21 Food and Drugs 1 2010-04-01 2010-04-01 false Table Of Contents Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL GENERAL ENFORCEMENT REGULATIONS Subpart A—General Provisions Sec. 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? Authority:

15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355, 360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262, 264.

Source:

42 FR 15553, Mar. 22, 1977, unless otherwise noted.