| 301. | Short title. | |
| 321. | Definitions; generally. | |
| 321a. | “Butter” defined. | |
| 321b. | “Package” defined. | |
| 321c. | Nonfat dry milk; “milk” defined. | |
| 321d. | Market names for catfish and ginseng. | |
| 331. | Prohibited acts. | |
| 332. | Injunction proceedings. | |
| 333. | Penalties. | |
| 333a. | Repealed. | |
| 334. | Seizure. | |
| 335. | Hearing before report of criminal violation. | |
| 335a. | Debarment, temporary denial of approval, and suspension. | |
| 335b. | Civil penalties. | |
| 335c. | Authority to withdraw approval of abbreviated drug applications. | |
| 336. | Report of minor violations. | |
| 337. | Proceedings in name of United States; provision as to subpoenas. | |
| 337a. | Extraterritorial jurisdiction. | |
| 341. | Definitions and standards for food. | |
| 342. | Adulterated food. | |
| 343. | Misbranded food. | |
| 343–1. | National uniform nutrition labeling. | |
| 343–2. | Dietary supplement labeling exemptions. | |
| 343–3. | Disclosure. | |
| 343a. | Repealed. | |
| 344. | Emergency permit control. | |
| 345. | Regulations making exemptions. | |
| 346. | Tolerances for poisonous or deleterious substances in food; regulations. | |
| 346a. | Tolerances and exemptions for pesticide chemical residues. | |
| 346b. | Authorization of appropriations. | |
| 347. | Intrastate sales of colored oleomargarine. | |
| 347a. | Congressional declaration of policy regarding oleomargarine sales. | |
| 347b. | Contravention of State laws. | |
| 348. | Food additives. | |
| 349. | Bottled drinking water standards; publication in Federal Register. | |
| 350. | Vitamins and minerals. | |
| 350a. | Infant formulas. | |
| 350a–1. | Protecting infants and improving formula supply. | |
| 350b. | New dietary ingredients. | |
| 350c. | Maintenance and inspection of records. | |
| 350d. | Registration of food facilities. | |
| 350e. | Sanitary transportation practices. | |
| 350f. | Reportable food registry. | |
| 350g. | Hazard analysis and risk-based preventive controls. | |
| 350h. | Standards for produce safety. | |
| 350i. | Protection against intentional adulteration. | |
| 350j. | Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report. | |
| 350k. | Laboratory accreditation for analyses of foods. | |
| 350l . | Mandatory recall authority. | |
| 350l –1. | Annual report to Congress. | |
| 350m. | Requirements for critical food. | |
| 351. | Adulterated drugs and devices. | |
| 352. | Misbranded drugs and devices. | |
| 353. | Exemptions and consideration for certain drugs, devices, and biological products. | |
| 353a. | Pharmacy compounding. | |
| 353a–1. | Enhanced communication. | |
| 353b. | Outsourcing facilities. | |
| 353c. | Prereview of television advertisements. | |
| 353d. | Process to update labeling for certain generic drugs. | |
| 354. | Veterinary feed directive drugs. | |
| 355. | New drugs. | |
| 355–1. | Risk evaluation and mitigation strategies. | |
| 355–2. | Actions for delays of generic drugs and biosimilar biological products. | |
| 355a. | Pediatric studies of drugs. | |
| 355b. | Adverse-event reporting. | |
| 355c. | Research into pediatric uses for drugs and biological products. | |
| 355c–1. | Report. | |
| 355d. | Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers. | |
| 355e. | Pharmaceutical security. | |
| 355f. | Extension of exclusivity period for new qualified infectious disease products. | |
| 355g. | Utilizing real world evidence. | |
| 355h. | Regulation of certain nonprescription drugs that are marketed without an approved drug application. | |
| 356. | Expedited approval of drugs for serious or life-threatening diseases or conditions. | |
| 356–1. | Accelerated approval of priority countermeasures. | |
| 356–2. | Accelerated approval Council. | |
| 356a. | Manufacturing changes. | |
| 356b. | Reports of postmarketing studies. | |
| 356c. | Discontinuance or interruption in the production of life-saving drugs. | |
| 356c–1. | Annual reporting on drug shortages. | |
| 356d. | Coordination; task force and strategic plan. | |
