US State Code:United States CodeTITLE 21 - FOOD AND DRUGS


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No person or persons, company or corporation, shall introduce into any State or Territory of the United States or the District of Columbia from any other State or Territory of...


If any person or persons violate the provisions of section 16 of this title, either in person or through another, he shall be guilty of a misdemeanor and shall be punished by a...


Whenever the President is satisfied that there is good reason to believe that any importation is being made, or is about to be made, into the United States, from any foreign...


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The standard grades for apples when packed in barrels which shall be shipped or delivered for shipment in interstate or foreign commerce, or which shall be sold or offered for...


The barrels in which apples are packed in accordance with the provisions of sections 20 to 23 of this title may be branded in accordance with the provisions of section 20 of...


Barrels packed with apples shall be deemed to be misbranded within the meaning of sections 20 to 23 of this title - First. If the barrel bears any statement, design, or device ...


Any person, firm or corporation, or association who shall knowingly pack or cause to be packed apples in barrels or who shall knowingly sell or offer for sale such barrels...


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All articles known as oleomargarine, butterine, imitation, process, renovated, or adulterated butter, or imitation cheese, or any substance in the semblance of butter or cheese...


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Whenever used in this chapter - (a) The term ''person'' includes an individual, partnership, corporation, or association; (b) The term ''interstate or foreign commerce''...


It is declared that filled milk, as defined in section 61 of this title, is an adulterated article of food, injurious to the public health, and its sale constitutes a fraud upon...


Any person violating any provision of this chapter shall upon conviction thereof be subject to a fine of not more than $1,000 or imprisonment of not more than one year, or both....


The Secretary of Health and Human Services is authorized and directed to make and enforce such regulations as may in his judgment be necessary to carry out the purposes of...


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Whenever, in the opinion of the President, it shall be necessary for the protection of animals in the United States against infectious or contagious diseases, he may, by...


The Secretary of Agriculture is authorized, at the expense of the owner, to place and retain in quarantine all neat cattle, sheep, and other ruminants, and all swine, imported...


The importation of all animals described in this subchapter into any port in the United States, except such as may be designated by the Secretary of Agriculture, with the approval...


(a) In general The Secretary of Agriculture may by regulation prohibit or restrict the importation or entry of any cattle, sheep, or other ruminants, or swine, that are...


The Secretary of Agriculture may cause careful inspection of any imported animals described in this subchapter, to ascertain whether such animals are infected with contagious...


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The Secretary of Agriculture shall have authority to make such regulations and take such measures as he may deem proper to prevent the introduction or dissemination of the...


In order to promote the exportation of livestock and/or live poultry from the United States the Secretary of Agriculture shall make special investigation as to the existence...


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In order to prevent the exportation from any port of the United States to any port in a foreign country of livestock and/or live poultry affected with any contagious, infectious,...


The Secretary of Agriculture is authorized to establish research laboratories, including the acquisition of necessary land, buildings, or facilities, and also the making of...


It shall be the duty of the Secretary of Agriculture to prepare such rules and regulations as he may deem necessary for the speedy and effectual suppression and extirpation...


The Secretary of Agriculture, either independently or in cooperation with States or political subdivisions thereof, farmers' associations and similar organizations, and...


Domestic animals which have reacted to a test recognized by the Secretary of Agriculture for paratuberculosis or which, never having been vaccinated for brucellosis, have reacted to...


The Secretary of Agriculture is authorized to cooperate with the Governments of foreign countries, and with foreign or international organizations or associations in carrying...


For purposes of sections 114a, and 114b to 114d-1 of this title, insofar as sections 114b to 114d-1 of this title relate to diseases which in the opinion of the Secretary...


(a) In general Notwithstanding section 114b of this title, the Secretary of Agriculture may, independently or in cooperation with any foreign government or any...


In carrying out sections 114b to 114d-1 of this title the Secretary of Agriculture is further authorized to cooperate with other public and private organizations and individuals. ...


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In order to protect, promote, and conserve livestock and livestock products and to minimize losses, the Secretary of Agriculture, either independently or in cooperation with...


As used in section 114e of this title, the term ''State'' includes the District of Columbia and the Territories and possessions of the United States. There is authorized to be ...


In order to safeguard the health of the swine herds of the Nation, to prevent the spread of hog cholera, to decrease substantially the estimated $50,000,000 annual loss from hog ...


(a) Establishment; membership The Secretary of Agriculture is authorized and directed to establish an advisory committee composed of (1) eleven members selected...


(a) Findings Congress finds that efforts to eradicate pseudorabies in United States swine populations by the Department of Agriculture in cooperation with State agencies and...


