Home/CFR/Title 21/Part 1
FEDERAL · 21 CFR

Part 1 — General Enforcement Regulations

251 sections · Title 21: Food and Drugs

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