r/title-21-FOOD-AND-DRUGS wiki — defined terms

“requestor” applies in that section

The terms “requestor” and “sponsor” have the meanings given such terms in section 355h of this title .

“sponsor” applies in that section

The terms “requestor” and “sponsor” have the meanings given such terms in section 355h of this title .

“Tier 1 OTC monograph order request” applies throughout its subpart

The term “Tier 1 OTC monograph order request” means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request. (9);

“Tier 2 OTC monograph order request” applies throughout its subpart

The term “Tier 2 OTC monograph order request” means, subject to subparagraph (B), an OTC monograph order request for— (i) the reordering of existing information in the drug facts label of an OTC monograph drug; (ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations); (iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 355h(c)(3)(A) of this title ; (iv) the standardization of the concentration or dose of a specific …

“drug” applies in that section

the term “drug” includes drugs for human use as well as biologicals under section 262 of title 42 or the Act of March 4, 1913 ( 37 Stat. 832–833 ) (commonly known as the Virus-Serum Toxin Act). (i) Exportation Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the insulin and antibiotic drugs meet the requirements of section 381(e)(1) of this title .

“importer” applies in that section

The term “importer” means a pharmacist or wholesaler. (2) Pharmacist

“pharmacist” applies in that section

The term “pharmacist” means a person licensed by a State to practice pharmacy, including the dispensing and selling of prescription drugs. (3) Prescription drug

“prescription drug” applies in that section

The term “prescription drug” means a drug subject to section 353(b) of this title , other than— (A) a controlled substance (as defined in section 802 of this title ); (B) a biological product (as defined in section 262 of title 42 ); (C) an infused drug (including a peritoneal dialysis solution); (D) an intravenously injected drug; (E) a drug that is inhaled during surgery; or (F) a drug which is a parenteral drug, the importation of which pursuant to subsection (b) is determined by the Secretary to pose a threat to the public health, in which case section 381(d)(1) of this title shall continue to apply. (4) Qualifying laboratory

“qualifying laboratory” applies in that section

The term “qualifying laboratory” means a laboratory in the United States that has been approved by the Secretary for the purposes of this section. (5) Wholesaler (A) In general

“wholesaler” applies in that section

The term “wholesaler” means a person licensed as a wholesaler or distributor of prescription drugs in the United States under section 353(e)(2)(A) of this title . (B) Exclusion The term “wholesaler” does not include a person authorized to import drugs under section 381(d)(1) of this title . (b) Regulations The Secretary, after consultation with the United States Trade Representative and the Commissioner of U.S. Customs and Border Protection, shall promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.

“importer” applies in that section

the term “importer” means, with respect to an article of food— (A) the United States owner or consignee of the article of food at the time of entry of such article into the United States; or (B) in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States. (b) Guidance Not later than 1 year after January 4, 2011 , the Secretary shall issue guidance to assist importers in developing foreign supplier verification programs.

“importer” applies in that section

the term “importer” means the person that brings food, or causes food to be brought, from a foreign country into the customs territory of the United States.

“accreditation body” applies in that section

The term “accreditation body” means an authority that performs accreditation of third-party auditors. (3) Third-party auditor

“accredited third-party auditor” applies in that section

The term “accredited third-party auditor” means a third-party auditor accredited by an accreditation body to conduct audits of eligible entities to certify that such eligible entities meet the applicable requirements of this section. An accredited third-party auditor may be an individual who conducts food safety audits to certify that eligible entities meet the applicable requirements of this section. (5) Consultative audit

“audit agent” applies in that section

The term “audit agent” means an individual who is an employee or agent of an accredited third-party auditor and, although not individually accredited, is qualified to conduct food safety audits on behalf of an accredited third-party auditor. (2) Accreditation body

“consultative audit” applies in that section

The term “consultative audit” means an audit of an eligible entity— (A) to determine whether such entity is in compliance with the provisions of this chapter and with applicable industry standards and practices; and (B) the results of which are for internal purposes only. (6) Eligible entity

“eligible entity” applies in that section

The term “eligible entity” means a foreign entity, including a foreign facility registered under section 350d of this title , in the food import supply chain that chooses to be audited by an accredited third-party auditor or the audit agent of such accredited third-party auditor. (7) Regulatory audit

“regulatory audit” applies in that section

The term “regulatory audit” means an audit of an eligible entity— (A) to determine whether such entity is in compliance with the provisions of this chapter; and (B) the results of which determine— (i) whether an article of food manufactured, processed, packed, or held by such entity is eligible to receive a food certification under section 381(q) of this title ; or (ii) whether a facility is eligible to receive a facility certification under section 384b(a) of this title for purposes of participating in the program under section 384b of this title .

