FEDERAL FOOD, DRUG, AND COSMETIC ACT
Title 21 - Food and Drugs
Short title
Definitions; generally
“Butter” defined
“Package” defined
Nonfat dry milk; “milk” defined
Market names for catfish and ginseng
Prohibited acts
Injunction proceedings
Penalties
Seizure
Hearing before report of criminal violation
Debarment, temporary denial of approval, and suspension
Civil penalties
Authority to withdraw approval of abbreviated drug applications
Report of minor violations
Proceedings in name of United States; provision as to subpoenas
Extraterritorial jurisdiction
Definitions and standards for food
Adulterated food
Misbranded food
National uniform nutrition labeling
Dietary supplement labeling exemptions
Disclosure
Emergency permit control
Regulations making exemptions
Tolerances for poisonous or deleterious substances in food; regulations
Tolerances and exemptions for pesticide chemical residues
Authorization of appropriations
Intrastate sales of colored oleomargarine
Congressional declaration of policy regarding oleomargarine sales
Contravention of State laws
Food additives
Bottled drinking water standards; publication in Federal Register
Vitamins and minerals
Infant formulas
Protecting infants and improving formula supply
New dietary ingredients
Maintenance and inspection of records
Registration of food facilities
Sanitary transportation practices
Reportable food registry
Hazard analysis and risk-based preventive controls
Standards for produce safety
Protection against intentional adulteration
Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report
Laboratory accreditation for analyses of foods
Mandatory recall authority
Annual report to Congress
Requirements for critical food
Adulterated drugs and devices
Misbranded drugs and devices
Exemptions and consideration for certain drugs, devices, and biological products
Pharmacy compounding
Enhanced communication
Outsourcing facilities
Prereview of television advertisements
Process to update labeling for certain generic drugs
Veterinary feed directive drugs
New drugs
Risk evaluation and mitigation strategies
Actions for delays of generic drugs and biosimilar biological products
Pediatric studies of drugs
Adverse-event reporting
Research into pediatric uses for drugs and biological products
Report
Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
Pharmaceutical security
Extension of exclusivity period for new qualified infectious disease products
Utilizing real world evidence
Regulation of certain nonprescription drugs that are marketed without an approved drug application
Expedited approval of drugs for serious or life-threatening diseases or conditions
Accelerated approval of priority countermeasures
Accelerated approval Council
Manufacturing changes
Reports of postmarketing studies
Discontinuance or interruption in the production of life-saving drugs
Annual reporting on drug shortages
Coordination; task force and strategic plan
Drug shortage list
Hospital repackaging of drugs in shortage
Standards for regenerative medicine and regenerative advanced therapies
Competitive generic therapies
Prompt reports of marketing status
Discontinuance or interruption in the production of medical devices
Platform technologies
Advanced manufacturing technologies designation program
Qualification of drug development tools
Authority to designate official names
Nonapplicability of subchapter to cosmetics
Registration of producers of drugs or devices
Clinical trial guidance for antibiotic drugs
Clinical trials
Susceptibility test interpretive criteria for microorganisms
Recommendations for investigations of drugs for rare diseases or conditions
New animal drugs
Priority zoonotic animal drugs
Designation of drugs for rare diseases or conditions
Expanded access to unapproved therapies and diagnostics
Expanded access policy required for investigational drugs
Investigational drugs for use by eligible patients
Dispute resolution
Classification of products
Authorization for medical products for use in emergencies
Emergency use of medical products
Products held for emergency use
Expedited development and review of medical products for emergency uses
Countermeasure development, review, and technical assistance
Priority review to encourage treatments for agents that present national security threats
Medical countermeasure master files
Critical Path Public-Private Partnerships
Emerging technology program
Risk communication
Notification
Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
Optimizing global clinical trials
Use of clinical investigation data from outside the United States
Patient participation in medical product discussion
Notification, nondistribution, and recall of controlled substances
Classification of devices intended for human use
Reporting
Protection for drugs for rare diseases or conditions
Conditional approval of new animal drugs for minor use and minor species and certain new animal drugs
Index of legally marketed unapproved new animal drugs for minor species
Designated new animal drugs for minor use or minor species
Performance standards
Open protocols for investigations of drugs for rare diseases or conditions
Definitions
Regulation of medical gases
Inapplicability of drug fees to designated medical gases
Premarket approval
Pediatric uses of devices
Breakthrough devices
Predetermined change control plans for devices
Grants and contracts for development of drugs for rare diseases and conditions
FDA rare neurodegenerative disease grant program
Requirements
National standards for prescription drug wholesale distributors
National standards for third-party logistics providers
Uniform national policy
Banned devices
Priority review to encourage treatments for rare pediatric diseases
Targeted drugs for rare diseases
Submission of requests
Eligibility determinations; data submission; filing
GRASE determination
Guidance; other provisions
Non-sunscreen time and extent applications
Sunset
Judicial review
Agency documentation and review of significant decisions regarding devices
Third party data transparency
Notification and other remedies
Program to improve the device recall system
Records and reports on devices
Program of control
General provisions respecting control of devices intended for human use
Studies by Secretary
State and local requirements respecting devices
Performance standards for electronic products
Postmarket surveillance
Notification of defects in and repair or replacement of electronic products
Accredited persons
Imports
Priority review to encourage treatments for tropical diseases
Priority review for qualified infectious disease products
Ensuring cybersecurity of devices
Inspection, records, and reports
Enforcement
Federal-State cooperation
State standards
Adulterated cosmetics
Misbranded cosmetics
Adverse events
Good manufacturing practice
Registration and product listing
Safety substantiation
Labeling
Records
Small businesses
Exemption for certain products and facilities
Preemption
Regulations and hearings
Examinations and investigations
Inspection
Inspections relating to food allergens
Publicity
Examination of sea food on request of packer; marking food with results; fees; penalties
Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests
Advertising of foods
Confidential information
Presumption of existence of jurisdiction