21 CFR Part 1: General Enforcement Regulations
Part 1 of title 21 runs to 251 sections across 14 subparts, and sits in subchapter A, General. Every section is reproduced in full and is current to 2026-09-10.
- Sections
- 251
- Subparts
- 14
- Words of regulation
- 93,945
- Current to
- 2026-09-10
Subpart A: General Provisions
Subpart B: General Labeling Requirements
Subpart D: Electronic Import Entries
- 1.70 Scope1
- 1.71 Definitions17
- 1.72 Data elements that must be submitted in ACE for articles regulated by FDA6
- 1.73 Food3
- 1.74 Human drugs11
- 1.75 Animal drugs and veterinary devices6
- 1.76 Medical devices8
- 1.77 Radiation-emitting electronic products1
- 1.78 Biological products, HCT/Ps, and related drugs and medical devices12
- 1.79 Tobacco products3
- 1.80 Cosmetics1
- 1.81 Rejection of entry filing1
Subpart E: Imports and Exports
- 1.83 Definitions3
- 1.90 Notice of sampling1
- 1.91 Payment for samples1
- 1.94 Hearing on refusal of admission or destruction3
- 1.95 Application for authorization to relabel and recondition3
- 1.96 Granting of authorization to relabel and recondition9
- 1.97 Bonds2
- 1.99 Costs chargeable in connection with relabeling and reconditioning inadmissible imports7
- 1.101 Notification and recordkeeping27
Subpart H: Registration of Food Facilities
- 1.225 Who must register under this subpart?3
- 1.226 Who does not have to register under this subpart?8
- 1.227 What definitions apply to this subpart?47
- 1.230 When must you register or renew your registration?3
- 1.231 How and where do you register or renew your registration?20
- 1.232 What information is required in the registration?31
- 1.233 Are there optional items included in the registration form?1
- 1.234 How and when do you update your facility's registration information?15
- 1.235 How and when do you cancel your facility's registration information?20
- 1.240 What other registration requirements apply?1
- 1.241 What are the consequences of failing to register, update, renew, or cancel your registration?4
- 1.242 What does assignment of a registration number mean?1
- 1.243 Is food registration information available to the public?2
- 1.245 Waiver request1
Subpart I: Prior Notice of Imported Food
- 1.276 What definitions apply to this subpart?23
- 1.277 What is the scope of this subpart?9
- 1.278 Who is authorized to submit prior notice?1
- 1.279 When must prior notice be submitted to FDA?13
- 1.280 How must you submit prior notice?5
- 1.281 What information must be in a prior notice?95
- 1.282 What must you do if information changes after you have received confirmation of a prior notice from FDA?7
- 1.283 What happens to food that is imported or offered for import without adequate prior notice?23
- 1.284 What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?5
- 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?20
Subpart J: Establishment, Maintenance, and Availability of Records
- 1.326 Who is subject to this subpart?2
- 1.327 Who is excluded from all or part of the regulations in this subpart?18
- 1.328 What definitions apply to this subpart?34
- 1.329 Do other statutory provisions and regulations apply?2
- 1.330 Can existing records satisfy the requirements of this subpart?1
- 1.337 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?7
- 1.345 What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?8
- 1.352 What information must transporters establish and maintain?47
- 1.360 What are the record retention requirements?8
- 1.361 What are the record availability requirements?1
- 1.362 What records are excluded from this subpart?1
- 1.363 What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?3
- 1.368 What are the compliance dates for this subpart?3
Subpart K: Administrative Detention of Food for Human or Animal Consumption
- 1.377 What definitions apply to this subpart?9
- 1.378 What criteria does FDA use to order a detention?1
- 1.379 How long may FDA detain an article of food?3
- 1.380 Where and under what conditions must the detained article of food be held?5
- 1.381 May a detained article of food be delivered to another entity or transferred to another location?11
- 1.382 What labeling or marking requirements apply to a detained article of food?5
- 1.383 What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?1
- 1.384 When does a detention order terminate?1
- 1.391 Who approves a detention order?1
- 1.392 Who receives a copy of the detention order?2
- 1.393 What information must FDA include in the detention order?16
- 1.401 Who is entitled to appeal?1
- 1.402 What are the requirements for submitting an appeal?6
- 1.403 What requirements apply to an informal hearing?12
- 1.404 Who serves as the presiding officer for an appeal and for an informal hearing?1
- 1.405 When does FDA have to issue a decision on an appeal?6
- 1.406 How will FDA handle classified information in an informal hearing?1
Subpart L: Foreign Supplier Verification Programs for Food Importers
- 1.500 What definitions apply to this subpart?38
- 1.501 To what foods do the requirements in this subpart apply?28
- 1.502 What foreign supplier verification program (FSVP) must I have?7
- 1.503 Who must develop my FSVP and perform FSVP activities?2
- 1.504 What hazard analysis must I conduct?25
- 1.505 What evaluation for foreign supplier approval and verification must I conduct?14
- 1.506 What foreign supplier verification and related activities must I conduct?28
- 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?21
- 1.508 What corrective actions must I take under my FSVP?3
- 1.509 How must the importer be identified at entry?2
- 1.510 How must I maintain records of my FSVP?12
- 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?30
- 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?38
- 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?4
- 1.514 What are some consequences of failing to comply with the requirements of this subpart?2
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?32
- 1.601 Who is subject to this subpart?20
