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6340

CONGRESSIONAL RECORD-SENATE

and supplemented, and for other purposes," approved July 13, 1943:

H. R. 213. An act for the relief of Mrs. Ruth

C. Stone;

H. R. 241. An act for the relief of Mrs. Ruby H. Hunsucker;

H. R. 699. An act to amend paragraph 682 of title 16 of the United States Code:

H.R. 715. An act to provide the transfer by the Secretary of War of the Roseburg Rifle Range, Douglas County, Oreg.. to the Defense Plant Corporation, and for other purposes;

H. R. 852. An act for the relief of Betty Jane Ritter:

H. R. 854. An act for the relief of Isabel Carlson;

H. R. 999. An act for the relief of Lily L Carren;

H. R. 1015. An act for the relief of G. H. Moore, of Eutler, Taylor County, Ga.;

H. R. 1057. An act for the relief of the legal guardian of Margaret Hockenberry, a minor;

H. R. 1067. An act for the relief of the estate of and/or the heirs at law of, Frank D. Howells, former treasurer of the city of Richmond. Ind.;

H. R. 1085. An act for the relief of Mrs. Celia Ellen Ashcraft;

H. R. 1089. An act for the relief of Albert Cantalupo;

H. R. 1245. An act for the relief of John F. Davis;

H. R. 1257. An act for the relief of George C. Tyler and Doris M. Tyler;

H. R. 1346. An act for the relief of Alaska D. Jennette;

H. R. 1564. An act for the relief of William W. Maddox and the legal guardian of Donna Sue Maddox and Saddie Inez Maddox;

H. R. 1601. An act for the relief of Dorothy M. Moon;

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H. R. 1647. An act to authorize the Secretary of War to convey to the Captain William Edmiston Chapter of the Daughters of the American Revolution a certain building and tract or parcel of land situated in Montgomery County, Tenn;

H. R. 1849. An act for the relief of Mrs. Ora R. Hutchinson;

H. R. 1882. An act for the relief of R. L. Whittington, Mrs. R. L. Whittington, and Mrs. J. B. Whittington;

H. R. 1690. An act for the relief of the estate of Peter G. Fabian, deceased;

H. R. 2028. An act for the relief of John Visnovec, Rose Visnovec, and Helen Visnovec:

H. R. 2032. An act authorizing the general shore-line investigations at Federal expense and to repeal an act for the improvement and protection of the beaches along the shores of the United States, approved June 26, 1936; H. R. 2069. An act for the relief of Edmund F. Danks, as administrator of the estate of Edna S. Danks, deceased;

H. R. 2103. An act for the relief of Teresa Tine:

H. R. 2226. An act for the relief of Hugh P. Gunnells and Mrs. Dezaree Gunnells;

H. R. 2249. An act for the relief of the Cape & Vineyard Electric Co.;

H. R. 2265. An act for the relief of owners of land and personal property of the Fort Knox area of Hardin County, Ky.;

H. R. 2266. An act for the relief of land and personal property owners of Fort Knox area of Meade County, Ky.;

H. R. 2225. An act to authorize the Secretary of Agriculture to prant and convey to SpringGeld Township, Montgomery County, Pa., for tain lands of the United States in SpringBeld Township, Mongomery County, Pa., for highway purposes and for ornamental-park ригрозев:

H. R. 2321. An act for the relief of the Springfield Cooperative Bank;

H. R. 2450. An act for the relief of Bruce Bros. Grain Co.;

H. R. 2477. An act to give recognition to the noncombatant services under enemy are per

formed by officers and enlisted men of the Medical Corps of the Army;

H. R. 2504. An act to discontinue certain reports now required by law;

H. R. 2511. An act for the relief of Patricia M. Kacprzyk and Alex D. Leontire;

H. R. 2515. An act for the relief of Harland Bartholomew & Associates;

H. R. 2538. An act to incorporate the Mothers of World War II, to set forth and establish the purposes and aims of the organization, fixing its corporate powers and establishing the rights of membership, and for other purposes;

H. R. 2621. An act for the relief of Haselden & Huggins Co.;

H. R. 2641. An act for the relief of Frank Gien;

H. R. 2763. An act for the relief of Fred Crago:

H. R. 2944. An act to continue in effect section 6 of the act of July 2, 1910 (54 Stat. 714), as amended, relating to the exportation of certain commodities;

H. R. 3046. An act for the relief of Thomas A. Butler;

H. R. 3193. An act to permit waiving of the bonds of Navy mail clerks and assistant Navy mail clerks, and for other purposes;

EI. R. 3232. An act to amend section 3 of the act entitled "An act to authorize the Presi dent to requisition certain articles and materials for the use of the United States, and for other purposes," approved October 10, 1940, as amended, for the purpose of continuing it in effect;