| 356e. | Drug shortage list. | |
| 356f. | Hospital repackaging of drugs in shortage. | |
| 356g. | Standards for regenerative medicine and regenerative advanced therapies. | |
| 356h. | Competitive generic therapies. | |
| 356i. | Prompt reports of marketing status. | |
| 356j. | Discontinuance or interruption in the production of medical devices. | |
| 356k. | Platform technologies. | |
| 356l. | Advanced manufacturing technologies designation program. | |
| 357. | Qualification of drug development tools. | |
| 358. | Authority to designate official names. | |
| 359. | Nonapplicability of subchapter to cosmetics. | |
| 360. | Registration of producers of drugs or devices. | |
| 360a. | Clinical trial guidance for antibiotic drugs. | |
| 360a–1. | Clinical trials. | |
| 360a–2. | Susceptibility test interpretive criteria for microorganisms. | |
| 360b. | New animal drugs. | |
| 360b–1. | Priority zoonotic animal drugs. | |
| 360c. | Classification of devices intended for human use. | |
| 360c–1. | Reporting. | |
| 360d. | Performance standards. | |
| 360e. | Premarket approval. | |
| 360e–1. | Pediatric uses of devices. | |
| 360e–3. | Breakthrough devices. | |
| 360e–4. | Predetermined change control plans for devices. | |
| 360f. | Banned devices. | |
| 360g. | Judicial review. | |
| 360g–1. | Agency documentation and review of significant decisions regarding devices. | |
| 360g–2. | Third party data transparency. | |
| 360h. | Notification and other remedies. | |
| 360h–1. | Program to improve the device recall system. | |
| 360i. | Records and reports on devices. | |
| 360j. | General provisions respecting control of devices intended for human use. | |
| 360k. | State and local requirements respecting devices. | |
| 360l. | Postmarket surveillance. | |
| 360m. | Accredited persons. | |
| 360n. | Priority review to encourage treatments for tropical diseases. | |
| 360n–1. | Priority review for qualified infectious disease products. | |
| 360n–2. | Ensuring cybersecurity of devices. | |
| 360aa. | Recommendations for investigations of drugs for rare diseases or conditions. | |
| 360bb. | Designation of drugs for rare diseases or conditions. | |
| 360cc. | Protection for drugs for rare diseases or conditions. | |
| 360dd. | Open protocols for investigations of drugs for rare diseases or conditions. | |
| 360ee. | Grants and contracts for development of drugs for rare diseases and conditions. | |
| 360ee–1. | FDA rare neurodegenerative disease grant program. | |
| 360ff. | Priority review to encourage treatments for rare pediatric diseases. | |
| 360ff–1. | Targeted drugs for rare diseases. | |
| 360hh. | Definitions. | |
| 360ii. | Program of control. | |
| 360jj. | Studies by Secretary. | |
| 360kk. | Performance standards for electronic products. | |
| 360ll. | Notification of defects in and repair or replacement of electronic products. | |
| 360mm. | Imports. | |
| 360nn. | Inspection, records, and reports. | |
| 360oo. | Prohibited acts. | |
| 360pp. | Enforcement. | |
| 360qq. | Repealed. | |
| 360rr. | Federal-State cooperation. | |
| 360ss. | State standards. | |
| 360aaa to 360aaa–6. | Omitted. | |
| 360bbb. | Expanded access to unapproved therapies and diagnostics. | |
| 360bbb–0. | Expanded access policy required for investigational drugs. | |
| 360bbb–0a. | Investigational drugs for use by eligible patients. | |
| 360bbb–1. | Dispute resolution. | |
| 360bbb–2. | Classification of products. | |
| 360bbb–3. | Authorization for medical products for use in emergencies. | |
| 360bbb–3a. | Emergency use of medical products. | |
| 360bbb–3b. | Products held for emergency use. | |
| 360bbb–3c. | Expedited development and review of medical products for emergency uses. | |
| 360bbb–4. | Countermeasure development, review, and technical assistance. | |
| 360bbb–4a. | Priority review to encourage treatments for agents that present national security threats. | |
| 360bbb–4b. | Medical countermeasure master files. | |
| 360bbb–5. | Critical Path Public-Private Partnerships. | |
| 360bbb–5a. | Emerging technology program. | |
| 360bbb–6. | Risk communication. | |
| 360bbb–7. | Notification. | |
| 360bbb–8. | Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments. | |
| 360bbb–8a. | Optimizing global clinical trials. | |
| 360bbb–8b. | Use of clinical investigation data from outside the United States. | |
| 360bbb–8c. | Patient participation in medical product discussion. | |
| 360bbb–8d. | Notification, nondistribution, and recall of controlled substances. | |
| 360ccc. | Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs. | |
| 360ccc–1. | Index of legally marketed unapproved new animal drugs for minor species. | |
| 360ccc–2. | Designated new animal drugs for minor use or minor species. | |
| 360ddd. | Definitions. | |
| 360ddd–1. | Regulation of medical gases. | |
| 360ddd–2. | Inapplicability of drug fees to designated medical gases. | |
| 360eee. | Definitions. | |
| 360eee–1. | Requirements. | |
| 360eee–2. | National standards for prescription drug wholesale distributors. | |
| 360eee–3. | National standards for third-party logistics providers. | |
| 360eee–4. | Uniform national policy. | |
| 360fff. | Definitions. | |
| 360fff–1. | Submission of requests. | |
| 360fff–2. | Eligibility determinations; data submission; filing. | |
| 360fff–3. | GRASE determination. | |
| 360fff–4. | Guidance; other provisions. | |
| 360fff–5. | Repealed. | |
| 360fff–6. | Non-sunscreen time and extent applications. | |
| 360fff–7. | Report. | |
| 360fff–8. | Sunset. | |
| 361. | Adulterated cosmetics. | |
| 362. | Misbranded cosmetics. | |
| 363. | Regulations making exemptions. | |
| 364. | Definitions. | |
| 364a. | Adverse events. | |
| 364b. | Good manufacturing practice. | |
| 364c. | Registration and product listing. | |
| 364d. | Safety substantiation. | |
| 364e. | Labeling. | |
| 364f. | Records. | |
| 364g. | Mandatory recall authority. | |
| 364h. | Small businesses. | |
| 364i. | Exemption for certain products and facilities. | |
| 364j. | Preemption. | |
| 371. | Regulations and hearings. | |
| 372. | Examinations and investigations. | |
| 372a. | Transferred. | |
| 373. | Records. | |
| 374. | Inspection. | |
| 374a. | Inspections relating to food allergens. | |
| 375. | Publicity. | |
| 376. | Examination of sea food on request of packer; marking food with results; fees; penalties. | |
| 377. | Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests. | |
| 378. | Advertising of foods. | |
| 379. | Confidential information. | |
| 379a. | Presumption of existence of jurisdiction. | |
| 379b. | Consolidated administrative and laboratory facility. | |
| 379c. | Transferred. | |
| 379d. | Automation of Food and Drug Administration. | |
| 379d–1. | Conflicts of interest. | |
| 379d–2. | Policy on the review and clearance of scientific articles published by FDA employees. | |
| 379d–3. | Streamlined hiring authority. | |
| 379d–3a. | Hiring authority for scientific, technical, and professional personnel. | |
| 379d–3b. | Strategic Workforce Plan and report. | |
| 379d–4. | Reporting requirements. | |
| 379d–5. | Guidance document regarding product promotion using the Internet. | |
| 379e. | Listing and certification of color additives for foods, drugs, devices, and cosmetics. | |
| 379f. | Recovery and retention of fees for freedom of information requests. | |
| 379g. | Definitions. | |
| 379h. | Authority to assess and use drug fees. | |
| 379h–1. | Fees relating to advisory review of prescription-drug television advertising. | |
| 379h–2. | Reauthorization; reporting requirements. | |
| 379i. | Definitions. | |
| 379j. | Authority to assess and use device fees. | |
| 379j–1. | Reauthorization; reporting requirements. | |
| 379j–11. | Definitions. | |
| 379j–12. | Authority to assess and use animal drug fees. | |
| 379j–13. | Reauthorization; reporting requirements. | |
| 379j–21. | Authority to assess and use generic new animal drug fees. | |
| 379j–22. | Reauthorization; reporting requirements. | |
| 379j–31. | Authority to collect and use fees. | |
