Title 21, Chapter 9
Food and Drugs — 250 sections
- § 0 Section 0 - Expanded access policy required for investigational drugs
- § 0a Section 0a - Investigational drugs for use by eligible patients
- § 1 Section 1 - Enforcement action plan for advertising and promotion restrictions
- § 2 Section 2 - Activities of the Food and Drug Administration
- § 3 Section 3 - Streamlined hiring authority
- § 3a Section 3a - Emergency use of medical products
- § 3b Section 3b - Products held for emergency use
- § 3c Section 3c - Expedited development and review of medical products for emergency uses
- § 4 Section 4 - Reporting requirements
- § 4a Section 4a - Priority review to encourage treatments for agents that present national security threats
- § 4b Section 4b - Medical countermeasure master files
- § 5 Section 5 - Guidance document regarding product promotion using the Internet
- § 5a Section 5a - Emerging technology program
- § 6 Section 6 - Non-sunscreen time and extent applications
- § 7 Section 7 - Report
- § 8a Section 8a - Optimizing global clinical trials
- § 8 Section 8 - Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
- § 8b Section 8b - Use of clinical investigation data from outside the United States
- § 8c Section 8c - Patient participation in medical product discussion
- § 8d Section 8d - Notification, nondistribution, and recall of controlled substances
- § 11 Section 11 - Definitions
- § 12 Section 12 - Authority to assess and use animal drug fees
- § 13 Section 13 - Reauthorization; reporting requirements
- § 21 Section 21 - Authority to assess and use generic new animal drug fees
- § 22 Section 22 - Reauthorization; reporting requirements
- § 31 Section 31 - Authority to collect and use fees
- § 41 Section 41 - Definitions
- § 42 Section 42 - Authority to assess and use human generic drug fees
- § 43 Section 43 - Reauthorization; reporting requirements
- § 51 Section 51 - Definitions
- § 52 Section 52 - Authority to assess and use biosimilar biological product fees
- § 53 Section 53 - Reauthorization; reporting requirements
- § 61 Section 61 - Definitions
- § 62 Section 62 - Authority to assess and use outsourcing facility fees
- § 71 Section 71 - Definitions
- § 72 Section 72 - Authority to assess and use OTC monograph fees
- § 73 Section 73 - Reauthorization; reporting requirements
- § 301 Section 301 - Short title
- § 321 Section 321 - Definitions; generally
- § 321a Section 321a - “Butter” defined
- § 321b Section 321b - “Package” defined
- § 321c Section 321c - Nonfat dry milk; “milk” defined
- § 321d Section 321d - Market names for catfish and ginseng
- § 331 Section 331 - Prohibited acts
- § 332 Section 332 - Injunction proceedings
- § 333 Section 333 - Penalties
- § 333a Section 333a - Repealed. Pub. L. 101–647, title XIX , § 1905, Nov. 29, 1990 , 104 Stat. 4853
- § 334 Section 334 - Seizure
- § 335 Section 335 - Hearing before report of criminal violation
- § 335a Section 335a - Debarment, temporary denial of approval, and suspension
- § 335c Section 335c - Authority to withdraw approval of abbreviated drug applications
- § 335b Section 335b - Civil penalties
- § 336 Section 336 - Report of minor violations
- § 337 Section 337 - Proceedings in name of United States; provision as to subpoenas
- § 337a Section 337a - Extraterritorial jurisdiction
- § 341 Section 341 - Definitions and standards for food
- § 342 Section 342 - Adulterated food
- § 343 Section 343 - Misbranded food
- § 343a Section 343a - Repealed. Pub. L. 106–554 , § 1(a)(1) [title V, § 517], Dec. 21, 2000 , 114 Stat. 2763 , 2763A–73
- § 344 Section 344 - Emergency permit control
- § 345 Section 345 - Regulations making exemptions
- § 346 Section 346 - Tolerances for poisonous or deleterious substances in food; regulations
- § 346a Section 346a - Tolerances and exemptions for pesticide chemical residues
- § 346b Section 346b - Authorization of appropriations
- § 347 Section 347 - Intrastate sales of colored oleomargarine
- § 347a Section 347a - Congressional declaration of policy regarding oleomargarine sales
- § 347b Section 347b - Contravention of State laws
- § 348 Section 348 - Food additives
- § 349 Section 349 - Bottled drinking water standards; publication in Federal Register
- § 350 Section 350 - Vitamins and minerals
- § 350a Section 350a - Infant formulas
- § 350b Section 350b - New dietary ingredients
- § 350c Section 350c - Maintenance and inspection of records
- § 350d Section 350d - Registration of food facilities
- § 350e Section 350e - Sanitary transportation practices
- § 350f Section 350f - Reportable food registry
- § 350g Section 350g - Hazard analysis and risk-based preventive controls
- § 350h Section 350h - Standards for produce safety
- § 350i Section 350i - Protection against intentional adulteration
- § 350j Section 350j - Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
- § 350k Section 350k - Laboratory accreditation for analyses of foods
- § 350l Section 350l - Mandatory recall authority
- § 350m Section 350m - Requirements for critical food
