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2012 U.S. Code
Title 21 - Food and Drugs
Chapter 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT (§§ 301 - 399f)
Front Matter
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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 Front Matter |
| Date | 2012 |
| Laws in Effect as of Date | January 15, 2013 |
| Positive Law | No |
| Disposition | standard |
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Part A—Drugs and Devices
| 351. | Adulterated drugs and devices. |
| 352. | Misbranded drugs and devices. |
| 353. | Exemptions and consideration for certain drugs, devices, and biological products. |
| 353a. | Pharmacy compounding. |
| 353b. | Prereview of television advertisements. |
| 354. | Veterinary feed directive drugs. |
| 355. | New drugs. |
| 355–1. | Risk evaluation and mitigation strategies. |
| 355a. | Pediatric studies of drugs. |
| 355b. | Adverse-event reporting. |
| 355c. | Research into pediatric uses for drugs and biological products. |
| 355c–1. | Report. |
| 355d. | Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers. |
| 355e. | Pharmaceutical security. |
| 355f. | Extension of exclusivity period for new qualified infectious disease products. |
| 356. | Expedited approval of drugs for serious or life-threatening diseases or conditions. |
| 356–1. | Accelerated approval of priority countermeasures. |
| 356a. | Manufacturing changes. |
| 356b. | Reports of postmarketing studies. |
| 356c. | Discontinuance or interruption in the production of life-saving drugs. |
| 356c–1. | Annual reporting on drug shortages. |
| 356d. | Coordination; task force and strategic plan. |
| 356e. | Drug shortage list. |
| 356f. | Hospital repackaging of drugs in shortage. |
| 357. | Repealed. |
| 358. | Authority to designate official names. |
| 359. | Nonapplicability of subchapter to cosmetics. |
| 360. | Registration of producers of drugs or devices. |
| 360a. | Clinical trial guidance for antibiotic drugs. |
| 360a–1. | Clinical trials. |
| 360b. | New animal drugs. |
| 360c. | Classification of devices intended for human use. |
| 360c–1. | Reporting. |
| 360d. | Performance standards. |
| 360e. | Premarket approval. |
| 360e–1. | Pediatric uses of devices. |
| 360f. | Banned devices. |
| 360g. | Judicial review. |
| 360g–1. | Agency documentation and review of significant decisions regarding devices. |
| 360h. | Notification and other remedies. |
| 360h–1. | Program to improve the device recall system. |
| 360i. | Records and reports on devices. |
| 360j. | General provisions respecting control of devices intended for human use. |
| 360k. | State and local requirements respecting devices. |
| 360l. | Postmarket surveillance. |
| 360m. | Accredited persons. |
| 360n. | Priority review to encourage treatments for tropical diseases. |
| 360n–1. | Priority review for qualified infectious disease products. |
Part B—Drugs for Rare Diseases or Conditions
| 360aa. | Recommendations for investigations of drugs for rare diseases or conditions. |
| 360bb. | Designation of drugs for rare diseases or conditions. |
| 360cc. | Protection for drugs for rare diseases or conditions. |
| 360dd. | Open protocols for investigations of drugs for rare diseases or conditions. |
| 360ee. | Grants and contracts for development of drugs for rare diseases and conditions. |
| 360ff. | Priority review to encourage treatments for rare pediatric diseases. |
Part C—Electronic Product Radiation Control
| 360hh. | Definitions. |
| 360ii. | Program of control. |
| 360jj. | Studies by Secretary. |
| 360kk. | Performance standards for electronic products. |
| 360ll. | Notification of defects in and repair or replacement of electronic products. |
| 360mm. | Imports. |
| 360nn. | Inspection, records, and reports. |
| 360oo. | Prohibited acts. |
| 360pp. | Enforcement. |
| 360qq. | Repealed. |
| 360rr. | Federal-State cooperation. |
| 360ss. | State standards. |
Part D—Dissemination of Treatment Information
| 360aaa to 360aaa–6. Omitted |
Part E—General Provisions Relating to Drugs and Devices
| 360bbb. | Expanded access to unapproved therapies and diagnostics. |
| 360bbb–1. | Dispute resolution. |
| 360bbb–2. | Classification of products. |
| 360bbb–3. | Authorization for medical products for use in emergencies. |
| 360bbb–4. | Technical assistance. |
| 360bbb–5. | Critical Path Public-Private Partnerships. |
| 360bbb–6. | Risk communication. |
| 360bbb–7. | Notification. |
| 360bbb–8. | Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments. |
| 360bbb–8a. | Optimizing global clinical trials. |
| 360bbb–8b. | Use of clinical investigation data from outside the United States. |
| 360bbb–8c. | Patient participation in medical product discussion. |
Part F—New Animal Drugs for Minor Use and Minor Species
| 360ccc. | Conditional approval of new animal drugs for minor use and minor species. |
| 360ccc–1. | Index of legally marketed unapproved new animal drugs for minor species. |
| 360ccc–2. | Designated new animal drugs for minor use or minor species. |
Part G—Medical Gases
| 360ddd. | Definitions. |
| 360ddd–1. | Regulation of medical gases. |
| 360ddd–2. | Inapplicability of drug fees to designated medical gases. |
SUBCHAPTER VI—COSMETICS
| 361. | Adulterated cosmetics. |
| 362. | Misbranded cosmetics. |
| 363. | Regulations making exemptions. |
| 364. | Repealed. |
SUBCHAPTER VII—GENERAL AUTHORITY Part A—General Administrative Provisions
| 371. | Regulations and hearings. |
| 372. | Examinations and investigations. |
| 372a. | Transferred. |
| 373. | Records. |
| 374. | Inspection. |
| 374a. | Inspections relating to food allergens. |
| 375. | Publicity. |