“third-party auditor” applies in that section

The term “third-party auditor” means a foreign government, agency of a foreign government, foreign cooperative, or any other third party, as the Secretary determines appropriate in accordance with the model standards described in subsection (b)(2), that is eligible to be considered for accreditation to conduct food safety audits to certify that eligible entities meet the applicable requirements of this section. A third-party auditor may be a single individual. A third-party auditor may employ or use audit agents to help conduct consultative and regulatory audits. (4) Accredited third-party auditor

“additive” applies throughout its subchapter

The term “additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical. (2) Brand

“brand” applies throughout its subchapter

The term “brand” means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name, identifiable pattern of colors, or any combination of such attributes. (3) Cigarette

“cigarette” applies throughout its subchapter

The term “cigarette”— (A) means a product that— (i) is a tobacco product; and (ii) meets the definition of the term “cigarette” in section 1332(1) of title 15 ; and (B) includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco. (4) Cigarette tobacco

“cigarette tobacco” applies throughout its subchapter

The term “cigarette tobacco” means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this subchapter shall also apply to cigarette tobacco. (5) Commerce

“commerce” applies throughout its subchapter

The term “commerce” has the meaning given that term by section 1332(2) of title 15 . (6) Counterfeit tobacco product

“counterfeit tobacco product” applies throughout its subchapter

The term “counterfeit tobacco product” means a tobacco product (or the container or labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a tobacco product listed in a registration under section 387e(i)(1) of this title . (7) Distributor The term “distributor” as regards a tobacco product means any person who furthers the distribution of a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption.

“illicit trade” applies throughout its subchapter

The term “illicit trade” means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct intended to facilitate such activity. (9) Indian country

“Indian country” applies throughout its subchapter

The term “Indian country” has the meaning given such term in section 1151 of title 18 . (10) Indian tribe

“Indian tribe” applies throughout its subchapter

The term “Indian tribe” has the meaning given such term in section 5304(e) of title 25 . (11) Little cigar

“little cigar” applies throughout its subchapter

The term “little cigar” means a product that— (A) is a tobacco product; and (B) meets the definition of the term “little cigar” in section 1332(7) of title 15 . (12) Nicotine

“nicotine” applies throughout its subchapter

The term “nicotine” means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl) pyridine or C[10]H[14]N[2], including any salt or complex of nicotine. (13) Package

“package” applies throughout its subchapter

The term “package” means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers. (14) Retailer

“retailer” applies throughout its subchapter

The term “retailer” means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted. (15) Roll-your-own tobacco

“roll-your-own tobacco” applies throughout its subchapter

The term “roll-your-own tobacco” means any tobacco product which, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes. (16) Small tobacco product manufacturer

“small tobacco product manufacturer” applies throughout its subchapter

The term “small tobacco product manufacturer” means a tobacco product manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a manufacturer under the preceding sentence, the employees of a manufacturer are deemed to include the employees of each entity that controls, is controlled by, or is under common control with such manufacturer. (17) Smoke constituent

“smoke constituent” applies throughout its subchapter

The term “smoke constituent” means any chemical or chemical compound in mainstream or sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product. (18) Smokeless tobacco

“smokeless tobacco” applies throughout its subchapter

The term “smokeless tobacco” means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity. (19) State; Territory The terms “State” and “Territory” shall have the meanings given to such terms in section 321 of this title . (20) Tobacco product manufacturer

“tobacco product manufacturer” applies throughout its subchapter

The term “tobacco product manufacturer” means any person, including any repacker or relabeler, who— (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or (B) imports a finished tobacco product for sale or distribution in the United States. (21) Tobacco warehouse (A) Subject to subparagraphs (B) and (C),

“tobacco warehouse” applies throughout its subchapter

the term “tobacco warehouse” includes any person— (i) who— (I) removes foreign material from tobacco leaf through nothing other than a mechanical process; (II) humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or (III) de-stems, dries, and packs tobacco leaf for storage and shipment; (ii) who performs no other actions with respect to tobacco leaf; and (iii) who provides to any manufacturer to whom the person sells tobacco all information related to the person’s actions described in clause (i) that is necessary for compliance with this chapter.

