21 C.F.R. PART 1--GENERAL ENFORCEMENT REGULATIONS
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
Subpart A--GENERAL PROVISIONS
Subpart B--GENERAL LABELING REQUIREMENTS
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| Presence of mandatory label information.
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| Failure to reveal material facts.
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| Procedures for requesting variations and exemptions from required label statements.
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| Exemptions from required label statements.
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Subparts C-D--[RESERVED]
Subpart E--IMPORTS AND EXPORTS
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| Hearing on refusal of admission.
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| Application for authorization to relabel and recondition.
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| Granting of authorization to relabel and recondition.
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| Costs chargeable in connection with relabeling and reconditioning inadmissible imports.
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| Notification and recordkeeping.
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Subparts F-G--[RESERVED]
Subpart H--REGISTRATION OF FOOD FACILITIES
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| Who must register under this subpart?
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| Who does not have to register under this subpart?
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| What definitions apply to this subpart?
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| How and where do you register?
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| What information is required in the registration?
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| What optional items are included in the registration form?
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| How and when do you update your facility's registration information?
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| How and when do you cancel your facility's registration information?
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| What other registration requirements apply?
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| What are the consequences of failing to register, update, or cancel your registration?
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| What does assignment of a registration number mean?
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| Is food registration information available to the public?
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Subpart I--PRIOR NOTICE OF IMPORTED FOOD
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| What definitions apply to this subpart?
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| What is the scope of this subpart?
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| Who is authorized to submit prior notice?
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| When must prior notice be submitted to FDA?
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| How must you submit prior notice?
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| What information must be in a prior notice?
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| What must you do if information changes after you have received confirmation of a prior notice from FDA?
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| What happens to food that is imported or offered for import without adequate prior notice?
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| What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?
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| 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?
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Subpart J--ESTABLISHMENT, MAINTENANCE, AND AVAILABILITY OF RECORDS
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| Who is subject to this subpart?
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| Who is excluded from all or part of the regulations in this subpart?
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| What definitions apply to this subpart?
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| Do other statutory provisions and regulations apply?
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| Can existing records satisfy the requirements of this subpart?
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| What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?
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| What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?
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| What information must transporters establish and maintain?
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| What are the record retention requirements?
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| What are the record availability requirements?
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| What records are excluded from this subpart?
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| What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?
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| What are the compliance dates for this subpart?
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Subpart K--ADMINISTRATIVE DETENTION OF FOOD FOR HUMAN OR ANIMAL CONSUMPTION
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| What definitions apply to this subpart?
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| What criteria does FDA use to order a detention?
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| How long may FDA detain an article of food?
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| Where and under what conditions must the detained article of food be held?
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| May a detained article of food be delivered to another entity or transferred to another location?
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| What labeling or marking requirements apply to a detained article of food?
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| What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?
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| When does a detention order terminate?
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| Who approves a detention order?
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| Who receives a copy of the detention order?
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| What information must FDA include in the detention order?
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| Who is entitled to appeal?
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| What are the requirements for submitting an appeal?
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| What requirements apply to an informal hearing?
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| Who serves as the presiding officer for an appeal, and for an informal hearing?
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| When does FDA have to issue a decision on an appeal?
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| How will FDA handle classified information in an informal hearing?
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