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Chap.

TITLE 21.-FOOD AND DRUGS

13. Drug Abuse Prevention and Control........ 16. Drug Abuse Prevention and Treatment [New]

Sec.

801

1101

Chapter 4.-ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS

§ 114b. Cooperation with Western Hemisphere countries in animal disease control.

The Secretary of Agriculture is authorized to cooperate with the Governments of Mexico, Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Colombia, and Canada in carrying out operations or measures to eradicate, suppress, or control, or to prevent or retard, any communicable disease of animals, including but not limited to foot-and-mouth disease, rinderpest, or screw-worm in such countries where he deems such action necessary to protect the livestock, poultry, and related industries of the United States. In performing the operations or measures authorized in sections 114b to 114d-1 of this title, the Governments of such countries shall be responsible for the authority necessary to carry out such operations or measures on all lands and properties therein and for such other facilities and means as in the discretion of the Secretary of Agriculture are necessary. The measure and character of cooperation carried out under said sections on the part of the United States and on the part of thhe Governments of such countries, including the expenditure or use of funds appropriated pursuant to said sections, shall be such as may be prescribed by the Secretary of Agriculture. Arrangements for the cooperation authorized by said sections shall be made through and in consultation with the Secretary of State. The authority contained in said sections is in addition to and not in substitution for the authority of existing law. (As amended Nov. 5, 1971, Pub. L. 92-152, § 1, 85 Stat. 418.)

AMENDMENTS

1971-Pub. L. 92-152 made the provisions applicable to and authorized cooperation of Secretary of Agriculture with Governments of Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Columbia, and Canada, directed operations and measures to be taken against communicable diseases of animals, and included protection of poultry within its scope.

§ 114c. Same; use of funds for purchase or hire of vehicles and airplanes, printing, and employment of personnel.

For purposes of sections 114b to 114d-1 and section 114a of this title, insofar as sections 114b to 114d-1 of this title relate to diseases which in the opinion of the Secretary constitute an emergency and threaten the livestock industry of the country, funds appropriated pursuant thereto may also be used for the Page 537

purchase or hire of passenger motor vehicles and aircraft, for printing and binding without regard to section 111 of Title 44, for personal services in the District of Columbia and elsewhere without regard to the limitations contained in section 947(g) of Title 5, including the employment of civilian nationals of Mexico, Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Columbia, and Canada, and for the construction and operation of research laboratories, quarantine stations and other buildings and facilities. (As amended Nov. 5, 1971, Pub. L. 92–152, § 2, 85 Stat. 419.)

AMENDMENTS

1971-Pub. L. 92–152 provided for use of funds for employment of civilian nationals of Guatemala, El Salvador, Costa Rica, Honduras, Nicaragua, British Honduras, Panama, Columbia, and Canada.

§§ 114d-2 to 114d-6. Repealed. Pub. L. 92–152, § 3, Nov. 5, 1971, 85 Stat. 419.

Sections, Pub. L. 90-388, §§ 1-5, July 6, 1968, 82 Stat. 294, provided for:

section 114d-2, cooperation with Central America in control and eradication of foot-and-mouth disease or rinderpest, now covered in section 114b of this title; section 114d-3, uses of funds, now covered in section 114c of this title;

section 114d-4, definition of governments of Central America, now listed in sections 114b and 114c of this title;

section 114d-5, cooperation with public and private organizations and individuals, now covered in section 114d-1 of this title; and

section 114d-6, authorization of appropriations, now covered in Appropriations note, set out under section 114b of this title.

§ 129. Expenses for arrest and eradication of contagious or infectious diseases of animals; transfer of appropriations.

