Guidance for Industry: Questions and Answers Regarding the Final Rule on Establishment and Maintenance of Records; Availability
other · Food and Drug Administration · Rule · Published 2005-09-12 · 70 FR 53728
Document
Document number
05-18039
Federal Register citation
70 FR 53728
CFR reference
21 CFR 1
Type
Rule
Action
Notice of availability of guidance.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2005-09-12
HHS docket
Docket No. 2005D-0356
Abstract
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Questions and Answers Regarding Establishment and Maintenance of Records." The guidance responds to various questions raised about the recordkeeping provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation, which requires the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food in the United States. Such records are to allow for the identification of the immediate previous sources and the immediate subsequent recipients of food.