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FD&C Act Chapter V: Drugs and Devices | FDA
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class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act" title="Federal Food, Drug, and Cosmetic Act (FD&C Act)"> Federal Food, Drug, and Cosmetic Act (FD&C Act) </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-14" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <h1 class="content-title text-center">FD&C Act Chapter V: Drugs and Devices</h1> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <div class="callout"> <p>To search the FD&C Act on the Law Revision Counsel website, you may either <a href="http://uscode.house.gov/browse.xhtml" target="_blank">search by U.S. code section number </a>or <a href="http://uscode.house.gov/browse/prelim@title21&edition=prelim" target="_blank">browse the Title 21 section listing</a>.</p> </div> <ul type="disc"> <li><a href="#Part_A">Part A - Drugs and Devices (sections 351 - 360n-1)</a></li> <li><a href="#Part_B">Part B - Drugs for Rare Diseases or Conditions (sections 360aa - 360ff)</a></li> <li><a href="#Part_C">Part C - Electronic Product Radiation Control (sections 360hh - 360ss)</a></li> <li><a href="#Part_D">Part D - Dissemination of Treatment Information (sections 360aaa - 360aaa-6)</a></li> <li><a href="#Part_E">Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-8c)</a></li> <li><a href="#Part_F">Part F - New Animal Drugs for Minor Use and Minor Species (sections 360ccc - 360ccc-2)</a></li> <li><a href="#part_g">Part G - Medical Gases (sections 360ddd to 360ddd-2)</a></li> <li><a href="#part_h">Part H - Pharmaceutical Distribution Supply Chain (sections 360eee to 360eee-4) </a></li> <li><a href="#part_i">Part I - Nonprescription Sunscreen and Other Active Ingredients (sections 360fff to 360fff-7) </a></li> </ul> <h4><a name="Part_A"></a>Part A - Drugs and Devices (sections 351 - 360n-1)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td>Sec. 501</td> <td>Sec. 351 - Adulterated drugs and devices</td> </tr> <tr> <td>Sec. 502</td> <td>Sec. 352 - Misbranded drugs and devices</td> </tr> <tr> <td>Sec. 503</td> <td>Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products</td> </tr> <tr> <td>Sec. 503A</td> <td>Sec. 353a - Pharmacy compounding</td> </tr> <tr> <td>Sec. 503A-1</td> <td>Sec. 353a-1 - Enhanced Communication</td> </tr> <tr> <td>Sec. 503B</td> <td>Sec. 353b - Outsourcing facilities</td> </tr> <tr> <td>Sec. 503C</td> <td>Sec. 353c - Prereview of television advertisements</td> </tr> <tr> <td>Sec. 504</td> <td>Sec. 354 - Veterinary feed directive drugs</td> </tr> <tr> <td>Sec. 505</td> <td>Sec. 355 - New drugs</td> </tr> <tr> <td> </td> <td>Sec. 355-1 - Risk evaluation and mitigation strategies</td> </tr> <tr> <td>Sec. 505A</td> <td>Sec. 355a - Pediatric studies of drugs</td> </tr> <tr> <td> </td> <td>Sec. 355b - Adverse-event reporting</td> </tr> <tr> <td>Sec. 505B</td> <td>Sec. 355c - Research into pediatric uses for drugs and biological products</td> </tr> <tr> <td> </td> <td>Sec. 355c-1 - Report</td> </tr> <tr> <td>Sec. 505C</td> <td>Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers</td> </tr> <tr> <td>Sec. 505D</td> <td>Sec. 355e - Pharmaceutical security</td> </tr> <tr> <td>Sec. 506</td> <td>Sec. 356 - Fast track products</td> </tr> <tr> <td> </td> <td>Sec. 355f - Extension of exclusivity period for new qualified infectious disease products</td> </tr> <tr> <td> </td> <td>Sec. 356. Expedited approval of drugs for serious or life-threatening diseases or conditions</td> </tr> <tr> <td> </td> <td>Sec. 356-1 - Accelerated approval of priority countermeasures</td> </tr> <tr> <td>Sec. 506A</td> <td>Sec. 356a - Manufacturing changes</td> </tr> <tr> <td>Sec. 506B</td> <td>Sec. 356b - Reports of postmarketing studies</td> </tr> <tr> <td>Sec. 506C</td> <td>Sec. 356c - Discontinuance or interruption in the production of life-saving drugs</td> </tr> <tr> <td> </td> <td>Sec. 356c-1 - Annual reporting on drug shortages</td> </tr> <tr> <td> </td> <td>Sec. 356d - Coordination; task force and strategic plan</td> </tr> <tr> <td> </td> <td>Sec. 356e - Drug shortage list</td> </tr> <tr> <td> </td> <td>Sec. 356f - Hospital repackaging of drugs in