§321. Definitions; generally — Inbound Citations
21 U.S.C. § 321
Implementing Regulations (Code of Federal Regulations)
Statutory authority for 4359 regulations in the Code of Federal Regulations.
Code of Federal Regulations Citations
Cited by 91 regulations in the Code of Federal Regulations.
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(b) A company organized under the laws of a foreign country and regulated or supervised by a foreign bank regulatory or supervisory authority which engages in the business of banking, including without limitation, foreign commercial banks, foreign merchant banks and other foreign institutions that engage in banking activities usual in connection with the business of banking in the countries where such foreign institutions are organized or operating; or
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(a) Substances subject to the Federal Food, Drug, and Cosmetic Act are exempted by section 2(f)(2) of the act; but where a food, drug, or cosmetic offers a substantial risk of injury or illness from any handling or use that is customary or usual it may be regarded as misbranded under the Federal Food, Drug, and Cosmetic Act because its label fails to reveal material facts with respect to consequences that may result from use of the article (21 U.S.C. 321(n)) when its label fails to bear information to alert the householder to this hazard.
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(ii) A food, drug, or cosmetic as those terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); or
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(32) All prepackaged nonemulsion-type liquid household chemical products that are drugs or cosmetics as defined in the Federal Food, Drug, and Cosmetics Act (FDCA) (21 U.S.C. 321(a)), and that contain 10 percent or more hydrocarbons by weight and have a viscosity of less than 100 SUS at 100 °F, shall be packaged in accordance with the provisions of § 1700.15(a), (b), and (c), except for the following:(i) Products in packages in which the only non-child-resistant access to the contents is by a spray device (e.g., aerosols, or pump-or trigger-actuated sprays where the pump or trigger mechanism has either a child-resistant or permanent attachment to the package).(ii) For the purposes of this requirement, hydrocarbons are defined as substances that consist solely of carbon and hydrogen. For products that contain multiple hydrocarbons, the total percentage of hydrocarbons in the product is the sum of the percentages by weight of the individual hydrocarbon components.
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(a) Where the petition requests an exemption for a drug, as defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1), the petitioner shall include those reports required to be filed under the Food and Drug Administration's Adverse Reaction Reporting Program.
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(c) The term consumer commodity or commodity means any article, product, or commodity of any kind or class which is customarily produced or distributed for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for purposes of personal care or in the performance of services ordinarily rendered within the household, and which usually is consumed or expended in the course of such consumption or use. For purposes of the regulations in this part the term consumer commodity does not include any food, drug, device or cosmetic as defined by section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); any meat or meat product, poultry or poultry product, or tobacco or tobacco product; any commodity subject to packaging or labeling requirements imposed by the Administrator of the Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.); any commodity subject to the provisions of the eighth paragraph under the heading “Bureau of Animal Industry” of the Virus-Serum-Toxin Act (21 U.S.C. 151-157); any beverage subject to or complying with packaging or labeling requirements imposed under the Federal Alcohol Administration Act (27 U.S.C. 201 et seq.); any commodity subject to the provisions of the Federal Seed Act (7 U.S.C. 1551-1610).
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(a) The importation into the United States of food, drugs, devices, cosmetics, and tobacco products as defined in section 201 (f), (g), (h), and (i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 (f), (g), (h), (i)) is governed by section 801 of the Act, as amended (21 U.S.C. 381) and regulations issued under authority of section 701(b) of the Act (21 U.S.C. 371(b)) by the Secretary of Health and Human Services and the Secretary of the Treasury (21 CFR 1.83 through 1.99).
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(3) For the purposes of this definition, “farm-operated business” means a business that is managed by one or more farms and conducts manufacturing/processing not on the farm(s).Trade name means the name or names under which the facility conducts business, or additional names by which the facility is known. A trade name is associated with a facility, and a brand name is associated with a product.U.S. agent means a person (as defined in section 201(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(e))) residing or maintaining a place of business in the United States whom a foreign facility designates as its agent for purposes of this subpart. A U.S. agent may not be in the form of a mailbox, answering machine or service, or other place where an individual acting as the foreign facility's agent is not physically present.
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(b) The definitions of terms in section 201 of the act (21 U.S.C. 321) apply when the terms are used in this subpart, unless defined in this section.(1) Calendar day means every day shown on the calendar.(2) Country from which the article originates means FDA Country of Production.(3) Country from which the article is shipped means the country in which the article of food is loaded onto the conveyance that brings it to the United States or, in the case of food sent by international mail, the country from which the article is mailed.(4) means: (i) For an article of food that is in its natural state, the country where the article of food was grown, including harvested or collected and readied for shipment to the United States. If an article of food is wild fish, including seafood that was caught or harvested outside the waters of the United States by a vessel that is not registered in the United States, the FDA Country of Production is the country in which the vessel is registered. If an article of food that is in its natural state was grown, including harvested or collected and readied for shipment, in a Territory, the FDA Country of Production is the United States.(ii) For an article of food that is no longer in its natural state, the country where the article was made; except that, if an article of food is made from wild fish, including seafood, aboard a vessel, the FDA Country of Production is the country in which the vessel is registered. If an article of food that is no longer in its natural state was made in a Territory, the FDA Country of Production is the United States.(5) has the meaning given in section 201(f) of the act, except as provided in paragraph (b)(5)(i) of this section.(A) Food contact substances as defined in section 409(h)(6) of the act (21 U.S.C. 348(h)(6)); or(B) Pesticides as defined in 7 U.S.C. 136(u).(ii) Examples of food include fruits, vegetables, fish, including seafood, dairy products, eggs, raw agricultural commodities for use as food or as components of food, animal feed (including pet food), food and feed ingredients, food and feed additives, dietary supplements and dietary ingredients, infant formula, beverages (including alcoholic beverages and bottled water), live food animals, bakery goods, snack foods, candy, and canned foods.(6) Full address means the facility's street name and number; suite/unit number, as appropriate; city; Province or State as appropriate; mail code as appropriate; and country.(7) Grower means a person who engages in growing and harvesting or collecting crops (including botanicals), raising animals (including fish, which includes seafood), or both.(8) International mail means foreign national mail services. International mail does not include express consignment operators or carriers or other private delivery services unless such service is operating under contract as an agent or extension of a foreign mail service.(9) Manufacturer means the last facility, as that word is defined in § 1.227, that manufactured/processed the food. A facility is considered the last facility even if the food undergoes further manufacturing/processing that consists of adding labeling or any similar activity of a de minimis nature. If the food undergoes further manufacturing/processing that exceeds an activity of a de minimis nature, then the subsequent facility that performed the additional manufacturing/processing is considered the manufacturer.(10) No longer in its natural state means that an article of food has been made from one or more ingredients or synthesized, prepared, treated, modified, or manipulated. Examples of activities that render food no longer in its natural state are cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juice, distilling, labeling, or packaging. Crops that have been cleaned (e.g., dusted, washed), trimmed, or cooled attendant to harvest or collection or treated against pests, or polished are still in their natural state for purposes of this subpart. Whole fish headed, eviscerated, or frozen attendant to harvest are still in their natural state for purposes of this subpart.(11) Port of arrival means the water, air, or land port at which the article of food is imported or offered for import into the United States. For an article of food arriving by water or air, this is the port of unloading. For an article of food arriving by land, this is the port where the article of food first crosses the border into the United States. The port of arrival may be different than the port where consumption or warehouse entry or foreign trade zone admission documentation is presented to the U.S. Customs and Border Protection (CBP).(12) , in section 801(m) and (l) of the act (21 U.S.C. 381(m) and (l)), means the port of entry as defined in 19 CFR 101.1.(13) Registration number means the registration number assigned to a facility by FDA under section 415 of the act (21 U.S.C. 350d) and subpart H of this part.(14) Shipper means the owner or exporter of the article of food who consigns and ships the article from a foreign country or the person who sends an article of food by international mail or express consignment operators or carriers or other private delivery service to the United States.(15) United States means the Customs territory of the United States (i.e., the 50 States, the District of Columbia, and the Commonwealth of Puerto Rico), but not the Territories.(16) You means the person submitting the prior notice, i.e., the submitter or the transmitter, if any.
