Federal (United States) · Statute compilation
Chapter V
122 sections
122 sections
- Act of June 25, 1938, ch. V, subch. A, sec. 501 (as amended)adulterated drugs and devices
- Act of June 25, 1938, ch. V, subch. A, sec. 502 (as amended)misbranded drugs and devices
- Act of June 25, 1938, ch. V, subch. A, sec. 503 (as amended)exemptions and consideration for certain drugs, devices, and biological products
- Act of June 25, 1938, ch. V, subch. A, sec. 503A (as amended)PHARMACY COMPOUNDING.
- Act of June 25, 1938, ch. V, subch. A, sec. 503B (as amended)OUTSOURCING FACILITIES.
- Act of June 25, 1938, ch. V, subch. A, sec. 503C (as amended)PREREVIEW OF TELEVISION ADVERTISEMENTS.
- Act of June 25, 1938, ch. V, subch. A, sec. 503D (as amended)PROCESS TO UPDATE LABELING FOR CERTAIN GENERIC DRUGS.
- Act of June 25, 1938, ch. V, subch. A, sec. 504 (as amended)veterinary feed directive drugs
- Act of June 25, 1938, ch. V, subch. A, sec. 505 (as amended)new drugs
- Act of June 25, 1938, ch. V, subch. A, sec. 505–1 (as amended)RISK EVALUATION AND MITIGATION STRATEGIES.
- Act of June 25, 1938, ch. V, subch. A, sec. 505A (as amended)PEDIATRIC STUDIES OF DRUGS.
- Act of June 25, 1938, ch. V, subch. A, sec. 505B (as amended)RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL PRODUCTS.
- Act of June 25, 1938, ch. V, subch. A, sec. 505C (as amended)INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS, AND WAIVERS.
- Act of June 25, 1938, ch. V, subch. A, sec. 505D (as amended)PHARMACEUTICAL SECURITY.
- Act of June 25, 1938, ch. V, subch. A, sec. 505E (as amended)EXTENSION OF EXCLUSIVITY PERIOD FOR NEW QUALIFIED INFECTIOUS DISEASE PRODUCTS.
- Act of June 25, 1938, ch. V, subch. A, sec. 505F (as amended)UTILIZING REAL WORLD EVIDENCE.
- Act of June 25, 1938, ch. V, subch. A, sec. 505G (as amended)REGULATION OF CERTAIN NONPRESCRIPTION DRUGS THAT ARE MARKETED WITHOUT AN APPROVED DRUG APPLICATION.
- Act of June 25, 1938, ch. V, subch. A, sec. 506 (as amended)EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-THREATENING DISEASES OR CONDITIONS.
- Act of June 25, 1938, ch. V, subch. A, sec. 506A (as amended)MANUFACTURING CHANGES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506B (as amended)REPORTS OF POSTMARKETING STUDIES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506C (as amended)DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF LIFE-SAVING DRUGS.
- Act of June 25, 1938, ch. V, subch. A, sec. 506C–1 (as amended)ANNUAL REPORTING ON DRUG SHORTAGES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506D (as amended)COORDINATION; TASK FORCE AND STRATEGIC PLAN.
- Act of June 25, 1938, ch. V, subch. A, sec. 506E (as amended)DRUG SHORTAGE LIST.
- Act of June 25, 1938, ch. V, subch. A, sec. 506F (as amended)HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
- Act of June 25, 1938, ch. V, subch. A, sec. 506G (as amended)STANDARDS FOR REGENERATIVE MEDICINE AND REGENERATIVE ADVANCED THERAPIES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506H (as amended)COMPETITIVE GENERIC THERAPIES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506I (as amended)PROMPT REPORTS OF MARKETING STATUS.
- Act of June 25, 1938, ch. V, subch. A, sec. 506J (as amended)DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION OF MEDICAL DEVICES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506K (as amended)PLATFORM TECHNOLOGIES.
- Act of June 25, 1938, ch. V, subch. A, sec. 506L (as amended)ADVANCED MANUFACTURING TECHNOLOGIES DESIGNATION PROGRAM.
- Act of June 25, 1938, ch. V, subch. A, sec. 507 (as amended)QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
- Act of June 25, 1938, ch. V, subch. A, sec. 508 (as amended)authority to designate official names
- Act of June 25, 1938, ch. V, subch. A, sec. 509 (as amended)nonapplicability to cosmetics
- Act of June 25, 1938, ch. V, subch. A, sec. 510 (as amended)
- Act of June 25, 1938, ch. V, subch. A, sec. 511 (as amended)CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.
