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Title 21 - Title 21
Part 1 - GENERAL ENFORCEMENT REGULATIONS
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GENERAL - GENERAL ENFORCEMENT REGULATIONS
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176 sections
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§1.1 - General.
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§1.101 - Notification and recordkeeping.
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§1.20 - Presence of mandatory label information.
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§1.21 - Failure to reveal material facts.
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§1.225 - Who must register under this subpart?
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§1.226 - Who does not have to register under this subpart?
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§1.227 - What definitions apply to this subpart?
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§1.23 - Procedures for requesting variations and exemptions from required label statements.
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§1.230 - When must you register or renew your registration?
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§1.231 - How and where do you register or renew your registration?
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§1.232 - What information is required in the registration?
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§1.233 - Are there optional items included in the registration form?
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§1.234 - How and when do you update your facility's registration information?
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§1.235 - How and when do you cancel your facility's registration information?
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§1.24 - Exemptions from required label statements.
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§1.240 - What other registration requirements apply?
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§1.241 - What are the consequences of failing to register, update, renew, or cancel your registration?
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§1.242 - What does assignment of a registration number mean?
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§1.243 - Is food registration information available to the public?
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§1.245 - Waiver request.
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§1.276 - What definitions apply to this subpart?
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§1.277 - What is the scope of this subpart?
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§1.278 - Who is authorized to submit prior notice?
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§1.279 - When must prior notice be submitted to FDA?
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§1.280 - How must you submit prior notice?
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§1.281 - What information must be in a prior notice?
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§1.282 - What must you do if information changes after you have received confirmation of a prior notice from FDA?
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§1.283 - What happens to food that is imported or offered for import without adequate prior notice?
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§1.284 - What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
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§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?
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§1.3 - Definitions.
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§1.326 - Who is subject to this subpart?
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§1.327 - Who is excluded from all or part of the regulations in this subpart?
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§1.328 - What definitions apply to this subpart?
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§1.329 - Do other statutory provisions and regulations apply?
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§1.330 - Can existing records satisfy the requirements of this subpart?
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§1.337 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?
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§1.345 - What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
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§1.352 - What information must transporters establish and maintain?
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§1.360 - What are the record retention requirements?
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§1.361 - What are the record availability requirements?
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§1.362 - What records are excluded from this subpart?
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§1.363 - What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?
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§1.368 - What are the compliance dates for this subpart?
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§1.377 - What definitions apply to this subpart?
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§1.378 - What criteria does FDA use to order a detention?
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§1.379 - How long may FDA detain an article of food?
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§1.380 - Where and under what conditions must the detained article of food be held?
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§1.381 - May a detained article of food be delivered to another entity or transferred to another location?
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§1.382 - What labeling or marking requirements apply to a detained article of food?
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§1.383 - What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
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§1.384 - When does a detention order terminate?
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§1.391 - Who approves a detention order?
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§1.392 - Who receives a copy of the detention order?
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§1.393 - What information must FDA include in the detention order?
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§1.4 - Authority citations.
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§1.401 - Who is entitled to appeal?
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§1.402 - What are the requirements for submitting an appeal?
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§1.403 - What requirements apply to an informal hearing?
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§1.404 - Who serves as the presiding officer for an appeal and for an informal hearing?
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§1.405 - When does FDA have to issue a decision on an appeal?
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§1.406 - How will FDA handle classified information in an informal hearing?
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§1.500 - What definitions apply to this subpart?
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§1.501 - To what foods do the requirements in this subpart apply?
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§1.502 - What foreign supplier verification program (FSVP) must I have?
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§1.503 - Who must develop my FSVP and perform FSVP activities?
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§1.504 - What hazard analysis must I conduct?
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§1.505 - What evaluation for foreign supplier approval and verification must I conduct?
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§1.506 - What foreign supplier verification and related activities must I conduct?
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§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?
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§1.508 - What corrective actions must I take under my FSVP?
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§1.509 - How must the importer be identified at entry?
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§1.510 - How must I maintain records of my FSVP?
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§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?
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§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?
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§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?
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§1.514 - What are some consequences of failing to comply with the requirements of this subpart?
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§1.600 - What definitions apply to this subpart?
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§1.601 - Who is subject to this subpart?
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§1.610 - Who is eligible to seek recognition?
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§1.611 - What legal authority must an accreditation body have to qualify for recognition?
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§1.612 - What competency and capacity must an accreditation body have to qualify for recognition?
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§1.613 - What protections against conflicts of interest must an accreditation body have to qualify for recognition?
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§1.614 - What quality assurance procedures must an accreditation body have to qualify for recognition?
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§1.615 - What records procedures must an accreditation body have to qualify for recognition?
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§1.620 - How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
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§1.621 - How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
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§1.622 - How must a recognized accreditation body monitor its own performance?
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§1.623 - What reports and notifications must a recognized accreditation body submit to FDA?