The Secretary may transfer from other appropriations or funds available to the agencies or corporations of the Department such sums as he may deem necessary, to be available only in emergencies for the arrest and eradication of foot-and-mouth disease, rinderpest, contagious pleuropneumonia, or other contagious or infectious diseases of animals, or European fowl pest and similar diseases in poultry, and for expenses in accordance with sections 114b and 114c of this title, and any unexpended balances of funds transferred for such emergency purposes in the fiscal year 1972 shall be merged with such transferred amounts. (Pub. L. 92-399, title I, § 101, Aug. 22, 1972, 86 Stat. 594.)

SIMILAR PROVISIONS

Section is from the Agriculture-Environmental and Consumer Protection Appropriation Act, 1973, Pub. L. 92-399. Similar provisions were contained in the following prior appropriation act:

1971-Aug. 10, 1971, Pub. L. 92-73, title I, § 101, 85 Stat. 185.

Chapter 9.-FEDERAL FOOD, DRUG, AND

COSMETIC ACT

§ 321. Definitions; generally.

For the purposes of this chapter

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(q) The term "pesticide chemical" means any substance which, alone, in chemical combination or in formulation with one or more other substances, is "a pesticide" within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.

(As amended Oct. 21, 1972, Pub. L. 92-516, § 3(3), 86 Stat. 998.)

REFERENCES IN TEXT

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in the text, is classified to chapter 6 of Title 7, Agriculture.

1972

AMENDMENTS

Subsec. (q). Pub. L. 92-516 substituted reference to pesticide for reference to economic poison.

EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92-516 effective at the close of Oct. 21, 1972, except if regulations are necessary for the implementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub. L. 92-516, set out as a note under section 136 of Title 7, Agriculture.

SECTION REFERRED TO IN OTHER SECTIONS This section is referred to in title 15 section 2052.

§ 331. Prohibited acts.

The following acts and the causing thereof are prohibited:

(p) The failure to register in accordance with section 360 of this title, the failure to provide any information required by section 360(j) of this title, or the failure to provide a notice required by section 360(j) (2) of this title. (As amended Aug. 16, 1972, Pub. L. 92-387, § 4(e), 86 Stat. 562.)

AMENDMENTS

1972 Subsec. (p). Pub. L. 92-387 added failure to provide information required by section 360 (1) of this title, and failure to provide notice required by section 360 (j) (2) of this title as prohibited acts.

EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92-387 effective on the first day of the sixth month beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set out as a note under section 360 of this title.

§ 332. Injunction proceedings. (a) Jurisdiction of courts.

The district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown, and subject to the provisions of section 381 (relating to notice to opposite party) of Title 28, as amended, to restrain violations of section 331 of this title, except paragraphs (h)-(j) of said section.

§ 346a. Tolerances for pesticide chemicals in or on raw agricultural commodities.

(d) Regulations pursuant to petition; publication of notice; time for issuance; referral to advisory committees; effective date; hearings.

(1) Any person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act may file with the Administrator a petition proposing the issuance of a regulation establishing a tolerance for a pesticide chemical which constitutes, or is an ingredient of, such pesticide, or exempting the pesticide chemical from the requirement of a tolerance. The petition shall contain data showing

(e) Regulations pursuant to Administrator's proposals. The Administrator may at any time, upon his own initiative or upon the request of any interested person, propose the issuance of a regulation establishing a tolerance for a pesticide chemical or exempting it from the necessity of a tolerance. Thirty days after publication of such a proposal, the Administrator may by order publish a regulation based upon the proposal which shall become effective upon publication unless within such thirty-day period a person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act containing the pesticide chemical named in the proposal, requests that the proposal be referred to an advisory committee. In the event of such a request, the Administrator shall forthwith submit the proposal and other relevant data before him to an advisory committee to be appointed in accordance with subsection (g) of this section. As soon as practicable after such referral, but not later than sixty days thereafter, unless extended as hereinafter provided, the committee shall, after independent study of the date submitted to it by the Administrator and other data before it, certify to the Administrator a report and recommendations on the proposal together with all underlying data and a statement of the reasons or basis for the recommendations. The sixty-day period provided for herein may be extended by the advisory committee for an additional thirty days if the advisory committee deems this necessary. Within thirty days after such certification, the Administrator may, after giving due consideration to all data before him, including such report, recommendations, underlying data and statement, by order publish a regulation establishing a tolerance for the pesticide chemical named in the proposal or exempting it from the necessity of a tolerance which shall become effective upon publication. Regulations issued under this subsection shall upon publication be subject to paragraph (5) of subsection (d) of this section.