- Act of June 25, 1938, ch. V, subch. A, sec. 511A (as amended)SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR MICROORGANISMS.
- Act of June 25, 1938, ch. V, subch. A, sec. 512 (as amended)new animal drugs
- Act of June 25, 1938, ch. V, subch. A, sec. 512A (as amended)PRIORITY ZOONOTIC ANIMAL DRUGS.
- Act of June 25, 1938, ch. V, subch. A, sec. 513 (as amended)classification of devices intended for human use
- Act of June 25, 1938, ch. V, subch. A, sec. 514 (as amended)performance standards
- Act of June 25, 1938, ch. V, subch. A, sec. 515 (as amended)premarket approval
- Act of June 25, 1938, ch. V, subch. A, sec. 515A (as amended)PEDIATRIC USES OF DEVICES.
- Act of June 25, 1938, ch. V, subch. A, sec. 515B (as amended)BREAKTHROUGH DEVICES.
- Act of June 25, 1938, ch. V, subch. A, sec. 515C (as amended)PREDETERMINED CHANGE CONTROL PLANS FOR DEVICES.
- Act of June 25, 1938, ch. V, subch. A, sec. 516 (as amended)banned devices
- Act of June 25, 1938, ch. V, subch. A, sec. 517 (as amended)judicial review
- Act of June 25, 1938, ch. V, subch. A, sec. 517A (as amended)AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT DECISIONS REGARDING DEVICES.
- Act of June 25, 1938, ch. V, subch. A, sec. 518 (as amended)notification and other remedies
- Act of June 25, 1938, ch. V, subch. A, sec. 518A (as amended)PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.
- Act of June 25, 1938, ch. V, subch. A, sec. 519 (as amended)records and reports on devices
- Act of June 25, 1938, ch. V, subch. A, sec. 520 (as amended)general provisions respecting control of devices intended for human use
- Act of June 25, 1938, ch. V, subch. A, sec. 521 (as amended)state and local requirements respecting devices
- Act of June 25, 1938, ch. V, subch. A, sec. 522 (as amended)POSTMARKET SURVEILLANCE.
- Act of June 25, 1938, ch. V, subch. A, sec. 523 (as amended)ACCREDITED PERSONS.
- Act of June 25, 1938, ch. V, subch. A, sec. 524 (as amended)PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL DISEASES.
- Act of June 25, 1938, ch. V, subch. A, sec. 524A (as amended)PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE PRODUCTS.
- Act of June 25, 1938, ch. V, subch. A, sec. 524B (as amended)ENSURING CYBERSECURITY OF DEVICES.
- Act of June 25, 1938, ch. V, subch. B, sec. 525 (as amended)recommendations for investigations of drugs for rare diseases or conditions
- Act of June 25, 1938, ch. V, subch. B, sec. 526 (as amended)designation of drugs for rare diseases or conditions
- Act of June 25, 1938, ch. V, subch. B, sec. 527 (as amended)protection for drugs for rare diseases or conditions
- Act of June 25, 1938, ch. V, subch. B, sec. 528 (as amended)open protocols for investigations of drugs for rare diseases or conditions
- Act of June 25, 1938, ch. V, subch. B, sec. 529 (as amended)PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.
- Act of June 25, 1938, ch. V, subch. B, sec. 529A (as amended)TARGETED DRUGS FOR RARE DISEASES.
- Act of June 25, 1938, ch. V, subch. C, sec. 531 (as amended)definitions
- Act of June 25, 1938, ch. V, subch. C, sec. 532 (as amended)electronic product radiation control program
- Act of June 25, 1938, ch. V, subch. C, sec. 533 (as amended)studies by the secretary
- Act of June 25, 1938, ch. V, subch. C, sec. 534 (as amended)performance standards for electronic products
- Act of June 25, 1938, ch. V, subch. C, sec. 535 (as amended)notification of defects in, and repair or replacement of, electronic products
- Act of June 25, 1938, ch. V, subch. C, sec. 536 (as amended)imports
- Act of June 25, 1938, ch. V, subch. C, sec. 537 (as amended)inspection and reports
- Act of June 25, 1938, ch. V, subch. C, sec. 538 (as amended)prohibited acts
- Act of June 25, 1938, ch. V, subch. C, sec. 539 (as amended)enforcement
- Act of June 25, 1938, ch. V, subch. C, sec. 541 (as amended)federal-state cooperation
- Act of June 25, 1938, ch. V, subch. C, sec. 542 (as amended)effect on state standards
- Act of June 25, 1938, ch. V, subch. D, sec. 551 (as amended)REQUIREMENTS FOR DISSEMINATION OF TREATMENT INFORMATION ON DRUGS OR DEVICES.
