Title 21, Part 1 — General Enforcement Regulations

General.

Definitions.

Authority citations.

Presence of mandatory label information.

Failure to reveal material facts.

Procedures for requesting variations and exemptions from required label statements.

Exemptions from required label statements.

Scope.

Definitions.

Data elements that must be submitted in ACE for articles regulated by FDA.

Food.

Human drugs.

Animal drugs and veterinary devices.

Medical devices.

Radiation-emitting electronic products.

Biological products, HCT/Ps, and related drugs and medical devices.

Tobacco products.

Cosmetics.

Rejection of entry filing.

Definitions.

Notice of sampling.

Payment for samples.

Hearing on refusal of admission or destruction.

Application for authorization to relabel and recondition.

Granting of authorization to relabel and recondition.

Bonds.

Costs chargeable in connection with relabeling and reconditioning inadmissible imports.

Notification and recordkeeping.

Who must register under this subpart?

Who does not have to register under this subpart?

What definitions apply to this subpart?

When must you register or renew your registration?

How and where do you register or renew your registration?

What information is required in the registration?

Are there optional items included in the registration form?

How and when do you update your facility's registration information?

How and when do you cancel your facility's registration information?

What other registration requirements apply?

What are the consequences of failing to register, update, renew, or cancel your registration?

What does assignment of a registration number mean?

Is food registration information available to the public?

Waiver request.

What definitions apply to this subpart?

What is the scope of this subpart?

Who is authorized to submit prior notice?

When must prior notice be submitted to FDA?

How must you submit prior notice?

What information must be in a prior notice?

What must you do if information changes after you have received confirmation of a prior notice from FDA?

What happens to food that is imported or offered for import without adequate prior notice?

What are the other consequences of failing to submit adequate prior notice or otherwise failing to comply with this subpart?

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?

Who is subject to this subpart?

Who is excluded from all or part of the regulations in this subpart?

What definitions apply to this subpart?

Do other statutory provisions and regulations apply?

Can existing records satisfy the requirements of this subpart?

What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate previous sources of food?

What information must nontransporters establish and maintain to identify the nontransporter and transporter immediate subsequent recipients of food?

What information must transporters establish and maintain?

What are the record retention requirements?

What are the record availability requirements?

What records are excluded from this subpart?

What are the consequences of failing to establish or maintain records or make them available to FDA as required by this subpart?

What are the compliance dates for this subpart?

What definitions apply to this subpart?

What criteria does FDA use to order a detention?

How long may FDA detain an article of food?

Where and under what conditions must the detained article of food be held?

May a detained article of food be delivered to another entity or transferred to another location?

What labeling or marking requirements apply to a detained article of food?

What expedited procedures apply when FDA initiates a seizure action against a detained perishable food?

When does a detention order terminate?

Who approves a detention order?

Who receives a copy of the detention order?

What information must FDA include in the detention order?

Who is entitled to appeal?

What are the requirements for submitting an appeal?

What requirements apply to an informal hearing?

Who serves as the presiding officer for an appeal and for an informal hearing?

When does FDA have to issue a decision on an appeal?

How will FDA handle classified information in an informal hearing?

What definitions apply to this subpart?

To what foods do the requirements in this subpart apply?

What foreign supplier verification program (FSVP) must I have?

Who must develop my FSVP and perform FSVP activities?

What hazard analysis must I conduct?

What evaluation for foreign supplier approval and verification must I conduct?

What foreign supplier verification and related activities must I conduct?

What requirements apply when I import a food that cannot be consumed without the hazards being controlled or for which the hazards are controlled after importation?

What corrective actions must I take under my FSVP?

How must the importer be identified at entry?

How must I maintain records of my FSVP?

What FSVP must I have if I am importing a food subject to certain requirements in the dietary supplement current good manufacturing practice regulation?

What FSVP may I have if I am a very small importer or I am importing certain food from certain small foreign suppliers?

What FSVP may I have if I am importing certain food from a country with an officially recognized or equivalent food safety system?

What are some consequences of failing to comply with the requirements of this subpart?

What definitions apply to this subpart?

Who is subject to this subpart?

Who is eligible to seek recognition?

What legal authority must an accreditation body have to qualify for recognition?

What competency and capacity must an accreditation body have to qualify for recognition?

What protections against conflicts of interest must an accreditation body have to qualify for recognition?

What quality assurance procedures must an accreditation body have to qualify for recognition?

What records procedures must an accreditation body have to qualify for recognition?

How must a recognized accreditation body evaluate third-party certification bodies seeking accreditation?

How must a recognized accreditation body monitor the performance of third-party certification bodies it accredited?

How must a recognized accreditation body monitor its own performance?

What reports and notifications must a recognized accreditation body submit to FDA?

How must a recognized accreditation body protect against conflicts of interest?

What records requirements must an accreditation body that has been recognized meet?

How do I apply to FDA for recognition or renewal of recognition?

How will FDA review my application for recognition or renewal of recognition and what happens once FDA decides on my application?

What is the duration of recognition?

How will FDA monitor recognized accreditation bodies?

When will FDA revoke recognition?

What if I want to voluntarily relinquish recognition or do not want to renew recognition?

How do I request reinstatement of recognition?

Who is eligible to seek accreditation?

What legal authority must a third-party certification body have to qualify for accreditation?

What competency and capacity must a third-party certification body have to qualify for accreditation?

What protections against conflicts of interest must a third-party certification body have to qualify for accreditation?

What quality assurance procedures must a third-party certification body have to qualify for accreditation?

What records procedures must a third-party certification body have to qualify for accreditation?

How must an accredited third-party certification body ensure its audit agents are competent and objective?

How must an accredited third-party certification body conduct a food safety audit of an eligible entity?