(g) Advisory committees; appointment; composition; compensation; clerical assistance.

Whenever the referral of a petition or proposal to an advisory committee is requested under this section, or the Administrator otherwise deems such

referral necessary the Administrator shall forthwith appoint a committee of competent experts to review the petition or proposal and to make a report and recommendations thereon. Each such advisory committee shall be composed of experts, qualified in the subject matter of the petition and of adequately diversified professional background selected by the National Academy of Sciences and shall include one or more representatives from landgrant colleges. The size of the committee shall be determined by the Administrator. Members of an advisory committee shall receive compensation and travel expenses in accordance with section 376 (b) (5) (D) of this title. The members shall not be subject to any other provisions of law regarding the appointment and compensation of employees of the United States. The Administrator shall furnish the committee with adequate clerical and other assistance, and shall by rules and regulations prescribe the procedure to be followed by the committee.

(1) Pesticides under Federal Insecticide, Fungicide, and Rodenticide Act; functions of Administrator of the Environmental Protection Agency; certifications; hearing; time limitation; opinion; regulations.

The Administrator, upon request of any person who has registered, or who has submitted an application for the registration of, a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act, and whose request is accompanied by a copy of a petition filed by such person under subsection (d) (1) of this section with respect to a pesticide chemical which constitutes, or is an ingredient of, such pesticide, shall, within thirty days or within sixty days if upon notice prior to the termination of such thirty days the Administrator deems it necessary to postpone action for such period, on the basis of data before him, either

(As amended Nov. 18, 1971, Pub. L. 92-157, title III, § 303 (a), 85 Stat. 464; Oct. 21, 1972, Pub. L. 92-516, §3(3), 86 Stat. 998.)

REFERENCES IN TEXT

The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in the text, is classified to chapter 6 of Title 7, Agriculture.

AMENDMENTS

1972 Subsecs. (d) (1), (e), (1). Pub. L. 92-516 substituted references to pesticide for references to economic poison wherever appearing therein.

1971-Subsec. (g). Pub. L. 92-157 struck out ", which the Secretary shall by rules and regulations prescribe," appearing following "as compensation for their services a reasonable per diem" prior to amendment in 1970, by Pub. L. 91-515, which overlooked such language when amending subsec. (g) as provided in 1970 Amendment note.

EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92-516 effective at the close of Oct. 21, 1972, except if regulations are necessary for the implementation of any provision that becomes effective on Oct. 21, 1972, and continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516 and regulations thereunder, see section 4 of Pub. L. 92-516, set out as a note under section 136 of Title 7, Agriculture.

§ 355. New drugs.

(e) Withdrawal of approval; grounds; immediate suspension upon finding imminent hazard to public health.

The Secretary shall, after due notice and opportunity for hearing to the applicant, withdraw approval of an application with respect to any drug under this section if the Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; (2) that new evidence of clinical experience, not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved; or (3) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement of a material fact: Provided, That if the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the public health, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this proviso to suspend the approval of an application shall not be delegated. The Secretary may also, after due notice and opportunity for hearing to the applicant, withdraw the approval of an application with respect to any drug under this section if the Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with a regulation or order under subsection (j) of this section or to comply with the notice requirements of section 360 (j) (2) of this title, or the applicant has refused to permit access to, or copying or verification of, such records as required by paragraph (2) of such subsection; or (2) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its identity, strength, quality, and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or (3) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is

false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. Any order under this subsection shall state the findings upon which it is based.

