Sec. 1113. RULES OF CONSTRUCTION

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## SEC. 1113 RULES OF CONSTRUCTION **[**[21 U.S.C. 360ddd note](/us/usc/t21/s360ddd)**]** Nothing in this subtitle and the amendments made by this subtitle applies with respect to— ####

(1)a drug that is approved prior to May 1, 2012, pursuant to an application submitted under section 505 or 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b); ####

(2)any gas listed in subparagraphs

(A)through

(G)of section 575(1) of the Federal Food, Drug, and Cosmetic Act, as added by section 1111 of this Act, or any combination of any such gases, for an indication that— #####

(A)is not included in, or is different from, those specified in subclauses

(I)through

(VII)of section 576(a)(3)(A)(i) of such Act; and #####

(B)is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512; or ####

(3)any designated medical gas added pursuant to subparagraph

(H)of section 575(1) of such Act for an indication that— #####

(A)is not included in, or is different from, those originally added pursuant to subparagraph

(H)of section 575(1) and section 576(a)(3)(A)(i)(VIII); and #####

(B)is approved on or after May 1, 2012, pursuant to an application submitted under section 505 or 512 of such Act. ## Subtitle C Miscellaneous Provisions

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U.S. Code

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Sec. 1113

RULES OF CONSTRUCTION

U.S.C.§ 360ddd

U.S.C.§ 355

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