H. R. 3233. An act to permit members of the Army, Navy, Marine Corps, Coast Guard, Coast and Geodetic Survey, Public Health Service, and their dependents, to occupy certain Government housing facilities on a rental basis without loss of rental allowances;

H. R. 3234. An act to amend the act entitled "An act to authorize the President of the United States to requisition property required for the defense of the United States," approved October 16, 1941, as amended, for the purpose of continuing it in effect;

HR. 3266. An act to amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of penicillin or any derivative thereof, and for other purposes:

H.R. 3269. An act further amending the part of the act entitled "An act making appropriations for the naval service for the fiscal year ending June 30, 1921, and for other purposes," approved June 4, 1920, as amended, relating to the conservation, care, custody, protection, and operation of the naval petroleum and oil-shale reserves;

H. R. 3278. An act to amend section 204 of the act entitled "An act to expedite the provision of housing in connection with national defense, and for other purposes, approved October 14, 1940, as amended, to increase the amount authorized to be appropriated therein, and for other purposes;

H R. 3426. An act providing for a medal for service in the armed forces during the present war:

H. R. 3440. An act authorizing appropriations for a permanent program of scientific research in the interest of national security;

H. J. Res. 116. Joint resolution to facilitate the execution of subsection (d) of section 13 of the Railroad Unemployment Insurance Act, as amended; and

H. J. Res. 184. Joint resolution to continue the temporary increases in postal rates on first-class matter, and for other purposes.

The message also announced that the House had agreed to a concurrent resolution (H. Con. Res. 50) declaring Congress to have recognized and approved the provisions of section 29.23 (m)-16 of Treasury Regulations 111, and for other

JUNE 20

purposes, in which it requested the concurrence of the Senate.

HOUSE BILLS AND JOINT RESOLUTIONS REFERRED OR PLACED ON THE CALENDAR

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The following bills and joint resolutions were severally read twice by their titles and referred, or ordered to be placed on the calendar, as indicated:

H. R. 169. An act to amend section 8 of the act entitled "An act to amend the act entitled 'An act to provide that the United States shall aid the States in the construction of rural post roads, and for other purposes,' approved July 11, 1916, as amended and supplemented, and for other purposes." approved July 13, 1943; to the Committee on Post Offices and Post Roads.

H. R. 213. An act for the relief of Mrs. Ruth C. Stone:

H. R. 241. An act for the relief of Mrs. Ruby H. Hunsucker;

H. R. 852. An act for the relief of Betty Jane Ritter:

H. R. 854. An act for the relief of Isabel Carlson;

H. R. 999. An act for the relief of Lily L. Carren;

H. R. 1015. An act for the relief of G. H. Mcore, of Butler, Taylor County, Ga.; H. R. 1057. An act for the relief of the legal guardian of Margaret Hockenberry, a minor;

H. R. 1067. An act for the relief of the estate of, and/or the heirs at law of, Frank D. Howells, former treasurer of the city of Richmond, Ind.;

H. R. 1085. An act for the relief of Mrs. Celia Ellen Ashcraft;

H. R. 1089. An act for the relief of Albert Cantalupo;

H. R. 1245. An act for the relief of John F. Davis;

H. R. 1257. An act for the relief of George C. Tyler and Doris M. Tyler;

H. R. 1346. An act for the relief of Alaska D. Jennette:

H. R. 1564. An act for the relief of William W. Maddox and the legal guardian of Donna Sue Maddox and Saddle Inez Maddox;

H. R. 1601. An act for the relief of Dorothy M. Moon:

H. R. 1849. An act for the relief of Mrs. Ora R. Hutchinson;

H. R. 1882. An act for the relief of R. L. Whittington, Mrs. R. L. Whittington, and Mrs. J. B. Whittington;

H. R. 1890. An act for the relief of the estate of Peter G. Fabian, deceased;

H. R. 2028. An act for the relief of John Visnovec, Rose Visnovec, and Helen Visnovec: H. R. 2089. An act for the relief of Edmund F. Danks, as administrator of the estate of Edna S. Danks, deceased;

