21 CFR Part 1
PART 1—GENERAL ENFORCEMENT REGULATIONS
- PART 1—GENERAL ENFORCEMENT REGULATIONS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- 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.
- Subpart C [Reserved]
- 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 [Reserved]
- 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?
- 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?
- 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.
- Subpart I—Prior Notice of Imported Food
- General Provisions
- § 1.276 What definitions apply to this subpart?
- § 1.277 What is the scope of this subpart?
- 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?
- 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?
- Subpart J—Establishment, Maintenance, and Availability of Records
- 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?
- 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?
- 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 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?
- Compliance Dates
- § 1.368 What are the compliance dates for this subpart?
- Subpart K—Administrative Detention of Food for Human or Animal Consumption
- 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?
- 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?
- 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?
- 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 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 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?
- 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?
- 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?
- 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 Eligible Entities Under This Subpart
- § 1.680 How and when will FDA monitor eligible entities?
- § 1.681 How frequently must eligible entities be recertified?
- 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?
- 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?
- Subpart N [Reserved]
- Subpart O—Sanitary Transportation of Human and Animal Food
- 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?
- Vehicles and Transportation Equipment
- § 1.906 What requirements apply to vehicles and transportation equipment?
- Transportation Operations
- § 1.908 What requirements apply to transportation operations?
- Training
- § 1.910 What training requirements apply to carriers engaged in transportation operations?
- Records
- § 1.912 What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
- 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?
- Subpart P [Reserved]
- 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
- 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?
- 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 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- 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?
- Consequences of Failure To Comply
- § 1.1460 What consequences could result from failing to comply with the requirements of this subpart?
- Updating the Food Traceability List
- § 1.1465 How will FDA update the Food Traceability List?
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