(As amended Aug. 16, 1972, Pub. L. 92-387, § 4(d), 86 Stat. 562.)

AMENDMENTS

1972 Subsec. (e). Pub. L. 92-387 inserted "or to comply with the notice requirements of section 360(j) (2) of this title" in clause (1) of the second sentence relating to the maintenance of records.

EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92-387 effective on the first day of the sixth month beginning after Aug. 16, 1972, see section 5 of Pub. L. 92-387, set out as a note under section 360 of this title.

§ 357. Certification of drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug.

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(e) Exempted new drugs subject to section 355 of this title; request for certification of exempted drug; determination of compliance with sections 351(b) and 352(g) of this title.

No drug which is subject to this section shall be deemed to be subject to any provision of section 355 of this title except a new drug exempted from the requirements of this section and of section 352(1) of this title pursuant to regulations promulgated by the Secretary: Provided, That, for purposes of section 355 of this title, the initial request for certification, as thereafter duly amended, pursuant to this section, of a new drug so exempted shall be considered a part of the application filed pursuant to section 355 (b) of this title with respect to the person filing such request and to such drug of the date of the exemption, Compliance of any drug subject to section 352 (1) of this title or this section with sections 351(b) and 352(g) of this title 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 this section.

§ 360. Registration of drug producers.

(e) Registration number.

The Secretary may assign a registration number to any person or any establishment registered in accordance with this section. The Secretary may also assign a listing number to each drug or class of drugs listed under subsection (j) of this section. Any number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code.

(f) Availability of registrations for inspection.

The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this section; except that any list submitted pursuant to paragraph (3) of subsection (j) of this section and the information accompanying any list or notice filed under paragraph (1) or (2) of that subsection shall be exempt from such inspec

tion unless the Secretary finds that such an exemption would be inconsistent with protection of the public health.

(i) Foreign establishments.

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 require such establishment to provide the information required by subsection (j) of this section and 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 381 of this title.

(j) Filing of list of drugs manufactured, prepared, propagated and compounded by registrants.

(1) Every person who registers with the Secretary under subsection (b), (c), or (d) of this section shall, at the time of registration under any such subsection, file with the Secretary a list of all drugs (by established name (as defined in section 352(e) of this title) and by any proprietary name) which are being manufactured, prepared, propagated, compounded, or processed by him for commercial distribution and which he has not included in any list of drugs filed by him with the Secretary under this paragraph or paragraph (2) before such time of registration. Such list shall be prepared in such form and manner as the Secretary may prescribe and shall be accompanied by

(A) in the case of a drug contained in such list and subject to sections 355, 356, 357, or 360b of this title, a reference to the authority for the marketing of such drug and a copy of all labeling for such drug;

(B) in the case of any other drug contained in such list

(i) which is subject to section 353(b)(1) of this title, a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or

(ii) which is not subject to section 353 (b) (1) of this title, the label and package insert for such drug and a representative sampling of any other labeling for such drug;

(C) in the case of any drug contained in such list which is described in subparagraph (B), a quantitative listing of its active ingredient or ingredients, except that with respect to a particular drug product the Secretary may require the submission of a quantitative listing of all ingredients if he finds that such submission is necessary to carry out the purposes of this chapter; and

(D) if the registrant filing the list has determined that a particular drug product contained

in such list is not subject to section 355, 356, 357, or 360b of this title, a brief statement of the basis upon which the registrant made such determination if the Secretary requests such a statement with respect to that particular drug product.

(2) Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following information:

(A) A list of each drug introduced by the registrant for commercial distribution which has not been included in any list previously filed by him with the Secretary under this subparagraph or paragraph (1) of this subsection. A list under this subparagraph shall list a drug by its established name (as defined in section 352(e) of this title), and by any proprietary name it may have and shall be accompanied by the other information required by paragraph (1).

