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Sen. Karina Villa
Filed: 5/2/2025
| | 10400HB3637sam001 | | LRB104 10660 BDA 25785 a |
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| 1 | | AMENDMENT TO HOUSE BILL 3637
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| 2 | | AMENDMENT NO. ______. Amend House Bill 3637 on page 171, |
| 3 | | by replacing lines 17 through 23 with the following: |
| 4 | | "(h) If a drug had been approved by the U.S. Food and Drug |
| 5 | | Administration before January 1, 2025, the revocation of |
| 6 | | approval of the drug by the U.S. Food and Drug Administration |
| 7 | | after that date shall not cause it to be deemed an adulterated |
| 8 | | drug in violation of this Act if the drug is recommended for |
| 9 | | use by the World Health Organization, even if the drug's |
| 10 | | labeling reflects prior approval that is no longer in effect, |
| 11 | | so long as the drug's labeling was true and accurate at the |
| 12 | | time of its manufacture. This subsection (h) is inoperative on |
| 13 | | and after January 1, 2035.". |
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