Front Matter
*Title 1—General Provisions
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Title 2—The Congress
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*Title 3—The President
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*Title 4—Flag And Seal, Seat Of Government, And The States
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*Title 5—Government Organization And Employees
; and
Appendix
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Title 6—Domestic Security
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Title 7—Agriculture
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Title 8—Aliens And Nationality
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*Title 9—Arbitration
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*Title 10—Armed Forces
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*Title 11—Bankruptcy
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Appendix
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Title 12—Banks And Banking
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*Title 13—Census
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*Title 14—Coast Guard
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Title 15—Commerce And Trade
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Title 16—Conservation
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*Title 17—Copyrights
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*Title 18—Crimes And Criminal Procedure
; and
Appendix
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Title 19—Customs Duties
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Title 20—Education
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Title 21—Food And Drugs
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TITLE 21—Front Matter
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CHAPTER 1—ADULTERATED OR MISBRANDED FOODS OR DRUGS
(sections 1 to 26)
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CHAPTER 2—TEAS
(sections 41 to 50)
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CHAPTER 3—FILLED MILK
(sections 61 to 64)
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CHAPTER 4—ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS
(sections 71 to 149)
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CHAPTER 5—VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS PRODUCTS
(sections 151 to 159)
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CHAPTER 5A—BUREAU OF NARCOTICS
(sections 161 to 165)
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CHAPTER 6—NARCOTIC DRUGS
(sections 171 to 200b)
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CHAPTER 7—PRACTICE OF PHARMACY AND SALE OF POISONS IN CONSULAR DISTRICTS IN CHINA
(sections 201 to 215)
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CHAPTER 8—NARCOTIC FARMS
(sections 221 to 237)
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CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT
(sections 321 to 399i)
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CHAPTER 9—Front Matter
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SUBCHAPTER I—SHORT TITLE
(section 301)
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SUBCHAPTER II—DEFINITIONS
(sections 321 to 321d)
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SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES
(sections 331 to 337a)
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SUBCHAPTER IV—FOOD
(sections 341 to 350m)
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SUBCHAPTER V—DRUGS AND DEVICES
(sections 351 to 360fff-8)
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SUBCHAPTER V—Front Matter
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Part A—Drugs and Devices
(sections 351 to 360n-2)
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Part A—Front Matter
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Sec. 351. Adulterated drugs and devices
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Sec. 352. Misbranded drugs and devices
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Sec. 353. Exemptions and consideration for certain drugs, devices, and biological products
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Sec. 353a. Pharmacy compounding
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Sec. 353a-1. Enhanced communication
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Sec. 353b. Outsourcing facilities
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Sec. 353c. Prereview of television advertisements
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Sec. 353d. Process to update labeling for certain generic drugs
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Sec. 354. Veterinary feed directive drugs
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Sec. 355. New drugs
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Sec. 355-1. Risk evaluation and mitigation strategies
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Sec. 355-2. Actions for delays of generic drugs and biosimilar biological products
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Sec. 355a. Pediatric studies of drugs
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Sec. 355b. Adverse-event reporting
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Sec. 355c. Research into pediatric uses for drugs and biological products
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Sec. 355c-1. Report
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Sec. 355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
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Sec. 355e. Pharmaceutical security
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Sec. 355f. Extension of exclusivity period for new qualified infectious disease products
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Sec. 355g. Utilizing real world evidence
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Sec. 355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application
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Sec. 356. Expedited approval of drugs for serious or life-threatening diseases or conditions
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Sec. 356-1. Accelerated approval of priority countermeasures
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Sec. 356-2. Accelerated approval Council
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Sec. 356a. Manufacturing changes
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Sec. 356b. Reports of postmarketing studies
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Sec. 356c. Discontinuance or interruption in the production of life-saving drugs
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Sec. 356c-1. Annual reporting on drug shortages
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Sec. 356d. Coordination; task force and strategic plan
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Sec. 356e. Drug shortage list
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Sec. 356f. Hospital repackaging of drugs in shortage
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Sec. 356g. Standards for regenerative medicine and regenerative advanced therapies
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Sec. 356h. Competitive generic therapies
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Sec. 356i. Prompt reports of marketing status
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Sec. 356j. Discontinuance or interruption in the production of medical devices
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Sec. 356k. Platform technologies
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Sec. 356l. Advanced manufacturing technologies designation program
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Sec. 357. Qualification of drug development tools
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Sec. 358. Authority to designate official names
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Sec. 359. Nonapplicability of subchapter to cosmetics
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Sec. 360. Registration of producers of drugs or devices
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Sec. 360a. Clinical trial guidance for antibiotic drugs
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Sec. 360a-1. Clinical trials
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Sec. 360a-2. Susceptibility test interpretive criteria for microorganisms
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Sec. 360b. New animal drugs
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Sec. 360b-1. Priority zoonotic animal drugs
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Sec. 360c. Classification of devices intended for human use
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Sec. 360c-1. Reporting
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Sec. 360d. Performance standards
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Sec. 360e. Premarket approval