- Act of June 25, 1938, ch. V, subch. D, sec. 552 (as amended)INFORMATION AUTHORIZED TO BE DISSEMINATED.
- Act of June 25, 1938, ch. V, subch. D, sec. 553 (as amended)ESTABLISHMENT OF LIST OF ARTICLES AND PUBLICATIONS DISSEMINATED AND LIST OF PROVIDERS THAT RECEIVED ARTICLES AND REFERENCE PUBLICATIONS.
- Act of June 25, 1938, ch. V, subch. D, sec. 554 (as amended)REQUIREMENT REGARDING SUBMISSION OF SUPPLEMENTAL APPLICATION FOR NEW USE; EXEMPTION FROM REQUIREMENT.
- Act of June 25, 1938, ch. V, subch. D, sec. 555 (as amended)CORRECTIVE ACTIONS; CESSATION OF DISSEMINATION.
- Act of June 25, 1938, ch. V, subch. D, sec. 556 (as amended)DEFINITIONS.
- Act of June 25, 1938, ch. V, subch. D, sec. 557 (as amended)RULES OF CONSTRUCTION.
- Act of June 25, 1938, ch. V, subch. E, sec. 561 (as amended)EXPANDED ACCESS TO UNAPPROVED THERAPIES AND DIAGNOSTICS.
- Act of June 25, 1938, ch. V, subch. E, sec. 561A (as amended)EXPANDED ACCESS POLICY REQUIRED FOR INVESTIGATIONAL DRUGS.
- Act of June 25, 1938, ch. V, subch. E, sec. 561B (as amended)INVESTIGATIONAL DRUGS FOR USE BY ELIGIBLE PATIENTS.
- Act of June 25, 1938, ch. V, subch. E, sec. 562 (as amended)DISPUTE RESOLUTION.
- Act of June 25, 1938, ch. V, subch. E, sec. 563 (as amended)CLASSIFICATION OF PRODUCTS.
- Act of June 25, 1938, ch. V, subch. E, sec. 564 (as amended)AUTHORIZATION FOR MEDICAL PRODUCTS FOR USE IN EMERGENCIES.
- Act of June 25, 1938, ch. V, subch. E, sec. 564A (as amended)EMERGENCY USE OF MEDICAL PRODUCTS.
- Act of June 25, 1938, ch. V, subch. E, sec. 564B (as amended)PRODUCTS HELD FOR EMERGENCY USE.
- Act of June 25, 1938, ch. V, subch. E, sec. 565 (as amended)COUNTERMEASURE DEVELOPMENT, REVIEW, AND TECHNICAL ASSISTANCE.
- Act of June 25, 1938, ch. V, subch. E, sec. 565A (as amended)PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR AGENTS THAT PRESENT NATIONAL SECURITY THREATS.
- Act of June 25, 1938, ch. V, subch. E, sec. 565B (as amended)MEDICAL COUNTERMEASURE MASTER FILES.
- Act of June 25, 1938, ch. V, subch. E, sec. 566 (as amended)CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.
- Act of June 25, 1938, ch. V, subch. E, sec. 566A (as amended)EMERGING TECHNOLOGY PROGRAM.
- Act of June 25, 1938, ch. V, subch. E, sec. 567 (as amended)RISK COMMUNICATION.
- Act of June 25, 1938, ch. V, subch. E, sec. 568 (as amended)NOTIFICATION.
- Act of June 25, 1938, ch. V, subch. E, sec. 569 (as amended)CONSULTATION WITH EXTERNAL EXPERTS ON RARE DISEASES, TARGETED THERAPIES, AND GENETIC TARGETING OF TREATMENTS.
- Act of June 25, 1938, ch. V, subch. E, sec. 569A (as amended)OPTIMIZING GLOBAL CLINICAL TRIALS.
- Act of June 25, 1938, ch. V, subch. E, sec. 569B (as amended)USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE THE UNITED STATES.