Compilation of Selected Acts Within The Jurisdiction of The Committee on Energy and Commerce, March 2005, 109-1 Committee Print 109-A, *2005 |
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Page 16
... record , or report required or requested under section 801 ( d ) ( 3 ) ; the failure to submit a certificate of anal- ysis as required under such section ; the failure to maintain records or to submit records or reports as required by ...
... record , or report required or requested under section 801 ( d ) ( 3 ) ; the failure to submit a certificate of anal- ysis as required under such section ; the failure to maintain records or to submit records or reports as required by ...
Page 29
... records , of records , or interference with , obstruction of an investigation into , or prosecution of , any criminal offense , or or ( II ) a conspiracy to commit , or aiding or abet- ting , such felony , if the Secretary finds , on ...
... records , of records , or interference with , obstruction of an investigation into , or prosecution of , any criminal offense , or or ( II ) a conspiracy to commit , or aiding or abet- ting , such felony , if the Secretary finds , on ...
Page 100
... records . Such requirements shall pro- vide for- ( i ) the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures prescribed by the Secretary under para- graph ...
... records . Such requirements shall pro- vide for- ( i ) the retention of all records necessary to demonstrate compliance with the good manufacturing practices and quality control procedures prescribed by the Secretary under para- graph ...
Page 101
... Records required under subparagraph ( A ) with respect to an infant formula shall be retained for at least one year after the expiration of the shelf life of such infant formula . Except as pro- vided in clause ( ii ) , such records ...
... Records required under subparagraph ( A ) with respect to an infant formula shall be retained for at least one year after the expiration of the shelf life of such infant formula . Except as pro- vided in clause ( ii ) , such records ...
Page 103
... records shall be retained for at least one year after the expiration of the shelf life of the infant formula . ( 2 ) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph ...
... records shall be retained for at least one year after the expiration of the shelf life of the infant formula . ( 2 ) To the extent that the Secretary determines that records are not being made or maintained in accordance with paragraph ...
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Common terms and phrases
action active ingredient amendment animal drug application animal feed appropriate approved new animal Attorney authorized bioequivalence cation certification classification clause clause iv clinical containing controlled substance court described dispensing distribution dosage form drug or device drug product ecgonine electronic product enactment established exemption expiration Federal Food Federal Register filed fiscal Food and Drug graph Health Service Act infant formula investigational issued labeling licensed listed chemical listed drug manufacturer ment notice notification panel paragraph patent period person pesticide petition phenylpropanolamine premarket prescribed proposed pseudoephedrine Public Law purposes referred registration regulation request respect retary route of administration safety and effectiveness safety or effectiveness schedule III Secretary determines Secretary finds section 351 sentence specified spect standard subchapter subclause submitted subparagraph substance in schedule supplement term of imprisonment tion United States Code United States Pharmacopoeia unless violation