Code of Federal Regulations (Last Updated: October 10, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter A - General |
Part 1 - General Enforcement Regulations |
Subpart A - General Provisions |
§ 1.1 - General. |
§ 1.3 - Definitions. |
§ 1.4 - Authority citations. |
Subpart B - General Labeling Requirements |
§ 1.20 - Presence of mandatory label information. |
§ 1.21 - Failure to reveal material facts. |
§ 1.23 - Procedures for requesting variations and exemptions from required label statements. |
§ 1.24 - Exemptions from required label statements. |
§ 1.31 - Package size savings. |
§ 1.35 - Cents-off,” or other savings representations. |
Subpart C - XXX |
Subpart D - Electronic Import Entries |
§ 1.70 - Scope. |
§ 1.71 - Definitions. |
§ 1.72 - Data elements that must be submitted in ACE for articles regulated by FDA. |
§ 1.73 - Food. |
§ 1.74 - Human drugs. |
§ 1.75 - Animal drugs and veterinary devices. |
§ 1.76 - Medical devices. |
§ 1.77 - Radiation-emitting electronic products. |
§ 1.78 - Biological products, HCT/Ps, and related drugs and medical devices. |
§ 1.79 - Tobacco products. |
§ 1.80 - Cosmetics. |
§ 1.81 - Rejection of entry filing. |
Subpart E - Imports and Exports |
§ 1.83 - Definitions. |
§ 1.90 - Notice of sampling. |
§ 1.91 - Payment for samples. |
§ 1.94 - Hearing on refusal of admission or destruction. |
§ 1.95 - Application for authorization to relabel and recondition. |
§ 1.96 - Granting of authorization to relabel and recondition. |
§ 1.97 - Bonds. |
§ 1.99 - Costs chargeable in connection with relabeling and reconditioning inadmissible imports. |
§ 1.101 - Notification and recordkeeping. |
Subparts F--G - XXX |
Subpart H - Registration of Food Facilities |
General Provisions |
§ 1.225 - Who must register under this subpart? |
§ 1.226 - Who does not have to register under this subpart? |
§ 1.227 - What definitions apply to this subpart? |
Additional Provisions |
§ 1.240 - What other registration requirements apply? |
§ 1.241 - What are the consequences of failing to register, update, renew, or cancel your registration? |
§ 1.242 - What does assignment of a registration number mean? |
§ 1.243 - Is food registration information available to the public? |
§ 1.245 - Waiver request. |
Procedures for Registration of Food Facilities |
§ 1.230 - When must you register or renew your registration? |
§ 1.231 - How and where do you register or renew your registration? |
§ 1.232 - What information is required in the registration? |
§ 1.233 - Are there optional items included in the registration form? |
§ 1.234 - How and when do you update your facility's registration information? |
§ 1.235 - How and when do you cancel your facility's registration information? |
Subpart I - Prior Notice of Imported Food |
Consequences |
§ 1.283 - What happens to food that is imported or offered for import without adequate prior notice? |
§ 1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart? |
§ 1.285 - What happens to food that is imported or offered for import from unregistered facilities that are required to register under subpart H of this part? |
Requirements to Submit Prior Notice of Imported Food |
§ 1.278 - Who is authorized to submit prior notice? |
§ 1.279 - When must prior notice be submitted to FDA? |
§ 1.280 - How must you submit prior notice? |
§ 1.281 - What information must be in a prior notice? |
§ 1.282 - What must you do if information changes after you have received confirmation of a prior notice from FDA? |
General Provisions |
§ 1.276 - What definitions apply to this subpart? |
§ 1.277 - What is the scope of this subpart? |
Subpart J - Establishment, Maintenance, and Availability of Records |
Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Subsequent Recipients of Food |
§ 1.345 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food? |
Requirements for Nontransporters to Establish and Maintain Records to Identify the Nontransporter and Transporter Immediate Previous Sources of Food |
§ 1.337 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food? |
General Provisions |
§ 1.326 - Who is subject to this subpart? |
§ 1.327 - Who is excluded from all or part of the regulations in this subpart? |
§ 1.328 - What definitions apply to this subpart? |
§ 1.329 - Do other statutory provisions and regulations apply? |
§ 1.330 - Can existing records satisfy the requirements of this subpart? |
Compliance Dates |
§ 1.368 - What are the compliance dates for this subpart? |
Requirements for Transporters to Establish and Maintain Records |
§ 1.352 - What information must transporters establish and maintain? |
General Requirements |
§ 1.360 - What are the record retention requirements? |
§ 1.361 - What are the record availability requirements? |
§ 1.362 - What records are excluded from this subpart? |
§ 1.363 - What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart? |
Subpart K - Administrative Detention of Food for Human or Animal Consumption |
How Does FDA Order a Detention? |
§ 1.391 - Who approves a detention order? |
§ 1.392 - Who receives a copy of the detention order? |
§ 1.393 - What information must FDA include in the detention order? |
General Provisions |
§ 1.377 - What definitions apply to this subpart? |
§ 1.378 - What criteria does FDA use to order a detention? |
§ 1.379 - How long may FDA detain an article of food? |
§ 1.380 - Where and under what conditions must the detained article of food be held? |
