PUBLIC LAW 105-115—NOV. 21, 1997 111 STAT. 2325 "(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the ^ drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.". (b) ANIMAL DRUGS. —Section 512(c) (21 U.S.C. 360b(c)) is amended by adding at the end the following: "(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.". SEC. 125. INSULIN AND ANTIBIOTICS. (a) CERTIFICATION OF DRUGS CONTAINING INSULIN. — (1) AMENDMENT.— Section 506 (21 U.S.C. 356), as in effect before the date of the enactment of this Act, is repealed. (2) CONFORMING AMENDMENTS.— (A) Section 301(j) (21 U.S.C. 331(j)) is amended by striking "506, 507,". (B) Subsection (k) of section 502 (21 U.S.C. 352) is I*6T)63.1GQ (C) Sections 301(i)(l), 510(j)(l)(A), and 510(j)(l)(D) (21 U.S.C. 331(i)(l), 360(j)(l)(A), 360(j)(l)(D)) are each amended by striking ", 506, 507,", (D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by inserting after "503(b)" the following: "cr composed wholly or partly of insulin". (E) Section 8126(h)(2) of title 38, United States Code, is amended by inserting "or" at the end of subparagraph (B), by striking "; or" at the end of subparagraph (C) and inserting a period, and by striking subparagraph (D). (b) CERTIFICATION OF ANTIBIOTICS. — (1) AMENDMENT.— Section 507 (21 U.S.C. 357) is repealed. (2) CONFORMING AMENDMENTS.— (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended by striking out "or 507", section 201(dd) (21 U.S.C. 321(dd)) is amended by striking "507,", and section 201(fD(3)(A) (21 U.S.C. 321(fD(3)(A)) is amended by striking ", certified as an antibiotic under section 507,". (B) Section 301(e) (21 U.S.C. 331(e)) is amended by striking "507(d) or (g),". (C) Section 306(d)(4)(B)(ii) (21 U.S.C. 335a(d)(4)(B)(ii)) is amended by striking "or 507". (D) Section 502 (21 U.S.C. 352) is amended by striking subsection (1). (E) Section 520(1) (21 U.S.C. 360j(l)) is amended by striking paragraph (4) and by striking "or Antibiotic Drugs" in the subsection heading. (F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by inserting "or" at the end of paragraph (1), by striking paragraph (2), and by redesignating paragraph (3) as paragraph (2).
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