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 11
... licensed as a biologic under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and was , prior to such approval , certification , or license , mar- keted as a dietary supplement or as a food unless the Sec- retary has ...
... licensed as a biologic under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) and was , prior to such approval , certification , or license , mar- keted as a dietary supplement or as a food unless the Sec- retary has ...
Page 12
... licensed as a biologic under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) , or ( ii ) an article authorized for investigation as a new drug , antibiotic , or biological for which substan- tial clinical investigations ...
... licensed as a biologic under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) , or ( ii ) an article authorized for investigation as a new drug , antibiotic , or biological for which substan- tial clinical investigations ...
Page 15
... licensed by applicable State law to administer such drug who makes written request for information as to such drug , true and correct copies of all printed matter which is required to be included in any package in which that drug is dis ...
... licensed by applicable State law to administer such drug who makes written request for information as to such drug , true and correct copies of all printed matter which is required to be included in any package in which that drug is dis ...
Page 116
... licensed by law to administer such drug ; or ( B ) is limited by an approved application under section 505 to use under the professional supervision of a practitioner li- censed by law to administer such drug ; shall be dispensed only ...
... licensed by law to administer such drug ; or ( B ) is limited by an approved application under section 505 to use under the professional supervision of a practitioner li- censed by law to administer such drug ; shall be dispensed only ...
Page 117
... licensed under State law and the term " emergency medical reasons " in- cludes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug ...
... licensed under State law and the term " emergency medical reasons " in- cludes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug ...
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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