- § 351 Section 351 - Adulterated drugs and devices
- § 352 Section 352 - Misbranded drugs and devices
- § 353 Section 353 - Exemptions and consideration for certain drugs, devices, and biological products
- § 353a Section 353a - Pharmacy compounding
- § 353c Section 353c - Prereview of television advertisements
- § 353b Section 353b - Outsourcing facilities
- § 353d Section 353d - Process to update labeling for certain generic drugs
- § 354 Section 354 - Veterinary feed directive drugs
- § 355 Section 355 - New drugs
- § 355a Section 355a - Pediatric studies of drugs
- § 355b Section 355b - Adverse-event reporting
- § 355c Section 355c - Research into pediatric uses for drugs and biological products
- § 355d Section 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
- § 355e Section 355e - Pharmaceutical security
- § 355f Section 355f - Extension of exclusivity period for new qualified infectious disease products
- § 355g Section 355g - Utilizing real world evidence
- § 355h Section 355h - Regulation of certain nonprescription drugs that are marketed without an approved drug application
- § 356 Section 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
- § 356b Section 356b - Reports of postmarketing studies
- § 356a Section 356a - Manufacturing changes
- § 356c Section 356c - Discontinuance or interruption in the production of life-saving drugs
- § 356d Section 356d - Coordination; task force and strategic plan
- § 356e Section 356e - Drug shortage list
- § 356f Section 356f - Hospital repackaging of drugs in shortage
- § 356g Section 356g - Standards for regenerative medicine and regenerative advanced therapies
- § 356h Section 356h - Competitive generic therapies
- § 356i Section 356i - Prompt reports of marketing status
- § 356j Section 356j - Discontinuance or interruption in the production of medical devices
- § 356k Section 356k - Platform technologies
- § 356l Section 356l - Advanced manufacturing technologies designation program
- § 357 Section 357 - Repealed. Pub. L. 105–115, title I , § 125(b)(1), Nov. 21, 1997 , 111 Stat. 2325
- § 358 Section 358 - Authority to designate official names
- § 359 Section 359 - Nonapplicability of subchapter to cosmetics
- § 360 Section 360 - Registration of producers of drugs or devices
- § 360a Section 360a - Clinical trial guidance for antibiotic drugs
- § 360aa Section 360aa - Recommendations for investigations of drugs for rare diseases or conditions
- § 360b Section 360b - New animal drugs
- § 360bb Section 360bb - Designation of drugs for rare diseases or conditions
- § 360bbb Section 360bbb - Expanded access to unapproved therapies and diagnostics
- § 360c Section 360c - Classification of devices intended for human use
- § 360cc Section 360cc - Protection for drugs for rare diseases or conditions
- § 360ccc Section 360ccc - Conditional approval of new animal drugs for minor use and minor species
- § 360d Section 360d - Performance standards
- § 360dd Section 360dd - Open protocols for investigations of drugs for rare diseases or conditions
- § 360ddd Section 360ddd - Definitions
- § 360e Section 360e - Premarket approval
- § 360ee Section 360ee - Grants and contracts for development of drugs for rare diseases and conditions
- § 360eee Section 360eee - Definitions
- § 360f Section 360f - Banned devices
- § 360ff Section 360ff - Priority review to encourage treatments for rare pediatric diseases
- § 360fff Section 360fff - Definitions
- § 360g Section 360g - Judicial review
- § 360h Section 360h - Notification and other remedies
- § 360hh Section 360hh - Definitions
- § 360i Section 360i - Records and reports on devices
- § 360ii Section 360ii - Program of control
- § 360j Section 360j - General provisions respecting control of devices intended for human use
- § 360jj Section 360jj - Studies by Secretary
- § 360k Section 360k - State and local requirements respecting devices
- § 360kk Section 360kk - Performance standards for electronic products
- § 360l Section 360l - Postmarket surveillance
- § 360ll Section 360ll - Notification of defects in and repair or replacement of electronic products
- § 360m Section 360m - Accredited persons
- § 360mm Section 360mm - Imports
- § 360n Section 360n - Priority review to encourage treatments for tropical diseases
- § 360nn Section 360nn - Inspection, records, and reports
- § 360oo Section 360oo - Prohibited acts
- § 360pp Section 360pp - Enforcement
- § 360qq Section 360qq - Repealed. Pub. L. 105–362, title VI , § 601(a)(2)(A), Nov. 10, 1998 , 112 Stat. 3285
- § 360rr Section 360rr - Federal-State cooperation
- § 360ss Section 360ss - State standards
- § 361 Section 361 - Adulterated cosmetics
- § 362 Section 362 - Misbranded cosmetics
- § 363 Section 363 - Regulations making exemptions
- § 364 Section 364 - Repealed. Pub. L. 86–618, title I , § 103(a)(3), July 12, 1960 , 74 Stat. 398
- § 364a Section 364a - Adverse events
- § 364b Section 364b - Good manufacturing practice
- § 364c Section 364c - Registration and product listing
- § 364d Section 364d - Safety substantiation
