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

The statute’s own glossary: every term Title 21 defines, in section order.

“filled milk” applies throughout its chapter

The term “filled milk” means any milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated, to which has been added, or which has been blended or compounded with, any fat or oil other than milk fat, so that the resulting product is in imitation or semblance of milk, cream, or skimmed milk, whether or not condensed, evaporated, concentrated, powdered, dried, or desiccated.

“interstate or foreign commerce” applies throughout its chapter

The term “interstate or foreign commerce” means commerce (1) between any State, Territory, or possession, or the District of Columbia, and any place outside thereof; (2) between points within the same State, Territory, or possession, or within the District of Columbia, but through any place outside thereof; or (3) within any Territory or possession, or within the District of Columbia; and;

“person” applies throughout its chapter

The term “person” includes an individual, partnership, corporation, or association;

21 U.S.C. § 136a — Collection of fees for inspection services

“animal quarantine laws” applies in that section

the term “animal quarantine laws” means— (A) section 306 of the Tariff Act of 1930 3 ( 19 U.S.C. 1306 ); (B) section 9 of the Act of August 30, 1890 ( 21 U.S.C. 101 ); (C) the Animal Health Protection Act [ 7 U.S.C. 8301 et seq.]; or (D) any other Act administered by the Secretary relating to plant or animal diseases or pests. (2) Customs territory For the purposes of subsection (a),

“customs territory of the United States” applies in that section

the term “customs territory of the United States” means the 50 States, the District of Columbia, and Puerto Rico. (3) Person For the purposes of this section,

“person” applies in that section

the term “person” means an individual, corporation, partnership, trust, association, or any other public or private entity, or any officer, employee, or agent thereof. (4) United States For the purposes of subsection (b),

“United States” applies in that section

the term “United States” means the several States of the United States, the District of Columbia, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, the Virgin Islands of the United States, and all other territories and possessions of the United States. (5) Vessel For the purposes of subsection (a), the term “vessel” does not include any ferry.

21 U.S.C. § 149 — Definitions

“person” applies throughout its subchapter

The term “person” means an individual, partnership, association, or corporation.;

“United States” applies throughout its subchapter

The term “United States” means the fifty States and the District of Columbia.

21 U.S.C. § 321 — Definitions; generally

“abbreviated drug application” applies throughout its chapter

The term “abbreviated drug application” means an application submitted under section 355(j) of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and— (1) in the case of section 335a of this title , includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and (2) in the case of sections 335b and 335c of this title, includes any supplement to such an application.;

“Administrator” applies throughout its chapter

The term “Administrator” means the Administrator of the United States Environmental Protection Agency.;

“antibiotic drug” applies throughout its chapter

The term “antibiotic drug” means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof. (kk) Priority supplement .—

“color” applies throughout its chapter

The term “color” includes black, white, and intermediate grays. (3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest. (u) The term “safe” as used in paragraph (s) of this section and in sections 348, 360b, 360ccc, and 379e of this title, has reference to the health of man or animal.;

“color additive” applies throughout its chapter

The term “color additive” means a material which— (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.;

“Commissioner” applies throughout its chapter

The term “Commissioner” means the Commissioner of Food and Drugs.;

“compounded positron emission tomography drug” applies throughout its chapter

The term “compounded positron emission tomography drug”— (1) means a drug that— (A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for the purpose of providing dual photon positron emission tomographic diagnostic images; and (B) has been compounded by or on the order of a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State’s law, for a patient or for research, teaching, or quality control; and (2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or …

“cosmetic” applies throughout its chapter

The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.;

“counterfeit device” applies throughout its chapter

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

“counterfeit drug” applies throughout its chapter

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

“critical food” applies throughout its chapter

The term “critical food” means a food that is— (1) an infant formula; or (2) a medical food, as defined in section 360ee(b)(3) of this title .

“critical reprocessed single-use device” applies throughout its chapter

The term “critical reprocessed single-use device” means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use.;

“Department” applies throughout its chapter

The term “Department” means Department of Health and Human Services.;

“dietary supplement” applies throughout its chapter

The term “dietary supplement”— (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); (2) means a product that— (A) (i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title ; or (ii) complies with section 350(c)(1)(B)(ii) of this title ; (B) is not …

“drug” applies throughout its chapter

The term “drug” means (A) articles recognized in the official United States Pharmacopoeia, 1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

“drug product” applies throughout its chapter

the term “drug product” means a drug subject to regulation under section 355, 360b, or 382 of this title or under section 262 of title 42 .;

“food” applies throughout its chapter

The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (g);

