Sec. 4. Waiver of certain FDA ANDA requirements
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Section 505(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(j) ) is amended by adding at the end the following: Notwithstanding any other provision of this section, the holder of an approved application under this subsection that changes the source of an active pharmaceutical ingredient of the drug that is the subject of such application to a source available through the Strategic Active Pharmaceutical Ingredient Reserve established under section 319N–1 of the Public Health Service Act— shall not be required to update the approved application with respect to such change before changing the source; and shall inform the Secretary of the change, through an update to the approved application or other manner determined appropriate by the Secretary, prior to commercial distribution of the drug. .
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Sec. 4
Waiver of certain FDA ANDA requirements
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