Title 21, Chapter 9 — Federal Food, Drug, and Cosmetic Act
310 sections
Section 301
Short title
Section 321
Definitions; generally
Section 321a
“Butter” defined
Section 321b
“Package” defined
Section 321c
Nonfat dry milk; “milk” defined
Section 321d
Market names for catfish and ginseng
Section 331
Prohibited acts
Section 332
Injunction proceedings
Section 333
Penalties
Section 333a
Repealed. Pub. L. 101–647, title XIX, § 1905, Nov. 29, 1990, 104 Stat. 4853
repealed
Section 334
Seizure
Section 335
Hearing before report of criminal violation
Section 335a
Debarment, temporary denial of approval, and suspension
Section 335b
Civil penalties
Section 335c
Authority to withdraw approval of abbreviated drug applications
Section 336
Report of minor violations
Section 337
Proceedings in name of United States; provision as to subpoenas
Section 337a
Extraterritorial jurisdiction
Section 341
Definitions and standards for food
Section 342
Adulterated food
Section 343
Misbranded food
Section 343–1
National uniform nutrition labeling
Section 343–2
Dietary supplement labeling exemptions
Section 343–3
Disclosure
Section 343a
Repealed. Pub. L. 106–554, § 1(a)(1) [title V, § 517], Dec. 21, 2000, 114 Stat. 2763, 2763A–73
repealed
Section 344
Emergency permit control
Section 345
Regulations making exemptions
Section 346
Tolerances for poisonous or deleterious substances in food; regulations
Section 346a
Tolerances and exemptions for pesticide chemical residues
Section 346b
Authorization of appropriations
Section 347
Intrastate sales of colored oleomargarine
Section 347a
Congressional declaration of policy regarding oleomargarine sales
Section 347b
Contravention of State laws
Section 348
Food additives
Section 349
Bottled drinking water standards; publication in Federal Register
Section 350
Vitamins and minerals
Section 350a
Infant formulas
Section 350a–1
Protecting infants and improving formula supply
Section 350b
New dietary ingredients
Section 350c
Maintenance and inspection of records
Section 350d
Registration of food facilities
Section 350e
Sanitary transportation practices
Section 350f
Reportable food registry
Section 350g
Hazard analysis and risk-based preventive controls
Section 350h
Standards for produce safety
Section 350i
Protection against intentional adulteration
Section 350j
Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
Section 350k
Laboratory accreditation for analyses of foods
Section 350l
Mandatory recall authority
Section 350l–1
Annual report to Congress
Section 350m
Requirements for critical food
Section 351
Adulterated drugs and devices
Section 352
Misbranded drugs and devices
Section 353
Exemptions and consideration for certain drugs, devices, and biological products
Section 353a
Pharmacy compounding
Section 353a–1
Enhanced communication
Section 353b
Outsourcing facilities
Section 353c
Prereview of television advertisements
Section 353d
Process to update labeling for certain generic drugs
Section 354
Veterinary feed directive drugs
Section 355
New drugs
Section 355–1
Risk evaluation and mitigation strategies
Section 355–2
Actions for delays of generic drugs and biosimilar biological products
Section 355a
Pediatric studies of drugs
Section 355b
Adverse-event reporting
Section 355c
Research into pediatric uses for drugs and biological products
Section 355c–1
Report
Section 355d
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Section 355e
Pharmaceutical security
Section 355f
Extension of exclusivity period for new qualified infectious disease products
Section 355g
Utilizing real world evidence
Section 355h
Regulation of certain nonprescription drugs that are marketed without an approved drug application
Section 356
Expedited approval of drugs for serious or life-threatening diseases or conditions
Section 356–1
Accelerated approval of priority countermeasures
Section 356–2
Accelerated approval Council
Section 356a
Manufacturing changes
Section 356b
Reports of postmarketing studies
Section 356c
Discontinuance or interruption in the production of life-saving drugs
Section 356c–1
Annual reporting on drug shortages
Section 356d
Coordination; task force and strategic plan
Section 356e
Drug shortage list
Section 356f
Hospital repackaging of drugs in shortage
Section 356g
Standards for regenerative medicine and regenerative advanced therapies
Section 356h
Competitive generic therapies
Section 356i
Prompt reports of marketing status
Section 356j
Discontinuance or interruption in the production of medical devices
Section 356k
Platform technologies
Section 356l
Advanced manufacturing technologies designation program
Section 357
Qualification of drug development tools
Section 358
Authority to designate official names
Section 359
Nonapplicability of subchapter to cosmetics
Section 360
Registration of producers of drugs or devices
Section 360a
Clinical trial guidance for antibiotic drugs
Section 360a–1
Clinical trials
Section 360a–2
Susceptibility test interpretive criteria for microorganisms
Section 360b
New animal drugs
Section 360b–1
Priority zoonotic animal drugs
Section 360c
Classification of devices intended for human use
Section 360c–1
Reporting
Section 360d
Performance standards
Section 360e
Premarket approval
Section 360e–1
Pediatric uses of devices
Section 360e–3
Breakthrough devices
Section 360e–4
Predetermined change control plans for devices
Section 360f