“food additive” applies throughout its chapter

The term “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to …

“high managerial agent” applies throughout its chapter

the term “high managerial agent”— (1) means— (A) an officer or director of a corporation or an association, (B) a partner of a partnership, or (C) any employee or other agent of a corporation, association, or partnership, having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and (2) includes persons having management responsibility for— (A) submissions to the Food and Drug Administration regarding the development or approval of any drug product, (B) production, quality assurance, or quality control of any drug product, or (C) research and development of any …

“infant formula” applies throughout its chapter

The term “infant formula” means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.;

“informal hearing” applies throughout its chapter

The term “informal hearing” means a hearing which is not subject to section 554, 556, or 557 of title 5 and which provides for the following: (1) The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action. (2) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.

“interstate commerce” applies throughout its chapter

The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body.;

“knew” applies throughout its chapter

The term “knowingly” or “knew” means that a person, with respect to information— (1) has actual knowledge of the information, or (2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information. (cc) For purposes of section 335a of this title ,

“knowingly” applies throughout its chapter

“label” applies throughout its chapter

The term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper. (l) The term “immediate container” does not include package liners.;

“labeling” applies throughout its chapter

The term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article. (n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the …

“major food allergen” applies throughout its chapter

The term “major food allergen” means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, soybeans, and sesame. (2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil. (B) A food ingredient that is exempt under paragraph (6) or (7) of section 343(w) of this title . (rr);

“major species” applies throughout its chapter

The term “major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats, except that the Secretary may add species to this definition by regulation.;

“minor species” applies throughout its chapter

The term “minor species” means animals other than humans that are not major species.;

“minor use” applies throughout its chapter

The term “minor use” means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually.;

“new animal drug” applies throughout its chapter

The term “new animal drug” means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed,— (1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a “new animal drug” if at any time prior to June 25, 1938 , it was subject to the Food and Drug Act of June 30, 1906 , as amended, and if at …

“new drug” applies throughout its chapter

The term “new drug” means— (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not 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 thereof, except that such a drug not so recognized shall not be deemed to be a “new drug” if at any time prior to June 25, 1938 , it was subject to the Food and Drugs Act of June 30, 1906 , as amended, and if at such time its labeling contained the same representations …

“official compendium” applies throughout its chapter

The term “official compendium” means the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.;

“original device” applies throughout its chapter

The term “original device” means a new, unused single-use device. (mm);

“person” applies throughout its chapter

The term “person” includes individual, partnership, corporation, and association.;

“pesticide chemical” applies throughout its chapter

the term “pesticide chemical” means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [ 7 U.S.C. 136 et seq.], including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term “pesticide” within such meaning includes ethylene oxide and propylene oxide when such substances are applied on food.

“pesticide chemical residue” applies throughout its chapter

The term “pesticide chemical residue” means a residue in or on raw agricultural commodity or processed food of— (A) a pesticide chemical; or (B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical.

“priority supplement” applies throughout its chapter

The term “priority supplement” means a drug application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997 ( 111 Stat. 2298 ). (ll);

“processed food” applies throughout its chapter

The term “processed food” means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling.;

“raw agricultural commodity” applies throughout its chapter

The term “raw agricultural commodity” means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.;

“saccharin” applies throughout its chapter

The term “saccharin” includes calcium saccharin, sodium saccharin, and ammonium saccharin.;

“Secretary” applies throughout its chapter

The term “Secretary” means the Secretary of Health and Human Services.;

“semi-critical reprocessed single-use device” applies throughout its chapter

The term “semi-critical reprocessed single-use device” means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body.;

“single-use device” applies throughout its chapter

The term “single-use device” means a device that is intended for one use, or on a single patient during a single procedure. (2) (A) The term “reprocessed”, with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.

“Territory” applies throughout its chapter

The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone.;

“tobacco product” applies throughout its chapter

The term “tobacco product” means any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). (2) The term “tobacco product” does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353(g) of this title . (3) The products described in paragraph (2) shall be subject to subchapter V of this chapter.

21 U.S.C. § 331 — Prohibited acts

“plastic microbead” applies in that section

the term “plastic microbead” means any solid plastic particle that is less than five millimeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof; and;

“rinse-off cosmetic” applies in that section

the term “rinse-off cosmetic” includes toothpaste. (eee) The failure to comply with any order issued under section 360bbb–8d of this title . (fff) (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other identification upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device.

21 U.S.C. § 333 — Penalties

“human growth hormone” applies in that section

the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them. (5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection. (f) Violations related to devices (1) (A) Except as provided in subparagraph (B), any person who violates a requirement of this chapter which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding.

