Hand Sanitizer Testing Requirements

Updated February 10, 2021

Due to the continuing worldwide COVID-19 pandemic, the demand for hand sanitizers remains at a very high level as we move forward into 2021. As a result, FDA continues to allow these products to be placed into US distribution by either of two regulatory pathways:

There are significant differences between the requirements that are in place for products that result from the two pathways. Adding to the confusion of differing requirements for products resulting from each pathway, FDA has continued to revise and clarify their Temporary Policy due to the emergence of quality and safety issues relating to the usage of alcohols from non-pharmaceutical sources.

In an attempt to eliminate some of the confusion which currently exists, one may compare and contrast the requirements for hand sanitizer products which result from either regulatory pathway using the most current information available from FDA.

Hand Sanitizer Formulation Requirements

 OTC Drug Monograph Final RuleFDA Temporary Policy
Product FormLiquid, gel, foam, aerosol spray or wipes.Liquid ONLY.
Active Ingredients Allowed

(Only 1 Permitted)
Ethyl Alcohol 60 – 95% (v/v)
or
Isopropyl Alcohol 70 – 91.3% (v/v)
or
Benzalkonium Chloride (Range unspecified)
Alcohol (Ethyl Alcohol) 80% (v/v)
or
Isopropyl Alcohol 75% (v/v)

(Benzalkonium Chloride is not allowed.)
Other Ingredients
Allowed
No specific requirements.
(May include fragrance, emollients and thickeners.)
Glycerin (1.45%), Hydrogen Peroxide (0.125%) and Purified Water only.
(No other ingredients allowed.)
Alcohol GradePharmaceutical Grade (USP or FCC) ONLY.Non-Pharmaceutical Grades allowed but must meet specific impurity limits.

Hand Sanitizer Manufacturing Requirements

 OTC Drug Monograph Final RuleFDA Temporary Policy
FacilityMust be registered with FDA.Must be registered with FDA.
ComplianceFull GMP compliance.Relaxed requirements, so long as identity, strength and purity of the product is assured.
Stability Testing Prior to LaunchRequired.Not Required.

Raw Material (Ethyl Alcohol and Isopropyl Alcohol) Testing Requirements

 OTC Drug Monograph Final RuleFDA Temporary Policy
AssayEthyl Alcohol: 94.9% - 96.0% (v/v) prior to denaturing.

Dehydrated Ethyl Alcohol: NLT 99.0% (v/v)

Isopropyl Alcohol: NLT 99.0%
Ethyl Alcohol: NLT 94.9% (v/v) prior to denaturing.

Isopropyl Alcohol: NLT 99.0%
Impurity Limits for
Ethyl Alcohol:

(FDA strongly suggests that this testing be conducted by an FDA-registered GMP Laboratory)
Methanol: NMT 200 ppm
Benzene: NMT 2 ppm
Acetaldehyde and Acetal: NMT 10 ppm

Sum of all other impurities: NMT 300 ppm

No allowable exceptions.
Methanol: NMT 630 ppm
Benzene: NMT 2 ppm
Acetaldehyde: NMT 50 ppm
Acetal (1,1-diethoxyethans): NMT 50 ppm
Sum of all other impurities: NMT 300 ppm

If the sum of all other impurities exceeds 300 ppm but all of the specified impurities (above) meet their limits, the alcohol may be acceptable if each additional individual impurity is identified and meets the following requirements:

Acetone: NMT 4,400 ppm
n-Propanol (1-Propanol): NMT 1,000 ppm
Ethyl Acetate: NMT 2,200 ppm
Sec-Butanol (2-Butanol): NMT 6,200 ppm
Iso-Butanol (2-Methyl-1-Propanil): NMT 21,700 ppm
n-Butanol (1-Butanol): NMT 1,000 ppm
Iso-Amyl Alcohol: NMT 4,100 ppm
Amyl Alcohol: NMT 4,100 ppm
Impurity Limits for
Isopropyl Alcohol:

(FDA strongly suggests that this testing be conducted by an FDA-registered GMP Laboratory)
Methanol: NMT 200 ppm
Each Additional Individual Impurity: NMT 1,000 ppm
Total of all Impurities: NMT 10,000 ppm
Methanol: NMT 200 ppm
Other TestingMeets USP Monograph RequirementsNo other testing required.

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. 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 FDA might deem to be suitable testing of hand sanitizer final formulations however it is not a regulatory certainty by any means.

In contrast, FDA has indicated that hand sanitizers manufactured under the Temporary COVID Policy should be free from the impurities listed in their Temporary Policy, and that each batch should be tested to assure its identity (the alcohol listed on the label is the same alcohol in the batch), strength (Assay of the alcohol in the batch conforms to the labeled potency), and purity which many interpret as ‘microbiological purity’ which is demonstrated by conducting USP <61> and <62> Microbial Limits Testing.

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 FDA requires for determining the GRASE status of an active ingredient for inclusion into the Monograph; it is not intended as final formulation testing. Since FDA does indicate specific testing requirements for hand sanitizers manufactured under their Temporary Policy it would be prudent to conduct this same batch testing (at a minimum) for products launched under the OTC Monograph pathway.

Let CPT℠ Assist in the Protection of Your “Brand” and Your Reputation

We know how imperative it is to continue to bring new products to market during this time, especially ones, such as hand sanitizers, that can actively work to help safeguard health.

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 Final Rule. We can also assist compounding pharmacies and GMP manufacturers launch alcohol-based hand sanitizers under FDA’s “temporary” policies in response to the COVID-19 outbreak.

Our team is working diligently to assure the personalized level of service that we stand behind as a company while simultaneously meeting all government requirements. From strategic planning assistance to regulatory guidance and testing services, CPT℠ is here to help and be 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.

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.