“United States” applies throughout its subchapter

The term “United States” means the 50 States of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States.

“manufacture, preparation, compounding, or processing” applies in that section

The term “manufacture, preparation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user. (2) Name

“name” applies in that section

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) Registration by owners and operators On or before December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products shall register with the Secretary the name, places of business, and all such establishments of that person.

“characteristics” applies in that section

the term “characteristics” means the materials, ingredients, design, composition, heating source, or other features of a tobacco product. (C) Limitation A tobacco product may not be found to be substantially equivalent to a predicate tobacco product that has been removed from the market at the initiative of the Secretary or that has been determined by a judicial order to be misbranded or adulterated.

“new tobacco product” applies in that section

the term “new tobacco product” means— (A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007 ; or (B) any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007 .

“substantial equivalence” applies in that section

the term “substantially equivalent” or “substantial equivalence” means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product— (i) has the same characteristics as the predicate tobacco product; or (ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health. (B) Characteristics In subparagraph (A),

“substantially equivalent” applies in that section

the term “substantially equivalent” or “substantial equivalence” means, with respect to the tobacco product being compared to the predicate tobacco product, that the Secretary by order has found that the tobacco product— (i) has the same characteristics as the predicate tobacco product; or (ii) has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health. (B) Characteristics In subparagraph (A),

“modified risk tobacco product” applies in that section

The term “modified risk tobacco product” means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

“record” applies in that section

the term “record” means— (i) all notices and other matter published in the Federal Register with respect to the regulation or order reviewed; (ii) all information submitted to the Secretary with respect to such regulation or order; (iii) proceedings of any panel or advisory committee with respect to such regulation or order; (iv) any hearing held with respect to such regulation or order; and (v) any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order.

“eligible entity” applies in that section

the term “eligible entity” means an entity— (A) that is— (i) a State; (ii) a locality; (iii) a territory; (iv) an Indian tribe (as defined in section 5304(e) of title 25 ); or (v) a nonprofit food safety training entity that collaborates with 1 or more institutions of higher education; and (B) that submits an application to the Secretary at such time, in such manner, and including such information as the Secretary may reasonably require.

“biological product” applies in that section

The term “biological product” has the meaning given such term in section 262(i) of title 42 . (3) Drug

“drug” applies in that section

The term “drug” has the meaning given such term in section 321(g) of this title . (4) Institution of higher education

“institution of higher education” applies in that section

The term “institution of higher education” has the meaning given such term in section 1001(a) of title 20 . (5) Secretary

“Secretary” applies in that section

The term “Secretary” means the Secretary of Health and Human Services. (i) Authorization of appropriations (1) In general There is authorized to be appropriated to carry out this section $100,000,000 for the period of fiscal years 2023 through 2027. (2) Federal administrative expenses Of the amounts made available to carry out this section for a fiscal year, the Secretary shall not use more than 8 percent for Federal administrative expenses, including training, technical assistance, reporting, and evaluation.

“Abraham Accords country” applies in that section

the term “Abraham Accords country” means a country identified by the Department of State as having signed the Abraham Accords Declaration. (e) National security Nothing in this section shall be construed to require any action inconsistent with a national security recommendation provided by the Federal Government.

“animal food manufacturer” applies throughout its chapter

The term “animal food manufacturer” means any person engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of poultry.