No railroad company within the United States, or the owners or masters of any steam or sailing or other vessel or boat, shall receive for transportation or transport from one State...


Cattle which have reacted to the tuberculin test may be shipped, transported, or moved from one State, Territory, or the District of Columbia to any other State, Territory, or...


(a) Criminal penalty Any person or persons operating any railroad, or master or owner of any boat or vessel, or owner or custodian of, or person having control over, cattle...


It shall be the duty of the several United States attorneys to prosecute all violations of this Act which shall be brought to their notice or knowledge by any person making...


The Secretary of Agriculture is authorized to appoint two competent agents, who shall be practical stock raisers or experienced business men familiar with questions pertaining to ...


In order to enable the Secretary of Agriculture to effectually suppress and extirpate contagious pleuropneumonia, foot-and-mouth disease, and other dangerous contagious,...


Whenever any inspector or assistant inspector of the Bureau of Animal Industry shall issue a certificate showing that such officer had inspected any cattle or other livestock...


Any person, company, or corporation knowingly violating the provisions of this Act or the orders or regulations made in pursuance thereof shall be guilty of a misdemeanor, and on ...


The Secretary of Agriculture is authorized to quarantine by regulation any State or Territory or the District of Columbia, or any portion of any State or Territory or the District...


No railroad company or the owners or masters of any steam or sailing or other vessel or boat shall receive for transportation or transport from any quarantined State or Territory...


It shall be the duty of the Secretary of Agriculture, and he is authorized and directed, when the public safety will permit, to make and promulgate rules and regulations which...


Quarantined animals and/or live poultry may be moved from a quarantined State or Territory or the District of Columbia, or from the quarantined portion of any State or Territory...


Any person, company, or corporation violating the provisions of sections 124 or 126 of this title shall be guilty of a misdemeanor, and on conviction shall be punished by a fine...


The provisions of sections 123 to 127 of this title shall apply to any railroad company or other common carrier whose road or line forms any part of a route over which...


In emergencies which threaten any segment of the agricultural production industry of this country, the Secretary may transfer from other appropriations or funds available to...


The Secretary of Agriculture may, in connection with emergencies which threaten any segment of the agricultural production industry of this country, transfer from other...


Whenever any contagious, infectious, or communicable disease affecting domestic animals, and especially the disease known as pleuropneumonia, shall be brought into or shall break...


The Secretary of Agriculture may permit the erection of fences along international boundary lines, but entirely within the territory of the United States, for the purpose of...


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As used in this Act unless the context indicates otherwise - (a) The term ''Secretary'' means the Secretary of Agriculture. (b) The term ''animals'' means all members of...


(a) Authority of Secretary The Secretary, whenever he deems it necessary in order to guard against the introduction or dissemination of a communicable disease of livestock...


The Secretary, in order to protect the health of the livestock or poultry of the Nation, may promulgate regulations requiring that railway cars; vessels; airplanes; trucks; and...


The Secretary is authorized to promulgate regulations prohibiting or regulating the movement into the United States of any animals which are or have been affected with or exposed...


Employees of the Department of Agriculture designated by the Secretary for the purpose, when properly identified, shall have authority (1) to stop and inspect, without a warrant,...


(a) Criminal and civil penalties (1) Whoever knowingly violates any regulation promulgated pursuant to the provisions of sections 134 through 134d of this title shall be...


The Secretary is authorized to issue such regulations as he deems necessary to carry out the provisions of this Act. ...


The authority conferred by this Act shall be in addition to authority conferred by other statutes. Any provision of any other Act inconsistent with the provisions of this Act...


If any provision of this Act or application thereof to any person or circumstances is held invalid, the remainder of the Act and the application of such provision to other persons...


The Secretary of Agriculture is authorized, in his discretion, to establish and maintain an international animal quarantine station within the territory of the United States....


(a) Criminal penalty The provisions and penalties of section 545 of title 18 shall apply to the bringing of animals to the quarantine station or the subsequent movement of...


There are hereby authorized to be appropriated such sums as are necessary to carry out the provisions of sections 135 to 135b of this title. ...


The Secretary of Agriculture, in carrying out regulations prohibiting or restricting the entry of materials that may harbor pests, or diseases, is authorized to enter into...


(a) Quarantine and inspection fees (1) Fees authorized The Secretary of Agriculture may prescribe and collect fees sufficient - (A) to cover the cost of...


On and after May 16, 1927, the importation into the United States of milk and cream is prohibited unless the person by whom such milk or cream is shipped or transported into...


Milk or cream shall be considered unfit for importation (1) when all cows producing such milk or cream are not healthy and a physical examination of all such cows has not been...


