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2012 US Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399f)
Subchapter V - DRUGS AND DEVICES (§§ 351 - 360ddd-2)
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Metadata
Publication Title | United States Code, 2012 Edition, 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 360ddd-2 |
Date | 2012 |
Laws in Effect as of Date | January 15, 2013 |
Positive Law | No |
Disposition | standard |
- Part A - Drugs and Devices (§§ 351 - 360n-1)
- 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 353b - Prereview of television advertisements
- Section 354 - Veterinary feed directive drugs
- Section 355 - New drugs
- Section 355-1 - Risk evaluation and mitigation strategies
- 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 356 - Expedited approval of drugs for serious or life-threatening diseases or conditions
- Section 356-1 - Accelerated approval of priority countermeasures
- 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- Section 357 - Repealed. Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325
- 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 360b - New 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 360f - Banned devices
- Section 360g - Judicial review
- Section 360g-1 - Agency documentation and review of significant decisions regarding devices
- 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
- Part B - Drugs for Rare Diseases or Conditions (§§ 360aa - 360ff)
- 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 360ff - Priority review to encourage treatments for rare pediatric diseases
- Part C - Electronic Product Radiation Control (§§ 360hh - 360ss)
- 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
- Section 360rr - Federal-State cooperation
- Section 360ss - State standards
- Part D - Dissemination of Treatment Information (§§ 360aaa - 360aaa-6)
- Part E - General Provisions Relating to Drugs and Devices (§§ 360bbb - 360bbb-8c)
- Section 360bbb - Expanded access to unapproved therapies and diagnostics
- Section 360bbb-1 - Dispute resolution
- Section 360bbb-2 - Classification of products
- Section 360bbb-3 - Authorization for medical products for use in emergencies
- Section 360bbb-4 - Technical assistance
- Section 360bbb-5 - Critical Path Public-Private Partnerships
- 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
- Part F - New Animal Drugs for Minor Use and Minor Species (§§ 360ccc - 360ccc-2)
- Part G - Medical Gases (§§ 360ddd - 360ddd-2)
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