21 U.S.C. § 335a — Debarment, temporary denial of approval, and suspension

“pattern of importing or offering for import” applies in that section

the term “pattern of importing or offering for import” means importing or offering for import a drug described in clause (i) or (ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.

21 U.S.C. § 343 — Misbranded food

“fish” applies in that section

the term “fish” includes freshwater or marine fin fish, crustaceans, and mollusks, including shellfish, amphibians, and other forms of aquatic animal life. (F) No person who offers raw agricultural commodities or raw fish to consumers may be prosecuted for minor violations of this subparagraph if there has been substantial compliance with the requirements of this paragraph.

“food product” applies in that section

the term “food product” means food in any sized package which is manufactured by a single manufacturer or which bears the same brand name, which bears the same statement of identity, and which has similar preparation methods, and (III) the term “person” in the case of a corporation includes all domestic and foreign affiliates of the corporation.

“menu” applies in that section

the term “menu” or “menu board” means the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection. (r) Nutrition levels and health-related claims (1) Except as provided in clauses (A) through (C) of subparagraph (5), if it is a food intended for human consumption which is offered for sale and for which a claim is made in the label or labeling of the food which expressly or by implication— (A) characterizes the level of any nutrient which is of the type required by paragraph (q)(1) or (q)(2) to be in the label or labeling of the food unless the claim is made in accordance with subparagraph (2), or (B) characterizes the …

“menu board” applies in that section

“name of the food source from which the major food allergen is derived” applies in that section

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,

“unit” applies in that section

the term “unit” means the packaging or, if there is no packaging, the form in which a food product is offered for sale to consumers;

21 U.S.C. § 343–3 — Disclosure

“radiation disclosure statement” applies in that section

the term “radiation disclosure statement” means a written statement that discloses that a food has been intentionally subject to radiation.

21 U.S.C. § 346a — Tolerances and exemptions for pesticide chemical residues

“eligible pesticide chemical residue” applies in that section

the term “eligible pesticide chemical residue” means a pesticide chemical residue as to which— (I) the Administrator is not able to identify a level of exposure to the residue at which the residue will not cause or contribute to a known or anticipated harm to human health (referred to in this section as a “nonthreshold effect”); (II) the lifetime risk of experiencing the nonthreshold effect is appropriately assessed by quantitative risk assessment; and (III) with regard to any known or anticipated harm to human health for which the Administrator is able to identify a level at which the residue will not cause such harm (referred to in this section as a “threshold effect”), the Administrator …

“qualifying Federal determination” applies in that section

the term “qualifying Federal determination” means a tolerance or exemption from the requirement for a tolerance for a qualifying pesticide chemical residue that— (A) is issued under this section after August 3, 1996 , and determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption); or (B) (i) pursuant to subsection (j) is remaining in effect or is deemed to have been issued under this section, or is regarded under subsection (k) as exempt from the requirement for a tolerance; and (ii) is determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or …

“qualifying pesticide chemical residue” applies in that section

the term “qualifying pesticide chemical residue” means a pesticide chemical residue resulting from the use, in production, processing, or storage of a food, of a pesticide chemical that is an active ingredient and that— (A) was first approved for such use in a registration of a pesticide issued under section 3(c)(5) of the Federal Insecticide, Fungicide, and Rodenticide Act [ 7 U.S.C. 136a(c)(5) ] on or after April 25, 1985 , on the basis of data determined by the Administrator to meet all applicable requirements for data prescribed by regulations in effect under that Act [ 7 U.S.C.

21 U.S.C. § 348 — Food additives

“food contact substance” applies in that section

the term “food contact substance” means the substance that is the subject of a notification submitted under paragraph (1), and does not include a similar or identical substance manufactured or prepared by a person other than the manufacturer identified in the notification. (3) (A) The process in this subsection shall be utilized for authorizing the marketing of a food contact substance except where the Secretary determines that submission and review of a petition under subsection (b) is necessary to provide adequate assurance of safety, or where the Secretary and any manufacturer or supplier agree that such manufacturer or supplier may submit a petition under subsection (b).

21 U.S.C. § 350 — Vitamins and minerals

“children” applies in that section

the term “children” means individuals who are under the age of twelve years. (b) Labeling and advertising requirements for foods (1) A food to which this section applies shall not be deemed under section 343 of this title to be misbranded solely because its label bears, in accordance with section 343(i)(2) of this title , all the ingredients in the food or its advertising contains references to ingredients in the food which are not vitamins or minerals.

