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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2016.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 1GENERAL ENFORCEMENT REGULATIONS
 

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.

Subparts C-D [Reserved]

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?
   § 1.231 - How and where do you register?
   § 1.232 - What information is required in the registration?
   § 1.233 - What optional items are 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, 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 - [Reserved]

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

 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?

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.

Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342i, 343, 350c, 350d, 350e, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 373, 374, 381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.
Source: 42 FR 15553, Mar. 22, 1977, unless otherwise noted.

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