shortage</td> </tr> <tr> <td> </td> <td>Sec. 357 - Repealed. Pub. L. 105-115, title I, 搂125(b)(1), Nov. 21, 1997, 111 Stat. 2325</td> </tr> <tr> <td>Sec. 508</td> <td>Sec. 358 - Authority to designate official names</td> </tr> <tr> <td>Sec. 509</td> <td>Sec. 359 - Nonapplicability of subchapter to cosmetics</td> </tr> <tr> <td>Sec. 510</td> <td>Sec. 360 - Registration of producers of drugs or devices</td> </tr> <tr> <td>Sec. 511</td> <td>Sec. 360a - Clinical trial guidance for antibiotic drugs</td> </tr> <tr> <td> </td> <td>Sec. 360a-1 - Clinical trials</td> </tr> <tr> <td>Sec. 512</td> <td>Sec. 360b - New animal drugs</td> </tr> <tr> <td>Sec. 513</td> <td>Sec. 360c - Classification of devices intended for human use</td> </tr> <tr> <td> </td> <td>Sec. 360c-1 - Reporting</td> </tr> <tr> <td>Sec. 514</td> <td>Sec. 360d - Performance standards</td> </tr> <tr> <td>Sec. 515</td> <td>Sec. 360e - Premarket approval</td> </tr> <tr> <td>Sec. 515A</td> <td>Sec. 360e-1 - Pediatric uses of devices</td> </tr> <tr> <td>Sec. 516</td> <td>Sec. 360f - Banned devices</td> </tr> <tr> <td>Sec. 517</td> <td>Sec. 360g - Judicial review</td> </tr> <tr> <td> </td> <td>Sec. 360g-1. Agency documentation and review of significant decisions regarding devices</td> </tr> <tr> <td>Sec. 518</td> <td>Sec. 360h - Notification and other remedies</td> </tr> <tr> <td> </td> <td>Sec. 360h-1. Program to improve the device recall system</td> </tr> <tr> <td>Sec. 519</td> <td>Sec. 360i - Records and reports on devices</td> </tr> <tr> <td>Sec. 520</td> <td>Sec. 360j - General provisions respecting control of devices intended for human use</td> </tr> <tr> <td>Sec. 521</td> <td>Sec. 360k - State and local requirements respecting devices</td> </tr> <tr> <td>Sec. 522</td> <td>Sec. 360l - Postmarket surveillance</td> </tr> <tr> <td>Sec. 523</td> <td>Sec. 360m - Accredited persons</td> </tr> <tr> <td>Sec. 524</td> <td>Sec. 360n - Priority review to encourage treatments for tropical diseases</td> </tr> <tr> <td> </td> <td>Sec. 360n-1. Priority review for qualified infectious disease products</td> </tr> </tbody> </table> </div> <h4><a name="Part_B"></a>Part B - Drugs for Rare Diseases or Conditions (sections 360aa - 360ff)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td>Sec. 525</td> <td>Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditions</td> </tr> <tr> <td>Sec. 526</td> <td>Sec. 360bb - Designation of drugs for rare diseases or conditions</td> </tr> <tr> <td>Sec. 527</td> <td>Sec. 360cc - Protection for drugs for rare diseases or conditions</td> </tr> <tr> <td>Sec. 528</td> <td>Sec. 360dd - Open protocols for investigations of drugs for rare diseases or conditions</td> </tr> <tr> <td> </td> <td>Sec. 360ee - Grants and contracts for development of drugs for rare diseases and conditions</td> </tr> <tr> <td> </td> <td>Sec. 360ff - Priority review to encourage treatments for rare pediatric diseases</td> </tr> </tbody> </table> </div> <h4><a name="Part_C"></a>Part C - Electronic Product Radiation Control (sections 360hh - 360ss)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td>Sec. 531</td> <td>Sec. 360hh - Definitions</td> </tr> <tr> <td>Sec. 532</td> <td>Sec. 360ii - Program of control</td> </tr> <tr> <td>Sec. 533</td> <td>Sec. 360jj - Studies by Secretary</td> </tr> <tr> <td>Sec. 534</td> <td>Sec. 360kk - Performance standards for electronic products</td> </tr> <tr> <td>Sec. 535</td> <td>Sec. 360ll - Notification of defects in and repair or replacement of electronic products</td> </tr> <tr> <td>Sec. 536</td> <td>Sec. 360mm - Imports</td> </tr> <tr> <td>Sec. 537</td> <td>Sec. 360nn - Inspection, records, and reports</td> </tr> <tr> <td>Sec. 538</td> <td>Sec. 360oo - Prohibited acts</td> </tr> <tr> <td>Sec. 539</td> <td>Sec. 360pp - Enforcement</td> </tr> <tr> <td> </td> <td>Sec. 360qq - Repealed. Pub. L. 105-362, title VI, 搂601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285</td> </tr> <tr> <td>Sec. 541</td> <td>Sec. 360rr - Federal-State cooperation</td> </tr> <tr> <td>Sec. 542</td> <td>Sec. 360ss - State standards</td> </tr> </tbody> </table> </div> <h4><a name="Part_D"></a>Part D - Dissemination of Treatment Information (sections 360aaa - 360aaa-6)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td> </td> <td>Secs. 