§ 1.381 - May a detained article of food be delivered to another entity or transferred to another location? |
§ 1.382 - What labeling or marking requirements apply to a detained article of food? |
§ 1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable food? |
§ 1.384 - When does a detention order terminate? |
What Is the Appeal Process for a Detention Order? |
§ 1.401 - Who is entitled to appeal? |
§ 1.402 - What are the requirements for submitting an appeal? |
§ 1.403 - What requirements apply to an informal hearing? |
§ 1.404 - Who serves as the presiding officer for an appeal and for an informal hearing? |
§ 1.405 - When does FDA have to issue a decision on an appeal? |
§ 1.406 - How will FDA handle classified information in an informal hearing? |
Subpart L - Foreign Supplier Verification Programs for Food Importers |
§ 1.500 - What definitions apply to this subpart? |
§ 1.501 - To what foods do the requirements in this subpart apply? |
§ 1.502 - What foreign supplier verification program (FSVP) must I have? |
§ 1.503 - Who must develop my FSVP and perform FSVP activities? |
§ 1.504 - What hazard analysis must I conduct? |
§ 1.505 - What evaluation for foreign supplier approval and verification must I conduct? |
§ 1.506 - What foreign supplier verification and related activities must I conduct? |
§ 1.507 - What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation? |
§ 1.508 - What corrective actions must I take under my FSVP? |
§ 1.509 - How must the importer be identified at entry? |
§ 1.510 - How must I maintain records of my FSVP? |
§ 1.511 - What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation? |
§ 1.512 - What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers? |
§ 1.513 - What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system? |
§ 1.514 - What are some consequences of failing to comply with the requirements of this subpart? |
Subpart M - Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications |
§ 1.600 - What definitions apply to this subpart? |
§ 1.601 - Who is subject to this subpart? |
Xxx |
§§ 1.700--1.725 - [Reserved] |
Requirements for User Fees Under This Subpart |
§ 1.700 - Who is subject to a user fee under this subpart? |
§ 1.705 - What user fees are established under this subpart? |
§ 1.710 - How will FDA notify the public about the fee schedule? |
§ 1.715 - When must a user fee required by this subpart be submitted? |
§ 1.720 - Are user fees under this subpart refundable? |
§ 1.725 - What are the consequences of not paying a user fee under this subpart on time? |
General Requirements of This Subpart |
§ 1.690 - How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public? |
§ 1.691 - How do I request reconsideration of a denial by FDA of an application or a waiver request? |
§ 1.692 - How do I request internal agency review of a denial of an application or waiver request upon reconsideration? |
§ 1.693 - How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation? |
§ 1.694 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter? |
§ 1.695 - Are the records obtained by FDA under this subpart subject to public disclosure? |
Recognition of Accreditation Bodies Under This Subpart |
§ 1.610 - Who is eligible to seek recognition? |
§ 1.611 - What legal authority must an accreditation body have to qualify for recognition? |
§ 1.612 - What competency and capacity must an accreditation body have to qualify for recognition? |
§ 1.613 - What protections against conflicts of interest must an accreditation body have to qualify for recognition? |
§ 1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition? |
§ 1.615 - What records procedures must an accreditation body have to qualify for recognition? |
Requirements for Eligible Entities Under This Subpart |
§ 1.680 - How and when will FDA monitor eligible entities? |
§ 1.681 - How frequently must eligible entities be recertified? |
Procedures for Recognition of Accreditation Bodies Under This Subpart |
§ 1.630 - How do I apply to FDA for recognition or renewal of recognition? |
§ 1.631 - How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application? |
§ 1.632 - What is the duration of recognition? |
§ 1.633 - How will FDA monitor recognized accreditation bodies? |
§ 1.634 - When will FDA revoke recognition? |
§ 1.635 - What if I want to voluntarily relinquish recognition or do not want to renew recognition? |
§ 1.636 - How do I request reinstatement of recognition? |
Accreditation of Third-Party Certification Bodies Under This Subpart |
§ 1.640 - Who is eligible to seek accreditation? |
§ 1.641 - What legal authority must a third-party certification body have to qualify for accreditation? |
§ 1.642 - What competency and capacity must a third-party certification body have to qualify for accreditation? |
§ 1.643 - What protections against conflicts of interest must a third-party certification body have to qualify for accreditation? |
§ 1.644 - What quality assurance procedures must a third-party certification body have to qualify for accreditation? |
§ 1.645 - What records procedures must a third-party certification body have to qualify for accreditation? |
Additional Procedures for Direct Accreditation of Third-Party Certification Bodies Under This Subpart |
§ 1.670 - How do I apply to FDA for direct accreditation or renewal of direct accreditation? |
§ 1.671 - How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application? |
§ 1.672 - What is the duration of direct accreditation? |