| 376. | Examination of sea food on request of packer; marking food with results; fees; penalties. |
| 377. | Revision of United States Pharmacopoeia; development of analysis and mechanical and physical tests. |
| 378. | Advertising of foods. |
| 379. | Confidential information. |
| 379a. | Presumption of existence of jurisdiction. |
| 379b. | Consolidated administrative and laboratory facility. |
| 379c. | Transferred. |
| 379d. | Automation of Food and Drug Administration. |
| 379d–1. | Conflicts of interest. |
| 379d–2. | Policy on the review and clearance of scientific articles published by FDA employees. |
| 379d–3. | Streamlined hiring authority. |
| 379d–4. | Reporting requirements. |
| 379d–5. | Guidance document regarding product promotion using the Internet. |
Part B—Colors
| 379e. | Listing and certification of color additives for foods, drugs, devices, and cosmetics. |
Part C—Fees subpart 1—freedom of information fees
| 379f. | Recovery and retention of fees for freedom of information requests. |
subpart 2—fees relating to drugs
| 379g. | Definitions. |
| 379h. | Authority to assess and use drug fees. |
| 379h–1. | Fees relating to advisory review of prescription-drug television advertising. |
| 379h–2. | Reauthorization; reporting requirements. |
subpart 3—fees relating to devices
| 379i. | Definitions. |
| 379j. | Authority to assess and use device fees. |
| 379j–1. | Reauthorization; reporting requirements. |
subpart 4—fees relating to animal drugs
| 379j–11. | Definitions. |
| 379j–12. | Authority to assess and use animal drug fees. |
| 379j–13. | Reauthorization; reporting requirements. |
subpart 5—fees relating to generic new animal drugs
| 379j–21. | Authority to assess and use generic new animal drug fees. |
| 379j–22. | Reauthorization; reporting requirements. |
subpart 6—fees related to food
| 379j–31. | Authority to collect and use fees. |
subpart 7—fees relating to generic drugs
| 379j–41. | Definitions. |
| 379j–42. | Authority to assess and use human generic drug fees. |
| 379j–43. | Reauthorization; reporting requirements. |
subpart 8—fees relating to biosimilar biological products
| 379j–51. | Definitions. |
| 379j–52. | Authority to assess and use biosimilar biological product fees. |
| 379j–53. | Reauthorization; reporting requirements. |
Part D—Information and Education
| 379k. | Information system. |
| 379k–1. | Electronic format for submissions. |
| 379l. | Education. |
Part E—Environmental Impact Review
| 379o. | Environmental impact. |
Part F—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics
| 379r. | National uniformity for nonprescription drugs. |
| 379s. | Preemption for labeling or packaging of cosmetics. |
Part G—Safety Reports
| 379v. | Safety report disclaimers. |
Part H—Serious Adverse Event Reports
| 379aa. | Serious adverse event reporting for nonprescription drugs. |
| 379aa–1. | Serious adverse event reporting for dietary supplements. |
Part I—Reagan-Udall Foundation for the Food and Drug Administration
| 379dd. | Establishment and functions of the Foundation. |
| 379dd–1. | Location of Foundation. |
| 379dd–2. | Activities of the Food and Drug Administration. |
SUBCHAPTER VIII—IMPORTS AND EXPORTS
| 381. | Imports and exports. |
| 382. | Exports of certain unapproved products. |
| 383. | Office of International Relations. |
| 384. | Importation of prescription drugs. |
| 384a. | Foreign supplier verification program. |
| 384b. | Voluntary qualified importer program. |
| 384c. | Inspection of foreign food facilities. |
| 384d. | Accreditation of third-party auditors. |
| 384e. | Recognition of foreign government inspections. |
SUBCHAPTER IX—TOBACCO PRODUCTS
| 387. | Definitions. |
| 387a. | FDA authority over tobacco products. |
| 387a–1. | Final rule. |
| 387b. | Adulterated tobacco products. |
| 387c. | Misbranded tobacco products. |
| 387d. | Submission of health information to the Secretary. |
| 387e. | Annual registration. |
| 387f. | General provisions respecting control of tobacco products. |
| 387f–1. | Enforcement action plan for advertising and promotion restrictions. |
| 387g. | Tobacco product standards. |
| 387h. | Notification and other remedies. |
| 387i. | Records and reports on tobacco products. |
| 387j. | Application for review of certain tobacco products. |
| 387k. | Modified risk tobacco products. |
| 387l. | Judicial review. |
| 387m. | Equal treatment of retail outlets. |
| 387n. | Jurisdiction of and coordination with the Federal Trade Commission. |
| 387o. | Regulation requirement. |
| 387p. | Preservation of State and local authority. |
| 387q. | Tobacco Products Scientific Advisory Committee. |
| 387r. | Drug products used to treat tobacco dependence. |
| 387s. | User fees. |
| 387t. | Labeling, recordkeeping, records inspection. |
| 387u. | Studies of progress and effectiveness. |
SUBCHAPTER X—MISCELLANEOUS
| 391. | Separability clause. |
| 392. | Exemption of meats and meat food products. |
| 393. | Food and Drug Administration. |
| 393a. | Office of Pediatric Therapeutics. |
| 394. | Scientific review groups. |
| 395. | Loan repayment program. |
| 396. | Practice of medicine. |
| 397. | Contracts for expert review. |
| 398. | Notices to States regarding imported food. |
| 399. | Grants to enhance food safety. |
| 399a. | Office of the Chief Scientist. |
| 399b. | Office of Women's Health. |
| 399c. | Improving the training of State, local, territorial, and tribal food safety officials. |
| 399d. | Employee protections. |
| 399e. | Nanotechnology. |
| 399f. | Ensuring adequate information regarding pharmaceuticals for all populations, particularly underrepresented subpopulations, including racial subgroups. |
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