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2012 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399f)
Subchapter V - DRUGS AND DEVICES (§§ 351 - 360ddd-2)
Part A - Drugs and Devices (§§ 351 - 360n-1)
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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 Part A - Drugs and Devices |
| Contains | sections 351 to 360n-1 |
| Date | 2012 |
| Laws in Effect as of Date | January 15, 2013 |
| Positive Law | No |
| Disposition | standard |
- 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- Section 357 - Repealed.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
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