- 1.610 Who is eligible to seek recognition?1
- 1.611 What legal authority must an accreditation body have to qualify for recognition?6
- 1.612 What competency and capacity must an accreditation body have to qualify for recognition?5
- 1.613 What protections against conflicts of interest must an accreditation body have to qualify for recognition?3
- 1.614 What quality assurance procedures must an accreditation body have to qualify for recognition?5
- 1.615 What records procedures must an accreditation body have to qualify for recognition?3
- 1.620 How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?11
- 1.621 How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?2
- 1.622 How must a recognized accreditation body monitor its own performance?13
- 1.623 What reports and notifications must a recognized accreditation body submit to FDA?25
- 1.624 How must a recognized accreditation body protect against conflicts of interest?9
- 1.625 What records requirements must an accreditation body that has been recognized meet?11
- 1.630 How do I apply to FDA for recognition or renewal of recognition?4
- 1.631 How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?11
- 1.632 What is the duration of recognition?1
- 1.633 How will FDA monitor recognized accreditation bodies?2
- 1.634 When will FDA revoke recognition?20
- 1.635 What if I want to voluntarily relinquish recognition or do not want to renew recognition?8
- 1.636 How do I request reinstatement of recognition?2
- 1.640 Who is eligible to seek accreditation?3
- 1.641 What legal authority must a third-party certification body have to qualify for accreditation?5
- 1.642 What competency and capacity must a third-party certification body have to qualify for accreditation?5
- 1.643 What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?3
- 1.644 What quality assurance procedures must a third-party certification body have to qualify for accreditation?5
- 1.645 What records procedures must a third-party certification body have to qualify for accreditation?3
- 1.650 How must an accredited third-party certification body ensure its audit agents are competent and objective?8
- 1.651 How must an accredited third-party certification body conduct a food safety audit of an eligible entity?19
- 1.652 What must an accredited third-party certification body include in food safety audit reports?29
- 1.653 What must an accredited third-party certification body do when issuing food or facility certifications?17
- 1.654 When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?1
- 1.655 How must an accredited third-party certification body monitor its own performance?16
- 1.656 What reports and notifications must an accredited third-party certification body submit?11
- 1.657 How must an accredited third-party certification body protect against conflicts of interest?11
- 1.658 What records requirements must a third-party certification body that has been accredited meet?11
- 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?4
- 1.661 What is the duration of accreditation by a recognized accreditation body?1
- 1.662 How will FDA monitor accredited third-party certification bodies?8
- 1.663 How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?7
- 1.664 When would FDA withdraw accreditation?19
- 1.665 What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?4
- 1.666 How do I request reaccreditation?6
- 1.670 How do I apply to FDA for direct accreditation or renewal of direct accreditation?6
- 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?8
- 1.672 What is the duration of direct accreditation?1
- 1.680 How and when will FDA monitor eligible entities?1
- 1.681 How frequently must eligible entities be recertified?1
- 1.690 How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?1
- 1.691 How do I request reconsideration of a denial by FDA of an application or a waiver request?4
- 1.692 How do I request internal agency review of a denial of an application or waiver request upon reconsideration?5
- 1.693 How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?9
- 1.694 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?1
- 1.695 Are the records obtained by FDA under this subpart subject to public disclosure?1
- 1.700 Who is subject to a user fee under this subpart?4
- 1.705 What user fees are established under this subpart?9
- 1.710 How will FDA notify the public about the fee schedule?1
- 1.715 When must a user fee required by this subpart be submitted?2
- 1.720 Are user fees under this subpart refundable?1
- 1.725 What are the consequences of not paying a user fee under this subpart on time?9
Subpart O: Sanitary Transportation of Human and Animal Food
- 1.900 Who is subject to this subpart?5
- 1.902 How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?2
- 1.904 What definitions apply to this subpart?20
- 1.906 What requirements apply to vehicles and transportation equipment?4
- 1.908 What requirements apply to transportation operations?27
- 1.910 What training requirements apply to carriers engaged in transportation operations?2
- 1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?12
- 1.914 Under what circumstances will we waive a requirement of this subpart?3
- 1.916 When will we consider whether to waive a requirement of this subpart?1
- 1.918 What must be included in the Statement of Grounds in a petition requesting a waiver?3
- 1.920 What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?1
- 1.922 Who will respond to a petition requesting a waiver?1
- 1.924 What process applies to a petition requesting a waiver?6
- 1.926 Under what circumstances may we deny a petition requesting a waiver?1
- 1.928 What process will we follow when waiving a requirement of this subpart on our own initiative?1
- 1.930 When will a waiver that we grant become effective?1
- 1.932 Under what circumstances may we modify or revoke a waiver?1
- 1.934 What procedures apply if we determine that a waiver should be modified or revoked?5