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The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when used in this subpart. In addition, for the purposes of this subpart:
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The definitions of terms that appear in section 201 of the act (21 U.S.C. 321) apply when the terms are used in this subpart. In addition, for the purposes of this subpart:
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(1) A person who would be entitled to claim the drugs, if seized, may appeal a detention order. Any appeal must be submitted in writing to the FDA Division Director in whose division the drugs are located within 5 working days of receipt of a detention order. If the appeal includes a request for an informal hearing, as defined in section 201(x) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(x)), the appellant must request either that a hearing be held within 5 working days after the appeal is filed or that the hearing be held at a later date, which must not be later than 20 calendar days after receipt of a detention order.
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(1) Act means the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
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(B) A statement about the formulation of the product, including a claim that the product contains an ingredient (other than an ingredient that is an article included in the definition of “dietary supplement” under 21 U.S.C. 321(ff)(3)) that has been regulated by FDA as a drug and is well known to consumers for its use or claimed use in preventing or treating a disease;
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(26) Medical laser product means any laser product which is a medical device as defined in 21 U.S.C. 321(h) and is manufactured, designed, intended or promoted for in vivo laser irradiation of any part of the human body for the purpose of: (i) Diagnosis, surgery, or therapy; or (ii) relative positioning of the human body.
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The definitions in this section and the definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) shall apply to infant formula requirements in 21 CFR parts 106 and 107 of this chapter.
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(6) A substance that is not a food additive within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(s)) because the substance is not reasonably expected to become a component of food or otherwise affect the characteristics of food.
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(1) The submission does not pertain to a tobacco product as defined in 21 U.S.C. 321(rr).
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The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the FFDCA) (21 U.S.C. 321) are applicable to such terms when used in this part, except where they are redefined in this part. The following definitions also apply:
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(a) Any juice sold as such or used as an ingredient in beverages shall be processed in accordance with the requirements of this part. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. The requirements of this part shall apply to any juice regardless of whether the juice, or any of its ingredients, is or has been shipped in interstate commerce (as defined in section 201(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321(b)). Raw agricultural ingredients of juice are not subject to the requirements of this part. Processors should apply existing agency guidance to minimize microbial food safety hazards for fresh fruits and vegetables in handling raw agricultural products.
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(a) Under date of December 4, 1941, in a notice to manufacturers of glandular preparations, the Food and Drug Administration expressed the opinion that preparations of inert glandular materials intended for medicinal use should, in view of the requirement of section 201(n) of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C. 321(n)), be labeled with a statement of the material fact that there is no scientific evidence that the articles contain any therapeutic or physiologically active constituents. Numerous preparations of such inert glandular materials were subsequently marketed with disclaimers of the type suggested. The term inert glandular materials means preparations incapable of exerting an action or effect of some significant or measurable benefit in one way or another, i.e., in the diagnosis, cure, mitigation, treatment, or prevention of disease, or in affecting the structure or any function of the body.
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(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201 et seq. (21 U.S.C. 321 et seq.)).
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The following definitions apply to words and phrases as they are used in this part. Other definitions of these words may apply when they are used in other parts of this chapter.
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(a) The labeling of the product contains the established name of the drug, if any, and identifies the product as: (select one or both of the following: ‘anticavity’ or ‘fluoride’) (select one of the following as appropriate: “dentifrice,” “toothpaste,” “tooth polish,” “tooth powder;” (optional: “dental”) “preventive treatment gel;” or (optional: “treatment” or “dental”)) (select one of the following: “rinse,” “concentrated solution,” “rinse powder,” or “rinse effervescent tablets”). The word “mouthwash” may be substituted for the word “rinse” in this statement of identity if the product also has a cosmetic use, as defined in section 201(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(i)).
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(a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to those terms when used in this part.
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(k) Any latex condom not labeled with an expiration date as required by paragraph (c) of this section, and initially delivered for introduction into interstate commerce after the effective date of this regulation is misbranded under sections 201(n) and 502(a) and (f) of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(n) and 352(a) and (f)).
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(j) Any device subject to this section that is not labeled in accordance with paragraphs (d) through (h) of this section and that is initially introduced or initially delivered for introduction into interstate commerce after the effective date of this regulation is misbranded under sections 201(n) and 502(a), (c), and (f) of the act (21 U.S.C. 321(n) and 352(a), (c), and (f)).
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(c) If a request by the person named in a cease distribution and notification order for a regulatory hearing is granted, the regulatory hearing will be conducted in accordance with the procedures set out in section 201(x) of the act (21 U.S.C. 321(x)) and part 16 of this chapter, except that the order issued under § 810.10, rather than a notice under § 16.22(a) of this chapter, provides the notice of opportunity for a hearing and is part of the administrative record of the regulatory hearing under § 16.80(a) of this chapter. As provided in § 16.60(h) of this chapter, the Commissioner of Food and Drugs or presiding officer may waive, suspend, or modify any provision of part 16 under § 10.19 of this chapter. As provided in § 16.26(b), after the hearing commences, the presiding officer may issue a summary decision on any issue if the presiding officer determines that there is no genuine and substantial issue of fact respecting that issue.
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(a) The following terms, which are either not used or not defined in ISO 13485 or in Clause 3 of ISO 9000, also apply for the purposes of this part:Batch or lot means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly that is intended to be included as part of the finished, packaged, and labeled device.Federal Food, Drug, and Cosmetic Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended.Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) of this chapter and that is also regulated as a device.Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.
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(a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., as amended.
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As used in this part:
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(b) For purposes of this section, the terms “drug,” “biological product,” “device,” “combination product,” and “infant formula” have the meanings given to them in 21 U.S.C. 321(g)(1), 42 U.S.C. 262(i)(1), 21 U.S.C. 321(h)(1), 21 CFR 3.2(e), and 21 U.S.C. 321(z) respectively.
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(ix) Food (the term “food” means all “food,” as defined in 21 U.S.C. 321(f), including poultry and poultry products (as defined in 21 U.S.C. 453(e) and (f)), meat, meat food products (as defined in 21 U.S.C. 601(j)), and eggs and egg products (as defined in 21 U.S.C. 1033)).
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(2) The term medicine means an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) Medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this part, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and that, in the case of an item subject to the EAR, is designated as EAR99 or, in the case of an item not subject to the EAR, that would be designated as EAR99, if it were located in the United States.
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(c) The term medicine has the same meaning given the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) but does not include any item listed on the Commerce Control List in the Export Administration Regulations, 15 CFR part 774, supplement no. 1 (excluding items classified as EAR 99).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and that, in the case of an item subject to the EAR, is designated as EAR99 or, in the case of an item not subject to the EAR, is not listed under any multilateral export control regime.