“commerce” applies throughout its chapter

The term “commerce” means commerce between any State, any territory, or the District of Columbia, and any place outside thereof; or within any territory not organized with a legislative body, or the District of Columbia. (b) Except as otherwise provided in this chapter,

“container” applies throughout its chapter

The term “container” or “package” includes any box, can, tin, cloth, plastic, or other receptacle, wrapper, or cover.;

“Federal Food, Drug, and Cosmetic Act” applies throughout its chapter

The term “Federal Food, Drug, and Cosmetic Act” means the Act so entitled, approved June 25, 1938 ( 52 Stat. 1040 ) [ 21 U.S.C. 301 et seq.], and Acts amendatory thereof or supplementary thereto. (y) The terms “pesticide chemical”, “food additive”, “color additive”, and “raw agricultural commodity” shall have the same meanings for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.].;

“immediate container” applies throughout its chapter

The term “immediate container” includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed. (v) The term “capable of use as human food” shall apply to any carcass, or part or product of a carcass, of any poultry, unless it is denatured or otherwise identified as required by regulations prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans.;

“inspection service” applies throughout its chapter

The term “inspection service” means the official Government service within the Department of Agriculture designated by the Secretary as having the responsibility for carrying out the provisions of this chapter.;

“inspector” applies throughout its chapter

The term “inspector” means: (1) an employee or official of the United States Government authorized by the Secretary to inspect poultry and poultry products under the authority of this chapter, or (2) any employee or official of the government of any State or territory or the District of Columbia authorized by the Secretary to inspect poultry and poultry products under authority of this chapter, under an agreement entered into between the Secretary and the appropriate State or other agency.;

“label” applies throughout its chapter

The term “label” means a display of written, printed, or graphic matter upon any article or the immediate container (not including packaged liners) of any article; and

“labeling” applies throughout its chapter

the term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.;

“official certificate” applies throughout its chapter

The term “official certificate” means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.;

“official device” applies throughout its chapter

The term “official device” means any device prescribed or authorized by the Secretary for use in applying any official mark.;

“official establishment” applies throughout its chapter

The term “official establishment” means any establishment as determined by the Secretary at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained under the authority of this chapter.;

“official inspection legend” applies throughout its chapter

The term “official inspection legend” means any symbol prescribed by regulations of the Secretary showing that an article was inspected for wholesomeness in accordance with this chapter.;

“official mark” applies throughout its chapter

The term “official mark” means the official inspection legend or any other symbol prescribed by regulation of the Secretary to identify the status of any article or poultry under this chapter.;

“package” applies throughout its chapter

The term “container” or “package” includes any box, can, tin, cloth, plastic, or other receptacle, wrapper, or cover.;

“person” applies throughout its chapter

The term “person” means any individual, partnership, corporation, association, or other business unit.;

“poultry” applies throughout its chapter

The term “poultry” means any domesticated bird, whether live or dead.;

“poultry product” applies throughout its chapter

The term “poultry product” means any poultry carcass, or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting products which contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry, and which are exempted by the Secretary from definition as a poultry product under such conditions as the Secretary may prescribe to assure that the poultry ingredients in such products are not adulterated and that such products are not represented as poultry products.

“poultry products broker” applies throughout its chapter

The term “poultry products broker” means any person engaged in the business of buying or selling poultry products on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person.;

“processed” applies throughout its chapter

The term “processed” means slaughtered, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed.;

“renderer” applies throughout its chapter

The term “renderer” means any person engaged in the business of rendering carcasses, or parts or products of the carcasses, of poultry, except rendering conducted under inspection or exemption under this chapter.;

“Secretary” applies throughout its chapter

The term “Secretary” means the Secretary of Agriculture or his delegate.;

“shipping container” applies throughout its chapter

The term “shipping container” means any container used or intended for use in packaging the product packed in an immediate container.;

“State” applies throughout its chapter

the term “State” means any State of the United States and the Commonwealth of Puerto Rico.;

“territory” applies throughout its chapter

The term “territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.;

“United States” applies throughout its chapter

The term “United States” means the States, the District of Columbia, and the territories of the United States.;

“State” applies in that section

the term “State” means any State (including the Commonwealth of Puerto Rico) or organized territory.

“sanitary protection” applies in that section

the term “sanitary protection” means protection to safeguard public health. (B) The Secretary may— (i) determine, on a scientific basis, that the standard of the exporting country does not achieve the level of protection that the Secretary considers appropriate; and (ii) provide the basis for the determination in writing to the exporting country on request. (3) Any such imported poultry article that does not meet such standards shall not be permitted entry into the United States.

