Page:United States Statutes at Large Volume 111 Part 3.djvu/239

 PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2327 505(c) of such Act (21 U.S.C. 355(c)), except that if such application for marketing was in the form of an abbreviated apphcation, the appHcation shall be considered to have been filed and approved under section 505(j) of such Act (21 U.S.C. 355(j)). (2) EXCEPTION.— The following subsections of section 505 (21 U.S.C. 355) shall not apply to any application for marketing in which the drug that is the subject of the application contains an antibiotic drug and the antibiotic drug was the subject of any application for marketing received by the Secretary of Health and Human Services under section 507 of such Act (21 U.S.C. 357) before the date of the enactment of this Act: (A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and (ii) The third and fourth sentences of subsection (b)(1) (regarding the filing and publication of patent information); and (B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if the investigations relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. (3) PUBLICATION.—For purposes of this section, the Secretary is authorized to make available to the public the established name of each antibiotic drug that was the subject of any application for marketing received by the Secretary for Health and Human Services under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) before the date of enactment of this Act. (e) DEFINITION.—Section 201 (21 U.S.C. 321), as amended by section 121(a)(1), is further amended by adding at the end the following: "(jj) The term 'antibiotic drug* means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (inclu(Ung a chemically synthesized equivalent of any such substance) or any derivative thereof.". SEC. 126. ELIMINATION OF CERTAIN LABELING REQUIREMENTS. (a) PRESCRIPTION DRUGS. —Section 503(b)(4) (21 U.S.C. 353(b)(4)) is amended to read as follows: "(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing the label of the drug fails to bear, at a minimum, the sjnnbol *Rx only'. "(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).". (b) MISBRANDED DRUG.— Section 502(d) (21 U.S.C. 352(d)) is repealed. (c) CONFORMING AMENDMENTS.— (1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended— (A) by striking subparagraph (A); and

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