The Secretary of Health and Human Services shall cause such inspections to be made as are necessary to insure that milk and cream are so produced and handled as to comply with...


It shall be unlawful for any person in the United States to receive milk or cream imported into the United States unless the importation is in accordance with the provisions of this ...


Any person who knowingly violates any provision of this subchapter shall, in addition to all other penalties prescribed by law, be punished by a fine of not less than $50 nor...


There is authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, the sum of $50,000 per annum, to enable the Secretary of Health and...


Any laws or parts of laws inconsistent with this subchapter are repealed. ...


Nothing in this subchapter is intended nor shall be construed to affect the powers of any State, or any political subdivision thereof, to regulate the shipment of milk or cream...


When used in this subchapter - (a) The term ''person'' means an individual, partnership, association, or corporation. (b) The term ''United States'' means the fifty States...


It shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia, or in the Territories, or in any place under...


The importation into the United States of any virus, serum, toxin, or analogous product for use in the treatment of domestic animals, and the importation of any...


The Secretary of Agriculture is authorized to cause the Bureau of Animal Industry to examine and inspect all viruses, serums, toxins, and analogous products, for use in the...


The Secretary of Agriculture is authorized to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter,...


In order to meet an emergency condition, limited market or local situation, or other special circumstance (including production solely for intrastate use under a...


The Secretary of Agriculture is authorized to issue permits for the importation into the United States of viruses, serums, toxins, and analogous products, for use in the treatment...


All licenses issued under authority of this chapter to establishments where such viruses, serums, toxins, or analogous products are prepared for sale, barter, exchange, or...


Any officer, agent, or employee of the Department of Agriculture duly authorized by the Secretary of Agriculture for the purpose may, at any hour during the daytime or...


Any person, firm, or corporation who shall violate any of the provisions of this chapter shall be deemed guilty of a misdemeanor, and shall, upon conviction, be punished by a fine...


The procedures of sections 672, 673, and 674 of this title (relating to detentions, seizures and condemnations, and injunctions, respectively) shall apply to the enforcement of this ...


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It shall be unlawful in the consular districts of the United States in China for any person whose permanent allegiance is due to the United States not licensed as a pharmacist...


Nothing in section 201 of this title shall be construed to interfere with any recognized and reputable practitioner of medicine, dentistry, or veterinary surgery in the...


Every person whose permanent allegiance is due to the United States desiring to practice as a pharmacist in the consular districts in China shall file with the consul an...


If the applicant for license as a pharmacist has complied with the requirements of section 203 of this title, the consul shall issue to him a license which shall entitle him...


Every license to practice pharmacy shall be conspicuously displayed by the person to whom the same has been issued in the pharmacy, drug store, or place of business, if any, of...


The license of any person whose permanent allegiance is due to the United States to practice pharmacy in the consular districts of the United States in China may be revoked by...


It shall be unlawful for any person, firm, or corporation whose permanent allegiance is due to the United States, either personally or by servant or agent or as the servant or...


The provisions of section 207 of this title shall not apply to preparations containing not more than two grains of opium or not more than one-quarter grain of morphine, or not...


It shall be unlawful for any person, firm, or corporation whose permanent allegiance is due to the United States to sell or deliver to any other person any of the...


It shall be unlawful for any person whose permanent allegiance is due to the United States, not legally licensed as a pharmacist, to take, use, or exhibit the title of pharmacist,...


Every person, firm, or corporation whose permanent allegiance is due to the United States owning, partly owning, or managing a drug store or pharmacy shall keep in his place...


Any person, firm, or corporation, whose permanent allegiance is due to the United States, violating any of the provisions of this chapter shall be deemed guilty of a misdemeanor...


No person, firm, or corporation whose permanent allegiance is due to the United States seeking to procure in the consular districts of the United States in China any substance...


Nothing in this chapter shall be construed as modifying or revoking any of the provisions of sections 191 to 193 (FOOTNOTE 1) of this title. (FOOTNOTE 1) See References in...


The word ''consul'' as used in this chapter shall mean the consular officer in charge of the district concerned. ...


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This chapter may be cited as the Federal Food, Drug, and Cosmetic Act. ...


For the purposes of this chapter - (a)(1) The term ''State'', except as used in the last sentence of section 372(a) of this title, means any State or Territory of the ...


For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) ''butter'' shall be understood to mean the food product usually known as...


The word ''package'' where it occurs the second and last time in the act entitled ''An act to amend section 8 of an act entitled, 'An act for preventing the manufacture, sale,...


For the purposes of the Federal Food, Drug, and Cosmetic Act of June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) (21 U.S.C. 301 et seq.) nonfat dry milk is the product resulting...


