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§301. Short title — Inbound Citations

21 U.S.C. § 301

Implementing Regulations (Code of Federal Regulations)

Statutory authority for 10 regulations in the Code of Federal Regulations.

Code of Federal Regulations Citations

Cited by 41 regulations in the Code of Federal Regulations.

  • 19 C.F.R. § 147.23(b) — Compliance with Plant Quarantine Act and Federal Food, Drug, and Cosmetic Act.
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    (b) The entry of food products shall conform to the requirements of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), and the regulations issued thereunder.
  • 19 C.F.R. § 162.91 — Exemptions.
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    The provisions of this subpart will apply to all seizures of property for civil forfeiture made by Customs and Border Protection or Immigration and Customs Enforcement officers except for those seizures of property to be forfeited under the following statutes: The Tariff Act of 1930 or any other provision of law codified in title19, United States Code; the Internal Revenue Code of 1986 (26 U.S.C. 1 et seq.); the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); the Trading with the Enemy Act (50 U.S.C. App. 1 et seq.); the International Emergency Economic Powers Act (IEEPA) (50 U.S.C. 1701 et seq.); and section 1 of title VI of the Act of June 15, 1917 (40 Stat. 233; 22 U.S.C. 401).
  • 21 C.F.R. § 1300.01(b)(2)(ii)(B) — Definitions relating to controlled substances.
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    (B) Is a dietary ingredient for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); and
  • 21 C.F.R. § 1302.08(b)(1) — False labeling of anabolic steroids.
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    (1) A product described in paragraph (b)(2) of this section is exempt from the International Union of Pure and Applied Chemistry nomenclature requirement of this section if such product is labeled in the manner required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
  • 21 C.F.R. § 1308.21(a) — Application for exclusion of a nonnarcotic substance.
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    (a) Any person seeking to have any nonnarcotic drug that may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, excluded from any schedule, pursuant to section 201(g)(1) of the Act (21 U.S.C. 811(g)(1)), may apply to the Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration. See the Table of DEA Mailing Addresses in § 1321.01 of this chapter for the current mailing address.
  • 21 C.F.R. § 1308.22 — Excluded substances.
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    The following nonnarcotic substances which may, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully sold over the counter without a prescription, are excluded from all schedules pursuant to section 201(g) (1) of the Act (21 U.S.C. 811(g) (1)):
  • 21 C.F.R. § 1316.24(a) — Exemption from prosecution for researchers.
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    (a) Upon registration of an individual to engage in research in controlled substances under the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801), the Administrator of the Drug Enforcement Administration, on his own motion or upon request in writing from the Secretary or from the researcher or researching practitioner, may exempt the registrant when acting within the scope of his registration, from prosecution under Federal, State, or local laws for offenses relating to possession, distribution or dispensing of those controlled substances within the scope of his exemption. However, this exemption does not diminish any requirement of compliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301).
  • 21 C.F.R. § 203.3(a) — Definitions.
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    (a) The act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).
  • 21 C.F.R. § 206.3 — Definitions.
    Go to regulation →
    The following definitions apply to this part:
  • 21 C.F.R. § 210.3(b)(1) — Definitions.
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    (1) Act means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.).
  • 21 C.F.R. § 314.3(b) — Definitions.
    Go to regulation →
    (b) 180-day exclusivity period is the 180-day period beginning on the date of the first commercial marketing of the drug (including the commercial marketing of the reference listed drug) by any first applicant. The 180-day period ends on the day before the date on which an ANDA submitted by an applicant other than a first applicant could be approved.
    505(b)(2) application is an NDA submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act for a drug for which at least some of the investigations described in section 505(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act and relied upon by the applicant for approval of the NDA were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.
    Abbreviated application, abbreviated new drug application, or ANDA is the application described under § 314.94, including all amendments and supplements to the application.
    Acknowledgment letter is a written, postmarked communication from FDA to an applicant stating that the Agency has determined that an ANDA is sufficiently complete to permit a substantive review. An acknowledgment letter indicates that the ANDA is regarded as received.
    Act is the Federal Food, Drug, and Cosmetic Act (section 201 et seq. (21 U.S.C. 301 et seq.)).
    Active ingredient is any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. The term includes those components that may undergo chemical change in the manufacture of the drug product and be present in the drug product in a modified form intended to furnish the specified activity or effect.
    Active moiety is the molecule or ion, excluding those appended portions of the molecule that cause the drug to be an ester, salt (including a salt with hydrogen or coordination bonds), or other noncovalent derivative (such as a complex, chelate, or clathrate) of the molecule, responsible for the physiological or pharmacological action of the drug substance.
    ANDA holder is the applicant that owns an approved ANDA.
    Applicant is any person who submits an NDA (including a 505(b)(2) application) or ANDA or an amendment or supplement to an NDA or ANDA under this part to obtain FDA approval of a new drug and any person who owns an approved NDA (including a 505(b)(2) application) or ANDA.
    Application, new drug application, or NDA is the application described under § 314.50, including all amendments and supplements to the application. An NDA refers to “stand-alone” applications submitted under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act and to 505(b)(2) applications.
    Approval letter is a written communication to an applicant from FDA approving an NDA or an ANDA.
    Assess the effects of the change is to evaluate the effects of a manufacturing change on the identity, strength, quality, purity, and potency of a drug product as these factors may relate to the safety or effectiveness of the drug product.
    Authorized generic drug is a listed drug, as defined in this section, that has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act and is marketed, sold, or distributed directly or indirectly to the retail class of trade with 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 trademark that differs from that of the listed drug.
    Bioavailability is the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of drug action. For drug products that are not intended to be absorbed into the bloodstream, bioavailability may be assessed by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of drug action.
    Bioequivalence is the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. Where there is an intentional difference in rate (e.g., in certain extended-release dosage forms), certain pharmaceutical equivalents or alternatives may be considered bioequivalent if there is no significant difference in the extent to which the active ingredient or moiety from each product becomes available at the site of drug action. This applies only if the difference in the rate at which the active ingredient or moiety becomes available at the site of drug action is intentional and is reflected in the proposed labeling, is not essential to the attainment of effective body drug concentrations on chronic use, and is considered medically insignificant for the drug. For drug products that are not intended to be absorbed into the bloodstream, bioequivalence may be assessed by scientifically valid measurements intended to reflect the rate and extent to which the active ingredient or active moiety becomes available at the site of drug action.
    Bioequivalence requirement is a requirement imposed by FDA for in vitro and/or in vivo testing of specified drug products that must be satisfied as a condition of marketing.
    Class 1 resubmission is the resubmission of an NDA or efficacy supplement, following receipt of a complete response letter, that contains one or more of the following: Final printed labeling, draft labeling, certain safety updates, stability updates to support provisional or final dating periods, commitments to perform postmarketing studies (including proposals for such studies), assay validation data, final release testing on the last lots used to support approval, minor reanalyses of previously submitted data, and other comparatively minor information.
    Class 2 resubmission is the resubmission of an NDA or efficacy supplement, following receipt of a complete response letter, that includes any item not specified in the definition of “Class 1 resubmission,” including any item that would require presentation to an advisory committee.
    Commercial marketing is the introduction or delivery for introduction into interstate commerce of a drug product described in an ANDA, outside the control of the ANDA applicant, except that the term does not include transfer of the drug product for investigational use under part 312 of this chapter or transfer of the drug product to parties identified in the ANDA for reasons other than sale. Commercial marketing includes the introduction or delivery for introduction into interstate commerce of the reference listed drug by the ANDA applicant.
    Complete response letter is a written communication to an applicant from FDA usually describing all of the deficiencies that the Agency has identified in an NDA or ANDA that must be satisfactorily addressed before it can be approved.
    Component is any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product.
    Date of approval is the date on the approval letter from FDA stating that the NDA or ANDA is approved, except that the date of approval for an NDA described in section 505(x)(1) of the Federal Food, Drug, and Cosmetic Act is determined as described in section 505(x)(2) of the Federal Food, Drug, and Cosmetic Act. “Date of approval” refers only to a final approval and not to a tentative approval.
    Dosage form is the physical manifestation containing the active and inactive ingredients that delivers a dose of the drug product. This includes such factors as:
    (1) The physical appearance of the drug product;
    (2) The physical form of the drug product prior to dispensing to the patient;
    (3) The way the product is administered; and
    (4) Drug product is a finished dosage form, e.g., tablet, capsule, or solution, that contains a drug substance, generally, but not necessarily, in association with one or more other ingredients.
    Drug substance is an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.
