art Analytical Chemistry and Microbiology Laboratories are professionally staffed and stand ready to assist you in actively protecting your “brand” and your reputation as a whole. We can help ensure your hand sanitizer meets proper guidelines. Why not contact us today?

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Request a quote to test your hand sanitizer.

OTC Drug Monograph Final Rule –

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

  1. Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the Temporary Guidances must cease production of these products.

  2. 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.

  3. 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.

Issues of Concern and Specific Abuses of FDA’s Temporary Guidelines

Unfortunately, this temporarily relaxed regulatory environment relating to the manufacturing of hand sanitizers has facilitated an influx of opportunist and unqualified organizations into the hand sanitizer supply chain.  As a result, FDA is finding illegal and in some instances, dangerous products on store shelves.  Examples include products containing Methanol (“wood” alcohol) which is highly toxic; combinations of alcohols which are not permitted under the OTC Drug Monograph or the temporary FDA Guidelines; subpotent levels of alcohol, and the inclusion of excipient ingredients not permitted under the temporary Guidelines.