“food to which this section applies” applies in that section

the term “food to which this section applies” means a food for humans which is a food for special dietary use— (A) which is or contains any natural or synthetic vitamin or mineral, and (B) which— (i) is intended for ingestion in tablet, capsule, powder, softgel, gelcap, or liquid form, or (ii) if not intended for ingestion in such a form, is not represented as conventional food and is not represented for use as a sole item of a meal or of the diet.

21 U.S.C. § 350a — Infant formulas

“final product stage” applies in that section

the term “final product stage” means the point in the manufacturing process, before distribution of an infant formula, at which an infant formula is homogenous and is not subject to further degradation. (4) (A) The Secretary shall by regulation establish requirements respecting the retention of records.

“major change” applies in that section

the term “major change” has the meaning given to such term in section 106.30(c)(2) of title 21, Code of Federal Regulations (as in effect on August 1, 1986 ), and guidelines issued thereunder. (d) Submission of information about new infant formula required (1) A person shall, with respect to any infant formula subject to subsection (c), make a submission to the Secretary which shall include— (A) the quantitative formulation of the infant formula, (B) a description of any reformulation of the formula or change in processing of the infant formula, (C) assurances that the infant formula will not be marketed unless it meets the requirements of subsections (b)(1) and (i), as demonstrated by the …

“new infant formula” applies in that section

the term “new infant formula” includes— (A) an infant formula manufactured by a person which has not previously manufactured an infant formula, and (B) an infant formula manufactured by a person which has previously manufactured infant formula and in which there is a major change, in processing or formulation, from a current or any previous formulation produced by such manufacturer. For purposes of this paragraph,

“specialty infant formula” applies in that section

the term “specialty infant formula” means infant formula described in subsection (h)(1).

21 U.S.C. § 350a–1 — Protecting infants and improving formula supply

“infant formula” applies in that 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) ). (2) Omitted (b) Office of Critical Foods (1) In general The Secretary shall establish within the Center for Food Safety and Applied Nutrition an office to be known as the Office of Critical Foods. The Secretary shall appoint a Director to lead such Office. (2) Duties 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).

21 U.S.C. § 350b — New dietary ingredients

“anabolic steroid” applies in that section

the term “anabolic steroid” has the meaning given such term in section 802(41) of this title ; and;

“analogue of an anabolic steroid” applies in that section

the term “analogue of an anabolic steroid” means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid. (d) “New dietary ingredient” defined For purposes of this section,

“new dietary ingredient” applies in that section

the term “new dietary ingredient” means a dietary ingredient that was not marketed in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994 .

21 U.S.C. § 350d — Registration of food facilities

“domestic facility” applies in that section

The term “domestic facility” means a facility located in any of the States or Territories. (3);

“facility” applies in that section

The term “facility” includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).;

“foreign facility” applies in that section

The term “foreign facility” means a facility that manufacturers, 1 processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States. (B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.

21 U.S.C. § 350e — Sanitary transportation practices

“bulk vehicle” applies in that section

The term “bulk vehicle” includes a tank truck, hopper truck, rail tank car, hopper car, cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which food is shipped in bulk, with the food coming into direct contact with the vehicle. (2) Transportation

“transportation” applies in that section

The term “transportation” means any movement in commerce by motor vehicle or rail vehicle. (b) Regulations The Secretary shall by regulation require shippers, carriers by motor vehicle or rail vehicle, receivers, and other persons engaged in the transportation of food to use sanitary transportation practices prescribed by the Secretary to ensure that food is not transported under conditions that may render the food adulterated.

21 U.S.C. § 350f — Reportable food registry

“reportable food” applies in that section

The term “reportable food” means an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. (b) Establishment (1) In general Not later than 1 year after September 27, 2007 , the Secretary shall establish within the Food and Drug Administration a Reportable Food Registry to which instances of reportable food may be submitted by the Food and Drug Administration after receipt of reports under subsection (d), via an electronic portal, from— (A) Federal, State, and local public health officials; or (B) responsible parties.

21 U.S.C. § 350g — Hazard analysis and risk-based preventive controls

“affiliate” applies in that section

The term “affiliate” means any facility that controls, is controlled by, or is under common control with another facility. (B) Qualified end-user The term “qualified end-user”, with respect to a food, means— (i) the consumer of the food; or (ii) a restaurant or retail food establishment (as those terms are defined by the Secretary for purposes of section 350d of this title ) that— (I) is located— (aa) in the same State as the qualified facility that sold the food to such restaurant or establishment; or (bb) not more than 275 miles from such facility; and (II) is purchasing the food for sale directly to consumers at such restaurant or retail food establishment.

