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...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