• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-

The information on this page is current as of April 1 2015.

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

New Search
Help | More About 21CFR
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.
   § 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?

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 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, 343, 350c, 350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 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.

-
-