Banned devices
Section 360g
Judicial review
Section 360g–1
Agency documentation and review of significant decisions regarding devices
Section 360g–2
Third party data transparency
Section 360h
Notification and other remedies
Section 360h–1
Program to improve the device recall system
Section 360i
Records and reports on devices
Section 360j
General provisions respecting control of devices intended for human use
Section 360k
State and local requirements respecting devices
Section 360l
Postmarket surveillance
Section 360m
Accredited persons
Section 360n
Priority review to encourage treatments for tropical diseases
Section 360n–1
Priority review for qualified infectious disease products
Section 360n–2
Ensuring cybersecurity of devices
Section 360aa
Recommendations for investigations of drugs for rare diseases or conditions
Section 360bb
Designation of drugs for rare diseases or conditions
Section 360cc
Protection for drugs for rare diseases or conditions
Section 360dd
Open protocols for investigations of drugs for rare diseases or conditions
Section 360ee
Grants and contracts for development of drugs for rare diseases and conditions
Section 360ee–1
FDA rare neurodegenerative disease grant program
Section 360ff
Priority review to encourage treatments for rare pediatric diseases
Section 360ff–1
Targeted drugs for rare diseases
Section 360hh
Definitions
Section 360ii
Program of control
Section 360jj
Studies by Secretary
Section 360kk
Performance standards for electronic products
Section 360ll
Notification of defects in and repair or replacement of electronic products
Section 360mm
Imports
Section 360nn
Inspection, records, and reports
Section 360oo
Prohibited acts
Section 360pp
Enforcement
Section 360qq
Repealed. Pub. L. 105–362, title VI, § 601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
repealed
Section 360rr
Federal-State cooperation
Section 360ss
State standards
Section 360aaa to 360aaa–6
Omitted
omitted
Section 360bbb
Expanded access to unapproved therapies and diagnostics
Section 360bbb–0
Expanded access policy required for investigational drugs
Section 360bbb–0a
Investigational drugs for use by eligible patients
Section 360bbb–1
Dispute resolution
Section 360bbb–2
Classification of products
Section 360bbb–3
Authorization for medical products for use in emergencies
Section 360bbb–3a
Emergency use of medical products
Section 360bbb–3b
Products held for emergency use
Section 360bbb–3c
Expedited development and review of medical products for emergency uses
Section 360bbb–4
Countermeasure development, review, and technical assistance
Section 360bbb–4a
Priority review to encourage treatments for agents that present national security threats
Section 360bbb–4b
Medical countermeasure master files
Section 360bbb–5
Critical Path Public-Private Partnerships
Section 360bbb–5a
Emerging technology program
Section 360bbb–6
Risk communication
Section 360bbb–7
Notification
Section 360bbb–8
Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
Section 360bbb–8a
Optimizing global clinical trials
Section 360bbb–8b
Use of clinical investigation data from outside the United States
Section 360bbb–8c
Patient participation in medical product discussion
Section 360bbb–8d
Notification, nondistribution, and recall of controlled substances
Section 360ccc
Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
Section 360ccc–1
Index of legally marketed unapproved new animal drugs for minor species
Section 360ccc–2
Designated new animal drugs for minor use or minor species
Section 360ddd
Definitions
Section 360ddd–1
Regulation of medical gases
Section 360ddd–2
Inapplicability of drug fees to designated medical gases
Section 360eee
Definitions
Section 360eee–1
Requirements
Section 360eee–2
National standards for prescription drug wholesale distributors
Section 360eee–3
National standards for third-party logistics providers
Section 360eee–4
Uniform national policy
Section 360fff
Definitions
Section 360fff–1
Submission of requests
Section 360fff–2
Eligibility determinations; data submission; filing
Section 360fff–3
GRASE determination
Section 360fff–4
Guidance; other provisions
Section 360fff–5
Repealed. Pub. L. 116–136, div. A, title III, § 3854(b)(5), Mar. 27, 2020, 134 Stat. 456
repealed
Section 360fff–6
Non-sunscreen time and extent applications
Section 360fff–7
Report
Section 360fff–8
Sunset
Section 361
Adulterated cosmetics
Section 362
Misbranded cosmetics
Section 363
Regulations making exemptions
Section 364
Definitions
Section 364a
Adverse events
Section 364b
Good manufacturing practice
Section 364c
Registration and product listing
Section 364d
Safety substantiation
Section 364e
Labeling
Section 364f
Records
Section 364g
Mandatory recall authority
Section 364h
Small businesses
Section 364i
Exemption for certain products and facilities
Section 364j
Preemption
Section 371
Regulations and hearings
Section 372
Examinations and investigations
Section 372a
Transferred
transferred
Section 373
Records
Section 374
Inspection
Section 374a
Inspections relating to food allergens
Section 375
Publicity
Section 376
Examination of sea food on request of packer; marking food with results; fees; penalties
Section 377
Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
Section 378
Advertising of foods
Section 379
Confidential information
Section 379a
Presumption of existence of jurisdiction
Section 379b