“critical control point” applies in that section

The term “critical control point” means a point, step, or procedure in a food process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce such hazard to an acceptable level. (2) Facility

“facility” applies in that section

The term “facility” means a domestic facility or a foreign facility that is required to register under section 350d of this title . (3) Preventive controls

“preventive controls” applies in that section

The term “preventive controls” means those risk-based, reasonably appropriate procedures, practices, and processes that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the hazard analysis conducted under subsection (b) and that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. Those procedures, practices, and processes may include the following: (A) Sanitation procedures for food contact surfaces and utensils and food-contact surfaces of equipment.

“subsidiary” applies in that section

The term “subsidiary” means any company which is owned or controlled directly or indirectly by another company. (5) Study (A) In general The Secretary, in consultation with the Secretary of Agriculture, shall conduct a study of the food processing sector regulated by the Secretary to determine— (i) the distribution of food production by type and size of operation, including monetary value of food sold; (ii) the proportion of food produced by each type and size of operation; (iii) the number and types of food facilities co-located on farms, including the number and proportion by commodity and by manufacturing or processing activity; (iv) the incidence of foodborne illness originating from …

21 U.S.C. § 350i — Protection against intentional adulteration

“farm” applies in that section

the term “farm” has the meaning given that term in section 1.227 of title 21, Code of Federal Regulations (or any successor regulation).

21 U.S.C. § 350j — Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

“facility” applies in that section

the term “facility” means a domestic facility or a foreign facility that is required to register under section 350d of this title .

21 U.S.C. § 350m — Requirements for critical food

“meaningful disruption” applies in that section

the term “meaningful disruption”— (A) means a change in production that is reasonably likely to lead to a significant reduction in the supply of a critical food by a manufacturer that affects the ability of the manufacturer to meet expected demand for its product; and (B) does not include interruptions in manufacturing due to matters such as routine maintenance, changes or discontinuance of flavors, colors, or other insignificant formulation characteristics, or insignificant changes in manufacturing so long as the manufacturer expects to resume operations in a short period of time.

21 U.S.C. § 351 — Adulterated drugs and devices

“current good manufacturing practice” applies in that section

the term “current good manufacturing practice” includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.

21 U.S.C. § 352 — Misbranded drugs and devices

“health care economic information” applies in that section

the term “health care economic information” means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug or device. Such analysis may be comparative to the use of another drug or device, to another health care intervention, or to no intervention.

“product information” applies in that section

the term “product information” includes— (A) information describing the drug or device (such as drug class, device description, and features); (B) information about the indication or indications being investigated; (C) the anticipated timeline for a possible approval, clearance, marketing authorization, or licensure pursuant to section 355, 360(k), 360c, or 360e of this title or section 262 of title 42 ; (D) drug or device pricing information; (E) patient utilization projections; (F) product-related programs or services; and (G) factual presentations of results from studies that do not characterize or make conclusions regarding safety or efficacy.

21 U.S.C. § 353 — Exemptions and consideration for certain drugs, devices, and biological products

“affiliate” applies in that section

the term “affiliate” means a business entity that has a relationship with a second business entity if, directly or indirectly— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has the power to control, both of the business entities.

“agency center” applies in that section

The term “agency center” means a center or alternative organizational component of the Food and Drug Administration.;

“approved drug” applies in that section

the term “approved drug” means an active ingredient— (i) that was in an application previously approved under section 355(c) of this title ; (ii) where such application is relied upon by the applicant submitting the application or request described in subparagraph (A); (iii) for which full reports of investigations that have been made to show whether such drug is safe for use and whether such drug is effective in use were not conducted by or for the applicant submitting the application or request described in subparagraph (A); and (iv) for which the applicant submitting the application or request described in subparagraph (A) has not obtained a right of reference or use from the person by …

“authorized distributors of record” applies in that section

the term “authorized distributors of record” means those distributors with whom a manufacturer has established an ongoing relationship to distribute such manufacturer’s products. (e) Licensing and reporting requirements for wholesale distributors; fees; definitions (1) Requirement .— Subject to section 360eee–2 of this title : (A) In general .— No person may engage in wholesale distribution of a drug subject to subsection (b)(1) in any State unless such person— (i) (I) is licensed by the State from which the drug is distributed; or (II) if the State from which the drug is distributed has not established a licensure requirement, is licensed by the Secretary; and (ii) if the drug is …

“biological product” applies in that section

The term “biological product” has the meaning given the term in section 351(i) of the Public Health Service Act ( 42 U.S.C. 262(i) ).;

“contrast agent” applies in that section

The term “contrast agent” means an article that is intended for use in conjunction with a medical imaging device, and— (i) is a diagnostic radiopharmaceutical, as defined in sections 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or (ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.;

“coupon” applies in that section

the term “coupon” means a form which may be redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with subsection (b). (3) (A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any drug— (i) which is subject to subsection (b), and (ii) (I) which was purchased by a public or private hospital or other health care entity, or (II) which was donated or supplied at a reduced price to a charitable organization described in section 501(c)(3) of title 26 .

