Overview:

FDA is reminding companies that manufactured alcohol-based hand sanitizers consistent with FDA’s temporary policies (withdrawn on December 31, 2021), they must stop distribution of any remaining hand sanitizer produced consistent with the temporary policies by March 31, 2022.

Introduction:

This includes distribution to wholesalers, retailers, and hospitals. In addition, manufacturers are reminded that all hand sanitizer manufactured since January 1, 2022, must be in full compliance with.

• The Federal Food, Drug and Cosmetic Act.
• Current good manufacturing practice (CGMP) regulations.
• and alcohol used must be fully compliant with the United States Pharmacopeia monograph.

Only hand sanitizers prepared in compliance with all applicable requirements, including the tentative final monograph for over-the-counter topical antiseptics, as amended, may be distributed by manufacturers after March 31, 2022.

MEASURES TAKEN BY FDA ON HAND Sanitizers

After that date, manufacturers should destroy undistributed hand sanitizer prepared consistent with the temporary policies.

Manufacturers should maintain records with information concerning a product’s destruction, including the product name, manufacturer, lot number, quantity, disposition date, and disposition method.

  • Safe Disposal of Uncompliant Products contact: The Environmental Protection Agency and your local waste management and recycling center for information on safe disposal.
  • Establishment Registration Required:  FDA asks manufacturers to deregister their establishment if they are no longer producing drug products by following the instructions on the Electronic Drug Registration and Listing Instructions page.

If a manufacturer is no longer producing hand sanitizer but is continuing to produce other drugs and would like to remain registered, they can renew their registration and drug listing for the other products and just delist the hand sanitizer products.

Learn more about hand sanitizers and the FDA!

GRP Whitepaper: Registration of Hand Sanitizer with FDA

The US FDA considers alcohol-based hand sanitizers as Over the Counter Products (OTC). The OTC are divided into two categories either health care antiseptics or consumer antiseptics. The registration pathway and indication depends heavily on the ingredients in the product.

Brochure : GRP USA Services

We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

Follow GRP on Social Media !

Subscribe to our Blogs & Newsletter

Share This Post: