FDA Corrects its Final Rule on Recordkeeping Under the Bioterrorism Act
The Food and Drug Administration (FDA) has issued a final rule, effective February 7, 2005, that corrects its December 9, 2004 final rule that requires the establishment and maintenance of records by certain persons (unless excepted) who manufacture, import, process, pack, transport, distribute, receive, or hold food in the U.S.
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(The FDA's December 9, 2004 final rule implements section 306 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act).)
FDA Corrects Compliance Date for Small Businesses
Most of the corrections in FDA's correction notice are related to the final rule's compliance dates. (The FDA's December 9, 2004 final rule was effective February 7, 2005, but has various compliance dates, depending on the size of the business.)
In several sections of its December 9, 2004 final rule, FDA is correcting its language to state that for small businesses (i.e., those employing fewer than 500, but more than 10 full-time equivalent employees), the compliance date is June 9, 2006 (the FDA's December 9, 2004 final rule had incorrectly stated that the compliance date was June 9, 2005 or June 9, 2004).
(Subscribers should note that BP's summaries of the FDA's December 9, 2005 final rule contained the correct small business compliance date and noted the above discrepancy. (See ITT's Online Archives or 01/05/05 news, 05010510, for Part I of BP's multi-part series of summaries on the FDA final rule, which noted the compliance date discrepancy.)
FDA Amends Regulations on the Consequences of Failing to Establish/Maintain Records
The FDA is also correcting 21 CFR 1.363, which contains regulations outlining the consequences of failing to establish or maintain records or make them available to FDA as required by new 21 CFR Part 1, Subpart J.
FDA is correcting 21 CFR 1.363(b) to state that the failure of a nontransporter immediate previous source or a nontransporter immediate subsequent recipient who enters an agreement under 21 CFR 1.352(e) to establish, maintain, or establish and maintain, records required under 21 CFR 1.352(a), (b), (c), or (d), or the refusal to permit access to or verification or copying of any such required record, is a prohibited act under section 301 of the Federal Food, Drug, and Cosmetic Act.
(Previously, 21 CFR 1.363(b) had referred only to agreements to establish, maintain, or establish and maintain records required under 21 CFR 1.352(a) or (b).)
Other Miscellaneous Corrections
The FDA is also making corrections to:
the economic impact section of its December 9, 2004 final rule in order to modify the section that estimates the benefits when selected sectors are excluded; and
the list of references that FDA states have been placed on display for viewing by interested persons.
FDA contact - Nega Beru (301) 436-1400
FDA correction final rule (FR Pub 02/23/05, D/N 2002N-0277) available at http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/pdf/05-3424.pdf.