| 379j–41. | Definitions. | |
| 379j–42. | Authority to assess and use human generic drug fees. | |
| 379j–43. | Reauthorization; reporting requirements. | |
| 379j–51. | Definitions. | |
| 379j–52. | Authority to assess and use biosimilar biological product fees. | |
| 379j–53. | Reauthorization; reporting requirements. | |
| 379j–61. | Definitions. | |
| 379j–62. | Authority to assess and use outsourcing facility fees. | |
| 379j–71. | Definitions. | |
| 379j–72. | Authority to assess and use OTC monograph fees. | |
| 379j–73. | Reauthorization; reporting requirements. | |
| 379k. | Information system. | |
| 379k–1. | Electronic format for submissions. | |
| 379l . | Education. | |
| 379o . | Environmental impact. | |
| 379r. | National uniformity for nonprescription drugs. | |
| 379s. | Preemption for labeling or packaging of cosmetics. | |
| 379v. | Safety report disclaimers. | |
| 379aa. | Serious adverse event reporting for nonprescription drugs. | |
| 379aa–1. | Serious adverse event reporting for dietary supplements. | |
| 379dd. | Establishment and functions of the Foundation. | |
| 379dd–1. | Location of Foundation. | |
| 379dd–2. | Activities of the Food and Drug Administration. | |
| 381. | Imports and exports. | |
| 382. | Exports of certain unapproved products. | |
| 383. | Office of International Relations. | |
| 384. | Importation of prescription drugs. | |
| 384a. | Foreign supplier verification program. | |
| 384b. | Voluntary qualified importer program. | |
| 384c. | Inspection of foreign food facilities. | |
| 384d. | Accreditation of third-party auditors. | |
| 384e. | Recognition of foreign government inspections. | |
| 384f. | Strengthening FDA and CBP coordination and capacity. | |
| 384g. | Restricting entrance of illicit drugs. | |
| 387. | Definitions. | |
| 387a. | FDA authority over tobacco products. | |
| 387a–1. | Final rule. | |
| 387b. | Adulterated tobacco products. | |
| 387c. | Misbranded tobacco products. | |
| 387d. | Submission of health information to the Secretary. | |
| 387e. | Annual registration. | |
| 387f. | General provisions respecting control of tobacco products. | |
| 387f–1. | Enforcement action plan for advertising and promotion restrictions. | |
| 387g. | Tobacco product standards. | |
| 387h. | Notification and other remedies. | |
| 387i. | Records and reports on tobacco products. | |
| 387j. | Application for review of certain tobacco products. | |
| 387k. | Modified risk tobacco products. | |
| 387l . | Judicial review. | |
| 387m. | Equal treatment of retail outlets. | |
| 387n. | Jurisdiction of and coordination with the Federal Trade Commission. | |
| 387o . | Regulation requirement. | |
| 387p. | Preservation of State and local authority. | |
| 387q. | Tobacco Products Scientific Advisory Committee. | |
| 387r. | Drug products used to treat tobacco dependence. | |
| 387s. | User fees. | |
| 387t. | Labeling, recordkeeping, records inspection. | |
| 387u. | Studies of progress and effectiveness. | |
| 387v. | Reporting on tobacco regulation activities. | |
| 391. | Separability clause. | |
| 392. | Exemption of meats and meat food products. | |
| 393. | Food and Drug Administration. | |
| 393a. | Office of Pediatric Therapeutics. | |
| 394. | Scientific review groups. | |
| 395. | Loan repayment program. | |
| 396. | Practice of medicine. | |
| 397. | Contracts for expert review. | |
| 398. | Notices to States regarding imported food. | |
| 399. | Grants to enhance food safety. | |
| 399a. | Office of the Chief Scientist. | |
| 399b. | Office of Women’s Health. | |
| 399c. | Improving the training of State, local, territorial, and tribal food safety officials. | |
| 399d. | Employee protections. | |
| 399e. | Nanotechnology. | |
| 399f. | Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups. | |
| 399g. | Food and Drug Administration Intercenter Institutes. | |
| 399h. | National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing. | |
| 399i. | Food and Drug Administration Working Capital Fund. | |
| 399j. | Abraham Accords Office. | |