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(b) For the purposes of this section only, the term medical device has the meaning given the term “device” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), including medical supplies, but does not include any item listed on the Commerce Control List in the Export Administration Regulations, 15 CFR part 774, supplement no. 1.
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(b) For the purposes of this section only, the term medical device has the meaning given the term “device” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), including medical supplies, but does not include any item listed on the Commerce Control List in the Export Administration Regulations, 15 CFR part 774, supplement no. 1.
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(2) For the purposes of this section, medicine is an item that falls within the definition of the term “drug” in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(B) If a medical device (as defined by 21 U.S.C. 321(h)) with an Investigational Device Exemption (IDE) approved by the Food and Drug Administration is categorized by the FDA as experimental/investigational (FDA Category A).
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(7) Any other application, petition, or submission sent to EPA intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide.Batch means a specific quantity or lot of a test, control, or reference substance that has been characterized according to § 160.105(a).Carrier means any material, including but not limited to feed, water, soil, nutrient media, with which the test substance is combined for administration to a test system.Control substance means any chemical substance or mixture, or any other material other than a test substance, feed, or water, that is administered to the test system in the course of a study for the purpose of establishing a basis for comparison with the test substance for known chemical or biological measurements.EPA means the U.S. Environmental Protection Agency.Experimental start date means the first date the test substance is applied to the test system.Experimental termination date means the last date on which data are collected directly from the study.FDA means the U.S. Food and Drug Administration.FFDCA means the Federal Food, Drug and Cosmetic Act, as amended (21 U.S.C. 321 et seq).FIFRA means the Federal Insecticide, Fungicide and Rodenticide Act as amended (7 U.S.C. 136 et seq).Person means an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit thereof, or any other legal entity.Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of the studies.Raw data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. “Raw data” may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.Reference substance means any chemical substance or mixture, or analytical standard, or material other than a test substance, feed, or water, that is administered to or used in analyzing the test system in the course of a study for the purposes of establishing a basis for comparison with the test substance for known chemical or biological measurements.Specimen means any material derived from a test system for examination or analysis.Sponsor means:
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(1) A “new drug” (21 U.S.C. sec. 321(p) and sec. 355).
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(b) When the plant-incorporated protectant is intended to be produced and used in a crop used as food, the residues of the active ingredient of the plant-incorporated protectant are either exempted from the requirement of a tolerance under FFDCA (21 U.S.C. 321 et seq.) as listed in subpart W of this part, or no tolerance would otherwise be required.
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Terms used in this part have the same meaning as in FIFRA. In addition, the following terms have the meaning set forth in this section.
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The terms have the same meaning as in the Federal Insecticide, Fungicide, and Rodenticide Act section 2, and in the Federal Food, Drug, and Cosmetic Act section 201 and § 166.3 of this chapter. In addition, the following terms are defined for the purposes of this part.
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(e) Drug means any substance defined as a drug in section 201(g)(1) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321).
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(a) The following terms will have the meaning contained in the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the regulations issued under such Act: Cosmetic, device, drug, food, and food additive. In addition, the term food includes poultry and poultry products, as defined in the Poultry Products Inspection Act, 21 U.S.C. 453 et seq.; meats and meat food products, as defined in the Federal Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.
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(2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use; and
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(3) A clinical trial of a combination product with a device primary mode of action under 21 CFR part 3, provided that it meets all other criteria of the definition under this part.Applicable drug clinical trial means a controlled clinical investigation, other than a phase 1 clinical investigation, of a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product subject to section 351 of the Public Health Service Act (42 U.S.C. 262), where “clinical investigation” has the meaning given in 21 CFR 312.3 and “phase 1” has the meaning given in 21 CFR 312.21. A clinical trial of a combination product with a drug primary mode of action under 21 CFR part 3 is also an applicable drug clinical trial, provided that it meets all other criteria of the definition under this part.Approved drug means a drug product that is approved for any use under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or a biological product licensed for any use under section 351 of the Public Health Service Act (42 U.S.C. 262).Approved or cleared device means a device product that is cleared for any use under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360(k)) or approved for any use under sections 515 or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360e, 360j(m)).Arm means a pre-specified group or subgroup of human subject(s) in a clinical trial assigned to receive specific intervention(s) (or no intervention) according to a protocol.Clinical study means research according to a protocol involving one or more human subjects to evaluate biomedical or health-related outcomes, including interventional studies and observational studies.Clinical trial means a clinical investigation or a clinical study in which human subject(s) are prospectively assigned, according to a protocol, to one or more interventions (or no intervention) to evaluate the effect(s) of the intervention(s) on biomedical or health-related outcomes.Clinical trial information means the data elements, including clinical trial registration information and clinical trial results information, that the responsible party is required to submit to ClinicalTrials.gov, as specified in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) and this part.Clinical trial registration information means the data elements that the responsible party is required to submit to ClinicalTrials.gov, as specified in section 402(j)(2)(A)(ii) of the Public Health Service Act (42 U.S.C. 282(j)(2)(A)(ii)) or § 11.28, as applicable.Clinical trial results information means the data elements that the responsible party is required to submit to ClinicalTrials.gov, as specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and (I)) or § 11.48, as applicable. If a responsible party submits clinical trial results information voluntarily for a clinical trial, clinical trial results information also means § 11.60(b)(2)(i)(B) or § 11.60(c)(2)(i)(B), as applicable.Comparison group means a grouping of human subjects in a clinical trial that is or may be used in analyzing the results data collected during the clinical trial.Completion date means, for a clinical trial, including an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the pre-specified protocol or was terminated. In the case of clinical trials with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all of the primary outcomes. For a pediatric postmarket surveillance of a device product that is not a clinical trial, completion date means the date on which the final report of the pediatric postmarket surveillance of the device product is submitted to FDA. For purposes of this part, completion date is referred to as “primary completion date.”Control or controlled means, with respect to a clinical trial, that data collected on human subjects in the clinical trial will be compared to concurrently collected data or to non-concurrently collected data (e.g., historical controls, including a human subject's own baseline data), as reflected in the pre-specified primary or secondary outcome measures. For purposes of this part, all clinical trials with one or more arms and pre-specified outcome measure(s) are controlled.Device means a device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).Director means the NIH Director or any official of NIH to whom the NIH Director delegates authorities granted in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).Drug means a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) or a biological product as defined in section 351 of the Public Health Service Act (42 U.S.C. 262).Enroll or enrolled means a human subject's, or their legally authorized representative's, agreement to participate in a clinical trial following completion of the informed consent process, as required in 21 CFR part 50 and/or 45 CFR part 46, as applicable. For the purposes of this part, potential subjects who are screened for the purpose of determining eligibility for a trial, but do not participate in the trial, are not considered enrolled, unless otherwise specified by the protocol.Human subjects protection review board means an institutional review board (IRB) as defined in 21 CFR 50.3 or 45 CFR 46.102, as applicable, that is responsible for assuring the protection of the rights, safety, and well-being of human subjects involved in a clinical trial and is adequately constituted to provide assurance of that protection. An IRB may also be known as an “independent ethics committee.”Interventional means, with respect to a clinical study or a clinical investigation, that participants are assigned prospectively to an intervention or interventions according to a protocol to evaluate the effect of the intervention(s) on biomedical or other health-related outcomes.Investigational Device Exemption (IDE) has the meaning given in 21 CFR part 812.Investigational New Drug Application (IND) has the meaning given in 21 CFR 312.3.NCT number means the unique identification code assigned to each record in ClinicalTrials.gov, including a record for an applicable clinical trial, a clinical trial, or an expanded access program.Ongoing means, with respect to a clinical trial of a drug product (including a biological product) or a device product and to a date, that one or more human subjects is enrolled in the clinical trial, and the date is before the primary completion date of the clinical trial. With respect to a pediatric postmarket surveillance of a device product, ongoing means a date between the date on which FDA approves the