"Public Health Security and Bioterrorism Preparedness"
As a result of the events of September 11, 2001 the U.S. Government sought to reinforced and enhance the security of the United States. Consequently Congress passed several laws to better prepare the nation, some of these that affecting the FDA. In particular, on June 12, 2002 the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act") was signed into law. In 2004 section 564 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bbb-3) was amended by the Project Bioshield Act of 2004 (Public Law 108-276).
FDA is responsible for carrying out certain provisions of the Bioterrorism Act, particularly Title III, Subtitle A (Protection of Food Supply) and Subtitle B (Protection of Drug Supply).
The Project Bioshield Act 2004 permits the FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency involving a heightened risk of attack on the public or U.S. military forces, or a significant potential to affect national security.
Whether you manufacture, distribute, import or export food, drugs or medical devices, ST&R can help you meet all the regulatory requirements so your business is always in compliance with The Bioterrorism Act.
ST&R provides services that will make you compliant with the requirements of the Bioterrorism Act. These services include:
- FDA Bioterrorism Programs
- FDA Bio. Prog.
- FDA Facility Reg.
- Important Info.
- Client Advisory
- News Release
- FDA Rulemaking Seminars
- ST&R Food Validation & Cert. Prog.
- C-TPAT and Border Sec.
- Global Sec. Verif. Prog.
If you require assistance with Bioterrorism Act compliance, please contact Edgar J. Asebey-Birkholm at
easebey@strtrade.com or at (305) 913-3902.