FDA posts guidance for bioterrorism record keeping
The U.S. Food and Drug Administration has published its guidance for industry record keeping requirements under the 2002 Public Health Security and Bioterrorism Preparedness and Response Act.
The Bioterrorism Act requires record keeping for persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. These records help the FDA to identify sources and recipients of food.
The guidance for the industry, titled “Questions and Answers Regarding Establishment and Maintenance of Records,” responds to questions about the final rule on records, the FDA said.
The guidance is available online at http://www.cfsan.fda.gov/guidance.html.