H. R. 2163. An act for the relief of Teresa Tine;

H. R. 2226. An act for the relief of Hugh P. Gunnells and Mrs. Dezaree Gunnells;

H. R. 2249. An act for the relief of the Cape & Vineyard Electric Co.

H. R. 2265. An act for the relief of owners of land and personal property of the Fort Knox area of Hardin County, Ky.;

H. R. 2266. An act for the relief of land and personal property owners of Fort Knox area of Meade County, Ky.;

H. R. 2321. An act for the relief of the Springfield Co-operative Bank;

H. R. 2450. An act for the relief of Bruce Brothers Grain Co.:

H. R. 2511. An act for the relief of Patricia M. Kacprzyk and Alex D. Leontire;

H. R. 2515. An act for the relief of Harland Bartholomew & Associates;

H. R. 2621. An act for the relief of Haselden & Huggins Co.;

H. R. 2641. An act for the relief of Frank Glen;

79TH CONGRESS

1ST SESSION

H. R. 3266

IN THE SENATE OF THE UNITED STATES

JUNE 20 (legislative day, JUNE 4), 1945

Read twice and referred to the Committee on Commerce

AN ACT

To amend the Federal Food, Drug, and Cosmetic Act of June 25, 1938, as amended, by providing for the certification of batches of drugs composed wholly or partly of any kind of penicillin or any derivative thereof, and for other purposes. 1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 3 That section 301 (i) of the Federal Food, Drug, and Cos4 metic Act of June 25, 1938 (21 U. S. C. 301 and the 5 following), as amended, is amended by inserting "507" 6 after "506,".

7 SEC. 2. Section 502 of such Act, as amended, is amended 8 by adding a new paragraph at the end thereof, as follows:

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"(1) If it is, or purports to be, or is represented as a

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1 drug composed wholly or partly of any kind of penicillin

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or any derivative thereof, unless (1) it is from a batch with 3 respect to which a certificate or release has been issued pur4 suant to section 507, and (2) such certificate or release is in 5 effect with respect to such drug: Provided, That this para6 graph shall not apply to any drug or class of drugs exempted 7 by regulations promulgated under section 507 (c) or (d).” SEC. 3. Chapter V of such Act, as amended, is amended 9 by adding a new section at the end thereof, as follows: "CERTIFICATION OF DRUGS CONTAINING PENICILLIN

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"SEC. 507. (a) The Federal Security Administrator, pursuant to regulations promulgated by him, shall provide 13 for the certification of batches of drugs composed wholly or 14 partly of any kind of penicillin or any derivative thereof. 15 A batch of any such drug shall be certified if such drug 16 has such characteristics of identity and such batch has such 17 characteristics of strength, quality, and purity, as the Ad18 ministrator prescribes in such regulations as necessary to 19 adequately insure safety and efficacy of use, but shall not 20 otherwise be certified. Prior to the effective date of such 21 regulations the Administrator, in lieu of certification, shall 22 issue a release for any batch which, in his judgment, may 23 be released without risk as to the safety and efficacy of its Such release shall prescribe the date of its expiration

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1 and other conditions under which it shall cease to be effective

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as to such batch and as to portions thereof.

"(b) Regulations providing for such certifications shall 4 contain such provisions as are necessary to carry out the 5 purposes of this section, including provisions prescribing (1) 6 standards of identity and of strength, quality, and purity; 7 (2) tests and methods of assay to determine compliance with 8 such standards; (3) effective periods for certificates, and 9 other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) ad11 ministration and procedure; and (5) such fees, specified in 12 such regulations, as are necessary to provide, equip, and 13 maintain an adequate certification service. Such regulations 14 shall prescribe only such tests and methods of assay as will 15 provide for certification or rejection within the shortest time 16 consistent with the purposes of this section.

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"(c) Whenever in the judgment of the Administrator, 18 the requirements of this section and of section 502 (1) with 19 respect to any drug or class of drugs are not necessary 20 to insure safety and efficacy of use, the Administrator shall 21 promulgate regulations exempting such drug or class of drugs 22 from such requirements.

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"(d) The Administrator shall promulgate regulations

24 exempting from any requirement of this section and of

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1 section 502 (1), (1) drugs which are to be stored, processed, 2 labeled, or repacked at establishments other than those where 3 manufactured, on condition that such drugs comply with all 4 such requirements upon removal from such establishments;

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(2) drugs which conform to applicable standards of identity, 6 strength, quality, and purity prescribed by these regulations 7 and are intended for use in manufacturing other drugs; and 8 (3) drugs which are intended solely for investigational use 9 by experts qualified by scientific training and experience to 10 investigate the safety and efficacy of drugs.

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"(e) No drug which is subject to section 507 shall be 12 deemed to be subject to any provision of section 505. Com13 pliance of any drug subject to section 502 (1) or 507 with 14 sections 501 (b) and 502 (g) shall be determined by 15 the application of the standards of strength, quality, and 16 purity, the tests and methods of assay, and the require17 ments of packaging and labeling, respectively, prescribed 18 by regulations promulgated under section 507.

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"(f) Any interested person may file with the Adminis20 trator a petition proposing the issuance, amendment, or repeal 21 of any regulation contemplated by this section. The peti22 tion shall set forth the proposal in general terms and shall 23 state reasonable grounds therefor. The Administrator shall 24 give public notice of the proposal and an opportunity for 25 all interested persons to present their views thereon, orally

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