[CHAPTER 281-1ST SESSION]

[H. R. 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.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 301 (i) of the Federal Food, Drug, and Cosmetic Act of June 25, 1938 (21 U. S. C. 301 and the following), as amended, is amended by inserting "507" after "506,".

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

"(1) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin or any derivative thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to section 507, and (2) such certificate or release is in effect with respect to such drug: Provided, That this paragraph shall not apply to any drug or class of drugs exempted by regulations promulgated under section 507 (c) or (d)."

SEC. 3. Chapter V of such Act, as amended, is amended by adding a new section at the end thereof, as follows:

"CERTIFICATION OF DRUGS CONTAINING PENICILLIN

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

"(b) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this section, including provisions prescribing (1) standards of identity and of strength, quality, and purity; (2) tests and methods of assay to determine compliance with such standards; (3) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; (4) administration and procedure; and (5) such fees, specified in such

regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this section.

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

"(d) The Administrator shall promulgate regulations exempting from any requirement of this section and of section 502 (1), (1) drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; (2) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed by these regulations and are intended for use in manufacturing other drugs; and (3) drugs which are intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and efficacy of drugs.

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

"(f) Any interested person may file with the Administrator a petition proposing the issuance, amendment, or repeal of any regulation contemplated by this section. The petition shall set forth the proposal in general terms and shall state reasonable grounds therefor. The Administrator shall give public notice of the proposal and an opportunity for all interested persons to present their views thereon, orally or in writing, and as soon as practicable thereafter shall make public his action upon such proposal. At any time prior to the thirtieth day after such action is made public any interested person may file objections to such action, specifying with particularity the changes desired, stating reasonable grounds therefor, and requesting a public hearing upon such objections. The Administrator shall thereupon, after due notice, hold such public hearing. As soon as practicable after completion of the hearing, the Administrator shall by order make public his action on such objections. The Administrator shall base his order only on substantial evidence of record at the hearing and shall set forth as part of the order detailed findings of fact on which the order is based. The order shall be subject to the provisions of section 701 (f) and (g).”

Approved July 6, 1945.

[CHAPTER 332-1ST SESSION]

[S. 1270]

AN ACT

Relating to the payment of subsidies by the Commodity Credit Corporation and the Reconstruction Finance Corporation.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That the amount of funds authorized to be expended by Commodity Credit Corporation pursuant to section 3 of the Act of April 12, 1945 (Public, 30, Seventyninth Congress), shall be increased by such amounts as may from time to time be determined by the Secretary of Agriculture as follows: (1) Not to exceed with respect to livestock and livestock products, $595,000,000, (2) not to exceed with respect to wheat and wheat products, $190,000,000; and (3) not to exceed with respect to butterfat and butter, $100,000,000: Provided, That the amounts authorized to be expended pursuant to section 1 of the Act of June 23, 1945 (Public Law 88, Seventy-ninth Congress), for subsidy payments on meat, butter, and flour shall be reduced correspondingly. Approved July 31, 1945.

[CHAPTER 242-2D SESSION]

[H. R. 2115]

AN ACT

Relating to the domestic raising of fur-bearing animals.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That for the purposes of all classification and administration of Acts of Congress, Executive orders, administrative orders, and regulations pertaining

to

(a) fox, rabbit, mink, chinchilla, marten, fisher, muskrat, karakul and all other fur-bearing animals, raised in captivity for breeding or other useful purposes shall be deemed domestic animals;

(b) such animals and the products thereof shall be deemed agricultural products; and

(c) the breeding, raising, producing, or marketing of such animals or their products by the producer shall be deemed an agricultural pursuit.

SEC. 2. (a) All the functions of the Secretary of the Interior and the Fish and Wildlife Service of the Department of the Interior, which affect the breeding, raising, producing, marketing, or any other phase of the production or distribution, of domestically raised furbearing animals, or products thereof, are hereby transferred to and vested in the Secretary of Agriculture.

(b) Appropriations and unexpended balances of appropriations, or parts thereof, which the Director of the Budget determines to be available for expenditure for the administration of any function transferred by this Act, shall be available for expenditure for the continued administration of such function by the officer to whom such function is so transferred.

(c) All records and property (including office furniture and equipment) under the jurisdiction of the Secretary of the Interior and the Fish and Wildlife Service of the Department of the Interior used primarily in connection with the administration of functions transferred by this Act are hereby transferred to the jurisdiction of the Secretary of Agriculture.

SEC. 3. This Act shall take effect sixty days after the date of its

enactment.

Approved April 30, 1946.

[CHAPTER 459-2D SESSION]

[H. R. 3611]

AN ACT

To authorize the condemnation of materials which are intended for use in process or renovated butter and which are unfit for human consumption, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That section 2325 of the Internal Revenue Code, approved February 10, 1939 (53 Stat. 254), is amended to read as follows:

"SEC. 2325. INSPECTION OF PROCESS OR RENOVATED BUTTER.

"For the purpose of protecting interstate and foreign commerce from process or renovated butter which is unclean, unwholesome, unhealthful, or otherwise unfit for human food

"(a) The Secretary of Agriculture shall, through inspectors appointed by him, cause inspections to be made of all milk, butter, butter oil, and other ingredients intended for use in the manufacture of process or renovated butter. All ingredients which are found to be putrid or decomposed or which contain organic or inorganic substances which are foreign to such ingredients when properly made, manufactured, produced, collected, stored, transported, or handled, and which organic or inorganic substances cannot be removed by processing, shall be deemed unfit for use in the manufacture of process or renovated butter, shall be marked 'U. S. Inspected and Condemned', and shall be denatured or destroyed under the supervision of the inspector. All other ingredients shall be marked U. S. Inspected and Passed', and shall be deemed fit for use in the manufacture of process or renovated butter.

"(b) The Secretary of Agriculture shall cause inspections to be made of all process or renovated butter. If such butter is found to be clean, wholesome, healthful, and otherwise fit for human food, it shall be marked 'U. S. Inspected and Passed'. Process or renovated butter that is found to be unclean, unwholesome, unhealthful, or otherwise unfit for human food shall be denatured or destroyed under the supervision of the inspector.

"(c) The Secretary of Agriculture shall cause inspections to be made of all factories wherein process or renovated butter is manufactured to determine the sanitary conditions thereof, and if it is found that the conditions existing in any such factory do not meet the standards prescribed by the Secretary in his regulations, he shall cause inspection to be withdrawn therefrom.

"(d) The Secretary of Agriculture is authorized to withdraw inspection from any factory wherein process or renovated butter is made, if the manufacturer shall fail to comply with any of the provisions of this section or with any of the rules and regulations prescribed hereunder.