“appropriate State agency” applies in that section

The term “appropriate State agency” means a State agency described in section 454(a)(1) of this title . (2) Designated personnel

“designated personnel” applies in that section

The term “designated personnel” means inspection personnel of a State agency that have undergone all necessary inspection training and certification to assist the Secretary in the administration and enforcement of this chapter, including rules and regulations issued under this chapter. (3) Eligible establishment

“eligible establishment” applies in that section

The term “eligible establishment” means an establishment that is in compliance with— (A) the State inspection program of the State in which the establishment is located; and (B) this chapter, including rules and regulations issued under this chapter. (4) Poultry item

“poultry item” applies in that section

The term “poultry item” means— (A) a portion of poultry; and (B) a poultry product. (5) Selected establishment

“selected establishment” applies in that section

The term “selected establishment” means an eligible establishment that is selected by the Secretary, in coordination with the appropriate State agency of the State in which the eligible establishment is located, under subsection (b) to ship poultry items in interstate commerce.

“amenable species” applies throughout its chapter

The term “amenable species” means— (1) those species subject to the provisions of this chapter on the day before November 10, 2005 ; (2) all fish of the order Siluriformes; and (3) any additional species of livestock that the Secretary considers appropriate.

“animal food manufacturer” applies throughout its chapter

The term “animal food manufacturer” means any person, firm, or corporation engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines.;

“commerce” applies throughout its chapter

The term “commerce” means commerce between any State, any Territory, or the District of Columbia, and any place outside thereof; or within any Territory not organized with a legislative body, or the District of Columbia.;

“Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.]” applies in that section

The term “Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.]” means the Act so entitled, approved June 25, 1938 ( 52 Stat. 1040 ), and Acts amendatory thereof or supplementary thereto. (r) The terms “pesticide chemical,” “food additive,” “color additive,” and “raw agricultural commodity” shall have the same meanings for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [ 21 U.S.C. 301 et seq.].;

“firm” applies throughout its chapter

The term “firm” means any partnership, association, or other unincorporated business organization.;

“label” applies in that section

The term “label” means a display of written, printed, or graphic matter upon the immediate container (not including package liners) of any article.;

“labeling” applies in that section

The term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.;

“meat broker” applies throughout its chapter

The term “meat broker” means any person, firm, or corporation engaged in the business of buying or selling carcasses, parts of carcasses, meat, or meat food products of cattle, sheep, swine, goats, horses, mules, or other equines on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person, firm, or corporation.;

“meat food product” applies throughout its chapter

The term “meat food product” means any product capable of use as human food which is made wholly or in part from any meat or other portion of the carcass of any cattle, sheep, swine, or goats, excepting products which contain meat or other portions of such carcasses only in a relatively small proportion or historically have not been considered by consumers as products of the meat food industry, and which are exempted from definition as a meat food product by the Secretary under such conditions as he may prescribe to assure that the meat or other portions of such carcasses contained in such product are not adulterated and that such products are not represented as meat food products.

“official certificate” applies throughout its chapter

The term “official certificate” means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.;

“official device” applies throughout its chapter

The term “official device” means any device prescribed or authorized by the Secretary for use in applying any official mark.;

“official inspection legend” applies throughout its chapter

The term “official inspection legend” means any symbol prescribed by regulations of the Secretary showing that an article was inspected and passed in accordance with this chapter.;

“official mark” applies throughout its chapter

The term “official mark” means the official inspection legend or any other symbol prescribed by regulations of the Secretary to identify the status of any article or animal under this chapter.;

“prepared” applies in that section

The term “prepared” means slaughtered, canned, salted, rendered, boned, cut up, or otherwise manufactured or processed. (m) The term “adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances: (1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; (2) (A) if it bears or contains (by reason of administration of any substance to the live animal or …

“renderer” applies throughout its chapter

The term “renderer” means any person, firm, or corporation engaged in the business of rendering carcasses or parts or products of the carcasses, of cattle, sheep, swine, goats, horses, mules, or other equines, except rendering conducted under inspection or exemption under this subchapter.;

“Secretary” applies throughout its chapter

The term “Secretary” means the Secretary of Agriculture of the United States or his delegate.;

“State” applies throughout its chapter

The term “State” means any State of the United States and the Commonwealth of Puerto Rico.;

