Document Detail

Petition to request an exemption from 100 percent identity testing of dietary ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Interim final rule.
MedLine Citation:
PMID:  17674485     Owner:  HSR     Status:  MEDLINE    
The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Federal register     Volume:  72     ISSN:  0097-6326     ISO Abbreviation:  Fed Regist     Publication Date:  2007 Jun 
Date Detail:
Created Date:  2007-08-03     Completed Date:  2007-08-17     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7808722     Medline TA:  Fed Regist     Country:  United States    
Other Details:
Languages:  eng     Pagination:  34959-69     Citation Subset:  T    
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MeSH Terms
Dietary Supplements / analysis,  standards*
Food Contamination / prevention & control
Food Handling / legislation & jurisprudence
Food Industry / legislation & jurisprudence*
Food Labeling / legislation & jurisprudence
Food Packaging / legislation & jurisprudence
Quality Control*
United States
United States Food and Drug Administration / legislation & jurisprudence*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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