There Is a Newer Version
of
this Subchapter
- 2023 U.S. Code
- 2022 U.S. Code (here)
- 2021 U.S. Code
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2022 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - Federal Food, Drug, and Cosmetic Act
Subchapter V - Drugs and Devices
| Publication Title | United States Code, 2018 Edition, Supplement 4, Title 21 - FOOD AND DRUGS |
| Category | Bills and Statutes |
| Collection | United States Code |
| SuDoc Class Number | Y 1.2/5: |
| Contained Within | Title 21 - FOOD AND DRUGS CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT SUBCHAPTER V - DRUGS AND DEVICES |
| Contains | sections 351 to 360fff-8 |
| Date | 2022 |
| Laws In Effect As Of Date | January 5, 2023 |
| Positive Law | No |
| Disposition | standard |
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Part A - Drugs and Devices
(Section 351 - 360n-2)
- Sec. 351 - Adulterated drugs and devices
- Sec. 352 - Misbranded drugs and devices
- Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products
- Sec. 353a - Pharmacy compounding
- Sec. 353a-1 - Enhanced communication
- Sec. 353b - Outsourcing facilities
- Sec. 353c - Prereview of television advertisements
- Sec. 353d - Process to update labeling for certain generic drugs
- Sec. 354 - Veterinary feed directive drugs
- Sec. 355 - New drugs
- Sec. 355-1 - Risk evaluation and mitigation strategies
- Sec. 355-2 - Actions for delays of generic drugs and biosimilar biological products
- Sec. 355a - Pediatric studies of drugs
- Sec. 355b - Adverse-event reporting
- Sec. 355c - Research into pediatric uses for drugs and biological products
- Sec. 355c-1 - Report
- Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
- Sec. 355e - Pharmaceutical security
- Sec. 355f - Extension of exclusivity period for new qualified infectious disease products
- Sec. 355g - Utilizing real world evidence
- Sec. 355h - Regulation of certain nonprescription drugs that are marketed without an approved drug application
- Sec. 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
- Sec. 356-1 - Accelerated approval of priority countermeasures
- Sec. 356-2 - Accelerated approval Council
- Sec. 356a - Manufacturing changes
- Sec. 356b - Reports of postmarketing studies
- Sec. 356c - Discontinuance or interruption in the production of life-saving drugs
- Sec. 356c-1 - Annual reporting on drug shortages
- Sec. 356d - Coordination; task force and strategic plan
- Sec. 356e - Drug shortage list
- Sec. 356f - Hospital repackaging of drugs in shortage
- Sec. 356g - Standards for regenerative medicine and regenerative advanced therapies
- Sec. 356h - Competitive generic therapies
- Sec. 356i - Prompt reports of marketing status
- Sec. 356j - Discontinuance or interruption in the production of medical devices
- Sec. 356k - Platform technologies
- Sec. 356l - Advanced manufacturing technologies designation program
- Sec. 357 - Qualification of drug development tools
- Sec. 358 - Authority to designate official names
- Sec. 359 - Nonapplicability of subchapter to cosmetics
- Sec. 360 - Registration of producers of drugs or devices
- Sec. 360a - Clinical trial guidance for antibiotic drugs
- Sec. 360a-1 - Clinical trials
- Sec. 360a-2 - Susceptibility test interpretive criteria for microorganisms
- Sec. 360b - New animal drugs
- Sec. 360b-1 - Priority zoonotic animal drugs
- Sec. 360c - Classification of devices intended for human use
- Sec. 360c-1 - Reporting
- Sec. 360d - Performance standards
- Sec. 360e - Premarket approval
- Sec. 360e-1 - Pediatric uses of devices
- Sec. 360e-3 - Breakthrough devices
- Sec. 360e-4 - Predetermined change control plans for devices
- Sec. 360f - Banned devices
- Sec. 360g - Judicial review
- Sec. 360g-1 - Agency documentation and review of significant decisions regarding devices
- Sec. 360g-2 - Third party data transparency
- Sec. 360h - Notification and other remedies
- Sec. 360h-1 - Program to improve the device recall system
- Sec. 360i - Records and reports on devices
- Sec. 360j - General provisions respecting control of devices intended for human use
- Sec. 360k - State and local requirements respecting devices