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§1.624 - How must a recognized accreditation body protect against conflicts of interest?
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§1.625 - What records requirements must an accreditation body that has been recognized meet?
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§1.630 - How do I apply to FDA for recognition or renewal of recognition?
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§1.631 - How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
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§1.632 - What is the duration of recognition?
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§1.633 - How will FDA monitor recognized accreditation bodies?
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§1.634 - When will FDA revoke recognition?
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§1.635 - What if I want to voluntarily relinquish recognition or do not want to renew recognition?
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§1.636 - How do I request reinstatement of recognition?
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§1.640 - Who is eligible to seek accreditation?
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§1.641 - What legal authority must a third-party certification body have to qualify for accreditation?
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§1.642 - What competency and capacity must a third-party certification body have to qualify for accreditation?
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§1.643 - What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
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§1.644 - What quality assurance procedures must a third-party certification body have to qualify for accreditation?
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§1.645 - What records procedures must a third-party certification body have to qualify for accreditation?
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§1.650 - How must an accredited third-party certification body ensure its audit agents are competent and objective?
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§1.651 - How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
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§1.652 - What must an accredited third-party certification body include in food safety audit reports?
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§1.653 - What must an accredited third-party certification body do when issuing food or facility certifications?
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§1.654 - When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
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§1.655 - How must an accredited third-party certification body monitor its own performance?
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§1.656 - What reports and notifications must an accredited third-party certification body submit?
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§1.657 - How must an accredited third-party certification body protect against conflicts of interest?
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§1.658 - What records requirements must a third-party certification body that has been accredited meet?
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§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?
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§1.661 - What is the duration of accreditation by a recognized accreditation body?
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§1.662 - How will FDA monitor accredited third-party certification bodies?
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§1.663 - How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
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§1.664 - When would FDA withdraw accreditation?
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§1.665 - What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
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§1.666 - How do I request reaccreditation?
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§1.670 - How do I apply to FDA for direct accreditation or renewal of direct accreditation?
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§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?
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§1.672 - What is the duration of direct accreditation?
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§1.680 - How and when will FDA monitor eligible entities?
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§1.681 - How frequently must eligible entities be recertified?
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§1.690 - How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
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§1.691 - How do I request reconsideration of a denial by FDA of an application or a waiver request?
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§1.692 - How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
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§1.693 - How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
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§1.694 - Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
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§1.695 - Are the records obtained by FDA under this subpart subject to public disclosure?
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§1.70 - Scope.
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§1.700 - Who is subject to a user fee under this subpart?
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§1.705 - What user fees are established under this subpart?
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§1.71 - Definitions.
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§1.710 - How will FDA notify the public about the fee schedule?
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§1.715 - When must a user fee required by this subpart be submitted?
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§1.72 - Data elements that must be submitted in ACE for articles regulated by FDA.
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§1.720 - Are user fees under this subpart refundable?
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§1.725 - What are the consequences of not paying a user fee under this subpart on time?
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§1.73 - Food.
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§1.74 - Human drugs.
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§1.75 - Animal drugs.
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§1.76 - Medical devices.
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§1.77 - Radiation-emitting electronic products.
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§1.78 - Biological products, HCT/Ps, and related drugs and medical devices.
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§1.79 - Tobacco products.
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§1.80 - Cosmetics.
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§1.81 - Rejection of entry filing.
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§1.83 - Definitions.
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§1.90 - Notice of sampling.
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§1.900 - Who is subject to this subpart?
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§1.902 - How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?
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§1.904 - What definitions apply to this subpart?
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§1.906 - What requirements apply to vehicles and transportation equipment?
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§1.908 - What requirements apply to transportation operations?
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§1.91 - Payment for samples.
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§1.910 - What training requirements apply to carriers engaged in transportation operations?
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§1.912 - What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
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§1.914 - Under what circumstances will we waive a requirement of this subpart?
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§1.916 - When will we consider whether to waive a requirement of this subpart?
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§1.918 - What must be included in the Statement of Grounds in a petition requesting a waiver?
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§1.920 - What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?
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§1.922 - Who will respond to a petition requesting a waiver?
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§1.924 - What process applies to a petition requesting a waiver?
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§1.926 - Under what circumstances may we deny a petition requesting a waiver?
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§1.928 - What process will we follow when waiving a requirement of this subpart on our own initiative?
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§1.930 - When will a waiver that we grant become effective?
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§1.932 - Under what circumstances may we modify or revoke a waiver?
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§1.934 - What procedures apply if we determine that a waiver should be modified or revoked?
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§1.94 - Hearing on refusal of admission or destruction.
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§1.95 - Application for authorization to relabel and recondition.
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§1.96 - Granting of authorization to relabel and recondition.
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§1.97 - Bonds.
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§1.980 - Administrative detention of drugs.
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§1.99 - Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
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