effective dates and application of part a

effective dates and application of part a Sec. 107. (a) Except as otherwise provided in this section, the amendments made by the foregoing sections of this part A shall take effect on the date of enactment of this Act. (b) The amendments made by sections 101,103,105, and 106 of this part. A shall, with respect to any drug, take effect on the first day of the seventh calendar month following the month in which this Act is enacted. (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. (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as such amendments relate to the effectiveness of drugs, shall not, so long as approval of such application is not withdrawn or suspended pursuant to section 505(e) of that Act, apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in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 76 Stat. 789occurs: (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.