“Territory” applies throughout its chapter

The term “Territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.;

“United States” applies throughout its chapter

The term “United States” means the States, the District of Columbia, and the Territories of the United States.;

“meat articles” applies in that section

The term “meat articles” means carcasses, meat and meat food products of cattle, sheep, swine, goats, horses, mules, or other equines, that are capable of use as human food.;

“standards” applies in that section

The term “standards” means inspection, building construction, sanitary, quality, species verification, residue, and other standards that are applicable to meat articles. (2) On request of the Committee on Agriculture or the Committee on Ways and Means of the House of Representatives or the Committee on Agriculture, Nutrition, and Forestry or the Committee on Finance of the Senate, or at the initiative of the Secretary, the Secretary shall, as soon as practicable, determine whether a particular foreign country applies standards for the importation of meat articles from the United States that are not related to public health concerns about end-product quality that can be substantiated by …

“State” applies in that section

the term “State” means any State (including the Commonwealth of Puerto Rico) or organized Territory.

“appropriate State agency” applies in that section

The term “appropriate State agency” means a State agency described in section 661(b) of this title . (2) Designated personnel

“designated personnel” applies in that section

The term “designated personnel” means inspection personnel of a State agency that have undergone all necessary inspection training and certification to assist the Secretary in the administration and enforcement of this chapter, including rules and regulations issued under this chapter. (3) Eligible establishment

“eligible establishment” applies in that section

The term “eligible establishment” means an establishment that is in compliance with— (A) the State inspection program of the State in which the establishment is located; and (B) this chapter, including rules and regulations issued under this chapter. (4) Meat item

“meat item” applies in that section

The term “meat item” means— (A) a portion of meat; and (B) a meat food product. (5) Selected establishment

“selected establishment” applies in that section

The term “selected establishment” means an eligible establishment that is selected by the Secretary, in coordination with the appropriate State agency of the State in which the eligible establishment is located, under subsection (b) to ship carcasses, portions of carcasses, and meat items in interstate commerce.

“addict” applies throughout its subchapter

The term “addict” means any individual who habitually uses any narcotic drug so as to endanger the public morals, health, safety, or welfare, or who is so far addicted to the use of narcotic drugs as to have lost the power of self-control with reference to his addiction. (2) The term “administer” refers to the direct application of a controlled substance to the body of a patient or research subject by— (A) a practitioner (or, in his presence, by his authorized agent), or (B) the patient or research subject at the direction and in the presence of the practitioner, whether such application be by injection, inhalation, ingestion, or any other means.;

“agent” applies throughout its subchapter

The term “agent” means an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser; except that such term does not include a common or contract carrier, public warehouseman, or employee of the carrier or warehouseman, when acting in the usual and lawful course of the carrier’s or warehouseman’s business.;

“anabolic steroid” applies throughout its subchapter

The term “anabolic steroid” means any drug or hormonal substance, chemically and pharmacologically related to testosterone (other than estrogens, progestins, corticosteroids, and dehydroepiandrosterone), and includes— (i) androstanediol— (I) 3β,17β-dihydroxy-5α-androstane; and (II) 3α,17β-dihydroxy-5α-androstane; (ii) androstanedione (5α-androstan-3,17-dione); (iii) androstenediol— (I) 1-androstenediol (3β,17β-dihydroxy-5α-androst-1-ene); (II) 1-androstenediol (3α,17β-dihydroxy-5α-androst-1-ene); (III) 4-androstenediol (3β,17β-dihydroxy-androst-4-ene); and (IV) 5-androstenediol (3β,17β-dihydroxy-androst-5-ene); (iv) androstenedione— (I) 1-androstenedione ([5α]-androst-1-en-3,17-dione); (II) …

“broker” applies throughout its chapter

The terms “broker” and “trader” mean a person that assists in arranging an international transaction in a listed chemical by— (A) negotiating contracts; (B) serving as an agent or intermediary; or (C) bringing together a buyer and seller, a buyer and transporter, or a seller and transporter.;

“chemical mixture” applies throughout its subchapter

The term “chemical mixture” means a combination of two or more chemical substances, at least one of which is not a list I chemical or a list II chemical, except that such term does not include any combination of a list I chemical or a list II chemical with another chemical that is present solely as an impurity. (41);

