Section 10609

SEC. 10609. LABELING CHANGES.

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:

'[10][A] If the proposed labeling of a drug that is the subject of an application under this subsection differs from the listed drug due to a labeling revision described under clause [i], the drug that is the subject of such application shall, notwithstanding any other provision of this Act, be eligible for approval and shall not be considered misbranded under section 502 if--

'[i] the application is otherwise eligible for approval under this subsection but for expiration of patent, an exclusivity period, or of a delay in approval described in paragraph [5][B][iii], and a revision to the labeling of the listed drug has been approved by the Secretary within 60 days of such expiration;

'[ii] the labeling revision described under clause [i] does not include a change to the 'Warnings' section of the labeling;

'[iii] the sponsor of the application under this subsection agrees to submit revised labeling of the drug that is the subject of such application not later than 60 days after the notification of any changes to such labeling required by the Secretary; and

'[iv] such application otherwise meets the applicable requirements for approval under this subsection.

'[B] If, after a labeling revision described in subparagraph [A][i], the Secretary determines that the continued presence in interstate commerce of the labeling of the listed drug [as in effect before the revision described in subparagraph [A][i]] adversely impacts the safe use of the drug, no application under this subsection shall be eligible for approval with such labeling.'.