plan for conducting the surveillance and the date on which the final report is submitted to FDA.Outcome measure means a pre-specified measurement that will be used to determine the effect of an experimental variable on the human subject(s) in a clinical trial. See also the definitions of “primary outcome measure” and “secondary outcome measure.”Pediatric postmarket surveillance of a device product means the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information conducted under section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360l) about a marketed device product that is expected to have significant use in patients who are 21 years of age or younger at the time of diagnosis or treatment. A pediatric postmarket surveillance of a device product may be, but is not always, a clinical trial.Primary completion date means, for purposes of this part, “completion date.” See the definition of “completion date.”Primary outcome measure means the outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation. Most clinical trials have one primary outcome measure, but a clinical trial may have more than one. For purposes of this part, “primary outcome” has the same meaning as primary outcome measure.Principal investigator means the individual who is responsible for the overall scientific and technical direction of the study.Protocol means the written description of the clinical trial, including objective(s), design, and methods. It may also include relevant scientific background and statistical considerations.Responsible party means, with respect to a clinical trial, the sponsor of the clinical trial, as defined in 21 CFR 50.3; or the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements under this part for the submission of clinical trial information. For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric postmarket surveillance of the device product.Secondary outcome measure means an outcome measure that is of lesser importance than a primary outcome measure, but is part of a pre-specified analysis plan for evaluating the effects of the intervention or interventions under investigation in a clinical trial and is not specified as an exploratory or other measure. A clinical trial may have more than one secondary outcome measure. For purposes of this part, “secondary outcome” has the same meaning as secondary outcome measure.Secretary means the Secretary of Health and Human Services or any other official(s) to whom the Secretary delegates the authority contained in section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)).Serious adverse event means an adverse event that results in any of the following outcomes: Death, a life-threatening adverse event as defined in 21 CFR 312.32, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the human subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of a substance use disorder.Sponsor means either a “sponsor” or “sponsor-investigator,” as each is defined in 21 CFR 50.3.Study completion date means, for a clinical trial, the date the final subject was examined or received an intervention for purposes of final collection of data for the primary and secondary outcome measures and adverse events (e.g., last subject's last visit), whether the clinical trial concluded according to the pre-specified protocol or was terminated.U.S. FDA-regulated device product means, for purposes of this part, a device product subject to section 510(k), 515, 520(m), or 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m), 21 U.S.C. 360l).U.S. FDA-regulated drug product means, for purposes of this part, a drug product subject to section 505 of the Federal Food, Drug, and Cosmetic Act or a biological product subject to section 351 of the Public Health Service Act (21 U.S.C. 355, 42 U.S.C. 262) .
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(d) has the meaning given that term by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)).
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(3) Disclosure of patient records maintained by an OTP is governed by the provisions of 42 CFR part 2 and 45 CFR parts 160 and 164, and every program must comply with these regulations, as applicable. Records on the receipt, storage, and distribution of MOUD are also subject to inspection under Federal controlled substances laws and under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.). Federally sponsored treatment programs are subject to applicable Federal confidentiality statutes.
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Accreditation. A determination made by the Secretary that authorizes a private, foreign, or State entity to conduct certification activities as a certifying agent under this part.
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(v) FNS will solicit bids for rebates only from infant formula manufacturers. FNS may limit advertising to contacting in writing each infant formula manufacturer which has registered with the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.).
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(4) A public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings.IHS means the Indian Health Service of the U.S. Department of Health and Human Services.Infant formula means a food that meets the definition of an infant formula in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)) and that meets the requirements for an infant formula under section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) and the regulations at 21 CFR parts 106 and 107.Institution means any residential accommodation which provides meal service, except private residences and homeless facilities.Infants means persons under one year of age.Inventory audit means the examination of food invoices or other proofs of purchase to determine whether a vendor has purchased sufficient quantities of supplemental foods to provide participants the quantities specified on food instruments redeemed by the vendor during a given period of time.Local agency means: (a) A public or private, nonprofit health or human service agency which provides health services, either directly or through contract, in accordance with § 246.5; (b) an IHS service unit; (c) an Indian tribe, band or group recognized by the Department of the Interior which operates a health clinic or is provided health services by an IHS service unit; or (d) an intertribal council or group that is an authorized representative of Indian tribes, bands or groups recognized by the Department of the Interior, which operates a health clinic or is provided health services by an IHS service unit.Members of populations means persons with a common special need who do not necessarily reside in a specific geographic area, such as off-reservation Indians or migrant farmworkers and their families.Migrant farmworker means an individual whose principal employment is in agriculture on a seasonal basis, who has been so employed within the last 24 months, and who establishes, for the purposes of such employment, a temporary abode.Multi-function equipment means Point-of-Sale equipment obtained by a WIC vendor through commercial suppliers, which is capable of supporting WIC EBT and other payment tender types.Net price means the difference between an infant formula manufacturer's lowest national wholesale price per unit for a full truckload of infant formula and the rebate level or the discount offered or provided by the manufacturer under an infant formula cost containment contract.Non-contract brand infant formula means all infant formula, including exempt infant formula, that is not covered by an infant formula cost containment contract awarded by that State agency.Nonprofit agency means a private agency which is exempt from income tax under the Internal Revenue Code of 1954, as amended.Nutrition education means individual and group sessions and the provision of materials that are designed to improve health status and achieve positive change in dietary and physical activity habits, and that emphasize the relationship between nutrition, physical activity, and health, all in keeping with the personal and cultural preferences of the individual.Nutrition Services and Administration (NSA) Costs means those direct and indirect costs, exclusive of food costs, as defined in § 246.14(c), which State and local agencies determine to be necessary to support Program operations. Costs include, but are not limited to, the costs of Program administration, start-up, monitoring, auditing, the development of and accountability for food delivery systems, nutrition education and breastfeeding promotion and support, outreach, certification, and developing and printing food instruments and cash-value vouchers.Nutritional risk means: (a) Detrimental or abnormal nutritional conditions detectable by biochemical or anthropometric measurements; (b) Other documented nutritionally related medical conditions; (c) Dietary deficiencies that impair or endanger health; (d) Conditions that directly affect the nutritional health of a person, including alcoholism or drug abuse; or (e) Conditions that predispose persons to inadequate nutritional patterns or nutritionally related medical conditions, including, but not limited to, homelessness and migrancy.OIG means the Department's Office of the Inspector General.Other harmful substances means other substances such as tobacco, prescription drugs and over-the-counter medications that can be harmful to the health of the WIC population, especially the pregnant woman and her fetus.Partially-redeemed food instrument means a paper food instrument which is redeemed for less than all of the supplemental foods authorized for that food instrument.Participant violation means any deliberate action of a participant, parent, or caretaker of an infant or child participant, or proxy that violates Federal or State statutes, regulations, policies, or procedures governing the Program. Participant violations include, but are not limited to, deliberately making false or misleading statements or deliberately misrepresenting, concealing, or withholding facts, to obtain benefits; selling or offering to sell WIC benefits, cash-value vouchers, paper food instruments, EBT cards, supplemental foods, or breast pumps in person, in print, or online; exchanging or attempting to exchange WIC benefits, cash-value vouchers, paper food instruments, EBT cards, supplemental foods, or breast pumps for cash, credit, services, non-food items, or unauthorized food items, including supplemental foods in excess of those listed on the participant's food instrument; threatening to harm or physically harming clinic, farmer, farmers' market, or vendor staff; and dual participation.Participants means pregnant women, breastfeeding women, postpartum women, infants and children who are receiving supplemental foods or food instruments or cash-value vouchers under the Program, and the breastfed infants of participant breastfeeding women.Participation means the sum of:
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(i) An incidental additive present in food at an insignificant level and that does not have any technical or functional effect in the food, as described in 21 CFR 101.100(a)(3).(ii) [Reserved]Bioengineered substance means substance that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.Compliance date means—
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Animal and Plant Health Inspection Service (APHIS). The agency in the Department of Agriculture responsible for licensing veterinary biological products under the Virus-Serum-Toxin Act.