    Efficacy supplement is a supplement to an approved NDA proposing to make one or more related changes from among the following changes to product labeling:
    (1) Add or modify an indication or claim;
    (2) Revise the dose or dose regimen;
    (3) Provide for a new route of administration;
    (4) Make a comparative efficacy claim naming another drug product;
    (5) Significantly alter the intended patient population;
    (6) Change the marketing status from prescription to over-the-counter use;
    (7) Provide for, or provide evidence of effectiveness necessary for, the traditional approval of a product originally approved under subpart H of this part; or
    (8) FDA or Agency is the Food and Drug Administration.
    First applicant is an ANDA applicant that, on the first day on which a substantially complete application containing a paragraph IV certification is submitted for approval of a drug, submits a substantially complete application that contains, and for which the applicant lawfully maintains, a paragraph IV certification for the drug.
    Inactive ingredient is any component other than an active ingredient.
    Listed drug is a new drug product that has been approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act for safety and effectiveness or under section 505(j) of the Federal Food, Drug, and Cosmetic Act, which has not been withdrawn or suspended under section 505(e)(1) through (5) or section 505(j)(6) of the Federal Food, Drug, and Cosmetic Act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness. Listed drug status is evidenced by the drug product's identification in the current edition of FDA's “Approved Drug Products With Therapeutic Equivalence Evaluations” (the list) as an approved drug. A drug product is deemed to be a listed drug on the date of approval for the NDA or ANDA for that drug product.
    NDA holder is the applicant that owns an approved NDA.
    Newly acquired information is data, analyses, or other information not previously submitted to the Agency, which may include (but is not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events, or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.
    Original application or original NDA is a pending NDA for which FDA has never issued a complete response letter or approval letter, or an NDA that was submitted again after FDA had refused to file it or after it was withdrawn without being approved.
    Paragraph IV acknowledgment letter is a written, postmarked communication from FDA to an applicant stating that the Agency has determined that a 505(b)(2) application or ANDA containing a paragraph IV certification is sufficiently complete to permit a substantive review. A paragraph IV acknowledgment letter indicates that the 505(b)(2) application is regarded as filed or the ANDA is regarded as received.
    Paragraph IV certification is a patent certification of invalidity, unenforceability, or noninfringement described in § 314.50(i)(1)(i)(A)(4) or § 314.94(a)(12)(i)(A)(4).
    Patent owner is the owner of the patent for which information is submitted for an NDA.
    Pharmaceutical alternatives are drug products that contain the identical therapeutic moiety, or its precursor, but not necessarily in the same amount or dosage form or as the same salt or ester. Each such drug product individually meets either the identical or its own respective compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times, and/or dissolution rates.
    Pharmaceutical equivalents are drug products in identical dosage forms and route(s) of administration that contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety, or, in the case of modified-release dosage forms that require a reservoir or overage or such forms as prefilled syringes where residual volume may vary, that deliver identical amounts of the active drug ingredient over the identical dosing period; do not necessarily contain the same inactive ingredients; and meet the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency and, where applicable, content uniformity, disintegration times, and/or dissolution rates.
    Postmark is an independently verifiable evidentiary record of the date on which a document is transmitted, in an unmodifiable format, to another party. For postmarks made by the U.S. Postal Service or a designated delivery service, the date of transmission is the date on which the document is received by the domestic mail service of the U.S. Postal Service or by a designated delivery service. For postmarks documenting an electronic event, the date of transmission is the date (in a particular time zone) that FDA sends the electronic transmission on its host system as evidenced by a verifiable record. If the sender and the intended recipient are located in different time zones, it is the sender's time zone that provides the controlling date of electronic transmission.
    Reference listed drug is the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its ANDA.
    Reference standard is the drug product selected by FDA that an applicant seeking approval of an ANDA must use in conducting an in vivo bioequivalence study required for approval.
    Resubmission, in the context of a complete response letter, is submission by the applicant of all materials needed to fully address all deficiencies identified in the complete response letter. An NDA or ANDA for which FDA issued a complete response letter, but which was withdrawn before approval and later submitted again, is not a resubmission.
    Right of reference or use is the authority to rely upon, and otherwise use, an investigation for the purpose of obtaining approval of an NDA, including the ability to make available the underlying raw data from the investigation for FDA audit, if necessary.
    Same drug product formulation is the formulation of the drug product submitted for approval and any formulations that have minor differences in composition or method of manufacture from the formulation submitted for approval, but are similar enough to be relevant to the Agency's determination of bioequivalence.