360aaa to 360aaa-6 - Omitted</td> </tr> </tbody> </table> </div> <h4><a name="Part_E"></a>Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-8c)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td>Sec. 561</td> <td>Sec. 360bbb - Expanded access to unapproved therapies and diagnostics</td> </tr> <tr> <td>Sec. 652</td> <td>Sec. 360bbb-1 - Dispute resolution</td> </tr> <tr> <td>Sec. 563</td> <td>Sec. 360bbb-2 - Classification of products</td> </tr> <tr> <td>Sec. 564</td> <td>Sec. 360bbb-3 - Authorization for medical products for use in emergencies</td> </tr> <tr> <td> </td> <td>Sec. 360bbb-3a - Emergency use of medical products</td> </tr> <tr> <td> </td> <td>Sec. 360bbb-3b - Products held for emergency use</td> </tr> <tr> <td>Sec. 565</td> <td>Sec. 360bbb-4 - Countermeasure development, review, and technical assistance</td> </tr> <tr> <td>Sec. 566</td> <td>Sec. 360bbb-5 - Critical Path Public-Private Partnerships</td> </tr> <tr> <td>Sec. 567</td> <td>Sec. 360bbb-6 - Risk communication</td> </tr> <tr> <td> </td> <td>Sec. 360bbb-7 - Notification</td> </tr> <tr> <td> </td> <td>Sec. 360bbb-8 - Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments</td> </tr> <tr> <td> </td> <td>Sec. 360bbb-8a - Optimizing global clinical trials</td> </tr> <tr> <td> </td> <td>Sec. 360bbb-8b - Use of clinical investigation data from outside the United States<br /> </td> </tr> <tr> <td> </td> <td>Sec. 360bbb-8c - Patient participation in medical product discussion</td> </tr> </tbody> </table> </div> <h4><a name="Part_F"></a>Part F - New Animal Drugs for Minor Use and Minor Species (sections 360ccc - 360ccc-2)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td>Sec. 571</td> <td>Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor species</td> </tr> <tr> <td>Sec. 572</td> <td>Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor species</td> </tr> <tr> <td>Sec. 573</td> <td>Sec. 360ccc-2 - Designated new animal drugs for minor use or minor species</td> </tr> </tbody> </table> </div> <h4><a name="part_g"></a>Part G - Medical Gases (sections 360ddd to 360ddd-2)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <th scope="col" width="30%"> </th> <td width="70%">Sec. 360ddd - Definitions</td> </tr> <tr> <th scope="col" width="30%"> </th> <td width="70%">Sec. 360ddd-1 - Regulation of medical gases</td> </tr> <tr> <th scope="col" width="30%"> </th> <td width="70%">Sec. 360ddd-2 - Inapplicability of drug fees to designated medical gases</td> </tr> </tbody> </table> </div> <h4><a name="part_h"></a>Part H - Pharmaceutical Distribution Supply Chain (sections 360eee to 360eee-4)</h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td> </td> <td>Sec. 360eee - Definitions</td> </tr> <tr> <td> </td> <td>Sec. 360eee-1 - Requirements</td> </tr> <tr> <td> </td> <td>Sec. 360eee-2 - National standards for prescription drug wholesale distributors</td> </tr> <tr> <td> </td> <td>Sec. 360eee-3 - National standards for third-party logistics providers</td> </tr> <tr> <td> </td> <td>Sec. 360eee-4 - Uniform national policy</td> </tr> </tbody> </table> </div> <h4><font face="Arial"><a name="part_i"></a>Part I鈥擭onprescription Sunscreen and Other Active Ingredients (sections 360fff to 360fff-7)</font></h4> <div class="table-responsive"> <table class="table" summary="Two-column table with column headers" width="98%"> <thead> <tr> <th scope="col" width="30%">FD&C Act Section Number</th> <th scope="col" width="70%">Title</th> </tr> </thead> <tbody> <tr> <td> </td> <td>Sec. 360fff - Definitions</td> </tr> <tr> <td> </td> <td>Sec. 360fff-1 - Submission of requests</td> </tr> <tr> <td> </td> <td>Sec. 360fff-2 - Eligibility determinations; data submission; filing</td> </tr> <tr> <td> </td> <td>Sec. 360fff-3 - GRASE determination</td> </tr> <tr> <td> </td> <td>Sec. 360fff-4 - Guidance; other provisions</td> </tr> <tr> <td> </td> <td>Sec. 360fff-5 - Sunscreen monograph</td> </tr> <tr> <td> </td> <td>Sec. 360fff-6 - Non-sunscreen time and extent applications</td> </tr> <tr> <td> </td> <td>Sec. 360fff-7 - Report</td> </tr> </tbody> </table> </div> <p> </p> <br> <br> </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top" > <ul role="menu" 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