(B) If since the date the registrant last made a report under this paragraph (or if he has not made a report under this paragraph, since the effective date of this subsection) he has discontinued the manufacture, preparation, propagation, compounding, or processing for commercial distribution of a drug included in a list filed by him under subparagraph (A) or paragraph (1); notice of such discontinuance, the date of such discontinuance, and the identity (by established name (as defined in section 352(e) of this title) and by any proprietary name) of such drug.

(C) If since the date the registrant reported pursuant to subparagraph (B) a notice of discontinuance he has resumed the manufacture, preparation, propagation, compounding, or processing for commercial distribution of the drug with respect to which such notice of discontinuance was reported; notice of such resumption, the date of such resumption, the identity of such drug (by established name (as defined in section 352(e) of this title) and by any proprietary name), and the other information required by paragraph (1), unless the registrant has previously reported such resumption to the Secretary pursuant to this subparagraph.

(D) Any material change in any information previously submitted pursuant to this paragraph or paragraph (1).

(3) The Secretary may also require each registrant under this section to submit a list of each drug product which (A) the registrant is manufacturing, preparing, propagating, compounding, or processing for commercial distribution, and (B) contains a particular ingredient. The Secretary may not require the submission of such a list unless he has made a finding that the submission of such a list is necessary to carry out the purposes of this chapter. (As amended Aug. 16, 1972, Pub. L. 92-387, §§ 3, 4(a)(c), 86 Stat. 560-562.)

REFERENCES IN TEXT

Effective date of this subsection, referred to in subsec. (1) (2) (B), means the effective date of 1972 Amendment. See effective date of 1972 amendment note below.

AMENDMENTS

1972 Subsec. (e). Pub. L. 92-387, § 4(a), added provision that the Secretary may assign a listing number to each drug or class of drugs listed under subsec. (J).

Subsec. (f). Pub. L. 92-387, § 4(b), added exception that the list submitted under subsec. (j) (3) and information submitted under subsec. (J) (1), (2) shall be exempt from inspection unless the Secretary determines otherwise.

Subsec. (1). Pub. L. 92-387, § 4(c), added provision that the regulations shall require such establishment to provide the information required by subsec. (J).

Subsec. (J). Pub. L. 92-387, § 3, added subsec. (j).

EFFECTIVE DATE OF 1972 AMENDMENT

Section 5 of Pub. L. 92-387 provided that: "The amendments made by this Act [amending this section and sections 331 and 335 of this title and enacting provisions set out as notes under this section] shall take effect on the first day of the sixth month beginning after the date of enactment of this Act [Aug. 16, 1972]."

SHORT TITLE

Section 1 of Pub. L. 92-387 provided that: "This Act [amending this section and sections 331 and 335 of this title and enacting provisions set out as notes under this section] may be cited as the 'Drug Listing Act of 1972'."

DECLARATION OF POLICY OF DRUG LISTING ACT OF 1972 Section 2 of Pub. L. 92-387 provided that: "The Federal Government which is responsible for regulating drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act [this chapter] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement of Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507 [section 355 or 357 of this title], or to other provisions of the Federal Food, Drug, and Cosmetic Act [this chapter]."

Chapter 10.-POULTRY AND POULTRY PRODUCTS INSPECTION

§ 451. Congressional statement of findings.

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in title 15 section 2052.

§ 467d. Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts.

For the efficient administration and enforcement of this chapter, the provision (including penalties) of sections 46, 48, 49 and 50 of Title 15 (except paragraphs (c) through (h) of section 46 of Title 15 and the last paragraph of section 49 of Title 15), and the provisions of section 409(1) of Title 47, are made applicable to the jurisdiction, powers, and duties of the Secretary in administering and enforcing the provisions of this chapter and to any person with respect to whom such authority is exercised. The Secretary, in person or by such agents as he may designate, may prosecute any inquiry necessary to his duties under this chapter in any part of the United States, and the powers conferred by said sections 49 and 50 of Title 15 on the district courts of the United

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