- § 364e Section 364e - Labeling
- § 364f Section 364f - Records
- § 364g Section 364g - Mandatory recall authority
- § 364h Section 364h - Small businesses
- § 364i Section 364i - Exemption for certain products and facilities
- § 364j Section 364j - Preemption
- § 371 Section 371 - Regulations and hearings
- § 372a Section 372a - Transferred
- § 372 Section 372 - Examinations and investigations
- § 373 Section 373 - Records
- § 374 Section 374 - Inspection
- § 374a Section 374a - Inspections relating to food allergens
- § 375 Section 375 - Publicity
- § 376 Section 376 - Examination of sea food on request of packer; marking food with results; fees; penalties
- § 377 Section 377 - Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
- § 378 Section 378 - Advertising of foods
- § 379 Section 379 - Confidential information
- § 379a Section 379a - Presumption of existence of jurisdiction
- § 379b Section 379b - Consolidated administrative and laboratory facility
- § 379aa Section 379aa - Serious adverse event reporting for nonprescription drugs
- § 379c Section 379c - Transferred
- § 379d Section 379d - Automation of Food and Drug Administration
- § 379dd Section 379dd - Establishment and functions of the Foundation
- § 379e Section 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
- § 379f Section 379f - Recovery and retention of fees for freedom of information requests
- § 379g Section 379g - Definitions
- § 379h Section 379h - Authority to assess and use drug fees
- § 379i Section 379i - Definitions
- § 379j Section 379j - Authority to assess and use device fees
- § 379k Section 379k - Information system
- § 379l Section 379l - Education
- § 379o Section 379o - Environmental impact
- § 379r Section 379r - National uniformity for nonprescription drugs
- § 379s Section 379s - Preemption for labeling or packaging of cosmetics
- § 379v Section 379v - Safety report disclaimers
- § 381 Section 381 - Imports and exports
- § 382 Section 382 - Exports of certain unapproved products
- § 383 Section 383 - Office of International Relations
- § 384 Section 384 - Importation of prescription drugs
- § 384a Section 384a - Foreign supplier verification program
- § 384b Section 384b - Voluntary qualified importer program
- § 384c Section 384c - Inspection of foreign food facilities
- § 384d Section 384d - Accreditation of third-party auditors
- § 384e Section 384e - Recognition of foreign government inspections
- § 384f Section 384f - Strengthening FDA and CBP coordination and capacity
- § 384g Section 384g - Restricting entrance of illicit drugs
- § 387 Section 387 - Definitions
- § 387a Section 387a - FDA authority over tobacco products
- § 387c Section 387c - Misbranded tobacco products
- § 387d Section 387d - Submission of health information to the Secretary
- § 387b Section 387b - Adulterated tobacco products
- § 387e Section 387e - Annual registration
- § 387f Section 387f - General provisions respecting control of tobacco products
- § 387g Section 387g - Tobacco product standards
- § 387h Section 387h - Notification and other remedies
- § 387j Section 387j - Application for review of certain tobacco products
- § 387i Section 387i - Records and reports on tobacco products
- § 387k Section 387k - Modified risk tobacco products
- § 387l Section 387l - Judicial review
- § 387m Section 387m - Equal treatment of retail outlets
- § 387n Section 387n - Jurisdiction of and coordination with the Federal Trade Commission
- § 387p Section 387p - Preservation of State and local authority
- § 387o Section 387o - Regulation requirement
- § 387q Section 387q - Tobacco Products Scientific Advisory Committee
- § 387r Section 387r - Drug products used to treat tobacco dependence
- § 387t Section 387t - Labeling, recordkeeping, records inspection
- § 387s Section 387s - User fees
- § 387u Section 387u - Studies of progress and effectiveness
- § 387v Section 387v - Reporting on tobacco regulation activities
- § 391 Section 391 - Separability clause
- § 392 Section 392 - Exemption of meats and meat food products
- § 393 Section 393 - Food and Drug Administration
- § 393a Section 393a - Office of Pediatric Therapeutics
- § 394 Section 394 - Scientific review groups
- § 395 Section 395 - Loan repayment program
- § 396 Section 396 - Practice of medicine
- § 397 Section 397 - Contracts for expert review
- § 398 Section 398 - Notices to States regarding imported food
- § 399a Section 399a - Office of the Chief Scientist
- § 399 Section 399 - Grants to enhance food safety
- § 399b Section 399b - Office of Women’s Health
- § 399c Section 399c - Improving the training of State, local, territorial, and tribal food safety officials
- § 399d Section 399d - Employee protections
- § 399e Section 399e - Nanotechnology
- § 399f Section 399f - Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
- § 399g Section 399g - Food and Drug Administration Intercenter Institutes
- § 399h Section 399h - National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
- § 399i Section 399i - Food and Drug Administration Working Capital Fund