Subpart Q: Administrative Detention of Drugs Intended for Human or Animal Use
Subpart R: Laboratory Accreditation for Analyses of Foods
- 1.1101 What documents are incorporated by reference in this subpart4
- 1.1102 What definitions apply to this subpart?16
- 1.1103 Who is subject to this subpart?3
- 1.1107 When must food testing be conducted under this subpart?11
- 1.1108 When and how will FDA issue a directed food laboratory order?3
- 1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?5
- 1.1110 What are the general requirements for submitting information to FDA under this subpart?2
- 1.1113 What are the eligibility requirements for a recognized accreditation body?5
- 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?3
- 1.1115 How will FDA evaluate applications for recognition and renewal of recognition?8
- 1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?3
- 1.1117 How may an accreditation body request reinstatement of recognition?2
- 1.1119 What are the conflict of interest requirements for a recognized accreditation body?13
- 1.1120 How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?10
- 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?20
- 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
- 1.1123 What reports, notifications, and documentation must a recognized accreditation body submit to FDA?35
- 1.1124 What are the records requirements for a recognized accreditation body?11
- 1.1125 What are the internal audit requirements for a recognized accreditation body?1
- 1.1130 How will FDA oversee recognized accreditation bodies?5
- 1.1131 When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?16
- 1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?7
- 1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?3
- 1.1140 What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?2
- 1.1141 What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?4
- 1.1142 How does a laboratory request reinstatement of LAAF-accreditation?4
- 1.1147 What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?6
- 1.1149 What oversight standards apply to sampling?28
- 1.1150 What are the requirements for analysis of samples by a LAAF-accredited laboratory?8
- 1.1151 What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?16
- 1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?39
- 1.1153 What are the requirements for submitting abridged analytical reports?17
- 1.1154 What other records requirements must a LAAF-accredited laboratory meet?10
- 1.1159 How will FDA oversee LAAF-accredited laboratories?10
- 1.1160 How will FDA review test results and analytical reports?8
- 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?21
- 1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?5
- 1.1171 How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?3
- 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?8
- 1.1174 How does an owner or consignee request a regulatory hearing on a directed food laboratory order?8
- 1.1199 Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?1
- 1.1200 Are the records obtained by FDA under this subpart subject to public disclosure?1
Subpart S: Additional Traceability Records for Certain Foods
- 1.1300 Who is subject to this subpart?1
- 1.1305 What foods and persons are exempt from this subpart?53
- 1.1310 What definitions apply to this subpart?47
- 1.1315 What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?9
- 1.1320 When must I assign traceability lot codes to foods on the Food Traceability List?2
- 1.1325 What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?19
- 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?36
- 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?8
- 1.1340 What records must I keep and provide when I ship a food on the Food Traceability List?11
- 1.1345 What records must I keep when I receive a food on the Food Traceability List?18
- 1.1350 What records must I keep when I transform a food on the Food Traceability List?14
- 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?2
- 1.1365 When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?1
- 1.1370 What must be included in a petition requesting modified requirements or an exemption from the requirements?4
- 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
- 1.1380 What process applies to a petition requesting modified requirements or an exemption?6
- 1.1385 What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?2
- 1.1390 When will modified requirements that we adopt or an exemption that we grant become effective?1
- 1.1395 Under what circumstances may FDA revise or revoke modified requirements or an exemption?1
- 1.1400 What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?4
- 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?4
- 1.1410 When will FDA consider whether to waive a requirement of this subpart?3
- 1.1415 How may I request a waiver for an individual entity?6
- 1.1420 What process applies to a request for a waiver for an individual entity?2
- 1.1425 What must be included in a petition requesting a waiver for a type of entity?5
- 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
- 1.1435 What process applies to a petition requesting a waiver for a type of entity?6
- 1.1440 What process will FDA follow when waiving a requirement of this subpart on our own initiative?3
- 1.1445 Under what circumstances may FDA modify or revoke a waiver?4
- 1.1450 What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?6
- 1.1455 How must records required by this subpart be maintained and made available?19
- 1.1460 What consequences could result from failing to comply with the requirements of this subpart?2
- 1.1465 How will FDA update the Food Traceability List?3
Read 21 CFR part 1 at the eCFR · All of 21 CFR for food safety
Questions
- What does 21 CFR part 1 cover?
- 21 CFR part 1 is General Enforcement Regulations. It runs to 251 sections across 14 subparts and sits in subchapter A of chapter I, General.
Every section of part 1 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.