Hand Sanitizer Testing
We know how important it is to continue to bring new and effective products to market in the time of COVID-19 and especially those such as hand sanitizers that actively work to safeguard the health of the general public.
CPT℠ Labs can provide strategic planning assistance, regulatory guidance and testing services that are appropriate for launching OTC consumer hand sanitizer products in accordance with the OTC Drug Monograph Final Rule.
Our team is working diligently to assure the personalized level of service that we stand behind as a Company, whilst simultaneously meeting all government requirements. From strategic planning assistance to regulatory guidance and testing services, CPT℠ is here to help and act as a resource for you and your business. CPT℠’s state-of-the-art Analytical Chemistry and Microbiology Laboratories are professionally staffed and stand ready to assist in whatever your needs may be.
OTC Drug Monograph Final Rule Requirements: Hand Sanitizers
Liquid, gel, foam, aerosol spray or wipes.
Ethyl Alcohol 60 – 95% (v/v)
or
Isopropyl Alcohol 70 – 91.3% (v/v)
or
Benzalkonium Chloride (Range unspecified)
May include fragrance, emollients and thickeners.
Pharmaceutical Grade (USP or FCC) ONLY
Hand Sanitizer Final Formulation Testing Requirements
The OTC-Drug Monograph Final Rule for Consumer Antiseptic Rubs does not include specific testing requirements for hand sanitizer final formulations. The FDA explains that since they do not find any active ingredient(s) to be GRASE (Generally Regarded as Safe and Effective) and thus suitable for inclusion in the Monograph, they will not establish testing requirements for final formulations until such time that GRASE status has been granted to at least one of the three active ingredients currently under consideration.
In the absence of specific testing requirements, one may refer to the Food, Drug and Cosmetic Act and 21 CFR Parts 210 and 211 whereby it is stated that all drug products must satisfy basic requirements for identity, strength, quality and purity. From this, we may surmise what the FDA might deem to be suitable testing of hand sanitizer final formulations however it is not a regulatory certainty by any means.
It should be noted that the OTC-Drug Monograph Final Rule for Consumer Antiseptic Rubs does discuss testing which includes in vitro Time Kill Studies and also in vivo human clinical studies however this testing is what the FDA requires for determining the GRASE status of an active ingredient for inclusion into the Monograph; it is not intended as final formulation testing.
Let CPT℠ Assist in the Protection of Your “Brand” and Your Reputation
Since it was clearly shown that illegal and in some instances, dangerous hand sanitizer products had been offered for sale within the US during the COVID-19 pandemic, both FDA and FTC have become extremely vigilant of hand sanitizer product launches. If you are planning to launch a hand sanitizer product in accordance with the OTC-Drug Monograph Final Rule for Consumer Antiseptic Rubs, let us assist so that your product launches legally and in the shortest amount of time.
CPT can provide the required testing of Ethyl Alcohol, Isopropyl Alcohol and Benzalkonium Chloride Active Pharmaceutical Ingredients (APIs). We can also conduct assay, impurity screening and stability testing of finished hand sanitizer batches 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 and toxic impurities.
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. Why not contact us today?
Request a Quote for Hand Sanitizer Testing
Please Note: CPT℠ only performs testing for companies. We do not perform product testing for the general public.
