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FAQ: Hand Sanitizers

The information provided below does not, and is not intended to, constitute legal advice; instead, all information and content posted on this website are for general informational purposes only. If you have any questions please email us [email protected] all your emails will be responded promptly.

How to get FDA approval for Hand Sanitizers

FDA does not approve OTC hand sanitizers, you can sell hand sanitizers by complying with “Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry” .   You can find an overview of the FDA’s temporary policy on our website.  FDAbasics can assist you to comply with … Continue reading How to get FDA approval for Hand Sanitizers

What information is required for registration and listing ?

  For establishment registration–  Company Name , DUNS, Physical address, contact person information    For drug listing – Proprietary name, Active /inactive names, Information about pack /pack type, representative  image of the product label and name and DUNS number of the manufacturer. 

When a new NDC is required ?

New NDC is required for ; New strength or new active ingredient New Dosage form  Any change in physical appearance (size, shape, color, scoring, imprint, etc.)   Changes to inactive ingredients  Change in proprietary  name 

Who is required to appoint a US Agent?  What are the responsibilities of a US Agent?

It is mandatory for foreign companies to appoint a US Agent for FDA communication purposes.  The US Agent acts as a medium of communication between the FDA and the Foreign company.

Does FDA issue certificates  upon completion of the successful  registration and listing  process ?

No, the FDA does not issue the certificate. Registration /listing status can be verified on the FDA website.  If required,  we can issue the certificate for your confirmation. 

Are surface disinfectants regulated by the FDA ?

  No, surface disinfectants are regulated by the EPA.

Is there a seperate fee for each pack size listing ?

  No, we can cover multiple pack sizes under one fee .

Is FDA prior inspection required for Hand Sanitizer manufacturing facilities ?

FDA’s Temporary policy for hand sanitizers  does not mention about the  facility inspection. However, manufacturing should be under sanitary conditions.  For  OTC Hand Sanitizer that  does not comply with FDA’s temporary policy , manufacturing  should be under GMP (Good Manufacturing Practice) conditions , However, prio inspection from FDA is not required, FDA may inspect your … Continue reading Is FDA prior inspection required for Hand Sanitizer manufacturing facilities ?

Who is a private label distributor (PLD) ?

A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.

NDC numbers are required on the product label ?

21 CFR 201.2 currently states that NDC’s are “requested but not required” to appear on all drug labels    

What is the labeler code and drug listing  ?

  You can find more information about    https://www.fdabasics.com/our-faq/ndc-number/

Who is required to obtain the labeler code ?

Labeler code is a 5 digit number assigned by FDA for each company.  Manufacture, Packer  and Private label distributor are required to apply for the labeler code for drug listing purpose.  

Who is required to register (Drug Establishment Registration) ?

Drug establishment registration  is  applicable  for manufacturing facilities. Any Establishment engaged in the manufacture, preparation, propagation,compounding, repacking, relabeling, or processing of a drug product for commercial distribution is required to register with FDA. Private label distributors and importers are not required to register.

How can FDAbasics help you ? What is the time and cost? 

We offer below services to comply with FDA requirements for Hand Sanitizers. US Agent services– Appointment of US Agent is mandatory for foreign companies. Our fee for US Agent services is $ 299 per year. You can complete an  online form at the link below and make the payment.  After receipt of the completed form … Continue reading How can FDAbasics help you ? What is the time and cost? 

How are consumer hand sanitizers regulated in the USA ?

Before COVID 19 outbreak most of the hand sanitizers were marketed under the tentative final OTC monograph. On April 12, 2019 FDA issued the final rule, stating only three ingredients namely Ethyl alcohol, Benzalkonium chloride and Isopropyl alcohol are considered under the OTC monograph. As per FDA’s press announcement dated April 11, 2019,  “At this … Continue reading How are consumer hand sanitizers regulated in the USA ?

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