CFR - Code of Federal Regulations Title 21

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.nudge-right { margin-left: 2.5em; } </style> <SCRIPT LANGUAGE="JavaScript" TYPE="text/javascript">  </script>  <div class="cfr"> <div class="cfr-left"> <div class="cfr-alert"> <p><span class="updated">The information on this page is current as of <strong>Aug 30, 2024</strong>.</span> </p> <span style="font-size: 13px;"> <p>This online reference for CFR Title 21 is updated approximately 4 times per year if there are relevant changes. For the most up-to-date version of CFR Title 21, go to the <a href="https://www.ecfr.gov">Electronic Code of Federal Regulations (eCFR).</a></p> <p>This database includes a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. <p><a href="https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs" style="text-decoration:underline;">Learn More...</a></p> </p> </span> </div> <div id="cfr-form"> <table width="100%" id="cfr-form-title"> <tr> <td id="cfr-form-title-left">Search Database</td> <td id="cfr-form-title-right"><a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true"><img src="/scripts/cdrh/cfdocs/images/questionmark.gif"></a> <a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true">Help</a> </td> </tr> </table> <FORM method="post" action="CFRSearch.cfm" name="form1"> <table bgcolor="#f9f9f3" width="100%"> <TR VALIGN="top"> <TD BGCOLOR="#f9f9f3"> <TABLE BORDER="0" CELLPADDING="5" CELLSPACING="0" WIDTH="100%"> <tr> <td valign="top" align="left"><label for="FR">Title21 Part.Section<br><i>(e.g., 862.1385)</i></label></td> <td colspan="3"><INPUT type="text" name="FR" size="10" maxlength="12">    <label for="FRSearch">Full Text Search</label>    <INPUT name="FRSearch" value="" type="text" size="20" maxlength="100"> </td> </tr> <tr> <td valign="top" align="left"><label for="CFRPart">CFR Title 21 - Food and Drugs: Parts 1 to 1499</label></td> <td colspan="3"> <select name="CFRPart" multiple size="10" > <option value="1" > (1) General enforcement regulations <option value="2" > (2) General administrative rulings and decisions <option value="3" > (3) Product jurisdiction <option value="4" > (4) Regulation of combination products <option value="5" > (5) Organization <option value="7" > (7) Enforcement policy <option value="10" > (10) Administrative practices and procedures <option value="11" > (11) Electronic records; electronic signatures <option value="12" > (12) Formal evidentiary public hearing <option value="13" > (13) Public hearing before a public board of inquiry <option value="14" > (14) Public hearing before a public advisory committee <option value="15" > (15) Public hearing before the commissioner <option value="16" > (16) Regulatory hearing before the food and drug administration <option value="17" > (17) Civil money penalties hearings <option value="19" > (19) Standards of conduct and conflicts of interest <option value="20" > (20) Public information <option value="21" > (21) Protection of privacy <option value="25" > (25) Environmental impact considerations <option value="26" > (26) Mutual recognition of pharmaceutical good manufacturing prac ... <option value="50" > (50) Protection of human subjects <option value="54" > (54) Financial disclosure by clinical investigators <option value="56" > (56) Institutional review boards <option value="58" > (58) Good laboratory practice for nonclinical laboratory studies <option value="60" > (60) Patent term restoration <option value="70" > (70) Color additives <option value="71" > (71) Color additive petitions <option value="73" > (73) Listing of color additives exempt from certification <option value="74" > (74) Listing of color additives subject to certification <option value="80" > (80) Color additive certification <option value="81" > (81) General specifications and general restrictions for provisio ... <option value="82" > (82) Listing of certified provisionally listed colors and specifi ... <option value="0"> (83-98) [reserved] <option value="99" > (99) Dissemination of information on unapproved/new uses for mark ... <option value="100" > (100) General <option value="101" > (101) Food labeling <option value="102" > (102) Common or usual name for nonstandardized foods <option value="104" > (104) Nutritional quality guidelines for foods <option value="105" > (105) Foods for special dietary use <option value="106" > (106) Infant formula requirements pertaining to current good manuf ... <option value="107" > (107) Infant formula <option value="108" > (108) Emergency permit control <option value="109" > (109) Unavoidable contaminants in food for human consumption and f ... <option value="110" > (110) Current good manufacturing practice in manufacturing, packin ... <option value="111" > (111) Current good manufacturing practice in manufacturing, packag ... <option value="112" > (112) Standards for the growing, harvesting, packing, and holding ... <option value="113" > (113) Thermally processed low-acid foods packaged in hermetically ... <option value="114" > (114) Acidified foods <option value="115" > (115) Shell eggs <option value="117" > (117) Current good manufacturing practice, hazard analysis, and ri ... <option value="118" > (118) Production, storage, and