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Title 21 - Food and Drugs
CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 1 - GENERAL ENFORCEMENT REGULATIONS
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| 1-1 | General. | ||
| 1-3 | Definitions. | ||
| 1-4 | Authority citations. | ||
| 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. | ||
| 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. | ||
| 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? | ||
| 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? | ||
| 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? | ||
| 1-276 | What definitions apply to this subpart? | ||
| 1-277 | What is the scope of this subpart? | ||
| 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? | ||
| 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 21 CFR part 1, subpart H? | ||
| 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? | ||
| 1-337 | What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food? | ||
| 1-345 | What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food? | ||
| 1-352 | What information must transporters establish and maintain? | ||
| 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? | ||
| 1-368 | What are the compliance dates for this subpart? | ||
| 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? | ||
| 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? | ||
| 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? | ||