“drug sample” applies in that section

the term “drug sample” means a unit of a drug, subject to subsection (b), which is not intended to be sold and is intended to promote the sale of the drug. Nothing in this paragraph shall subject an officer or executive of a drug manufacturer or distributor to criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade in violation of this paragraph by other employees of the manufacturer or distributor. (2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit any coupon. For purposes of this paragraph,

“emergency medical reasons” applies in that section

the term “emergency medical reasons” includes transfers of a drug between health care entities or from a health care entity to a retail pharmacy undertaken to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules. (d) Distribution of drug samples (1) Except as provided in paragraphs (2) and (3), no person may distribute any drug sample.

“market clearance” applies in that section

The term “market clearance” includes— (i) approval of an application under section 355, 357, 4 360e, or 360j(g) of this title; (ii) a finding of substantial equivalence under this part; (iii) approval of a biologics license application under subsection (a) of section 351 of the Public Health Service Act ( 42 U.S.C. 262 ); and (iv) de novo classification under section 360c(a)(1) of this title .;

“OTC monograph drug” applies in that section

The term “OTC monograph drug” has the meaning given such term in section 379j–71 of this title . (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.

“premarket review” applies in that section

The terms “premarket review” and “reviews” include all activities of the Food and Drug Administration conducted prior to approval or clearance of an application, notification, or request for classification submitted under section 355, 360(k), 360c(f)(2), 360e, or 360j of this title or under section 351 of the Public Health Service Act [ 42 U.S.C. 262 ], including with respect to investigational use of the product. (h) Regulation of certain products as drugs (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 . (2) For purposes of this subsection:;

“primary mode of action” applies in that section

the term “primary mode of action” means the single mode of action of a combination product expected to make the greatest contribution to the overall intended therapeutic effects of the combination product. (D) The Secretary shall determine the primary mode of action of the combination product.

“radioactive drug” applies in that section

The term “radioactive drug” has the meaning given such term in section 310.3(n) of title 21, Code of Federal Regulations (or any successor regulations), except that such term does not include— (i) an implant or article similar to an implant; (ii) an article that applies radiation from outside of the body; or (iii) the radiation source of an article described in clause (i) or (ii).;

“reviews” applies in that section

“wholesale distribution” applies in that section

the term “wholesale distribution” means the distribution of a drug subject to subsection (b) to a person other than a consumer or patient, or receipt of a drug subject to subsection (b) by a person other than the consumer or patient, but does not include— (A) intracompany distribution of any drug between members of an affiliate or within a manufacturer; (B) the distribution of a drug, or an offer to distribute a drug among hospitals or other health care entities which are under common control; (C) the distribution of a drug or an offer to distribute a drug for emergency medical reasons, including a public health emergency declaration pursuant to section 319 of the Public Health Service Act …

21 U.S.C. § 353b — Outsourcing facilities

“approved drug” applies in that section

The term “approved drug” means a drug that is approved under section 355 of this title and does not appear on the list described in subsection (a)(4) of drugs that have been withdrawn or removed from the market because such drugs or components of such drugs have been found to be unsafe or not effective. (4);

“compounding” applies in that section

The term “compounding” includes the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug.;

“essentially a copy of an approved drug” applies in that section

The term “essentially a copy of an approved drug” means— (A) a drug that is identical or nearly identical to an approved drug, or a marketed drug not subject to section 353(b) of this title and not subject to approval in an application submitted under section 355 of this title , unless, in the case of an approved drug, the drug appears on the drug shortage list in effect under section 356e of this title at the time of compounding, distribution, and dispensing; or (B) a drug, a component of which is a bulk drug substance that is a component of an approved drug or a marketed drug that is not subject to section 353(b) of this title and not subject to approval in an application submitted under …

“outsourcing facility” applies in that section

The term “outsourcing facility” means a facility at one geographic location or address that— (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. (B) An outsourcing facility is not required to be a licensed pharmacy. (C) An outsourcing facility may or may not obtain prescriptions for identified individual patients.;

“sterile drug” applies in that section

The term “sterile drug” means a drug that is intended for parenteral administration, an ophthalmic or oral inhalation drug in aqueous format, or a drug that is required to be sterile under Federal or State law. (d) 2 Obligation to pay fees Payment of the fee under section 379j–62 of this title , as described in subsection (a)(9), shall not relieve an outsourcing facility that is licensed as a pharmacy in any State that requires pharmacy licensing fees of its obligation to pay such State fees.