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(1) No substance which is a “food additive” as defined under 21 U.S.C. 321(s), including sources of radiation, may be used in the processing of egg products unless this use is authorized under the Federal Food, Drug, and Cosmetic Act.
United States Code Citations
Cited by 139 provisions in release 119-102.
Citations to 21 U.S.C. § 321 as a whole
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(u) The term “pesticide” means (1) any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and (3) any nitrogen stabilizer, except that the term “pesticide” shall not include any article that is a “new animal drug” within the meaning of section 321(w)1 of title 21, that has been determined by the Secretary of Health and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaning of section 321(x)1 of title 21 bearing or containing a new animal drug. The term “pesticide” does not include liquid chemical sterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 321 of title 21. For purposes of the preceding sentence, the term “critical device” includes any device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterile areas of the body and the term “semi-critical device” includes any device which contacts intact mucous membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.
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(2) The term “food” means a food (as defined in section 321 of title 21) that is intended for human consumption.
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(a) In this subchapter, the term “food” has the meaning given the term in section 321 of title 21.
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(3) the authority of the Food and Drug Administration under the provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 3211 et seq.).
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(a) The authority to promulgate regulations under this chapter is vested in (A) the Secretary of Health and Human Services (referred to hereinafter as the “Secretary”) with respect to any consumer commodity which is a food, drug, device, or cosmetic, as each such term is defined by section 321 of title 21; and (B) the Federal Trade Commission (referred to hereinafter as the “Commission”) with respect to any other consumer commodity.
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(a) Any consumer commodity which is a food, drug, device, or cosmetic, as each such term is defined by section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), and which is introduced or delivered for introduction into commerce in violation of any of the provisions of this chapter, or the regulations issued pursuant to this chapter, shall be deemed to be misbranded within the meaning of chapter III of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 331 et seq.], but the provisions of section 303 of that Act (21 U.S.C. 333) shall have no application to any violation of section 1452 of this title.
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(B) a food, drug, or cosmetic as those terms are defined in section 321 of title 21; or
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(A) any “food”, “drug”, “device”, or “cosmetic”, as those terms are respectively defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321); or
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(6) the term “drug” means a drug, as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
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(3) the term “device” has the meaning given the term in section 321 of this title;
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(4) In this subsection, the term “medical product” means a drug (as defined in section 321 of this title), a device (as defined in such section 321 of this title), or a biological product (as defined in section 262 of title 42).
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(b) In this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].
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(19) The terms “State” and “Territory” shall have the meanings given to such terms in section 321 of this title.
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(4) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(5) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(7) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(8) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(B) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(C) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(2) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(3) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(10) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(11) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(3) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(4) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(2) The term “medical device” has the meaning given the term “device” in section 321 of title 21.
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(3) The term “medicine” has the meaning given the term “drug” in section 321 of title 21.
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(5) The terms “drug” and “device” have the meanings given those terms in section 321 of title 21.
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(C) The term “medication” means a drug as that term is defined in section 321 of title 21 and includes inhaled bronchodilators and auto-injectable epinephrine.
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(2) The terms “drug” and “device” have the meanings given such terms in section 321 of title 21.
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(d) For purposes of this section, the term “new drug” has the meaning given such term in section 321 of title 21.
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(8) The term “medical device” means any device (as defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)), diagnostic product, drug (as defined in the Federal Food, Drug, and Cosmetic Act), and drug delivery system—(A) if such device, product, drug, or drug delivery system utilizes a class I or class II substance for which no safe and effective alternative has been developed, and where necessary, approved by the Commissioner; and(B) if such device, product, drug, or drug delivery system, has, after notice and opportunity for public comment, been approved and determined to be essential by the Commissioner in consultation with the Administrator.
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(C) The term “medical malpractice or medical product liability action or claim” means a medical malpractice action or claim (as defined in section 11151(7) of this title) and includes a liability action or claim relating to a health care provider’s prescription or provision of a drug, device, or biological product (as such terms are defined in section 321 of title 21 or section 262 of this title).
Citations to §321(b)
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(3) The term “interstate commerce” has the meaning prescribed for it by section 321(b) of title 21.
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(2) The term “interstate commerce” has the meaning given such term in section 321(b) of title 21.
Citations to §321(f)
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(3) require that the label on each package of a consumer commodity (other than one which is a food within the meaning of section 321(f) of title 21) bear (A) the common or usual name of such consumer commodity, if any, and (B) in case such consumer commodity consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in this paragraph shall be deemed to require that any trade secret be divulged; or
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(I) food. The term “food”, as used in this subparagraph means all “food”, as defined in section 201(f) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(f)], including poultry and poultry products (as defined in sections 4(e) and (f) of the Poultry Products Inspection Act [21 U.S.C. 453(e) and (f)]), meat, meat food products (as defined in section 1(j) of the Federal Meat Inspection Act [21 U.S.C. 601(j)]), and eggs and egg products (as defined in section 4 of the Egg Products Inspection Act [21 U.S.C. 1033]).
Citations to §321(ff)
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(i) the name of each ingredient of the supplement that is described in section 321(ff) of this title; and
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(2) The labeling for any food to which this section applies may not list its ingredients which are not dietary supplement ingredients described in section 321(ff) of this title (i) except as a part of a list of all the ingredients of such food, and (ii) unless such ingredients are listed in accordance with applicable regulations under section 343 of this title. To the extent that compliance with clause (i) of this subparagraph is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary.
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(5) Paragraphs (1) through (4) shall not apply with respect to products defined in section 321(ff) of this title.
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(d) As used in this section, the term “dietary supplement” has the meaning given the term in section 321(ff) of title 21.
Citations to §321(ff)(1)(C)
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(C) the supplement contains an ingredient described in section 321(ff)(1)(C) of this title, and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived;
Citations to §321(g)
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(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 321(g) of this title and not a device under section 321(h) of this title.
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(3) Nothing in this subsection shall be construed as allowing for the classification of a product as a drug (as defined in section 321(g) of this title) if such product—(A) is not described in paragraph (1); and(B) meets the definition of a device under section 321(h) of this title,unless another provision of this chapter otherwise indicates a different classification.
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(A) means a drug (as defined in section 321(g) of this title) that is intended for human use and that is subject to section 353(b)(1) of this title; and
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(2) Paragraph (1) shall not be construed as bearing on or being relevant to the question of whether any product other than a contact lens is a device as defined by section 321(h) of this title or a drug as defined by section 321(g) of this title.
