Sec. 107. EFFECTIVE DATES AND APPLICATION OF PART A

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## Sec. 107 EFFECTIVE DATES AND APPLICATION OF PART A * * * * * * * ###

(c)####

(1)As used in this subsection, the term “**enactment date**” means the date of enactment of this Act; and the term “**basic Act**” means the Federal Food, Drug, and Cosmetic Act. 1Public Law 87–781, which was enacted October 10, 1962. The amendments made by such Public Law to the Federal Food, Drug, and Cosmetic Act included amendments establishing the requirement that new drugs be effective. Section 107(c) concerned the applicability of the amendments. ####

(2)An application filed pursuant to section 505(b) of the basic Act which was “effective” within the meaning of that Act on the day immediately preceding the enactment date shall be deemed, as of the enactment date, to be an application “approved” by the Secretary within the meaning of the basic Act as amended by this Act. ####

(3)In the case of any drug with respect to which an application filed under section 505(b) of the basic Act is deemed to be an approved application on the enactment date by virtue of paragraph

(2)of this subsection— #####

(A)the amendments made by this Act to section 201(p), and to subsections

(b)and

(d)of section 505, of the basic Act, insofar as such amendments relate to the effectiveness of drugs, shall not, so long as approval of such application is not withdrawn or suspended pursuant to section 505(e) of that Act, apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application, but shall apply to any changed use, or conditions of use, prescribed, recommended, or suggested in its labeling, including such conditions of use as are the subject of an amendment or supplement to such application pending on, or filed after, the enactment date; and #####

(B)clause

(3)of the first sentence of section 505(e) of the basic Act, as amended by this Act, shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application (except with respect to such use, or conditions of use, as are the subject of an amendment or supplement to such approved application, which amendment or supplement has been approved after the enactment date under section 505 of the basic Act as amended by this Act) until whichever of the following first occurs:

(i)the expiration of the two-year period beginning with the enactment date;

(ii)the effective date of an order under section 505(e) of the basic Act, other than clause

(3)of the first sentence of such section 505(e), withdrawing or suspending the approval of such application. ####

(4)In the case of any drug which, on the day immediately preceding the enactment date,

(A)was commercially used or sold in the United States,

(B)was not a new drug as defined by section 201(p) of the basic Act as then in force, and

(C)was not covered by an effective application under section 505 of that Act, the amendments to section 201(p) made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day.