transportation of shell eggs <option value="119" > (119) Dietary supplements that present a significant or unreasonab ... <option value="120" > (120) Hazard analysis and critical control point (haccp) systems <option value="121" > (121) Mitigation strategies to protect food against intentional ad ... <option value="123" > (123) Fish and fishery products <option value="129" > (129) Processing and bottling of bottled drinking water <option value="130" > (130) Food standards: general <option value="131" > (131) Milk and cream <option value="133" > (133) Cheeses and related cheese products <option value="135" > (135) Frozen desserts <option value="136" > (136) Bakery products <option value="137" > (137) Cereal flours and related products <option value="139" > (139) Macaroni and noodle products <option value="145" > (145) Canned fruits <option value="146" > (146) Canned fruit juices <option value="150" > (150) Fruit butters, jellies, preserves, and related products <option value="155" > (155) Canned vegetables <option value="156" > (156) Vegetable juices <option value="158" > (158) Frozen vegetables <option value="160" > (160) Eggs and egg products <option value="161" > (161) Fish and shellfish <option value="163" > (163) Cacao products <option value="164" > (164) Tree nut and peanut products <option value="165" > (165) Beverages <option value="166" > (166) Margarine <option value="168" > (168) Sweeteners and table sirups <option value="169" > (169) Food dressings and flavorings <option value="170" > (170) Food additives <option value="171" > (171) Food additive petitions <option value="172" > (172) Food additives permitted for direct addition to food for hum ... <option value="173" > (173) Secondary direct food additives permitted in food for human ... <option value="174" > (174) Indirect food additives: general <option value="175" > (175) Indirect food additives: adhesives and components of coating ... <option value="176" > (176) Indirect food additives: paper and paperboard components <option value="177" > (177) Indirect food additives: polymers <option value="178" > (178) Indirect food additives: adjuvants, production aids, and san ... <option value="179" > (179) Irradiation in the production, processing and handling of fo ... <option value="180" > (180) Food additives permitted in food or in contact with food on ... <option value="181" > (181) Prior-sanctioned food ingredients <option value="182" > (182) Substances generally recognized as safe <option value="184" > (184) Direct food substances affirmed as generally recognized as s ... <option value="186" > (186) Indirect food substances affirmed as generally recognized as ... <option value="189" > (189) Substances prohibited from use in human food <option value="190" > (190) Dietary supplements <option value="0"> (191-199) [reserved] <option value="200" > (200) General <option value="201" > (201) Labeling <option value="202" > (202) Prescription drug advertising <option value="203" > (203) Prescription drug marketing <option value="205" > (205) Guidelines for state licensing of wholesale prescription dru ... <option value="206" > (206) Imprinting of solid oral dosage form drug products for human ... <option value="207" > (207) Requirements for foreign and domestic establishment registra ... <option value="208" > (208) Medication guides for prescription drug products <option value="209" > (209) Requirement for authorized dispensers and pharmacies to dist ... <option value="210" > (210) Current good manufacturing practice in manufacturing, proces ... <option value="211" > (211) Current good manufacturing practice for finished pharmaceuti ... <option value="212" > (212) Current good manufacturing practice for positron emission to ... <option value="213" > (213) Xxx <option value="216" > (216) Human drug compounding <option value="225" > (225) Current good manufacturing practice for medicated feeds <option value="226" > (226) Current good manufacturing practice for type a medicated art ... <option value="230" > (230) Xxx <option value="250" > (250) Special requirements for specific human drugs <option value="251" > (251) Section 804 importation program <option value="290" > (290) Controlled drugs <option value="299" > (299) Drugs; official names and established names <option value="300" > (300) General <option value="310" > (310) New drugs <option value="312" > (312) Investigational new drug application <option value="314" > (314) Applications for fda approval to market a new drug <option value="315" > (315) Diagnostic radiopharmaceuticals <option value="316" > (316) Orphan drugs <option value="317" > (317) Qualifying pathogens <option value="320" > (320) Bioavailability and bioequivalence requirements <option value="328" > (328) Over-the-counter drug products intended for oral ingestion t ... <option value="329" > (329) Nonprescription human drug products subject to section 760 o ... <option value="330" > (330) Over-the-counter (otc) human drugs which are generally recog ... <option value="331" > (331) Antacid products for over-the-counter (otc) human use <option value="332" > (332) Antiflatulent products for over-the-counter human use <option value="333" > (333) Topical antimicrobial drug products