    Specification is the quality standard (i.e., tests, analytical procedures, and acceptance criteria) provided in an approved NDA or ANDA to confirm the quality of drug substances, drug products, intermediates, raw materials, reagents, components, in-process materials, container closure systems, and other materials used in the production of a drug substance or drug product. For the purpose of this definition, acceptance criteria means numerical limits, ranges, or other criteria for the tests described.
    Strength is the amount of drug substance contained in, delivered, or deliverable from a drug product, which includes:
    (i) The total quantity of drug substance in mass or units of activity in a dosage unit or container closure (e.g., weight/unit dose, weight/volume or weight/weight in a container closure, or units/volume or units/weight in a container closure); and/or, as applicable.
    (ii) The concentration of the drug substance in mass or units of activity per unit volume or mass (e.g., weight/weight, weight/volume, or units/volume); or
    (2) Such other criteria the Agency establishes for determining the amount of drug substance contained in, delivered, or deliverable from a drug product if the weights and measures described in paragraph (i) of this definition do not apply (e.g., certain drug-device combination products for which the amount of drug substance is emitted per use or unit time).
    Substantially complete application is an ANDA that on its face is sufficiently complete to permit a substantive review. Sufficiently complete means that the ANDA contains all the information required under section 505(j)(2)(A) of the Federal Food, Drug, and Cosmetic Act and does not contain a deficiency described in § 314.101(d) and (e).
    Tentative approval is notification that an NDA or ANDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but cannot be approved because there is a 7-year period of orphan exclusivity for a listed drug under section 527 of the Federal Food, Drug, and Cosmetic Act and § 316.31 of this chapter, or that a 505(b)(2) application or ANDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but cannot be approved until the conditions in § 314.107(b)(1)(iii), (b)(3), or (c) are met; because there is a period of exclusivity for the listed drug under § 314.108; because there is a period of pediatric exclusivity for the listed drug under section 505A of the Federal Food, Drug, and Cosmetic Act; because there is a period of exclusivity for the listed drug under section 505E of the Federal Food, Drug, and Cosmetic Act; or because a court order pursuant to 35 U.S.C. 271(e)(4)(A) orders that the NDA or ANDA may be approved no earlier than the date specified. A drug product that is granted tentative approval is not an approved drug and will not be approved until FDA issues an approval letter after any necessary additional review of the NDA or ANDA.
    The list is the list of approved drug products published in FDA's current “Approved Drug Products With Therapeutic Equivalence Evaluations,” available electronically on FDA's Web site at http://www.fda.gov/cder.
    Therapeutic equivalents are approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.
  • 21 C.F.R. § 7.1 — Scope.
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    This part governs the practices and procedures applicable to regulatory enforcement actions initiated by the Food and Drug Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other laws that it administers. This part also provides guidance for manufacturers and distributors to follow with respect to their voluntary removal or correction of marketed violative products. This part is promulgated to clarify and explain the regulatory practices and procedures of the Food and Drug Administration, enhance public understanding, improve consumer protection, and assure uniform and consistent application of practices and procedures throughout the agency.
  • 21 C.F.R. § 822.3(a) — How do you define the terms used in this part?
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    (a) Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., as amended.
  • 28 C.F.R. § 0.45(j) — General functions.
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    (j) All civil and criminal litigation and grand jury proceedings arising under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Hazardous Substances Act (15 U.S.C. 1261 et seq.), the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.), the Automobile Information Disclosure Act (15 U.S.C. 1231 et seq.), the odometer requirements section and the fuel economy labeling section of the Motor Vehicle Information and Cost Savings Act (15 U.S.C. 1981 et seq.), the Federal Cigarette Labeling and Advertising Act (15 U.S.C. 1331 et seq.), the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), the Federal Caustic Poison Act (15 U.S.C. 401 note), the Consumer Credit Protection Act (15 U.S.C. 1611, 1681q and 1681r), the Wool Products Labeling Act of 1939 (15 U.S.C. 68), the Fur Products Labeling Act (15 U.S.C. 69), the Textile Fiber Products Identification Act (15 U.S.C. 70 et seq.), the Consumer Product Safety Act (15 U.S.C. 2051 et seq.), the Flammable Fabrics Act (15 U.S.C. 1191 et seq.), the Refrigerator Safety Device Act (15 U.S.C. 1211 et seq.), title I of the Magnuson-Moss Warranty—Federal Trade Commission Improvement Act (15 U.S.C. 2301 et seq.), the Federal Trade Commission Act (15 U.S.C. 41 et seq.), and section 11(1) of the Clayton Act (15 U.S.C. 21(1)) relating to violations of orders issued by the Federal Trade Commission. Upon appropriate certification by the Federal Trade Commission, the institution of criminal proceedings, under the Federal Trade Commission Act (15 U.S.C. 56(b)), the determination whether the Attorney General will commence, defend or intervene in civil proceedings under the Federal Trade Commission Act (15 U.S.C. 56(a)), and the determination under the Consumer Product Safety Act (15 U.S.C. 2076(b)(7)), whether the Attorney General will initiate, prosecute, defend or appeal an action relating to the Consumer Product Safety Commission.
