Food and Drug Administration Modernization Act of 1997

Pub. L. 105–115

72 sections of the Code credited to this law, found between Public Law 104-333 and Public Law 105-153.

• 21 U.S.C. § 321 — Definitions; generally
• 21 U.S.C. § 331 — Prohibited acts
• 21 U.S.C. § 334 — Seizure
• 21 U.S.C. § 335a — Debarment, temporary denial of approval, and suspension
• 21 U.S.C. § 343 — Misbranded food
• 21 U.S.C. § 343-3 — 343–3. Disclosure
• 21 U.S.C. § 348 — Food additives
• 21 U.S.C. § 351 — Adulterated drugs and devices
• 21 U.S.C. § 352 — Misbranded drugs and devices
• 21 U.S.C. § 353 — Exemptions and consideration for certain drugs, devices, and biological products
• 21 U.S.C. § 353a — Pharmacy compounding
• 21 U.S.C. § 355 — New drugs
• 21 U.S.C. § 355a — Pediatric studies of drugs
• 21 U.S.C. § 356 — Fast track products
• 21 U.S.C. § 356a — Manufacturing changes
• 21 U.S.C. § 356b — Reports of postmarketing studies
• 21 U.S.C. § 356c — Discontinuance of life saving product
• 21 U.S.C. § 360 — Registration of producers of drugs or devices
• 21 U.S.C. § 360b — New animal drugs
• 21 U.S.C. § 360c — Classification of devices intended for human use
• 21 U.S.C. § 360d — Performance standards
• 21 U.S.C. § 360e — Premarket approval
• 21 U.S.C. § 360g — Judicial review
• 21 U.S.C. § 360i — Records and reports on devices
• 21 U.S.C. § 360j — General provisions respecting control of devices intended for human use
• 21 U.S.C. § 360l — Postmarket surveillance
• 21 U.S.C. § 360m — Accredited persons
• 21 U.S.C. § 360aa — Recommendations for investigations of drugs for rare diseases or conditions
• 21 U.S.C. § 360bb — Designation of drugs for rare diseases or conditions
• 21 U.S.C. § 360cc — Protection for drugs for rare diseases or conditions
• 21 U.S.C. § 360ee — Grants and contracts for development of drugs for rare diseases and conditions
• 21 U.S.C. § 360aaa — Requirements for dissemination of treatment information on drugs or devices
• 21 U.S.C. § 360aaa-1 — 360aaa–1. Information authorized to be disseminated
• 21 U.S.C. § 360aaa-2 — 360aaa–2. Establishment of list of articles and publications disseminated and list of providers that received articles and reference publications
• 21 U.S.C. § 360aaa-3 — 360aaa–3. Requirement regarding submission of supplemental application for new use; exemption from requirement
• 21 U.S.C. § 360aaa-4 — 360aaa–4. Corrective actions; cessation of dissemination
• 21 U.S.C. § 360aaa-5 — 360aaa–5. Definitions
• 21 U.S.C. § 360aaa-6 — 360aaa–6. Rules of construction
• 21 U.S.C. § 360bbb — Expanded access to unapproved therapies and diagnostics
• 21 U.S.C. § 360bbb-1 — 360bbb–1. Dispute resolution
• 21 U.S.C. § 360bbb-2 — 360bbb–2. Classification of products
• 21 U.S.C. § 371 — Regulations and hearings
• 21 U.S.C. § 374 — Inspection
• 21 U.S.C. § 379a — Presumption of existence of jurisdiction
• 21 U.S.C. § 379g — Definitions
• 21 U.S.C. § 379h — Authority to assess and use drug fees
• 21 U.S.C. § 379k — Information system
• 21 U.S.C. § 379l — Education
• 21 U.S.C. § 379o — Environmental impact
• 21 U.S.C. § 379r — National uniformity for nonprescription drugs
• 21 U.S.C. § 379s — Preemption for labeling or packaging of cosmetics
• 21 U.S.C. § 379v — Safety report disclaimers
• 21 U.S.C. § 381 — Imports and exports
• 21 U.S.C. § 382 — Exports of certain unapproved products
• 21 U.S.C. § 383 — Office of International Relations
• 21 U.S.C. § 393 — Food and Drug Administration
• 21 U.S.C. § 396 — Practice of medicine
• 21 U.S.C. § 397 — Contracts for expert review
• 21 U.S.C. § 802 — Definitions
• 26 U.S.C. § 45C — Clinical testing expenses for certain drugs for rare diseases or conditions
• 35 U.S.C. § 156 — Extension of patent term
• 38 U.S.C. § 8126 — Limitation on prices of drugs procured by Department and certain other Federal agencies
• 42 U.S.C. § 247b-8 — 247b–8. Fellowship and training programs
• 42 U.S.C. § 262 — Regulation of biological products
• 42 U.S.C. § 263a — Certification of laboratories
• 42 U.S.C. § 282 — Director of National Institutes of Health
• 42 U.S.C. § 299a-3 — 299a–3. Demonstration program regarding centers for education and research on therapeutics
• 21 U.S.C. § 343–3 — Disclosure
• 21 U.S.C. §§ 360aaa to 360aaa–6 — Omitted
• 21 U.S.C. § 360bbb–1 — Dispute resolution
• 21 U.S.C. § 360bbb–2 — Classification of products
• 42 U.S.C. § 247b–8 — Fellowship and training programs