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Electronic Code of Federal Regulations

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e-CFR Data is current as of April 17, 2014

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL

PART 1—GENERAL ENFORCEMENT REGULATIONS

rule

Subpart A—GENERAL PROVISIONS

§1.1
General.
§1.3
Definitions.
§1.4
Authority citations.
rule

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.
rule

Subparts C-D [Reserved]

rule

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.
§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.
rule

Subparts F-G [Reserved]

rule

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?
rule

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?
rule

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?
rule

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?


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