Meeting the Demands for Commercial Use Alcohol-Based Hand Sanitizers

By: Jacqui Jenskey, Senior Regulatory Affairs Specialist, email

The demand on industry to produce alcohol-based hand sanitizers is still very high, especially as schools are opening.  If you have a domestic personal use NPN Hand Sanitizer (registered under the Antiseptic Skin Cleanser Category IV Monograph) there is an interim opportunity for you to distribute your domestic product to commercial establishments.  NNHPD recognizes that health care institutions, such as hospitals or clinics, or other commercial settings may be experiencing shortages and may wish to access these products.   During the COVID-19 pandemic, alcohol-based personal domestic use registered hand sanitizers may be distributed for use in hospitals, clinics, commercial settings and other acceptable facilities. However Health Canada must be notified of this intent.  Companies must send a notification to Health Canada which includes:

• the subject line COVID-19 product notification
• in the body of the email, information on the product (for instance, provide the product name and NPN) and its intended distribution (for example, hospitals)

Note that these products have not met the evidence requirements for higher-risk uses in a general health care setting or as pre-surgical scrubs. For this reason, they must be labelled for personal use only, as outlined below.  Companies must submit the email notification before distributing but do not need to await a response.  And if you choose to amend your Personal Domestic Use NPN so your products can be used for Personal commercial use long term, Dell Tech can amend your application.  This amendment will require some small label changes.

In addition,  Kill claims (such as “Kills 99.9%”)  are not allowed on labels unless you have submitted efficacy data for pre-market approval.  These claims fall outside of the Monograph and if they are on your label, you run the risk of a Health Canada recall.  See here for more information on requirements for kill claims.

Contact:
Dell Tech Laboratories
Jacqui Jenskey
Senior Regulatory Affairs Specialist
519-858-5021 x 2028
jjenskey@delltech.com

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