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(2) This subsection shall not be construed to bear upon any determination of whether an article is a drug within the meaning of section 321(g) of this title, other than for the purposes described in paragraph (1).
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(3) The term “drug” has the meaning given such term in section 321(g) of this title.
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(vii) The term “drug” means a drug as defined in section 321(g) of title 21 or a biological product as defined in section 262 of this title.
Citations to §321(g)(1)
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(12) The term “drug” has the meaning given that term by section 321(g)(1) of this title.
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(A) The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).
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(B) For purposes of this subsection, the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that—(I) the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;(II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title; or(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3].
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(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b]; or
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(7) The term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)),2 biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h))2 that is—(i) a product manufactured, used, designed, developed, modified, licensed, or procured—(I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or(II) to limit the harm such pandemic or epidemic might otherwise cause;(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title;(ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)]; or(iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b].
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(3) The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i)2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center—(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and(B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development.
Citations to §321(h)
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(1) Any contrast agent, radioactive drug, or OTC monograph drug shall be deemed to be a drug under section 321(g) of this title and not a device under section 321(h) of this title.
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(B) meets the definition of a device under section 321(h) of this title,
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(b) In this section, the term “medical product” means a drug, as defined in subsection (g) of section 321 of this title, a device, as defined in subsection (h) of such section, or a biological product, as defined in section 351(i) of the Public Health Service Act [42 U.S.C. 262(i)].
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(xviii) the distribution or sale of any licensed product under section 262 of title 42 that meets the definition of a device under section 321(h) of this title.
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(1) All contact lenses shall be deemed to be devices under section 321(h) of this title.
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(2) Paragraph (1) shall not be construed as bearing on or being relevant to the question of whether any product other than a contact lens is a device as defined by section 321(h) of this title or a drug as defined by section 321(g) of this title.
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(1) The term device,2 as defined in section 321(h) of this title, shall not include a software function that is intended—(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow;(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as—(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals;(ii) such records are part of health information technology that is certified under section 300jj–11(c)(5) of title 42; and(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition;(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; or(E) unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of—(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines);(ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and(iii) enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.
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(A) at least one software function that meets the criteria under paragraph (1) or that otherwise does not meet the definition of device under section 321(h) of this title; and
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(B) at least one function that does not meet the criteria under paragraph (1) and that otherwise meets the definition of a device under section 321(h) of this title,
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(A) Notwithstanding paragraph (1), a software function described in subparagraph (C), (D), or (E) of paragraph (1) shall not be excluded from the definition of device under section 321(h) of this title if—(i) the Secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences; and(ii) the software function has been identified in a final order issued by the Secretary under subparagraph (B).
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(7) The term “medical device” means a device, as defined in section 321(h) of this title, and includes any device component of any combination product as that term is used in section 353(g) of this title.
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(A) The term “qualified countermeasure” means a drug (as that term is defined by section 321(g)(1) of title 21), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 321(h) of title 21), that the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6)—(i) to diagnose, mitigate, prevent, or treat harm from any biological agent (including organisms that cause an infectious disease) or toxin, chemical, radiological, or nuclear agent that may cause a public health emergency affecting national security;(ii) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device that is used as described in this subparagraph; or(iii) is a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii).
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(B) For purposes of this subsection, the term “security countermeasure” means a drug (as that term is defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1))), biological product (as that term is defined by section 262(i) of this title), or device (as that term is defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) that—(I) the Secretary determines to be a priority (consistent with sections 182(2) and 184(a) of title 6) to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat under paragraph (2)(A)(ii), or to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent;(II) the Secretary determines under paragraph (2)(B)(ii) to be a necessary countermeasure; and(aa) is approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title; or(bb) is a countermeasure for which the Secretary determines that sufficient and satisfactory clinical experience or research data (including data, if available, from pre-clinical and clinical trials) support a reasonable conclusion that the countermeasure will qualify for approval or licensing within 10 years after the date of a determination under paragraph (5); or(ii) is authorized for emergency use under section 564 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3].
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(C) a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)), biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h)) that is authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b]; or
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(7) The term “qualified pandemic or epidemic product” means a drug (as such term is defined in section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)(1)),2 biological product (as such term is defined by section 262(i) of this title), or device (as such term is defined by section 201(h) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(h))2 that is—(i) a product manufactured, used, designed, developed, modified, licensed, or procured—(I) to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic; or(II) to limit the harm such pandemic or epidemic might otherwise cause;(ii) a product manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by a product described in clause (i); or(iii) a product or technology intended to enhance the use or effect of a drug, biological product, or device described in clause (i) or (ii); and(i) approved or cleared under chapter V of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or licensed under section 262 of this title;(ii) the object of research for possible use as described by subparagraph (A) and is the subject of an exemption under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(i), 360j(g)]; or(iii) authorized for emergency use in accordance with section 564, 564A, or 564B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3, 360bbb–3a, 360bbb–3b].
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(vi) The term “device” means a device as defined in section 321(h) of title 21.
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(3) The term “high need cure” means a drug (as that term is defined by section 321(g)(1) of title 21,1 biological product (as that term is defined by section 262(i)2 of this title), or device (as that term is defined by section 321(h) of title 21) that, in the determination of the Director of the Center—(A) is a priority to diagnose, mitigate, prevent, or treat harm from any disease or condition; and(B) for which the incentives of the commercial market are unlikely to result in its adequate or timely development.
Citations to §321(ii)
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(1) compounded positron emission tomography drugs as defined in section 321(ii) of this title; or
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(10) The term “positron emission tomography drug” has the meaning given to the term “compounded positron emission tomography drug” in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply.
Citations to §321(ii)(1)(B)
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(10) The term “positron emission tomography drug” has the meaning given to the term “compounded positron emission tomography drug” in section 321(ii) of this title, except that paragraph (1)(B) of such section shall not apply.
Citations to §321(k)
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(a) It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label (as defined in section 321(k) of this title) containing an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances.
Citations to §321(m)
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(2) the term “labeling” has the meaning given such term in section 201(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(m));
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(n) In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of (1) the established name as defined in paragraph (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under paragraph (e), and (3) such other information in brief summary relating to side effects, contraindications, and effectiveness as shall be required in regulations which shall be issued by the Secretary in accordance with section 371(a) of this title, and in the case of published direct-to-consumer advertisements the following statement printed in conspicuous text: “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1–800-FDA-1088.”, except that (A) except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement, and (B) no advertisement of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertisements of prescription drugs, shall with respect to the matters specified in this paragraph or covered by such regulations, be subject to the provisions of sections 52 to 57 of title 15. This paragraph (n) shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 321(m) of this title. Nothing in the Convention on Psychotropic Substances, signed at Vienna, Austria, on February 21, 1971, shall be construed to prevent drug price communications to consumers. In the case of an advertisement for a drug subject to section 353(b)(1) of this title presented directly to consumers in television or radio format and stating the name of the drug and its conditions of use, the major statement relating to side effects and contraindications shall be presented in a clear, conspicuous, and neutral manner.
