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Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020 April 22, 2020

Understanding Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry   To prepare hand sanitizer as per the FDA’s temporary policy, you should consider compliance with the below requirements.   Because of the public health emergency posed by COVID-19, FDA does not intend to take … Continue reading Understanding FDA temporary policy for Hand sanitizer -Updated 15th April 2020 .... Read More

FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products March 14, 2020

Summary of  FDA guidance for alcohol based hand sanitizers (temporary policy)   FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products . Here is the summary of FDA’s temporary policy for hand sanitizers. Because of the public health emergency posed by COVID-19, FDA does not intend to take action against compounders … Continue reading FDA has published Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products .... Read More

How to get DUNS number for free March 9, 2020

The  DUNS number is a  9 digit unique  number assigned by the D&B  (DUN and Bradstreet) which is  a private company. In this blog, we have explained “How to get DUNS number  for free. Why  DUNS number  ? DUNS number for drug establishment registration -Having a  DUNS number is a mandatory requirement for  drug establishment  … Continue reading How to get DUNS number for free .... Read More

FDA requirements for hand sanitizers (FDA regulations for hand sanitizers) March 4, 2020

Amid the novel coronavirus outbreak COVID-19, we are getting many questions about FDA requirements for hand sanitizers and other questions related to  FDA regulations for hand sanitizers.  FDA Regulations for Hand  Sanitizers   On 24th April 2019 FDA published final rule stating that the three active ingredients namely benzalkonium chloride, ethyl alcohol, and isopropyl alcohol—are … Continue reading FDA requirements for hand sanitizers (FDA regulations for hand sanitizers) .... Read More

How To Register With The FDA October 18, 2019

The US FDA requires facilities who are engaged in manufacturing, processing, packaging or storing food pharmaceuticals, and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facility and list the products. Companies must annual renew the registration and listings.  FDA US agent is required … Continue reading How To Register With The FDA .... Read More

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