Making Hand Sanitizers Available to Americans

Posted April 10, 2020
Category Company News
FDA plays a critical role in protecting the United States from emerging infectious diseases, such as the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support continuity and response efforts to this pandemic. As part of these efforts, FDA published three guidance’s to help meet the increased demand for hand sanitizers during the Coronavirus Disease 2019 (COVID-19) public health emergency. During the COVID-19 public health emergency, entities that are not currently registered drug manufacturers can register as over-the-counter (OTC) drug manufacturers and make alcohol-based hand sanitizers, pharmacies and registered outsourcing facilities can compound certain alcohol-based…

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FDA Releases Guidance Documents for Meeting New FSMA Standards

FDA has issued five guidance documents to help importers and food producers meet key food safety provisions mandated by the FDA Food Safety Modernization Act (FSMA).   The guidance documents include:   ·         A draft guidance on Foreign Supplier Verification Program (FSVP) rule ·         A Small Entity Compliance Guide on the FSVP rule ·         A draft guidance on the term "Same Level of Public Health Protection" used in both the FSVP and Produce Safety regulations ·         Chapter 15 of the draft Preventive Controls for Human Food guidance regarding Supply-Chain requirements ·         Enforcement Discretion guidance regarding the application of FSVP to…

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FSVP Program ~ Review & Requirements

FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals Introduction The FDA FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is now final, and compliance dates for some businesses begin in 18 months. The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. This rule is the product of a significant level of outreach by the FDA to industry, consumer groups, the agency’s…

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FDA's Biennial Food Facility Registration Renewal Period Opens

The 2016 Biennial Registration Renewal Period begins Saturday, October 1, 2016 and ends on Saturday, December 31, 2016 at 11:59 PM. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If you register your food facility before October 1, 2016, you must renew your registration before December 31, 2016 and provide us with any updated information, if applicable. If you updated your food facility registration…

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FDA's Biennial Food Facility Registration Renewal Period Opens

The 2016 Biennial Registration Renewal Period begins Saturday, October 1, 2016 and ends on Saturday, December 31, 2016 at 11:59 PM. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If you register your food facility before October 1, 2016, you must renew your registration before December 31, 2016 and provide us with any updated information, if applicable. If you updated your food facility registration…

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