  • 29 C.F.R. § 1910.1200(b)(5)(iii) — Hazard communication.
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    (iii) Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device or product, including materials intended for use as ingredients in such products (e.g., flavors and fragrances), as such terms are defined in the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Virus-Serum-Toxin Act of 1913 (21 U.S.C. 151 et seq.), and regulations issued under those Acts, when they are subject to the labeling requirements under those Acts by either the Food and Drug Administration or the Department of Agriculture;
  • 29 C.F.R. § 1987.100(a) — Purpose and scope.
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    (a) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety Modernization Act (FSMA), Public Law 111-353, 124 Stat. 3885, which was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. 301 et seq., by adding new section 1012. See 21 U.S.C. 399d. Section 1012 of the FD&C provides protection for an employee from retaliation because the employee has engaged in protected activity pertaining to a violation or alleged violation of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C.
  • 29 C.F.R. § 1987.101(f) — Definitions.
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    (f) FD&C means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq., which is chapter 9 of title 21.
  • 40 C.F.R. § 172.23(c)(1)(i)(D) — State plans.
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    (D) (1) The terms and conditions of the permit are being violated, or are inadequate to avoid unreasonable adverse effects on the environment;
    (2) Any required tolerance under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) has been revoked by EPA, or any exemption from the requirement for tolerance has been withdrawn by EPA; or
    (3) A failure by the permittee or any cooperator to meet any other provision of FIFRA or this subpart has occurred;
  • 40 C.F.R. § 172.3(f) — Scope of requirement.
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    (f) No EUP is required for a substance or mixture of substances being put through tests for the sole purpose of gathering data required for approval of such substance or mixture under the FFDCA (21 U.S.C. 301 et seq.) as:
    (1) A “new drug” (21 U.S.C. sec. 321(p) and sec. 355).
    (2) A “new animal drug” (21 U.S.C. sec. 321(w) and sec. 360(b)), or
    (3) An “animal feed” (21 U.S.C. sec. 321 (x)) containing a “new animal drug” (21 U.S.C. sec. 360(b)).
  • 40 C.F.R. § 2.308(a)(1) — Special rules governing certain information obtained under the Federal Food, Drug and Cosmetic Act.
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    (1) Act means the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. 301 et seq.
  • 41 C.F.R. § 102-71.10(3) — Definitions.
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    (3) A P.E., or similar designation, licensed in a related engineering discipline and holding the grade of Professional Member in the Society of Fire Protection Engineers.
    Real property means:
  • 42 C.F.R. § 2a.4(j)(3)(ii) — Contents of application; in general.
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    (ii) Release is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or regulations promulgated thereunder (title 21, Code of Federal Regulations), or
  • 42 C.F.R. § 2a.7(b)(3) — Effect of Confidentiality Certificate.
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    (3) Release of such information is required by the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301) or the regulations promulgated thereunder (title 21, Code of Federal Regulations).
  • 42 C.F.R. § 71.54(f)(5)(i) — Import regulations for infectious biological agents, infectious substances, and vectors.
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    (i) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), or
  • 42 C.F.R. § 73.5(c)(1) — Exemptions for HHS select agents and toxins.
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    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
  • 42 C.F.R. § 73.6(c)(1) — Exemptions for overlap select agents and toxins.
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    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.),
  • 48 C.F.R. § 1535.007-70(b) — Contract clauses.