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Sec. 360e-1. Pediatric uses of devices
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Sec. 360e-3. Breakthrough devices
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Sec. 360e-4. Predetermined change control plans for devices
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Sec. 360f. Banned devices
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Sec. 360g. Judicial review
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Sec. 360g-1. Agency documentation and review of significant decisions regarding devices
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Sec. 360g-2. Third party data transparency
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Sec. 360h. Notification and other remedies
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Sec. 360h-1. Program to improve the device recall system
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Sec. 360i. Records and reports on devices
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Sec. 360j. General provisions respecting control of devices intended for human use
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Sec. 360k. State and local requirements respecting devices
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Sec. 360l. Postmarket surveillance
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Sec. 360m. Accredited persons
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Sec. 360n. Priority review to encourage treatments for tropical diseases
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Sec. 360n-1. Priority review for qualified infectious disease products
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Sec. 360n-2. Ensuring cybersecurity of devices
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Part B—Drugs for Rare Diseases or Conditions
(sections 360aa to 360ff-1)
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Part C—Electronic Product Radiation Control
(sections 360hh to 360ss)
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Part D—Dissemination of Treatment Information
(sections 360aaa to 360aaa-6)
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Part E—General Provisions Relating to Drugs and Devices
(sections 360bbb to 360bbb-8d)
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Part F—New Animal Drugs for Minor Use and Minor Species
(sections 360ccc to 360ccc-2)
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Part G—Medical Gases
(sections 360ddd to 360ddd-2)
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Part H—Pharmaceutical Distribution Supply Chain
(sections 360eee to 360eee-4)
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Part I—Nonprescription Sunscreen and Other Active Ingredients
(sections 360fff to 360fff-8)
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SUBCHAPTER VI—COSMETICS
(sections 361 to 364j)
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SUBCHAPTER VII—GENERAL AUTHORITY
(sections 371 to 379dd-2)
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SUBCHAPTER VIII—IMPORTS AND EXPORTS
(sections 381 to 384g)
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SUBCHAPTER IX—TOBACCO PRODUCTS
(sections 387 to 387v)
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SUBCHAPTER X—MISCELLANEOUS
(sections 391 to 399i)
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CHAPTER 10—POULTRY AND POULTRY PRODUCTS INSPECTION
(sections 451 to 473)
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CHAPTER 11—MANUFACTURE OF NARCOTIC DRUGS
(sections 501 to 517)
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CHAPTER 12—MEAT INSPECTION
(sections 601 to 695)
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CHAPTER 13—DRUG ABUSE PREVENTION AND CONTROL
(sections 801 to 971)
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CHAPTER 14—ALCOHOL AND DRUG ABUSE EDUCATIONAL PROGRAMS AND ACTIVITIES
(sections 1001 to 1007)
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CHAPTER 15—EGG PRODUCTS INSPECTION
(sections 1031 to 1056)
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CHAPTER 16—DRUG ABUSE PREVENTION, TREATMENT, AND REHABILITATION
(sections 1101 to 1194)
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CHAPTER 17—NATIONAL DRUG ENFORCEMENT POLICY
(sections 1201 to 1204)
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CHAPTER 18—PRESIDENT'S MEDIA COMMISSION ON ALCOHOL AND DRUG ABUSE PREVENTION
(sections 1301 to 1308)
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CHAPTER 19—PESTICIDE MONITORING IMPROVEMENTS
(sections 1401 to 1403)
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CHAPTER 20—NATIONAL DRUG CONTROL PROGRAM
(sections 1501 to 1536)
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CHAPTER 21—BIOMATERIALS ACCESS ASSURANCE
(sections 1601 to 1606)
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CHAPTER 22—NATIONAL DRUG CONTROL POLICY
(sections 1701 to 1715)
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CHAPTER 23—NATIONAL YOUTH ANTI-DRUG MEDIA CAMPAIGN
(sections 1801 to 1804)
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CHAPTER 24—INTERNATIONAL NARCOTICS TRAFFICKING
(sections 1901 to 1908)
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CHAPTER 25—MISCELLANEOUS ANTI-DRUG ABUSE PROVISIONS
(sections 2001 to 2014)
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CHAPTER 26—FOOD SAFETY
(sections 2101 to 2110)
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CHAPTER 27—FOOD SAFETY MODERNIZATION
(sections 2201 to 2252)
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CHAPTER 28—SANCTIONS WITH RESPECT TO FOREIGN TRAFFICKERS OF ILLICIT SYNTHETIC OPIOIDS
(sections 2301 to 2335)
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CHAPTER 28A—FENTANYL ERADICATION AND NARCOTICS DETERRENCE OFF FENTANYL
(sections 2341 to 2355)
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CHAPTER 29—INTERNATIONAL SPORTS DOPING
(sections 2401 to 2404)
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Title 22—Foreign Relations And Intercourse
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*Title 23—Highways
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Title 24—Hospitals And Asylums
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Title 25—Indians
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Title 26—Internal Revenue Code
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Title 27—Intoxicating Liquors
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*Title 28—Judiciary And Judicial Procedure
; and
Appendix
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Title 29—Labor
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Title 30—Mineral Lands And Mining
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*Title 31—Money And Finance
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*Title 32—National Guard
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Title 33—Navigation And Navigable Waters
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Title 34—Crime Control And Law Enforcement
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*Title 35—Patents
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*Title 36—Patriotic And National Observances, Ceremonies, And Organizations
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*Title 37—Pay And Allowances Of The Uniformed Services
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*Title 38—Veterans' Benefits
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*Title 39—Postal Service
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*Title 40—Public Buildings, Property, And Works
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*Title 41—Public Contracts
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Title 42—The Public Health And Welfare
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Title 43—Public Lands
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*Title 44—Public Printing And Documents
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Title 45—Railroads
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*Title 46—Shipping
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Title 47—Telecommunications
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Title 48—Territories And Insular Possessions
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*Title 49—Transportation
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Title 50—War And National Defense
; and
Appendix
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*Title 51—National And Commercial Space Programs
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Title 52—Voting And Elections
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Title 53—[Reserved]
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*Title 54—National Park Service And Related Programs
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Popular Names and Tables
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