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(r) In the case of any restricted device distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that device (1) a true statement of the device’s established name as defined in subsection (e), printed prominently and in type at least half as large as that used for any trade or brand name thereof, and (2) a brief statement of the intended uses of the device and relevant warnings, precautions, side effects, and contraindications and, in the case of specific devices made subject to a finding by the Secretary after notice and opportunity for comment that such action is necessary to protect the public health, a full description of the components of such device or the formula showing quantitatively each ingredient of such device to the extent required in regulations which shall be issued by the Secretary after an opportunity for a hearing. Except in extraordinary circumstances, no regulation issued under this paragraph shall require prior approval by the Secretary of the content of any advertisement and no advertisement of a restricted device, published after the effective date of this paragraph shall, with respect to the matters specified in this paragraph or covered by regulations issued hereunder, be subject to the provisions of sections 52 through 55 of title 15. This paragraph shall not be applicable to any printed matter which the Secretary determines to be labeling as defined in section 321(m) of this title.
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(b) It shall be unlawful for the manufacturer of any controlled substance to distribute such substance unless the labeling (as defined in section 321(m) of this title) of such substance contains, when and as required by regulations of the Attorney General, the identifying symbol required under subsection (a).
Citations to §321(n)
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(iii) the claim and the food for which the claim is made are in compliance with clauses (A) and (B), and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and
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(iii) the claim and the food for which the claim is made are in compliance with clause (A)(ii) and are otherwise in compliance with paragraph (a) and section 321(n) of this title; and
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(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 is more prominent than the declaration of ingredients required by section 343(i)(2) of this title.
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(A) the Secretary may not establish, under section 321(n), 341, or 343 of this title, maximum limits on the potency of any synthetic or natural vitamin or mineral within a food to which this section applies;
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(C) the Secretary may not limit, under section 321(n), 341, or 343 of this title, the combination or number of any synthetic or natural—(i) vitamin,(ii) mineral, or(iii) other ingredient of food,within a food to which this section applies.
Citations to §321(p)
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(III) if the listed drug referred to in clause (i) has more than one active ingredient and if one of the active ingredients of the new drug is different and the application is filed pursuant to the approval of a petition filed under subparagraph (C), information to show that the other active ingredients of the new drug are the same as the active ingredients of the listed drug, information to show that the different active ingredient is an active ingredient of a listed drug or of a drug which does not meet the requirements of section 321(p) of this title, and such other information respecting the different active ingredient with respect to which the petition was filed as the Secretary may require;
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(II) that the different active ingredient is an active ingredient of a listed drug or a drug which does not meet the requirements of section 321(p) of this title,
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(1) A drug is deemed to be generally recognized as safe and effective under section 321(p)(1) of this title, not a new drug under section 321(p) of this title, and not subject to section 353(b)(1) of this title, if—(A) the drug is—(i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title; or(B) the drug is—(i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations;(ii) in conformity with the proposed requirements for nonprescription use of such tentative final monograph, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and(iii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.
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(4) A drug that is classified in category II for safety or effectiveness under a tentative final monograph or that is subject to a determination to be not generally recognized as safe and effective in a proposed rule that is the most recently applicable proposal issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title beginning on the day that is 180 calendar days after March 27, 2020, unless, before such day, the Secretary determines that it is in the interest of public health to extend the period during which the drug may be marketed without such an approved new drug application.
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(5) A drug that the Secretary has determined not to be generally recognized as safe and effective under section 321(p)(1) of this title under a final determination issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title.
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(6) Except as provided in subsection (m), a drug is deemed to be a new drug under section 321(p) of this title and misbranded under section 352(ee) of this title if the drug—(A) is not subject to section 353(b)(1) of this title; and
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(C) If the sponsor fails to provide such additional information within a time prescribed by the Secretary, or if the Secretary determines that such additional information does not demonstrate that the change does not—(i) affect the safety or effectiveness of the drug; or(ii) materially affect the extent of absorption or other exposure to the active ingredient in comparison to a suitable reference product,the drug as modified is a new drug under section 321(p) of this title and shall be deemed to be misbranded under section 352(ee) of this title.
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(f) The provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections 355(b)(1), 355(b)(2), and 355(j) of this title. A determination under this section that a drug is not subject to section 353(b)(1) of this title, is generally recognized as safe and effective under section 321(p)(1) of this title, and is not a new drug under section 321(p) of this title shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section 355(b)(2) of this title, so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section.
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(3) Nothing in this subsection shall be construed to alter, supersede, or limit the standards for making determinations of whether a drug is generally recognized as safe and effective under section 321(p) of this title or the standards set forth under section 355 of this title for determining the safety and effectiveness of drugs.
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(3) the term “GRASE” means generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling of a drug as described in section 321(p) of this title;
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(I) which was commercially used or sold in the United States before October 10, 1962, or which is identical, similar, or related (within the meaning of section 310.6(b)(1) of title 21 of the Code of Federal Regulations) to such a drug, and (II) which has not been the subject of a final determination by the Secretary that it is a “new drug” (within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(p)]) or an action brought by the Secretary under section 301, 302(a), or 304(a) of such Act [21 U.S.C. 331, 332(a), 334(a)] to enforce section 502(f) or 505(a) of such Act [21 U.S.C. 352(f), 355(a)]; or
Citations to §321(p)(1)
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(1) A drug is deemed to be generally recognized as safe and effective under section 321(p)(1) of this title, not a new drug under section 321(p) of this title, and not subject to section 353(b)(1) of this title, if—(A) the drug is—(i) in conformity with the requirements for nonprescription use of a final monograph issued under part 330 of title 21, Code of Federal Regulations (except as provided in paragraph (2)), the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title; or(B) the drug is—(i) classified in category I for safety and effectiveness under a tentative final monograph that is the most recently applicable proposal or determination issued under part 330 of title 21, Code of Federal Regulations;(ii) in conformity with the proposed requirements for nonprescription use of such tentative final monograph, any applicable subsequent determination by the Secretary, the general requirements for nonprescription drugs, and conditions or requirements under subsections (b), (c), and (k); and(iii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.
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(5) A drug that the Secretary has determined not to be generally recognized as safe and effective under section 321(p)(1) of this title under a final determination issued under part 330 of title 21, Code of Federal Regulations, shall be deemed to be a new drug under section 321(p) of this title, misbranded under section 352(ee) of this title, and subject to the requirement for an approved new drug application under section 355 of this title.
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(ii) generally recognized as safe and effective under section 321(p)(1) of this title.
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(C) The Secretary shall find that a drug is not generally recognized as safe and effective under section 321(p)(1) of this title if—(i) the evidence shows that the drug is not generally recognized as safe and effective under section 321(p)(1) of this title; or(ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective under section 321(p)(1) of this title.
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(i) the evidence shows that the drug is not generally recognized as safe and effective under section 321(p)(1) of this title; or
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(ii) the evidence is inadequate to show that the drug is generally recognized as safe and effective under section 321(p)(1) of this title.
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(B) When issuing an administrative order under paragraph (1) on the Secretary’s initiative proposing to determine that a drug described in subsection (a)(3) is not generally recognized as safe and effective under section 321(p)(1) of this title, the Secretary shall follow the procedures in subparagraph (A), except that—(i) the proposed order shall include notice of—(I) the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section 321(p)(1) of this title; and(II) the format for submissions by interested persons;(ii) the Secretary shall provide for a public comment period of no less than 180 calendar days with respect to such proposed order, except when the Secretary determines, for good cause, that a shorter period is in the interest of public health; and(iii) any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section 321(p)(1) of this title.
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(I) the general categories of data the Secretary has determined necessary to establish that the drug is generally recognized as safe and effective under section 321(p)(1) of this title; and
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(iii) any person who submits data in such comment period shall include a certification that the person has submitted all evidence created, obtained, or received by that person that is both within the categories of data identified in the proposed order and relevant to a determination as to whether the drug is generally recognized as safe and effective under section 321(p)(1) of this title.
