Page:United States Statutes at Large Volume 76.djvu/841

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[76 Stat. 793]
PUBLIC LAW 87-000—MMMM. DD, 1962
[76 Stat. 793]

76

STAT.]

PUBLIC LAW 87-781-OCT. 10, 1962

793

and inspection under regulations lawfully issued pursuant to section 505 (i) or (j) or section 507(d) or (g) of this Act, and data, relating Ante, pp.783, to other drugs, which in the case of a new drug would be subject to '*^' ^^* reporting or inspection under lawful regulations issued pursuant to section 505(j) of this Act). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness. The provisions of the second sentence of this subsection shall not apply to— "(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs, upon prescriptions of practitioners licensed to administer such drugs to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs for sale other than in the regular course of their business of dispensing or selling drugs at retail; "(2) practitioners licensed by law to prescribe or administer drugs and who manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice; " (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 inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health." (b) Section 704(b) of such Act (21 U.S.C. 374(b)) is amended by e? Stat. 477. inserting after "warehouse," the words "consulting laboratory,". (c) Section 302(a) of such Act (21 U.S.C. 332(a)) is amended by 52 Stat. 1043. striking out " (f), ". (d) Nothing in the amendments made by subsections (a) and (b) of this section shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act. E F F E C T ON STATE LAWS

SEC. 202. Nothing in the amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law. EFFECTIVE DATE

SEC. 203. The amendments made by this title shall take effect on the date of enactment of this Act. TITLE III — R E G I S T R A T I O N O F DRUG ESTABLISHMENT S AND PATENT INFORMATION F I N D I N G S AND DECLARATION

SEC. 301. The Congress hereby finds and declares that in order to make regulation of interstate commerce in drugs effective, it is necessary to provide for registration and inspection of all establishments in which drugs are manufactured, prepared, propagated, compounded,

52 Stat. 1040. ^^ "^^ ^°^-