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    (b) The Contracting Officer shall insert the clause at 48 CFR 1552.235-71, Treatment of Confidential Business Information, in solicitations and contracts when the Contracting Officer has determined that in the performance of the contract, EPA may furnish confidential business information to the contractor obtained from third parties under the Clean Air Act (42 U.S.C. 7401 et seq.), the Federal Water Pollution Control Act (33 U.S.C. 1251 et seq.), the Safe Drinking Water Act (42 U.S.C. 300f et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Resource Conservation and Recovery Act (42 U.S.C. 301 et seq.), the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.), the Comprehensive Environmental Response, Compensation, and Liability Act (42 U.S.C. 9601 et seq.), and the provision at 48 CFR 1552.235-70, Release of Contractor Confidential Business Information. EPA regulations on confidentiality of business information in 40 CFR part 2, subpart B require that the contractor agree to the clause entitled “Treatment of Confidential Business Information” before any confidential business information may be furnished to the contractor.
  • 48 C.F.R. § 1552.235-71 — Treatment of confidential business information.
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    As prescribed in 1535.007-70(b), insert the following contract clause in all types of contracts when the Contracting Officer has determined that in the performance of a contract, EPA may furnish confidential business information to the Contractor that EPA obtained under the Clean Air Act (42 U.S.C. 7401 et seq.), the Federal Water Pollution Control Act (33 U.S.C. 1251, et seq.), the Safe Drinking Water Act (42 U.S.C. 300f et seq.), the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Resource Conservation and Recovery Act (42 U.S.C. 6901 et seq.), or the Toxic Substances Control Act (15 U.S.C. 2601 et seq.). EPA regulations on confidentiality of business information in 40 CFR part 2 subpart B require that the Contractor agree to the clause entitled “Treatment of Confidential Business Information” before any confidential business information may be furnished to the Contractor:
  • 48 C.F.R. § 846.370-2(b) — Frozen processed foods.
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    (b) The following frozen processed food products must contain a label that complies with the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301), which requires all ingredients be listed in accordance with their predominance order:
  • 49 C.F.R. § 173.134(b)(16) — Class 6, Division 6.2—Definitions and exceptions.
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    (16) A raw agricultural commodity as defined in the Federal Food, Drug, and Cosmetics Act (21 U.S.C. 301 et seq.).
  • 50 C.F.R. § 14.82(b)(2) — Alternatives and exceptions to the marking requirement.
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    (2) Fish or shellfish contained in retail consumer packages labeled pursuant to the Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.; or
  • 50 C.F.R. § 300.161(b)(2) — Alternatives and exceptions.
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    (2) Fish or shellfish contained in retail consumer packages labeled pursuant to the Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.; or
  • 50 C.F.R. § 622.106(a)(6) — Aquaculture operations.
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    (6) Use of drugs, pesticides, and biologics must comply with all applicable Food and Drug Administration (FDA), EPA, and USDA requirements (e.g., Federal, Food, Drug and Cosmetic Act, 21 U.S.C. 301 et seq.; Clean Water Act, 40 CFR part 122; 9 CFR parts 101 through 124; 21 CFR parts 500 through 599; and 40 CFR parts 150 through 189).
  • 6 C.F.R. § 139.15 — Definitions.
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    For purposes of this part—
  • 7 C.F.R. § 246.10(g) — Supplemental foods.
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    (g) Infant formula manufacturers supplying formula to the WIC Program must be registered with the Secretary of Health and Human Services under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). Such manufacturers wishing to bid for a State contract to supply infant formula to the Program must certify with the State health department that their formulas comply with the Federal Food, Drug, and Cosmetic Act and regulations in this chapter issued pursuant to the Act.
  • 7 C.F.R. § 35.12(e) — Inspection and certification.
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    (e) If the inspector has reason to believe that samples of a lot of any variety of vinifera species table grapes have been obtained for a determination as to compliance with tolerance for spray residue, established under the Federal Food, Drug and Cosmetic Act, as amended (52 Stat. 1040; 21 U.S.C. 301 et seq.), he shall not issue a certificate on the lot unless it complies with such tolerances.
  • 9 C.F.R. § 121.5(d)(1) — Exemptions for VS select agents and toxins.
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    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
  • 9 C.F.R. § 121.6(c)(1) — Exemptions for overlap select agents and toxins.
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    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
  • 9 C.F.R. § 309.17(a)(4) — Livestock used for research.