“control” applies throughout its subchapter

The term “control” means to add a drug or other substance, or immediate precursor, to a schedule under part B of this subchapter, whether by transfer from another schedule or otherwise.;

“controlled substance” applies throughout its subchapter

The term “controlled substance” means a drug or other substance, or immediate precursor, included in schedule I, II, III, IV, or V of part B of this subchapter. The term does not include distilled spirits, wine, malt beverages, or tobacco, as those terms are defined or used in subtitle E of the Internal Revenue Code of 1986.;

“controlled substance analogue” applies throughout its subchapter

the term “controlled substance analogue” means a substance— (i) the chemical structure of which is substantially similar to the chemical structure of a controlled substance in schedule I or II; (ii) which has a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the stimulant, depressant, or hallucinogenic effect on the central nervous system of a controlled substance in schedule I or II; or (iii) with respect to a particular person, which such person represents or intends to have a stimulant, depressant, or hallucinogenic effect on the central nervous system that is substantially similar to or greater than the …

“Convention on Psychotropic Substances” applies throughout its subchapter

The term “Convention on Psychotropic Substances” means the Convention on Psychotropic Substances signed at Vienna, Austria, on February 21, 1971 ; and

“counterfeit substance” applies throughout its subchapter

The term “counterfeit substance” means a controlled substance which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, number, or device, or any likeness thereof, of a manufacturer, distributor, or dispenser other than the person or persons who in fact manufactured, distributed, or dispensed such substance and which thereby falsely purports or is represented to be the product of, or to have been distributed by, such other manufacturer, distributor, or dispenser.;

“deliver” applies throughout its subchapter

The terms “deliver” or “delivery” mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship.;

“delivery” applies throughout its subchapter

The terms “deliver” or “delivery” mean the actual, constructive, or attempted transfer of a controlled substance or a listed chemical, whether or not there exists an agency relationship.;

“depressant or stimulant substance” applies throughout its subchapter

The term “depressant or stimulant substance” means— (A) a drug which contains any quantity of barbituric acid or any of the salts of barbituric acid; or (B) a drug which contains any quantity of (i) amphetamine or any of its optical isomers; (ii) any salt of amphetamine or any salt of an optical isomer of amphetamine; or (iii) any substance which the Attorney General, after investigation, has found to be, and by regulation designated as, habit forming because of its stimulant effect on the central nervous system; or (C) lysergic acid diethylamide; or (D) any drug which contains any quantity of a substance which the Attorney General, after investigation, has found to have, and by regulation …

“detoxification treatment” applies throughout its subchapter

The term “detoxification treatment” means the dispensing, for a period not in excess of one hundred and eighty days, of a narcotic drug in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period.;

“dispense” applies throughout its subchapter

The term “dispense” means to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery.

“dispenser” applies throughout its subchapter

The term “dispenser” means a practitioner who so delivers a controlled substance to an ultimate user or research subject.;

“distribute” applies throughout its subchapter

The term “distribute” means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical.

“distributor” applies throughout its subchapter

The term “distributor” means a person who so delivers a controlled substance or a listed chemical.;

“drug” applies throughout its subchapter

The term “drug” has the meaning given that term by section 321(g)(1) of this title .;

“Drug Enforcement Administration” applies throughout its subchapter

The term “Drug Enforcement Administration” means the Drug Enforcement Administration in the Department of Justice.;

“felony” applies throughout its subchapter

The term “felony” means any Federal or State offense classified by applicable Federal or State law as a felony.;

“felony drug offense” applies throughout its chapter

The term “felony drug offense” means an offense that is punishable by imprisonment for more than one year under any law of the United States or of a State or foreign country that prohibits or restricts conduct relating to narcotic drugs, marihuana, anabolic steroids, or depressant or stimulant substances. (45);

“fentanyl-related substance” applies in that section

The term “fentanyl-related substance” has the meaning given the term in subsection (e)(2) of schedule I of section 812(c) of this title .

