US Code

Public Law 119-87 (04/30/2026)

Part A Drugs and Devices

Browse 0 units and 67 sections in Part A Drugs and Devices of Title 21.

Sections in Part A

§ 351 Adulterated drugs and devices § 352 Misbranded drugs and devices § 353 Exemptions and consideration for certain drugs, devices, and biological products § 353a Pharmacy compounding § 353a–1 Enhanced communication § 353b Outsourcing facilities § 353c Prereview of television advertisements § 353d Process to update labeling for certain generic drugs § 354 Veterinary feed directive drugs § 355 New drugs § 355–1 Risk evaluation and mitigation strategies § 355–2 Actions for delays of generic drugs and biosimilar biological products § 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 § 355g Utilizing real world evidence § 355h Regulation of certain nonprescription drugs that are marketed without an approved drug application § 356 Expedited approval of drugs for serious or life-threatening diseases or conditions § 356–1 Accelerated approval of priority countermeasures § 356–2 Accelerated approval Council § 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 § 356g Standards for regenerative medicine and regenerative advanced therapies § 356h Competitive generic therapies § 356i Prompt reports of marketing status § 356j Discontinuance or interruption in the production of medical devices § 356k Platform technologies § 356l Advanced manufacturing technologies designation program § 357 Qualification of drug development tools § 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 § 360a–2 Susceptibility test interpretive criteria for microorganisms § 360b New animal drugs § 360b–1 Priority zoonotic 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 § 360e–3 Breakthrough devices § 360e–4 Predetermined change control plans for devices § 360f Banned devices § 360g Judicial review § 360g–1 Agency documentation and review of significant decisions regarding devices § 360g–2 Third party data transparency § 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 § 360n–2 Ensuring cybersecurity of devices