- Sec. 360l - Postmarket surveillance
- Sec. 360m - Accredited persons
- Sec. 360n - Priority review to encourage treatments for tropical diseases
- Sec. 360n-1 - Priority review for qualified infectious disease products
- Sec. 360n-2 - Ensuring cybersecurity of devices
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Part B - Drugs for Rare Diseases or Conditions
(Section 360aa - 360ff-1)
- Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditions
- Sec. 360bb - Designation of drugs for rare diseases or conditions
- Sec. 360cc - Protection for drugs for rare diseases or conditions
- Sec. 360dd - Open protocols for investigations of drugs for rare diseases or conditions
- Sec. 360ee - Grants and contracts for development of drugs for rare diseases and conditions
- Sec. 360ee-1 - FDA rare neurodegenerative disease grant program
- Sec. 360ff - Priority review to encourage treatments for rare pediatric diseases
- Sec. 360ff-1 - Targeted drugs for rare diseases
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Part C - Electronic Product Radiation Control
(Section 360hh - 360ss)
- Sec. 360hh - Definitions
- Sec. 360ii - Program of control
- Sec. 360jj - Studies by Secretary
- Sec. 360kk - Performance standards for electronic products
- Sec. 360ll - Notification of defects in and repair or replacement of electronic products
- Sec. 360mm - Imports
- Sec. 360nn - Inspection, records, and reports
- Sec. 360oo - Prohibited acts
- Sec. 360pp - Enforcement
- Sec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
- Sec. 360rr - Federal-State cooperation
- Sec. 360ss - State standards
- + Part D - Dissemination of Treatment Information (Section 360aaa - 360aaa-6)
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Part E - General Provisions Relating to Drugs and Devices
(Section 360bbb - 360bbb-8d)
- Sec. 360bbb - Expanded access to unapproved therapies and diagnostics
- Sec. 360bbb-0 - Expanded access policy required for investigational drugs
- Sec. 360bbb-0a - Investigational drugs for use by eligible patients
- Sec. 360bbb-1 - Dispute resolution
- Sec. 360bbb-2 - Classification of products
- Sec. 360bbb-3 - Authorization for medical products for use in emergencies
- Sec. 360bbb-3a - Emergency use of medical products
- Sec. 360bbb-3b - Products held for emergency use
- Sec. 360bbb-3c - Expedited development and review of medical products for emergency uses
- Sec. 360bbb-4 - Countermeasure development, review, and technical assistance
- Sec. 360bbb-4a - Priority review to encourage treatments for agents that present national security threats
- Sec. 360bbb-4b - Medical countermeasure master files
- Sec. 360bbb-5 - Critical Path Public-Private Partnerships
- Sec. 360bbb-5a - Emerging technology program
- Sec. 360bbb-6 - Risk communication
- Sec. 360bbb-7 - Notification
- Sec. 360bbb-8 - Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
- Sec. 360bbb-8a - Optimizing global clinical trials
- Sec. 360bbb-8b - Use of clinical investigation data from outside the United States
- Sec. 360bbb-8c - Patient participation in medical product discussion
- Sec. 360bbb-8d - Notification, nondistribution, and recall of controlled substances
- + Part F - New Animal Drugs for Minor Use and Minor Species (Section 360ccc - 360ccc-2)
- + Part G - Medical Gases (Section 360ddd - 360ddd-2)
- + Part H - Pharmaceutical Distribution Supply Chain (Section 360eee - 360eee-4)
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Part I - Nonprescription Sunscreen and Other Active Ingredients
(Section 360fff - 360fff-8)
- Sec. 360fff - Definitions
- Sec. 360fff-1 - Submission of requests
- Sec. 360fff-2 - Eligibility determinations; data submission; filing
- Sec. 360fff-3 - GRASE determination
- Sec. 360fff-4 - Guidance; other provisions
- Sec. 360fff-5 - Repealed. Pub. L. 116-136, div. A, title III, §3854(b)(5), Mar. 27, 2020, 134 Stat. 456
- Sec. 360fff-6 - Non-sunscreen time and extent applications
- Sec. 360fff-7 - Report
- Sec. 360fff-8 - Sunset
Disclaimer: These codes may not be the most recent version. United States may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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