for over-the-counter hum ... <option value="335" > (335) Antidiarrheal drug products for over-the-counter human use <option value="336" > (336) Antiemetic drug products for over-the-counter human use <option value="338" > (338) Nighttime sleep-aid drug products for over-the-counter human ... <option value="340" > (340) Stimulant drug products for over-the-counter human use <option value="341" > (341) Cold, cough, allergy, bronchodilator, and antiasthmatic drug ... <option value="343" > (343) Internal analgesic, antipyretic, and antirheumatic drug prod ... <option value="344" > (344) Topical otic drug products for over-the-counter human use <option value="346" > (346) Anorectal drug products for over-the-counter human use <option value="347" > (347) Skin protectant drug products for over-the-counter human use <option value="348" > (348) External analgesic drug products for over-the-counter human ... <option value="349" > (349) Ophthalmic drug products for over-the-counter human use <option value="350" > (350) Antiperspirant drug products for over-the-counter human use <option value="352" > (352) Sunscreen drug products for over-the-counter human use [stay ... <option value="355" > (355) Anticaries drug products for over-the-counter human use <option value="357" > (357) Miscellaneous internal drug products for over-the-counter hu ... <option value="358" > (358) Miscellaneous external drug products for over-the-counter hu ... <option value="361" > (361) Prescription drugs for human use generally recognized as saf ... <option value="369" > (369) Interpretative statements re warnings on drugs and devices f ... <option value="0"> (370-499) [reserved] <option value="500" > (500) General <option value="501" > (501) Animal food labeling <option value="502" > (502) Common or usual names for nonstandardized animal foods <option value="507" > (507) Current good manufacturing practice, hazard analysis, and ri ... <option value="509" > (509) Unavoidable contaminants in animal food and food-packaging m ... <option value="510" > (510) New animal drugs <option value="511" > (511) New animal drugs for investigational use <option value="514" > (514) New animal drug applications <option value="515" > (515) Medicated feed mill license <option value="516" > (516) New animal drugs for minor use and minor species <option value="520" > (520) Oral dosage form new animal drugs <option value="522" > (522) Implantation or injectable dosage form new animal drugs <option value="524" > (524) Ophthalmic and topical dosage form new animal drugs <option value="526" > (526) Intramammary dosage form new animal drugs <option value="528" > (528) Intentional genomic alterations in animals <option value="529" > (529) Certain other dosage form new animal drugs <option value="530" > (530) Extralabel drug use in animals <option value="556" > (556) Tolerances for residues of new animal drugs in food <option value="558" > (558) New animal drugs for use in animal feeds <option value="0"> (564) [reserved] <option value="570" > (570) Food additives <option value="571" > (571) Food additive petitions <option value="573" > (573) Food additives permitted in feed and drinking water of anima ... <option value="579" > (579) Irradiation in the production, processing, and handling of a ... <option value="582" > (582) Substances generally recognized as safe <option value="584" > (584) Food substances affirmed as generally recognized as safe in ... <option value="589" > (589) Substances prohibited from use in animal food or feed <option value="0"> (590-599) [reserved] <option value="600" > (600) Biological products: general <option value="601" > (601) Licensing <option value="606" > (606) Current good manufacturing practice for blood and blood comp ... <option value="607" > (607) Establishment registration and product listing for manufactu ... <option value="610" > (610) General biological products standards <option value="630" > (630) Requirements for blood and blood components intended for tra ... <option value="640" > (640) Additional standards for human blood and blood products <option value="660" > (660) Additional standards for diagnostic substances for laborator ... <option value="680" > (680) Additional standards for miscellaneous products <option value="700" > (700) General <option value="701" > (701) Cosmetic labeling <option value="710" > (710) Voluntary registration of cosmetic product establishments <option value="720" > (720) Voluntary filing of cosmetic product ingredient composition ... <option value="740" > (740) Cosmetic product warning statements <option value="0"> (741-799) [reserved] <option value="800" > (800) General <option value="801" > (801) Labeling <option value="803" > (803) Medical device reporting <option value="806" > (806) Medical devices; reports of corrections and removals <option value="807" > (807) Establishment registration and device listing for manufactur ... <option value="808" > (808) Exemptions from federal preemption of state and local medica ... <option value="809" > (809) In vitro diagnostic products for human use <option value="810" > (810) Medical device recall authority <option value="812" > (812) Investigational device exemptions <option