Page:United States Statutes at Large Volume 76.djvu/843

 76 STAT.]

795

PUBLIC LAW 87-781-OCT. 10, 1962

" (3) persons who manufacture, prepare, propagate, compound, or process drugs solely for use in research, teaching, or chemical analysis and not for sale; "(4) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that registration by such classes of persons in accordance with this section is not necessary for the protection of the public health. " (h) Every establishment in any State registered with the Secretary pursuant to this section shall be subject to inspection pursuant to section 704 and shall be so inspected by one or more officers or employees duly designated by the Secretary at least once in the twoyear period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive twoyear period thereafter. "(i) Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or (drugs shall be permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall include'provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether drugs manufactured, prepared, propagated, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 801(a) of this Act."

67 Stat. 477; Ante, p. 792. 21 USC 374.

Post,

p. 796.

Post,

p. 796.

Ante,

p. 794.

Ante,

p. 791.

Ante,

p. 7 9 1.

T R A N S I T I O N A L PROVISIONS

SEC. 303. Any person who, on the day immediately preceding the date of enactment of this Act, owned or operated any establishment in any State (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act as amended by this Act) engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs, shall, if he first registers in accordance with subsection (b) of section 510 of that Act (as added thereto by this Act) prior to the first day of the seventh calendar month following the month in which this Act is enacted, be deemed to have complied with that subsection for the calendar year 1962. Such registration, if made within such period and effected in 1963, shall also be deemed to be in compliance with such subsection for that calendar year. F A I L U R E TO REGISTER

SEC. 304. Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at the end thereof the following new paragraph: " ( p } The failure to register as required by section 510." DRUGS FROM NONREGISTERED ESTABLISHMENT S MISBRANDED

SEC. 305. Section 502 of such Act (21 U.S.C. 352) is amended by adding at the end thereof the following new paragraph: "(o) If it is a drug and was manufactured, prepared, propagated, compounded, or processed in an establishment m any State not duly registered under section 510."

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