21 U.S.C. § 353d — Process to update labeling for certain generic drugs

“covered drug” applies in that section

The term “covered drug” means a drug approved under section 355(c) of this title — (A) for which there are no unexpired patents included in the list under section 355(j)(7) of this title and no unexpired period of exclusivity; (B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and (C) for which— (i) (I) there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved labeling; (II) the approved labeling does not reflect current legal and regulatory requirements for content or format; or (III) there is a relevant accepted use in clinical practice that is not reflected …

“generic version” applies in that section

The term “generic version” means a drug approved under section 355(j) of this title whose reference listed drug is a covered drug.;

“relevant accepted use” applies in that section

The term “relevant accepted use” means a use for a drug in clinical practice that is supported by scientific evidence that appears to the Secretary to meet the standards for approval under section 355 of this title .;

“selected drug” applies in that section

The term “selected drug” means a covered drug for which the Secretary has determined through the process under subsection (c) that the labeling should be changed. (b) Identification of covered drugs The Secretary may identify covered drugs for which labeling updates would provide a public health benefit. To assist in identifying covered drugs, the Secretary may do one or both of the following: (1) Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such drugs.

21 U.S.C. § 355 — New drugs

“180-day exclusivity period” applies in that section

The term “180-day exclusivity period” means the 180-day period ending on the day before the date on which an application submitted by an applicant other than a first applicant could become effective under this clause. (bb) First applicant .— As used in this subsection,

“applicable medical imaging device” applies in that section

the terms “applicable medical imaging device” and “contrast agent” have the meanings given such terms in section 360j(p) of this title . (z) 6 Nonclinical test defined For purposes of this section,

“application” applies in that section

the term “application” means an application submitted under subsection (b)(2) or (j) of this section or section 262(k) of title 42 . (B) Petition For purposes of this subsection, other than paragraph (1)(A)(i),

“authorized generic drug” applies in that section

the term “authorized generic drug” means a listed drug (as that term is used in subsection (j)) that— (A) has been approved under subsection (c); and (B) is marketed, sold, or distributed directly or indirectly to retail class of trade under a different labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark than the listed drug.

“bioavailability” applies in that section

The term “bioavailability” means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action. (ii) For a drug that is not intended to be absorbed into the bloodstream, the Secretary may assess bioavailability by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or therapeutic ingredient becomes available at the site of drug action.

“competitive generic therapy” applies in that section

The term “competitive generic therapy” means a drug— (AA) that is designated as a competitive generic therapy under section 356h of this title ; and (BB) for which there are no unexpired patents or exclusivities on the list of products described in section 355(j)(7)(A) of this title at the time of submission.;

“contrast agent” applies in that section

“covered application” applies in that section

The term “covered application” means— (i) an application under subsection (b) for a drug that is subject to section 353(b) of this title ; and (ii) an application under section 262 of title 42 . (C) New safety information; serious risk

“date of approval” applies in that section

the term “date of approval” shall mean the later of— (A) the date an application under subsection (b) is approved under subsection (c); or (B) the date of issuance of the interim final rule controlling the drug. (y) Contrast agents intended for use with applicable medical imaging devices (1) In general The sponsor of a contrast agent for which an application has been approved under this section may submit a supplement to the application seeking approval for a new use following the authorization of a premarket submission for an applicable medical imaging device for that use with the contrast agent pursuant to section 360j(p)(1) of this title .

“first applicant” applies in that section

the term “first applicant” means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug. (cc) Substantially complete application .— As used in this subsection,

“first approved applicant” applies in that section

The term “first approved applicant” means any applicant that has submitted an application that— (AA) is for a competitive generic therapy that is approved on the first day on which any application for such competitive generic therapy is approved; (BB) is not eligible for a 180-day exclusivity period under clause (iv) for the drug that is the subject of the application for the competitive generic therapy; and (CC) is not for a drug for which all drug versions have forfeited eligibility for a 180-day exclusivity period under clause (iv) pursuant to subparagraph (D).

“new safety information” applies in that section

The terms “new safety information”, “serious risk”, and “signal of a serious risk” have the meanings given such terms in section 355–1(b) of this title . (3) Studies and clinical trials (A) In general For any or all of the purposes specified in subparagraph (B), the Secretary may, subject to subparagraph (D), require a responsible person for a drug to conduct a postapproval study or studies of the drug, or a postapproval clinical trial or trials of the drug, on the basis of scientific data deemed appropriate by the Secretary, including information regarding chemically-related or pharmacologically-related drugs.