Consolidated administrative and laboratory facility
Section 379c
Transferred
transferred
Section 379d
Automation of Food and Drug Administration
Section 379d–1
Conflicts of interest
Section 379d–2
Policy on the review and clearance of scientific articles published by FDA employees
Section 379d–3
Streamlined hiring authority
Section 379d–3a
Hiring authority for scientific, technical, and professional personnel
Section 379d–3b
Strategic Workforce Plan and report
Section 379d–4
Reporting requirements
Section 379d–5
Guidance document regarding product promotion using the Internet
Section 379e
Listing and certification of color additives for foods, drugs, devices, and cosmetics
Section 379f
Recovery and retention of fees for freedom of information requests
Section 379g
Definitions
Section 379h
Authority to assess and use drug fees
Section 379h–1
Fees relating to advisory review of prescription-drug television advertising
Section 379h–2
Reauthorization; reporting requirements
Section 379i
Definitions
Section 379j
Authority to assess and use device fees
Section 379j–1
Reauthorization; reporting requirements
Section 379j–11
Definitions
Section 379j–12
Authority to assess and use animal drug fees
Section 379j–13
Reauthorization; reporting requirements
Section 379j–21
Authority to assess and use generic new animal drug fees
Section 379j–22
Reauthorization; reporting requirements
Section 379j–31
Authority to collect and use fees
Section 379j–41
Definitions
Section 379j–42
Authority to assess and use human generic drug fees
Section 379j–43
Reauthorization; reporting requirements
Section 379j–51
Definitions
Section 379j–52
Authority to assess and use biosimilar biological product fees
Section 379j–53
Reauthorization; reporting requirements
Section 379j–61
Definitions
Section 379j–62
Authority to assess and use outsourcing facility fees
Section 379j–71
Definitions
Section 379j–72
Authority to assess and use OTC monograph fees
Section 379j–73
Reauthorization; reporting requirements
Section 379k
Information system
Section 379k–1
Electronic format for submissions
Section 379l
Education
Section 379o
Environmental impact
Section 379r
National uniformity for nonprescription drugs
Section 379s
Preemption for labeling or packaging of cosmetics
Section 379v
Safety report disclaimers
Section 379aa
Serious adverse event reporting for nonprescription drugs
Section 379aa–1
Serious adverse event reporting for dietary supplements
Section 379dd
Establishment and functions of the Foundation
Section 379dd–1
Location of Foundation
Section 379dd–2
Activities of the Food and Drug Administration
Section 381
Imports and exports
Section 382
Exports of certain unapproved products
Section 383
Office of International Relations
Section 384
Importation of prescription drugs
Section 384a
Foreign supplier verification program
Section 384b
Voluntary qualified importer program
Section 384c
Inspection of foreign food facilities
Section 384d
Accreditation of third-party auditors
Section 384e
Recognition of foreign government inspections
Section 384f
Strengthening FDA and CBP coordination and capacity
Section 384g
Restricting entrance of illicit drugs
Section 387
Definitions
Section 387a
FDA authority over tobacco products
Section 387a–1
Final rule
Section 387b
Adulterated tobacco products
Section 387c
Misbranded tobacco products
Section 387d
Submission of health information to the Secretary
Section 387e
Annual registration
Section 387f
General provisions respecting control of tobacco products
Section 387f–1
Enforcement action plan for advertising and promotion restrictions
Section 387g
Tobacco product standards
Section 387h
Notification and other remedies
Section 387i
Records and reports on tobacco products
Section 387j
Application for review of certain tobacco products
Section 387k
Modified risk tobacco products
Section 387l
Judicial review
Section 387m
Equal treatment of retail outlets
Section 387n
Jurisdiction of and coordination with the Federal Trade Commission
Section 387o
Regulation requirement
Section 387p
Preservation of State and local authority
Section 387q
Tobacco Products Scientific Advisory Committee
Section 387r
Drug products used to treat tobacco dependence
Section 387s
User fees
Section 387t
Labeling, recordkeeping, records inspection
Section 387u
Studies of progress and effectiveness
Section 387v
Reporting on tobacco regulation activities
Section 391
Separability clause
Section 392
Exemption of meats and meat food products
Section 393
Food and Drug Administration
Section 393a
Office of Pediatric Therapeutics
Section 394
Scientific review groups
Section 395
Loan repayment program
Section 396
Practice of medicine
Section 397
Contracts for expert review
Section 398
Notices to States regarding imported food
Section 399
Grants to enhance food safety
Section 399a
Office of the Chief Scientist
Section 399b
Office of Women’s Health
Section 399c
Improving the training of State, local, territorial, and tribal food safety officials
Section 399d
Employee protections
Section 399e
Nanotechnology
Section 399f
Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups
Section 399g
Food and Drug Administration Intercenter Institutes
Section 399h
National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing
Section 399i
Food and Drug Administration Working Capital Fund
Section 399j
Abraham Accords Office