What must an accredited third-party certification body include in food safety audit reports?

What must an accredited third-party certification body do when issuing food or facility certifications?

When must an accredited third-party certification body monitor an eligible entity that it has issued a food or facility certification?

How must an accredited third-party certification body monitor its own performance?

What reports and notifications must an accredited third-party certification body submit?

How must an accredited third-party certification body protect against conflicts of interest?

What records requirements must a third-party certification body that has been accredited meet?

Where do I apply for accreditation or renewal of accreditation by a recognized accreditation body and what happens once the recognized accreditation body decides on my application?

What is the duration of accreditation by a recognized accreditation body?

How will FDA monitor accredited third-party certification bodies?

How do I request an FDA waiver or waiver extension for the 13-month limit for audit agents conducting regulatory audits?

When would FDA withdraw accreditation?

What if I want to voluntarily relinquish accreditation or do not want to renew accreditation?

How do I request reaccreditation?

How do I apply to FDA for direct accreditation or renewal of direct accreditation?

How will FDA review my application for direct accreditation or renewal of direct accreditation and what happens once FDA decides on my application?

What is the duration of direct accreditation?

How and when will FDA monitor eligible entities?

How frequently must eligible entities be recertified?

How will FDA make information about recognized accreditation bodies and accredited third-party certification bodies available to the public?

How do I request reconsideration of a denial by FDA of an application or a waiver request?

How do I request internal agency review of a denial of an application or waiver request upon reconsideration?

How do I request a regulatory hearing on a revocation of recognition or withdrawal of accreditation?

Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?

Are the records obtained by FDA under this subpart subject to public disclosure?

Who is subject to a user fee under this subpart?

What user fees are established under this subpart?

How will FDA notify the public about the fee schedule?

When must a user fee required by this subpart be submitted?

Are user fees under this subpart refundable?

What are the consequences of not paying a user fee under this subpart on time?

Who is subject to this subpart?

How do the criteria and definitions in this subpart apply under the Federal Food, Drug, and Cosmetic Act?

What definitions apply to this subpart?

What requirements apply to vehicles and transportation equipment?

What requirements apply to transportation operations?

What training requirements apply to carriers engaged in transportation operations?

What record retention and other records requirements apply to shippers, receivers, loaders, and carriers engaged in transportation operations?

Under what circumstances will we waive a requirement of this subpart?

When will we consider whether to waive a requirement of this subpart?

What must be included in the Statement of Grounds in a petition requesting a waiver?

What information submitted in a petition requesting a waiver or submitted in comments on such a petition is publicly available?

Who will respond to a petition requesting a waiver?

What process applies to a petition requesting a waiver?

Under what circumstances may we deny a petition requesting a waiver?

What process will we follow when waiving a requirement of this subpart on our own initiative?

When will a waiver that we grant become effective?

Under what circumstances may we modify or revoke a waiver?

What procedures apply if we determine that a waiver should be modified or revoked?

Administrative detention of drugs.

What documents are incorporated by reference in this subpart

What definitions apply to this subpart?

Who is subject to this subpart?

When must food testing be conducted under this subpart?

When and how will FDA issue a directed food laboratory order?

How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?

What are the general requirements for submitting information to FDA under this subpart?

What are the eligibility requirements for a recognized accreditation body?

How does an accreditation body apply to FDA for recognition or renewal of recognition?

How will FDA evaluate applications for recognition and renewal of recognition?

What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?

How may an accreditation body request reinstatement of recognition?

What are the conflict of interest requirements for a recognized accreditation body?

How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?

When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?

What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?

What reports, notifications, and documentation must a recognized accreditation body submit to FDA?

What are the records requirements for a recognized accreditation body?

What are the internal audit requirements for a recognized accreditation body?

How will FDA oversee recognized accreditation bodies?

When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?

What are the eligibility requirements for a LAAF-accredited laboratory?

How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?

What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?

What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?

How does a laboratory request reinstatement of LAAF-accreditation?

What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?

What oversight standards apply to sampling?

What are the requirements for analysis of samples by a LAAF-accredited laboratory?

What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?

What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?

What are the requirements for submitting abridged analytical reports?

What other records requirements must a LAAF-accredited laboratory meet?

How will FDA oversee LAAF-accredited laboratories?

How will FDA review test results and analytical reports?

When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?

What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?

How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?

How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?

How does an owner or consignee request a regulatory hearing on a directed food laboratory order?

Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?

Are the records obtained by FDA under this subpart subject to public disclosure?

Who is subject to this subpart?

What foods and persons are exempt from this subpart?

What definitions apply to this subpart?

What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?

When must I assign traceability lot codes to foods on the Food Traceability List?

What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?

What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?

What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?

What records must I keep and provide when I ship a food on the Food Traceability List?

What records must I keep when I receive a food on the Food Traceability List?

What records must I keep when I transform a food on the Food Traceability List?

Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?

When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?

What must be included in a petition requesting modified requirements or an exemption from the requirements?

What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?

What process applies to a petition requesting modified requirements or an exemption?

What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?

When will modified requirements that we adopt or an exemption that we grant become effective?

Under what circumstances may FDA revise or revoke modified requirements or an exemption?

What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?

Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?

When will FDA consider whether to waive a requirement of this subpart?

How may I request a waiver for an individual entity?

What process applies to a request for a waiver for an individual entity?

What must be included in a petition requesting a waiver for a type of entity?

What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?

What process applies to a petition requesting a waiver for a type of entity?

What process will FDA follow when waiving a requirement of this subpart on our own initiative?

Under what circumstances may FDA modify or revoke a waiver?

What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?

How must records required by this subpart be maintained and made available?

What consequences could result from failing to comply with the requirements of this subpart?

How will FDA update the Food Traceability List?