“new use” applies in that section

the term “new use” means a use of a contrast agent that is described in the approved labeling of an applicable medical imaging device described in section 360j(p) of this title , but that is not described in the approved labeling of the contrast agent; and;

“nonclinical test” applies in that section

the term “nonclinical test” means a test conducted in vitro, in silico, or in chemico, or a nonhuman in vivo test, that occurs before or during the clinical trial phase of the investigation of the safety and effectiveness of a drug. Such test may include the following: (1) Cell-based assays. (2) Organ chips and microphysiological systems. (3) Computer modeling. (4) Other nonhuman or human biology-based test methods, such as bioprinting. (5) Animal tests.

“patent” applies in that section

the term “patent” means a patent issued by the United States Patent and Trademark Office. (n) Scientific advisory panels (1) For the purpose of providing expert scientific advice and recommendations to the Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug under this section or section 262 of title 42 , the Secretary shall establish panels of experts or use panels of experts established before November 21, 1997 , or both. (2) The Secretary may delegate the appointment and oversight authority granted under section 394 of this title to a director of a center or successor entity within the Food and Drug Administration.

“petition” applies in that section

the term “petition” means a request described in paragraph (1)(A)(i). (r) Postmarket drug safety information for patients and providers (1) Establishment Not later than 1 year after September 27, 2007 , the Secretary shall improve the transparency of information about drugs and allow patients and health care providers better access to information about drugs by developing and maintaining an Internet Web site that— (A) provides links to drug safety information listed in paragraph (2) for prescription drugs that are approved under this section or licensed under section 262 of title 42 ; and (B) improves communication of drug safety information to patients and providers.

“qualified data summary” applies in that section

the term “qualified data summary” means a summary of clinical data that demonstrates the safety and effectiveness of a drug with respect to a qualified indication. (d) Grounds for refusing application; approval of application; “substantial evidence” defined If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that (1) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, …

“qualified indication” applies in that section

the term “qualified indication” means an indication for a drug that the Secretary determines to be appropriate for summary level review under this paragraph; and;

“responsible person” applies in that section

The term “responsible person” means a person who— (i) has submitted to the Secretary a covered application that is pending; or (ii) is the holder of an approved covered application. (B) Covered application

“Rx-to-nonprescription switch” applies in that section

the term “Rx-to-nonprescription switch” means the approval of an application, or supplemental application, as applicable, submitted under this section by the holder of an approved application for a prescription drug seeking approval to market such drug as a nonprescription drug, including for— (i) a full Rx-to-nonprescription switch, under which a drug previously approved for prescription use only is— (I) approved for nonprescription use under the same conditions as applied to the drug when approved for prescription use; or (II) approved for nonprescription use subject to one or more additional conditions for nonprescription use; and (ii) a partial Rx-to-nonprescription switch, under which …

“serious risk” applies in that section

“signal of a serious risk” applies in that section

“substantial evidence” applies in that section

the term “substantial evidence” means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.

“substantially complete application” applies in that section

the term “substantially complete application” means an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A). (dd) Tentative approval.— (AA) In general .—

“tentative approval” applies in that section

The term “tentative approval” means notification to an applicant by the Secretary that an application under this subsection meets the requirements of paragraph (2)(A), but cannot receive effective approval because the application does not meet the requirements of this subparagraph, there is a period of exclusivity for the listed drug under subparagraph (F) or section 355a of this title , or there is a 7-year period of exclusivity for the listed drug under section 360cc of this title .

“therapeutic category” applies in that section

the term “therapeutic category” means a therapeutic category identified in the list developed by the United States Pharmacopeia pursuant to section 1395w–104(b)(3)(C)(ii) of title 42 and as in effect on September 27, 2007 . (B) Publication by Secretary The Secretary shall publish the list described in subparagraph (A) and may amend such list by regulation. (4) Availability The election referred to in paragraph (1) may be made only in an application that is submitted to the Secretary after September 27, 2007 , and before October 1, 2027 .

21 U.S.C. § 355a — Pediatric studies of drugs

“pediatric studies” applies in that section

the term “pediatric studies” or “studies” means at least one clinical investigation (that, at the Secretary’s discretion, may include pharmacokinetic studies) in pediatric age groups (including neonates in appropriate cases) in which a drug is anticipated to be used, and, at the discretion of the Secretary, may include preclinical studies.

“studies” applies in that section