FDA Issues "Q & A" on the Establishment and Maintenance of Records Under the Bioterrorism Act
The Food and Drug Administration (FDA) has recently posted to its Web site a guidance document entitled "Questions and Answers Regarding the Establishment and Maintenance of Records" under the Bioterrorism Act. The FDA states that this Q&A represents the FDA's current thinking on this topic and is immediately effective.
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(On December 9, 2004, the FDA issued a final rule which implemented Section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (Bioterrorism Act) requiring the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold or import food in the U.S. See ITT's Online Archives or 01/14/05 news, 05011415, for part V of BP's summary of FDA's final rule on recordkeeping under the Bioterrorism Act, with links to earlier installments).
Highlights of Q&As Contained in FDA's Guidance Document
The following are some of the questions contained in the guidance document (partial list):
- Who is excluded from all or part of the regulations?
- What information is required in the records you must establish and maintain to identify the non-transporter and transporter immediate previous source and immediate subsequent recipients?
- What are the compliance dates for this rule?
- Can existing records satisfy the requirements of this rule?
- What are the consequences of failing to establish and maintain records or make them available to FDA as required by this rule?
(See ITT's Online Archives or 04/06/05 news, 05040640, for BP summary of guidance booklet on the establishment and maintenance of records under the bioterrorism act).
FDA Contact - Denise Beavers (301) 436-1721
FDA Final Guidance document (dated 09/02/05), available at www:cfsan.fda.gov/dms/recguid.html