Requirements for Third-Party Certification Bodies That Have Been Accredited Under This Subpart |
§ 1.650 - How must an accredited third-party certification body ensure its audit agents are competent and objective? |
§ 1.651 - How must an accredited third-party certification body conduct a food safety audit of an eligible entity? |
§ 1.652 - What must an accredited third-party certification body include in food safety audit reports? |
§ 1.653 - What must an accredited third-party certification body do when issuing food or facility certifications? |
§ 1.654 - When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification? |
§ 1.655 - How must an accredited third-party certification body monitor its own performance? |
§ 1.656 - What reports and notifications must an accredited third-party certification body submit? |
§ 1.657 - How must an accredited third-party certification body protect against conflicts of interest? |
§ 1.658 - What records requirements must a third-party certification body that has been accredited meet? |
Requirements for Accreditation Bodies That Have Been Recognized Under This Subpart |
§ 1.620 - How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation? |
§ 1.621 - How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited? |
§ 1.622 - How must a recognized accreditation body monitor its own performance? |
§ 1.623 - What reports and notifications must a recognized accreditation body submit to FDA? |
§ 1.624 - How must a recognized accreditation body protect against conflicts of interest? |
§ 1.625 - What records requirements must an accreditation body that has been recognized meet? |
Procedures for Accreditation of Third-Party Certification Bodies Under This Subpart |
§ 1.660 - Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application? |
§ 1.661 - What is the duration of accreditation by a recognized accreditation body? |
§ 1.662 - How will FDA monitor accredited third-party certification bodies? |
§ 1.663 - How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits? |
§ 1.664 - When would FDA withdraw accreditation? |
§ 1.665 - What if I want to voluntarily relinquish accreditation or do not want to renew accreditation? |
§ 1.666 - How do I request reaccreditation? |
Subpart N - XXX |
Subpart O - Sanitary Transportation of Human and Animal Food |
§§ 1.900--1.934 - xxx |
Waivers |
§ 1.914 - Under what circumstances will we waive a requirement of this subpart? |
§ 1.916 - When will we consider whether to waive a requirement of this subpart? |
§ 1.918 - What must be included in the Statement of Grounds in a petition requesting a waiver? |
§ 1.920 - What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available? |
§ 1.922 - Who will respond to a petition requesting a waiver? |
§ 1.924 - What process applies to a petition requesting a waiver? |
§ 1.926 - Under what circumstances may we deny a petition requesting a waiver? |
§ 1.928 - What process will we follow when waiving a requirement of this subpart on our own initiative? |
§ 1.930 - When will a waiver that we grant become effective? |
§ 1.932 - Under what circumstances may we modify or revoke a waiver? |
§ 1.934 - What procedures apply if we determine that a waiver should be modified or revoked? |
Records |
§ 1.912 - What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations? |
Transportation Operations |
§ 1.908 - What requirements apply to transportation operations? |
General Provisions |
§ 1.900 - Who is subject to this subpart? |
§ 1.902 - How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act? |
§ 1.904 - What definitions apply to this subpart? |
Training |
§ 1.910 - What training requirements apply to carriers engaged in transportation operations? |
Vehicles and Transportation Equipment |
§ 1.906 - What requirements apply to vehicles and transportation equipment? |
Subpart P - XXX |
Subpart Q - Administrative Detention of Drugs Intended for Human or Animal Use |
§ 1.980 - Administrative detention of drugs. |
Subpart R - Laboratory Accreditation for Analyses of Foods |
Electronic Records and Public Disclosure Requirements |
§ 1.1199 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter? |
§ 1.1200 - Are the records obtained by FDA under this subpart subject to public disclosure? |
FDA Recognition of Accreditation Bodies |
§ 1.1113 - What are the eligibility requirements for a recognized accreditation body? |
§ 1.1114 - How does an accreditation body apply to FDA for recognition or renewal of recognition? |
§ 1.1115 - How will FDA evaluate applications for recognition and renewal of recognition? |
§ 1.1116 - What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition? |
§ 1.1117 - How may an accreditation body request reinstatement of recognition? |
FDA Oversight of Recognized Accreditation Bodies |
§ 1.1130 - How will FDA oversee recognized accreditation bodies? |
§ 1.1131 - When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body? |
General Provisions |
§ 1.1101 - What documents are incorporated by reference in this subpart |
§ 1.1102 - What definitions apply to this subpart? |
§ 1.1103 - Who is subject to this subpart? |
Requirements for Recognized Accreditation Bodies |
§ 1.1119 - What are the conflict of interest requirements for a recognized accreditation body? |
§ 1.1120 - How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories? |
§ 1.1121 - When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory? |
