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.
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?
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:
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.
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.
New Events Coming Soon!
70 New Dutch Ln
Fairfield, NJ 07004
973-808-7111
FDA
Registration# 1000151293
DEA
Registration# RC0199744 (Analytical Lab)
Schedule I-V license
Remember, Schedules I-II require DEA Form 222
Registration# RC0171568 (Researcher)
US EPA/NJ DEP
Registration# NJD982726648