The following acts and the causing thereof are prohibited: (a) The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that...


(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 (FOOTNOTE 1)...


(a) Violation of section 331 of this title; second violation; intent to defraud or mislead (1) Any person who violates a provision of section 331 of this title shall...


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(a) Grounds and jurisdiction (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held...


Before any violation of this chapter is reported by the Secretary to any United States attorney for institution of a criminal proceeding, the person against whom such proceeding...


(a) Mandatory debarment (1) Corporations, partnerships, and associations If the Secretary finds that a person other than an individual has been convicted, after May...


(a) In general Any person that the Secretary finds - (1) knowingly made or caused to be made, to any officer, employee, or agent of the Department of Health and Human ...


(a) In general The Secretary - (1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, ...


Nothing in this chapter shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel or injunction proceedings, minor violations of...


(a) Except as provided in subsection (b) of this section, all such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of...


Whenever in the judgment of the Secretary such action will promote honesty and fair dealing in the interest of consumers, he shall promulgate regulations fixing and establishing...


A food shall be deemed to be adulterated - (a) Poisonous, insanitary, etc., ingredients (1) If it bears or contains any poisonous or deleterious substance which may render...


A food shall be deemed to be misbranded - (a) False or misleading label If (1) its labeling is false or misleading in any particular, or (2) in the case of a food to...


(a) Except as provided in subsection (b) of this section, no State or political subdivision of a State may directly or indirectly establish under any authority or continue in...


(a) In general A publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article and...


(a) No provision of section 321(n), 343(a), or 348 of this title shall be construed to require on the label or labeling of a food a separate radiation disclosure statement that...


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(a) Conditions on manufacturing, processing, etc., as health measure Whenever the Secretary finds after investigation that the distribution in interstate commerce of any...


The Secretary shall promulgate regulations exempting from any labeling requirement of this chapter (1) small open containers of fresh fruits and fresh vegetables and (2) food...


Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice...


(a) Requirement for tolerance or exemption (1) General rule Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed...


There are authorized to be appropriated, out of any moneys in the Treasury not otherwise appropriated, such sums as may be necessary for the purpose and administration of...


(a) Law governing Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to...


The Congress finds and declares that the sale, or the serving in public eating places, of colored oleomargarine or colored margarine without clear identification as such or which...


Nothing in this Act shall be construed as authorizing the possession, sale, or serving of colored oleomargarine or colored margarine in any State or Territory in contravention of...


(a) Unsafe food additives; exception for conformity with exemption or regulation A food additive shall, with respect to any particular use or intended use of such...


(a) Except as provided in subsection (b) of this section, whenever the Administrator of the Environmental Protection Agency prescribes interim or revised national primary...


(a) Authority and limitations of Secretary; applicability (1) Except as provided in paragraph (2) - (A) the Secretary may not establish, under section 321(n), 341, or 343...


(a) Adulteration An infant formula, including an infant formula powder, shall be deemed to be adulterated if - (1) such infant formula does not provide nutrients as required ...


(a) In general A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 342(f) of this title unless it meets one of the...


A drug or device shall be deemed to be adulterated - (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture (1) If it consists in whole or in part...


A drug or device shall be deemed to be misbranded - (a) False or misleading label If its labeling is false or misleading in any particular. Health care economic...


(a) Regulations for goods to be processed, labeled, or repacked elsewhere The Secretary is directed to promulgate regulations exempting from any labeling or...


(a) In general Sections 351(a)(2)(B), 352(f)(1), and 355 of this title shall not apply to a drug product if the drug product is compounded for an identified individual...


(a) Lawful veterinary feed directive requirement (1) A drug intended for use in or on animal feed which is limited by an approved application filed pursuant to section 360b(b) of ...


(a) Necessity of effective approval of application No person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an ...


(a) Definitions As used in this section, the term ''pediatric studies'' or ''studies'' means at least one clinical investigation (that, at the Secretary's discretion, may...


(a) Toll-free number in labeling Not later than one year after January 4, 2002, the Secretary of Health and Human Services shall promulgate a final rule requiring that...


(a) Designation of drug as fast track product (1) In general The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite...


(a) In general With respect to a drug for which there is in effect an approved application under section 355 or 360b of this title or a license under section 262 of title 42,...


(a) Submission (1) In general A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to...


(a) In general A manufacturer that is the sole manufacturer of a drug - (1) that is - (A) life-supporting; (B) life-sustaining; or (C) intended...


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(a) Necessity or desirability; use in official compendiums; infringement of trademarks The Secretary may designate an official name for any drug or device if he...