§ 1.1122 - What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation? |
§ 1.1123 - What reports, notifications, and documentation must a recognized accreditation body submit to FDA? |
§ 1.1124 - What are the records requirements for a recognized accreditation body? |
§ 1.1125 - What are the internal audit requirements for a recognized accreditation body? |
Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions Under This Subpart |
§ 1.1171 - How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement? |
§ 1.1173 - How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory? |
§ 1.1174 - How does an owner or consignee request a regulatory hearing on a directed food laboratory order? |
LAAF-Accreditation of Laboratories |
§ 1.1138 - What are the eligibility requirements for a LAAF-accredited laboratory? |
§ 1.1139 - How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation? |
§ 1.1140 - What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation? |
§ 1.1141 - What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA? |
§ 1.1142 - How does a laboratory request reinstatement of LAAF-accreditation? |
General Requirements |
§ 1.1107 - When must food testing be conducted under this subpart? |
§ 1.1108 - When and how will FDA issue a directed food laboratory order? |
§ 1.1109 - How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public? |
§ 1.1110 - What are the general requirements for submitting information to FDA under this subpart? |
FDA Oversight of LAAF-Accredited Laboratories |
§ 1.1159 - How will FDA oversee LAAF-accredited laboratories? |
§ 1.1160 - How will FDA review test results and analytical reports? |
§ 1.1161 - When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports? |
§ 1.1162 - What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory? |
Requirements for LAAF-Accredited Laboratories |
§ 1.1147 - What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory? |
§ 1.1149 - What oversight standards apply to sampling? |
§ 1.1150 - What are the requirements for analysis of samples by a LAAF-accredited laboratory? |
§ 1.1151 - What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart? |
§ 1.1152 - What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA? |
§ 1.1153 - What are the requirements for submitting abridged analytical reports? |
§ 1.1154 - What other records requirements must a LAAF-accredited laboratory meet? |
Subpart S - Additional Traceability Records for Certain Foods |
General Provisions |
§ 1.1300 - Who is subject to this subpart? |
§ 1.1305 - What foods and persons are exempt from this subpart? |
§ 1.1310 - What definitions apply to this subpart? |
Waivers |
§ 1.1405 - Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity? |
§ 1.1410 - When will FDA consider whether to waive a requirement of this subpart? |
§ 1.1415 - How may I request a waiver for an individual entity? |
§ 1.1420 - What process applies to a request for a waiver for an individual entity? |
§ 1.1425 - What must be included in a petition requesting a waiver for a type of entity? |
§ 1.1430 - What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available? |
§ 1.1435 - What process applies to a petition requesting a waiver for a type of entity? |
§ 1.1440 - What process will FDA follow when waiving a requirement of this subpart on our own initiative? |
§ 1.1445 - Under what circumstances may FDA modify or revoke a waiver? |
§ 1.1450 - What procedures apply if FDA tentatively determines that a waiver should be modified or revoked? |
Records Maintenance and Availability |
§ 1.1455 - How must records required by this subpart be maintained and made available? |
Records of Critical Tracking Events |
§ 1.1325 - What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List? |
§ 1.1330 - What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List? |
§ 1.1335 - What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel? |
§ 1.1340 - What records must I keep and provide when I ship a food on the Food Traceability List? |
§ 1.1345 - What records must I keep when I receive a food on the Food Traceability List? |
§ 1.1350 - What records must I keep when I transform a food on the Food Traceability List? |
Consequences of Failure To Comply |
§ 1.1460 - What consequences could result from failing to comply with the requirements of this subpart? |
Traceability Plan |
§ 1.1315 - What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold? |
§ 1.1320 - When must I assign traceability lot codes to foods on the Food Traceability List? |
Procedures for Modified Requirements and Exemptions |
§ 1.1360 - Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart? |
§ 1.1365 - When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart? |
§ 1.1370 - What must be included in a petition requesting modified requirements or an exemption from the requirements? |
§ 1.1375 - What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available? |
§ 1.1380 - What process applies to a petition requesting modified requirements or an exemption? |
§ 1.1385 - What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative? |
§ 1.1390 - When will modified requirements that we adopt or an exemption that we grant become effective? |
§ 1.1395 - Under what circumstances may FDA revise or revoke modified requirements or an exemption? |
§ 1.1400 - What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked? |
Updating the Food Traceability List |
§ 1.1465 - How will FDA update the Food Traceability List? |