76 STAT. 794. or processed; that the products of all such establishments are likely REGISTRATION OF PRODUCERS OF DRUGS SEC. 302. Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end thereof the Ante, pp. 789, following section: "REGISTRATION OF PRODUCERS OF DRUGS "SEC. 510. (a) As used in this section "(1) the term 'manufacture, preparation, propagation, compounding, or processing' shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package in furtherance of the distribution of the drug from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer; "(2) the term 'name' shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. "(b) On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments. "(c) Every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs in any establishment which he owns or operates in any State shall immediately register with the Secretary his name, place of business, and such establishment. "(d) Every person duly registered in accordance with the foregoing subsections of this section shall immediately register with the Secretary any additional establishment which he owns or operates in any State and in which he begins the manufacture, preparation, propagation, compounding, or processing of a drug or drugs. "(e) The Secretary may assign a registration number to any person or any establishment registered in accordance with this section. "(f) The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this section. “(g) The foregoing subsections of this section 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 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; 791. 67 Stat. 477; Ante, p. 792. 21 USC 374. Post, p. 796. Post, P. 796. Ante, p. 794. Ante, p. 791. Ante, p. 791. 76 STAT. 795. "(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." TRANSITIONAL 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. FAILURE 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 ESTABLISHMENTS 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 in any State not duly registered under section 510." 76 STAT. 796. SAMPLES OF IMPORTED DRUGS SEC. 306. Section 801 (a) of such Act (21 U.S.C. 381 (a)) is amended 52 Stat. 1058. by inserting, after the first sentence thereof, the following new sen- 21 USC 381. tence: "The Secretary of Health, Education, and Welfare shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 510 and shall request that if any Ante, p. 795. drugs manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs be delivered to the Secretary of Health, Education, and Welfare, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health, Education, and Welfare and have the right to introduce testimony." DEFINITIONS SEC. 307. (a) Section 201 (a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (a)) is amended to read as follows: "(a) (1) The term 'State', except as used in the last sentence of section 702 (a), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. "(2) The term "Territory' means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone." (b) The second sentence of section 702 (a) of such Act (21 U.S.C. 372(a)) is amended by inserting before the words "a Territory" the words "the Commonwealth of Puerto Rico or". INFORMATION ON PATENTS FOR DRUGS 52 Stat. 1041. SEC. 308. Section 702 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 372) is amended by adding at the end thereof the following 52 Stat. 1056. new subsection: "(d) The Secretary is authorized and directed, upon request from the Commissioner of Patents, to furnish full and complete information with respect to such questions relating to drugs as the Commissioner may submit concerning any patent application. The Secretary is further authorized, upon receipt of any such request, to conduct or cause to be conducted, such research as may be required." Approved October 10, 1962. To further amend the transitional provisions of the Act approved September 6, 1958, entitled "An Act to protect the public health by amending the Federal Food, Drug, and Cosmetic Act to prohibit the use in food of additives which have not been adequately tested to establish their safety", and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may Food Additives be cited as the "Food Additives Transitional Provisions Amendment Transitional of 1964". Provisions Amend SEC. 2. The penultimate sentence of subsection (c) of section 6 of ment of 1964. the Food Additives Amendment of 1958 (Public Law 85-929, 72 Stat. 1784, 1788), as added by the "Food Additives Transitional Provisions Amendment of 1961" (Public Law 87-19, 75 Stat. 42), is hereby 21 USC 342 note. further amended by inserting before the period at the end thereof a colon and the following: "Provided, That if the Secretary has, pursuant to this sentence, granted an extension to June 30, 1964, he may, upon making the findings required by clause (1) (B) of this subsection and clauses (i) and (ii) of this sentence, further extend such effective date, but not beyond December 31, 1965". SEC. 3. The penultimate sentence of section 3 of the Nematocide, Plant Regulator, Defoliant, and Desiccant, Amendment of 1959 (Public Law 86-139, 73 Stat. 286, 288), as added by the "Food Additives Transitional Provisions Amendment of 1961" (Public Law 87-19, 75 Stat. 42), is hereby further amended by inserting before the 7 USC 135 note. period at the end thereof a colon and the following: "Provided, That if the Secretary has, pursuant to this sentence, granted an extension to June 30, 1964, he may, upon making the findings required by clause (1) of this paragraph (b) and clauses (A) and (B) of this sentence, further extend such expiration date, but not beyond December 31, 1965". Approved October 3, 1964. LEGISLATIVE HISTORY: HOUSE REPORT No. 1770 (Comm. on Interstate & Foreign Commerce). CONGRESSIONAL RECORD, Vol. 110 (1964): Sept. 3: Considered and passed House. Public Law 89-74 89th Congress, H. R. 2 July 15, 1965 An Act To protect the public health and safety by amending the Federal Food, Drug, and Cosmetic Act to establish special controls for depressant and stimulant drugs and counterfeit drugs, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That this Act may Drug Abuse Conbe cited as the "Drug Abuse Control Amendments of 1965". FINDINGS AND DECLARATION trol Amendments of 1965. SEC. 2. The Congress hereby finds and declares that there is a widespread illicit traffic in depressant and stimulant drugs moving in or otherwise affecting interstate commerce; that the use of such drugs, when not under the supervision of a licensed practitioner, often endan- 79 STAT, 226. gers safety on the highways (without distinction of interstate and 79 STAT. 227. intrastate traffic thereon) and otherwise has become a threat to the public health and safety, making additional regulation of such drugs necessary regardless of the intrastate or interstate origin of such drugs; that in order to make regulation and protection of interstate commerce in such drugs effective, regulation of intrastate commerce is also necessary because, among other things, such drugs, when held for illicit sale, often do not bear labeling showing their place of origin. and because in the form in which they are so held or in which they are consumed a determination of their place of origin is often extremely difficult or impossible; and that regulation of interstate commerce without the regulation of intrastate commerce in such drugs, as provided in this Act, would discriminate against and adversely affect interstate commerce in such drugs. CONTROL OF DEPRESSANT AND STIMULANT DRUGS SEC. 3. (a) Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end thereof the 52 Stat. 1040. following: "(v) The term 'depressant or stimulant drug' means "Depressant or "(1) any drug which contains any quantity of (A) barbituric stimulant drug." acid or any of the salts of barbituric acid; or (B) any derivative of barbituric acid which has been designated by the Secretary under section 502 (d) as habit forming; "(2) any drug which contains any quantity of (A) amphetamine or any of its optical isomers; (B) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (C) any substance which the Secretary, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or "(3) any drug which contains any quantity of a substance which the Secretary, after investigation, has found to have, and by regulation designates as having, a potential for abuse because of its depressant or stimulant effect on the central nervous system or its hallucinogenic effect; except that the Secretary shall not designate under this paragraph, or under clause (C) of subpara 21 USC 352. |