This subchapter, as amended by the Drug Amendments of 1962, shall not apply to any cosmetic unless such cosmetic is also a drug or device or component thereof. ...


(a) Definitions As used in this section - (1) the term ''manufacture, preparation, propagation, compounding, or processing'' shall include repackaging or ...


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(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances (1) A new animal drug...


(a) Classes of devices (1) There are established the following classes of devices intended for human use: (A) Class I, General Controls. - (i) A device for which...


(a) Reasonable assurance of safe and effective performance; periodic evaluation (1) The special controls required by section 360c(a)(1)(B) of this title shall...


(a) General requirement A class III device - (1) which is subject to a regulation promulgated under subsection (b) of this section; or (2) which is a class...


(a) General rule Whenever the Secretary finds, on the basis of all available data and information, that - (1) a device intended for human use presents substantial ...


(a) Petition; record Not later than thirty days after - (1) the promulgation of a regulation under section 360c of this title classifying a device in class I or...


(a) Notification If the Secretary determines that - (1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for ...


(a) General rule Every person who is a manufacturer or importer of a device intended for human use shall establish and maintain such records, make such reports, and provide...


(a) General rule Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device...


(a) General rule Except as provided in subsection (b) of this section, no State or political subdivision of a State may establish or continue in effect with respect to a...


(a) In general The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device...


(a) In general (1) Review and classification of devices Not later than 1 year after November 21, 1997, the Secretary shall, subject to paragraph (3), accredit persons...


(a) Request by sponsor; response by Secretary The sponsor of a drug for a disease or condition which is rare in the States may request the Secretary to provide written ...


(a) Request by sponsor; preconditions; ''rare disease or condition'' defined (1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as...


(a) Exclusive approval, certification, or license Except as provided in subsection (b) of this section, if the Secretary - (1) approves an application filed pursuant...


If a drug is designated under section 360bb of this title as a drug for a rare disease or condition and if notice of a claimed exemption under section 355(i) of this title...


(a) Authority of Secretary The Secretary may make grants to and enter into contracts with public and private entities and individuals to assist in (1) defraying the costs...


As used in this part - (1) the term ''electronic product radiation'' means - (A) any ionizing or non-ionizing electromagnetic or particulate radiation, or ...


(a) Establishment The Secretary shall establish and carry out an electronic product radiation control program designed to protect the public health and safety from...


(a) Report to Congress The Secretary shall conduct the following studies, and shall make a report or reports of the results of such studies to the Congress on or before January...


(a) Promulgation of regulations (1) The Secretary shall by regulation prescribe performance standards for electronic products to control the emission of electronic...


(a) Notification; exemption (1) Every manufacturer of electronic products who discovers that an electronic product produced, assembled, or imported by him has a defect...


(a) Refusal of admission to noncomplying electronic products Any electronic product offered for importation into the United States which fails to comply with an applicable...


(a) Inspection of premises If the Secretary finds for good cause that the methods, tests, or programs related to electronic product radiation safety in a particular...


(a) It shall be unlawful - (1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or to import into the United States, any...


(a) Jurisdiction of courts The district courts of the United States shall have jurisdiction, for cause shown, to restrain violations of section 360oo of this title and to...


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The Secretary is authorized (1) to accept from State and local authorities engaged in activities related to health or safety or consumer protection, on a reimbursable basis...


Whenever any standard prescribed pursuant to section 360kk of this title with respect to an aspect of performance of an electronic product is in effect, no State or...


(a) In general Notwithstanding sections 331(d), 352(f), and 355 of this title, and section 262 of title 42, a manufacturer may disseminate to - (1) a health...


(a) Authorized information A manufacturer may disseminate information under section 360aaa of this title on a new use only if the information - (1) is in the form of...


(a) In general A manufacturer may disseminate information under section 360aaa of this title on a new use only if the manufacturer prepares and submits to the Secretary...


(a) In general A manufacturer may disseminate information under section 360aaa of this title on a new use only if - (1)(A) the manufacturer has submitted to the Secretary a ...


(a) Postdissemination data regarding safety and effectiveness (1) Corrective actions With respect to data received by the Secretary after the dissemination of...


For purposes of this part: (1) The term ''health care practitioner'' means a physician, or other individual who is a provider of health care, who is licensed under the...


(a) Unsolicited request Nothing in section 360aaa of this title shall be construed as prohibiting a manufacturer from disseminating information in response to an...


(a) Emergency situations The Secretary may, under appropriate conditions determined by the Secretary, authorize the shipment of investigational drugs or investigational...


If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act (42 U.S.C. 262), there is a scientific controversy between...


(a) Request A person who submits an application or submission (including a petition, notification, and any other similar form of request) under this chapter for a product,...