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- 21 CFR 1.402 · What are the requirements for submitting an appeal?
- 21 CFR 1.403 · What requirements apply to an informal hearing?
- 21 CFR 1.404 · Who serves as the presiding officer for an appeal and for an informal hearing?
- 21 CFR 1.405 · When does FDA have to issue a decision on an appeal?
- 21 CFR 1.406 · How will FDA handle classified information in an informal hearing?
- 21 CFR 1.500 · What definitions apply to this subpart?
- 21 CFR 1.501 · To what foods do the requirements in this subpart apply?
- 21 CFR 1.502 · What foreign supplier verification program (FSVP) must I have?
- 21 CFR 1.503 · Who must develop my FSVP and perform FSVP activities?
- 21 CFR 1.504 · What hazard analysis must I conduct?
- 21 CFR 1.505 · What evaluation for foreign supplier approval and verification must I conduct?
- 21 CFR 1.506 · What foreign supplier verification and related activities must I conduct?
- 21 CFR 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 CFR 1.508 · What corrective actions must I take under my FSVP?
- 21 CFR 1.509 · How must the importer be identified at entry?
- 21 CFR 1.510 · How must I maintain records of my FSVP?
- 21 CFR 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?
- 21 CFR 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?
- 21 CFR 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?
- 21 CFR 1.514 · What are some consequences of failing to comply with the requirements of this subpart?
- 21 CFR 1.600 · What definitions apply to this subpart?
- 21 CFR 1.601 · Who is subject to this subpart?
- 21 CFR 1.610 · Who is eligible to seek recognition?
- 21 CFR 1.611 · What legal authority must an accreditation body have to qualify for recognition?
- 21 CFR 1.612 · What competency and capacity must an accreditation body have to qualify for recognition?
- 21 CFR 1.613 · What protections against conflicts of interest must an accreditation body have to qualify for recognition?
- 21 CFR 1.614 · What quality assurance procedures must an accreditation body have to qualify for recognition?
- 21 CFR 1.615 · What records procedures must an accreditation body have to qualify for recognition?
- 21 CFR 1.620 · How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?
- 21 CFR 1.621 · How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?
- 21 CFR 1.622 · How must a recognized accreditation body monitor its own performance?
- 21 CFR 1.623 · What reports and notifications must a recognized accreditation body submit to FDA?
- 21 CFR 1.624 · How must a recognized accreditation body protect against conflicts of interest?
- 21 CFR 1.625 · What records requirements must an accreditation body that has been recognized meet?
- 21 CFR 1.630 · How do I apply to FDA for recognition or renewal of recognition?
- 21 CFR 1.631 · How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?
- 21 CFR 1.632 · What is the duration of recognition?
- 21 CFR 1.633 · How will FDA monitor recognized accreditation bodies?
- 21 CFR 1.634 · When will FDA revoke recognition?
- 21 CFR 1.635 · What if I want to voluntarily relinquish recognition or do not want to renew recognition?
- 21 CFR 1.636 · How do I request reinstatement of recognition?
- 21 CFR 1.640 · Who is eligible to seek accreditation?
- 21 CFR 1.641 · What legal authority must a third-party certification body have to qualify for accreditation?
- 21 CFR 1.642 · What competency and capacity must a third-party certification body have to qualify for accreditation?
- 21 CFR 1.643 · What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?
- 21 CFR 1.644 · What quality assurance procedures must a third-party certification body have to qualify for accreditation?
- 21 CFR 1.645 · What records procedures must a third-party certification body have to qualify for accreditation?
- 21 CFR 1.650 · How must an accredited third-party certification body ensure its audit agents are competent and objective?
- 21 CFR 1.651 · How must an accredited third-party certification body conduct a food safety audit of an eligible entity?
- 21 CFR 1.652 · What must an accredited third-party certification body include in food safety audit reports?
- 21 CFR 1.653 · What must an accredited third-party certification body do when issuing food or facility certifications?
- 21 CFR 1.654 · When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?
- 21 CFR 1.655 · How must an accredited third-party certification body monitor its own performance?
- 21 CFR 1.656 · What reports and notifications must an accredited third-party certification body submit?
- 21 CFR 1.657 · How must an accredited third-party certification body protect against conflicts of interest?
- 21 CFR 1.658 · What records requirements must a third-party certification body that has been accredited meet?
- 21 CFR 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?
- 21 CFR 1.661 · What is the duration of accreditation by a recognized accreditation body?
- 21 CFR 1.662 · How will FDA monitor accredited third-party certification bodies?
- 21 CFR 1.663 · How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?
- 21 CFR 1.664 · When would FDA withdraw accreditation?
- 21 CFR 1.665 · What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?
- 21 CFR 1.666 · How do I request reaccreditation?
- 21 CFR 1.670 · How do I apply to FDA for direct accreditation or renewal of direct accreditation?
- 21 CFR 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?
- 21 CFR 1.672 · What is the duration of direct accreditation?
- 21 CFR 1.680 · How and when will FDA monitor eligible entities?
- 21 CFR 1.681 · How frequently must eligible entities be recertified?
- 21 CFR 1.690 · How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?
- 21 CFR 1.691 · How do I request reconsideration of a denial by FDA of an application or a waiver request?
- 21 CFR 1.692 · How do I request internal agency review of a denial of an application or waiver request upon reconsideration?
- 21 CFR 1.693 · How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?
- 21 CFR 1.694 · Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
- 21 CFR 1.695 · Are the records obtained by FDA under this subpart subject to public disclosure?
- 21 CFR 1.700 · Who is subject to a user fee under this subpart?
- 21 CFR 1.705 · What user fees are established under this subpart?
- 21 CFR 1.710 · How will FDA notify the public about the fee schedule?
- 21 CFR 1.715 · When must a user fee required by this subpart be submitted?
- 21 CFR 1.720 · Are user fees under this subpart refundable?
- 21 CFR 1.725 · What are the consequences of not paying a user fee under this subpart on time?
- 21 CFR 1.900 · Who is subject to this subpart?
- 21 CFR 1.902 · How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?
- 21 CFR 1.904 · What definitions apply to this subpart?
- 21 CFR 1.906 · What requirements apply to vehicles and transportation equipment?
- 21 CFR 1.908 · What requirements apply to transportation operations?
- 21 CFR 1.910 · What training requirements apply to carriers engaged in transportation operations?
- 21 CFR 1.912 · What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?
- 21 CFR 1.914 · Under what circumstances will we waive a requirement of this subpart?
- 21 CFR 1.916 · When will we consider whether to waive a requirement of this subpart?
- 21 CFR 1.918 · What must be included in the Statement of Grounds in a petition requesting a waiver?
- 21 CFR 1.920 · What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?
- 21 CFR 1.922 · Who will respond to a petition requesting a waiver?
- 21 CFR 1.924 · What process applies to a petition requesting a waiver?
- 21 CFR 1.926 · Under what circumstances may we deny a petition requesting a waiver?
- 21 CFR 1.928 · What process will we follow when waiving a requirement of this subpart on our own initiative?
- 21 CFR 1.930 · When will a waiver that we grant become effective?
- 21 CFR 1.932 · Under what circumstances may we modify or revoke a waiver?
- 21 CFR 1.934 · What procedures apply if we determine that a waiver should be modified or revoked?
- 21 CFR 1.980 · Administrative detention of drugs.
- 21 CFR 1.1101 · What documents are incorporated by reference in this subpart