value="0"> (813) [reserved] <option value="814" > (814) Premarket approval of medical devices <option value="820" > (820) Quality system regulation <option value="821" > (821) Medical device tracking requirements <option value="822" > (822) Postmarket surveillance <option value="830" > (830) Unique device identification <option value="860" > (860) Medical device classification procedures <option value="861" > (861) Procedures for performance standards development <option value="862" > (862) Clinical chemistry and clinical toxicology devices <option value="864" > (864) Hematology and pathology devices <option value="866" > (866) Immunology and microbiology devices <option value="868" > (868) Anesthesiology devices <option value="870" > (870) Cardiovascular devices <option value="872" > (872) Dental devices <option value="874" > (874) Ear, nose, and throat devices <option value="876" > (876) Gastroenterology-urology devices <option value="878" > (878) General and plastic surgery devices <option value="880" > (880) General hospital and personal use devices <option value="882" > (882) Neurological devices <option value="884" > (884) Obstetrical and gynecological devices <option value="886" > (886) Ophthalmic devices <option value="888" > (888) Orthopedic devices <option value="890" > (890) Physical medicine devices <option value="892" > (892) Radiology devices <option value="895" > (895) Banned devices <option value="898" > (898) Performance standard for electrode lead wires and patient ca ... <option value="900" > (900) Mammography <option value="1000" > (1000) General <option value="1002" > (1002) Records and reports <option value="1003" > (1003) Notification of defects or failure to comply <option value="1004" > (1004) Repurchase, repairs, or replacement of electronic products <option value="1005" > (1005) Importation of electronic products <option value="1010" > (1010) Performance standards for electronic products: general <option value="1020" > (1020) Performance standards for ionizing radiation emitting produc ... <option value="1030" > (1030) Performance standards for microwave and radio frequency emit ... <option value="1040" > (1040) Performance standards for light-emitting products <option value="1100" > (1100) Tobacco products subject to fda authority <option value="1105" > (1105) General <option value="1107" > (1107) Exemption requests and substantial equivalence reports <option value="1114" > (1114) Premarket tobacco product applications <option value="1140" > (1140) Cigarettes, smokeless tobacco, and covered tobacco products <option value="1141" > (1141) Required warnings for cigarette packages and advertisements <option value="1143" > (1143) Minimum required warning statements <option value="1150" > (1150) User fees <option value="1210" > (1210) Regulations under the federal import milk act <option value="1230" > (1230) Regulations under the federal caustic poison act <option value="1240" > (1240) Control of communicable diseases <option value="1250" > (1250) Interstate conveyance sanitation <option value="0"> (1251-1270) [reserved] <option value="1271" > (1271) Human cells, tissues, and cellular and tissue-based products <option value="0"> (1272-1299) [reserved] <option value="1300" > (1300) Definitions <option value="1301" > (1301) Registration of manufacturers, distributors, and dispensers ... <option value="1302" > (1302) Labeling and packaging requirements for controlled substance ... <option value="1303" > (1303) Quotas <option value="1304" > (1304) Records and reports of registrants <option value="1305" > (1305) Orders for schedule i and ii controlled substances <option value="1306" > (1306) Prescriptions <option value="1307" > (1307) Miscellaneous <option value="1308" > (1308) Schedules of controlled substances <option value="1309" > (1309) Registration of manufacturers, distributors, importers and e ... <option value="1310" > (1310) Records and reports of listed chemicals and certain machines ... <option value="1311" > (1311) Requirements for electronic orders and prescriptions <option value="1312" > (1312) Importation and exportation of controlled substances <option value="1313" > (1313) Importation and exportation of list i and list ii chemicals <option value="1314" > (1314) Retail sale of scheduled listed chemical products <option value="1315" > (1315) Importation and production quotas for ephedrine, pseudoephed ... <option value="1316" > (1316) Administrative functions, practices, and procedures <option value="1317" > (1317) Disposal <option value="1318" > (1318) Controls to satisfy the requirements of the act applicable t ... <option value="1321" > (1321) Dea mailing addresses <option value="0"> (1322-1399) [reserved] <option value="0"> (1400) [reserved] <option value="1401" > (1401) Public availability of information <option value="1402" > (1402) Mandatory declassification review <option value="0"> (1403-1499) [reserved] </select></td> </tr> <tr> <td colspan="2"> </td> <td align="right" colspan="2"> <A style="text-decoration:underline;" href="javascript:doClear();" onmouseover="window.status='Clear';return true;" onmouseout="window.status='';return true;">Clear Form</a>     <INPUT TYPE="submit" Name="Search" VALUE="Search">   </td> </tr> </table> </td> </tr> </table> </FORM> </div> </div> <div class="cfr-right"> <span style="font-weight: bold;">Other Databases</span> <ul style="margin:-5px;"> <li><a href="/scripts/cdrh/cfdocs/cfPMN/pmn.cfm" title="Database of new or significantly changed device information submitted by medical device manufacturers prior to commercial distribution.">510(k)s</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMN/denovo.cfm" title="Database of De Novos.">De Novo</a></li> <li><a href="/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm" title="Reports of adverse events involving medical devices.">Medical Device Reports (MAUDE)</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRL/DTLS/rl_cert.cfm" title="This searchable database contains valid export certificates submitted electronically via CECATS (CDRH Export Certification Application and Tracking System) and issued by the Center for Devices and Radiological Health.">CDRH Export Certificate Validation (CECV)</a></li> <li><a href="/scripts/cdrh/devicesatfda/readingroom.cfm" title="CDRH FOIA Electronic Reading Room.">CDRH FOIA Electronic Reading Room</a></li> <li><a href="/scripts/cdrh/cfdocs/cfClia/Search.cfm" title="Database of laboratory testing standards that ensure the accuracy, reliability and timeliness of patient tests.">CLIA</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD/classification.cfm" title="Database containing medical device names and associated information developed by the FDA Center for Devices and Radiological Health (CDRH) in support of its mission.">Device Classification</a></li> <li><a href="http://www.fda.gov/RegulatoryInformation/Guidances/default.htm" title="FDA Guidance Documents. ">FDA Guidance Documents </a></li> <li><a href="/scripts/cdrh/cfdocs/cfHDE/hde.cfm" title="Humanitaian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. ">Humanitarian Device Exemption </a></li> <li><a href="/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm" title="The Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.">Medsun Reports</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pma.cfm" title="Database of Class III devices that support or sustain human life or are of substantial importance in preventing impairment of human health.">Premarket Approvals (PMAs)</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm" title="Database of Post-Approval Studies">Post-Approval Studies</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pss.cfm" title="Database of Postmarket Surveillance Studies">Postmarket Surveillance Studies</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm" title="The Radiation-Emitting Electronic Product Codes Database contains names of radiation-emitting electronic products and devices and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains product names and their associated product codes. Additionally, the radiation type, definition, and applicable performance standards (21 CFR Parts 1020-1050) are provided.">Radiation-Emitting Products</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/rh_res.cfm" title="Electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.">Radiation-Emitting Electronic Products Corrective Actions</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRES/res.cfm" title="Database of classified medical device recalls since November 1, 2002.">Recalls</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRL/rl.cfm" title="Database of devices in commercial distribution in the United States submitted by domestic and foreign manufacturers and medical device establishment information submitted by domestic and foreign establishments.">Registration & Listing</a></li> <li><a href="/scripts/cdrh/cfdocs/cfStandards/search.cfm" title="Database of Recognized Consensus Standards with associated FDA, medical device and standards industry information.">Standards</a></li> <li><a href="/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm" title="The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls.">Total Product Life Cycle</a></li> <li><a href="/scripts/cdrh/cfdocs/cfAssem/assembler.cfm" title="Database of locations and identities of certified components of diagnostic x-ray systems for routine compliance testing at user facilities. ">X-Ray Assembler</a></li> </ul> </div> </div>  </span> <div class="clearfloat"> - </div> </div> <div class="clearfloat"> - </div>   <script type="text/javascript"> setStyle(); </script>   <div id="footer">  <div id="footnote"><h4>Links on this page:</h4><div></div></div>   <div id="pagetools_bottom"> <div id="pagetools_right"> <p>Page Last Updated: 08/30/2024</p> <p> Note: If you need help accessing information in different file formats, see <a href="https://www.fda.gov/about-fda/website-policies/viewing-files">Instructions for Downloading Viewers and Players</a>. <br>Language Assistance Available: <a title="Spanish" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#spanish">Español</a> | <a title="Chinese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#chinese">繁體中文</a> | <a title="Vietnamese" href="https://www.fda.gov/about-fda/about-website/language-assistance-services#vietnamese">Tiếng Việt</a> | <a title="Korean" 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