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    (4) In the case of an animal administered any investigational drug regulated under the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), the drug was prepared and distributed in compliance with the applicable provisions of part 135 of the regulations issued under said Act (21 CFR part 135), and used in accordance with the labeling approved under said regulations;
  • 9 C.F.R. § 381.1(viii) — Definitions.
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    (viii) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is.
    Animal food. Any article intended for use as food for dogs, cats, or other animals, derived wholly, or in part, from carcasses or parts or products of the carcass of poultry, except that the term animal food as used herein does not include (i) processed dry animal food or (ii) livestock or poultry feeds manufactured from processed poultry byproducts (such as poultry byproduct meal, hydrolyzed poultry feathers, and hydrolyzed poultry byproducts aggregate).
    Animal food manufacturer. “Animal Food Manufacturer” means any person engaged in the business of manufacturing or processing animal food.
    Applicant. “Applicant” means any person who requests inspection service, exemption, or other authorization under the regulations.
    Biological residue. “Biological Residue” means any substance, including metabolites, remaining in poultry at the time of slaughter or in any of its tissues after slaughter, as the result of treatment or exposure of the live poultry to a pesticide, organic compound, metallic or other inorganic compound, hormone, hormone-like substance, growth promoter, antibiotic, anthelmintic, tranquilizer, or other agent that leaves a residue.
    Capable of use as human food. The term “capable of use as human food” applies to any carcass, or part or product of a carcass of any poultry, unless it is denatured or otherwise identified as required by the regulations, or it is naturally inedible by humans.
    Carcass. This term means all parts, including viscera, of any slaughtered poultry.
    Commerce. “Commerce” means commerce between any State, any territory, or the District of Columbia, and any place outside thereof; or within any territory not organized with a legislative body, or the District of Columbia.
    Consumer package. “Consumer package” means any container in which a poultry product is enclosed for the purpose of display and sale to household consumers.
    Container. The term “container” includes any box, can, tin, cloth, plastic, or any other receptacle, wrapper, or cover.
    Edible. This term means that an article is intended for use as human food.
    Egg Products Inspection Act. “Egg Products Inspection Act” means the Act so entitled, approved December 29, 1970 (84 Stat. 1620, 21 U.S.C. 1031 et seq.).
    Federal Food, Drug, and Cosmetic Act. “Federal Food, Drug, and Cosmetic Act” means the Act so entitled, approved June 25, 1938 (52 Stat. 1040), and acts amendatory thereof or supplementary thereto (21 U.S.C. 301 et seq.).
    Federal Meat Inspection Act. “Federal Meat Inspection Act” means the Act so entitled, approved March 4, 1907, 34 Stat. 1260, as amended by the Wholesome Meat Act, 81 Stat. 584 (21 U.S.C. 601 et seq.).
    Free from protruding pinfeathers. “Free from protruding pinfeathers” means that the carcass is free from protruding pinfeathers which are visible to an inspector during an examination of the carcass at normal operating speeds. However, a carcass may be considered as being free from protruding pinfeathers if it has a generally clean appearance (especially on the breast), and if not more than an occasional protruding pinfeather is in evidence during a more careful examination of the carcass.
    Giblets. “Giblets” means the liver from which the bile sac has been removed, the heart from which the pericardial sac has been removed, and the gizzard from which the lining and contents have been removed: Provided, That each such organ has been properly trimmed and washed.
    Immediate container. “Immediate container” includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed.
    Inedible. This term means any carcass or any part of a carcass that is either naturally inedible by humans or is rendered unfit for human food by reason of adulteration or denaturing.
    Inspected for wholesomeness. This term means that the poultry product so identified has been inspected and was found at the time of such inspection to be not adulterated.
    Inspection. “Inspection” means any inspection required by the regulations to determine whether any poultry or poultry products comply with the requirements of the Act and the regulations.
    Label. This term applies to any display of written, printed, or graphic matter upon any article or the immediate container (not including package liners) of any article.
    Labeling. This term applies to all labels and other written, printed, or graphic matter (i) upon any article or any of its containers or wrappers, or (ii) accompanying such article.
    Misbranded. This term applies to any poultry product under one or more of the following circumstances:
  • 9 C.F.R. § 424.22(c)(3)(vii) — Certain other permitted uses.
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    (vii) Guarantees from the suppliers of all food-contact packaging materials that may be subject to irradiation that those materials comply with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

United States Code Citations

Cited by 134 provisions in release 119-102.

Citations to 21 U.S.C. § 301 as a whole