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(I) determining whether a drug is generally recognized as safe and effective under section 321(p)(1) of this title, exempt from section 353(b)(1) of this title, and not required to be the subject of an approved application under section 355 of this title; or
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(II) determining whether a change to a condition of use of a drug is generally recognized as safe and effective under section 321(p)(1) of this title, exempt from section 353(b)(1) of this title, and not required to be the subject of an approved application under section 355 of this title, if, absent such a changed condition of use, such drug is—(aa) generally recognized as safe and effective under section 321(p)(1) of this title in accordance with subsection (a)(1), (a)(2), or an order under this subsection; or(bb) subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective under section 321(p)(1) of this title, which is filed by the Secretary under subparagraph (A)(ii).
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(aa) generally recognized as safe and effective under section 321(p)(1) of this title in accordance with subsection (a)(1), (a)(2), or an order under this subsection; or
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(bb) subject to subsection (a)(3), but only if such requestor initiates such request in conjunction with a request for the Secretary to determine whether such drug is generally recognized as safe and effective under section 321(p)(1) of this title, which is filed by the Secretary under subparagraph (A)(ii).
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(ii) The Secretary is not required to complete review of a request for a change described in clause (i)(II) if the Secretary determines that there is an inadequate basis to find the drug is generally recognized as safe and effective under section 321(p)(1) of this title under paragraph (1) and issues a final order announcing that determination.
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(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or
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(aa) a proposed or final determination that a drug described in subclause (I), (II), or (III) of clause (iii) is generally recognized as safe and effective under section 321(p)(1) of this title; or
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(i) the information pertains to pharmaceutical quality information, unless such information is necessary to establish standards under which a drug is generally recognized as safe and effective under section 321(p)(1) of this title;
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(f) The provisions of this section shall not be construed to preclude a person from seeking or maintaining the approval of an application for a drug under sections 355(b)(1), 355(b)(2), and 355(j) of this title. A determination under this section that a drug is not subject to section 353(b)(1) of this title, is generally recognized as safe and effective under section 321(p)(1) of this title, and is not a new drug under section 321(p) of this title shall constitute a finding that the drug is safe and effective that may be relied upon for purposes of an application under section 355(b)(2) of this title, so that the applicant shall be required to submit for purposes of such application only information needed to support any modification of the drug that is not covered by such determination under this section.
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(B) Nothing in subsection (a) shall be construed to prohibit the Secretary from issuing an order under this section finding a drug to be not generally recognized as safe and effective under section 321(p)(1) of this title, as the Secretary determines appropriate.
Citations to §321(p)(2)
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(ii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title; or
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(iii) except as permitted by an order issued under subsection (b) or, in the case of a minor change in the drug, in conformity with an order issued under subsection (c), in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.
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(iii) in a dosage form that, immediately prior to March 27, 2020, had been used to a material extent and for a material time under section 321(p)(2) of this title; or
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(iii) in a dosage form that, immediately prior to March 27, 2020, has been used to a material extent and for a material time under section 321(p)(2) of this title.
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(ii) has been used to a material extent and for a material time under such conditions, as described in section 321(p)(2) of this title.
Citations to §321(q)
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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 sections 321(q), (r), 342(a)(2), and 346a of this title.
Citations to §321(q)(1)
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(4) With respect to a substance that is not included in the definition of the term “pesticide chemical” under section 321(q)(1) of this title but was so included on the day before October 30, 1998, the following applies as of October 30, 1998:(A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that was in effect on the day before October 30, 1998, and was on such day deemed in such paragraph to have been issued under this section, shall be considered to have been issued under section 348 of this title.(B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that was in effect on such day and was issued under this section (including any such regulation issued before August 3, 1996) is deemed to have been issued under section 348 of this title.
Citations to §321(qq)(1)
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(2) As used in this subsection, the term “name of the food source from which the major food allergen is derived” means the name described in section 321(qq)(1) of this title; provided that in the case of a tree nut, fish, or Crustacean shellfish, the term “name of the food source from which the major food allergen is derived” means the name of the specific type of nut or species of fish or Crustacean shellfish.
Citations to §321(qq)(2)
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(A) Any person may petition the Secretary to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection.
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(A) A person need not file a petition under paragraph (6) to exempt a food ingredient described in section 321(qq)(2) of this title from the allergen labeling requirements of this subsection, if the person files with the Secretary a notification containing—(i) scientific evidence (including the analytical method used) that demonstrates that the food ingredient (as derived by the method specified in the notification, where applicable) does not contain allergenic protein; or(ii) a determination by the Secretary that the ingredient does not cause an allergic response that poses a risk to human health under a premarket approval or notification program under section 348 of this title.
Citations to §321(qq)(2)(A)
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(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.
Citations to §321(qq)(2)(B)
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(ii) the name of the food source from which the major food allergen is derived appears elsewhere in the ingredient list, unless the name of the food source that appears elsewhere in the ingredient list appears as part of the name of a food ingredient that is not a major food allergen under section 321(qq)(2)(A) or (B) of this title.
Citations to §321(r)
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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 sections 321(q), (r), 342(a)(2), and 346a of this title.
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(f) The Secretary shall include in the report developed under subsection (a)(1) an analysis of the Food and Drug Administration’s performance in foodborne illness outbreaks during the 5-year period preceding January 4, 2011, involving fruits and vegetables that are raw agricultural commodities (as defined in section 321(r) of this title) and recommendations for enhanced surveillance, outbreak response, and traceability. Such findings and recommendations shall address communication and coordination with the public, industry, and State and local governments, as such communication and coordination relates to outbreak identification and traceback.
Citations to §321(s)
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(1) regarded by the Administrator or the Secretary as generally recognized as safe for use within the meaning of the provisions of subsection (a) or section 321(s) of this title as then in effect; or
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(4) The Secretary shall not list a color additive under this section for a proposed use unless the data before him establish that such use, under the conditions of use specified in the regulations, will be safe: Provided, however, That a color additive shall be deemed to be suitable and safe for the purpose of listing under this subsection for use generally in or on food, while there is in effect a published finding of the Secretary declaring such substance exempt from the term “food additive” because of its being generally recognized by qualified experts as safe for its intended use, as provided in section 321(s) of this title.
Citations to §321(s)(4)
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(2) regarded by the Secretary as a substance described by section 321(s)(4) of this title;
Citations to §321(ss)
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(2) The Office of Critical Foods shall be responsible for oversight, coordination, and facilitation of activities related to critical foods, as defined in section 201(ss) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(ss)], as added by subsection (a)(2).
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(1) A manufacturer of a critical food (as defined in section 321(ss) of this title) shall notify the Secretary of a permanent discontinuance in the manufacture or an interruption of the manufacture of such food that is likely to lead to a meaningful disruption in the supply of such food in the United States, and the reasons for such discontinuance or interruption, as soon as practicable, but not later than 5 business days after such discontinuance or such interruption.
Citations to §321(v)
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(II) information to show either that the different active ingredient is an active ingredient of another approved new animal drug or of an animal drug which does not meet the requirements of section 321(v) of this title, and
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(I) information to show either that the different animal drug proposed for use with the approved new animal drug in animal feed is an approved new animal drug permitted to be used in animal feed or does not meet the requirements of section 321(v) of this title when used with another animal drug in animal feed,
Citations to §321(z)
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(1) In this section, the term “infant formula” has the meaning given such term in section 201(z) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(z)).