“filling new prescriptions for controlled substances in schedule III, IV, or V” applies throughout its subchapter

The term “filling new prescriptions for controlled substances in schedule III, IV, or V” means filling a prescription for an individual for a controlled substance in schedule III, IV, or V, if— (A) the pharmacy dispensing that prescription has previously dispensed to the patient a controlled substance other than by means of the Internet and pursuant to the valid prescription of a practitioner that meets the applicable requirements of subsections (b) and (c) of section 829 of this title (in this paragraph referred to as the “original prescription”); (B) the pharmacy contacts the practitioner who issued the original prescription at the request of that individual to determine whether the …

“homepage” applies in that section

The term “homepage” means the opening or main page or screen of the website of an online pharmacy that is viewable on the Internet.;

“immediate precursor” applies throughout its subchapter

The term “immediate precursor” means a substance— (A) which the Attorney General has found to be and by regulation designated as being the principal compound used, or produced primarily for use, in the manufacture of a controlled substance; (B) which is an immediate chemical intermediary used or likely to be used in the manufacture of such controlled substance; and (C) the control of which is necessary to prevent, curtail, or limit the manufacture of such controlled substance. (24) The term “Secretary”, unless the context otherwise indicates, means the Secretary of Health and Human Services.;

“international transaction” applies throughout its chapter

The term “international transaction” means a transaction involving the shipment of a listed chemical across an international border (other than a United States border) in which a broker or trader located in the United States participates.;

“Internet” applies in that section

The term “Internet” means collectively the myriad of computer and telecommunications facilities, including equipment and operating software, which comprise the interconnected worldwide network of networks that employ the Transmission Control Protocol/Internet Protocol, or any predecessor or successor protocol to such protocol, to communicate information of all kinds by wire or radio. (51) The term “deliver, distribute, or dispense by means of the Internet” refers, respectively, to any delivery, distribution, or dispensing of a controlled substance that is caused or facilitated by means of the Internet.;

“isomer” applies throughout its subchapter

The term “isomer” means the optical isomer, except as used in schedule I(c) and schedule II(a)(4). As used in schedule I(c),

“list I chemical” applies throughout its subchapter

The term “list I chemical” means a chemical specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter and is important to the manufacture of the controlled substances, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following: (A) Anthranilic acid, its esters, and its salts. (B) Benzyl cyanide. (C) Ephedrine, its salts, optical isomers, and salts of optical isomers. (D) Ergonovine and its salts. (E) Ergotamine and its salts.

“list II chemical” applies throughout its subchapter

The term “list II chemical” means a chemical (other than a list I chemical) specified by regulation of the Attorney General as a chemical that is used in manufacturing a controlled substance in violation of this subchapter, and such term includes (until otherwise specified by regulation of the Attorney General, as considered appropriate by the Attorney General or upon petition to the Attorney General by any person) the following chemicals: (A) Acetic anhydride. (B) Acetone. (C) Benzyl chloride. (D) Ethyl ether. (E) Repealed. Pub. L. 101–647, title XXIII, § 2301(b) , Nov. 29, 1990 , 104 Stat. 4858 . (F) Potassium permanganate. (G) 2-Butanone (or Methyl Ethyl Ketone). (H) Toluene. (I) Iodine.

“listed chemical” applies throughout its subchapter

The term “listed chemical” means any list I chemical or any list II chemical.;

“maintenance treatment” applies throughout its subchapter

The term “maintenance treatment” means the dispensing, for a period in excess of twenty-one days, of a narcotic drug in the treatment of an individual for dependence upon heroin or other morphine-like drugs.;

“manufacture” applies throughout its subchapter

The term “manufacture” means the production, preparation, propagation, compounding, or processing of a drug or other substance, either directly or indirectly or by extraction from substances of natural origin, or independently by means of chemical synthesis or by a combination of extraction and chemical synthesis, and includes any packaging or repackaging of such substance or labeling or relabeling of its container; except that such term does not include the preparation, compounding, packaging, or labeling of a drug or other substance in conformity with applicable State or local law by a practitioner as an incident to his administration or dispensing of such drug or substance in the course …

“manufacturer” applies throughout its subchapter

The term “manufacturer” means a person who manufactures a drug or other substance. (16) (A) Subject to subparagraph (B),

“marihuana” applies throughout its subchapter

the terms “marihuana” and “marijuana” mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.

“marijuana” applies throughout its subchapter

the terms “marihuana” and “marijuana” mean all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin.