§ 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.

§ 1.70 Scope.

§ 1.71 Definitions.

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

§ 1.73 Food.

§ 1.74 Human drugs.

§ 1.75 Animal drugs.

§ 1.76 Medical devices.

§ 1.77 Radiation-emitting electronic products.

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

§ 1.79 Tobacco products.

§ 1.80 Cosmetics.

§ 1.81 Rejection of entry filing.

§ 1.83 Definitions.

§ 1.90 Notice of sampling.

§ 1.91 Payment for samples.

§ 1.94 Hearing on refusal of admission or destruction.

§ 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 or renew your registration?

§ 1.231 How and where do you register or renew your registration?

§ 1.232 What information is required in the registration?

§ 1.233 Are there optional items 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, renew, or cancel your registration?

§ 1.242 What does assignment of a registration number mean?

§ 1.243 Is food registration information available to the public?

§ 1.245 Waiver request.

§ 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 subpart H of this part?

§ 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?

§ 1.500 What definitions apply to this subpart?

§ 1.501 To what foods do the requirements in this subpart apply?

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

§ 1.503 Who must develop my FSVP and perform FSVP activities?

§ 1.504 What hazard analysis must I conduct?

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

§ 1.506 What foreign supplier verification and related activities must I conduct?

§ 1.507 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?

§ 1.508 What corrective actions must I take under my FSVP?

§ 1.509 How must the importer be identified at entry?

§ 1.510 How must I maintain records of my FSVP?

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

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

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

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

§ 1.610 Who is eligible to seek recognition?

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

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

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

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

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

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

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

§ 1.622 How must a recognized accreditation body monitor its own performance?

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

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

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

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

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

§ 1.632 What is the duration of recognition?

§ 1.633 How will FDA monitor recognized accreditation bodies?

§ 1.634 When will FDA revoke recognition?

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

§ 1.636 How do I request reinstatement of recognition?

§ 1.640 Who is eligible to seek accreditation?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

§ 1.660 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?

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

§ 1.662 How will FDA monitor accredited third-party certification bodies?

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

§ 1.664 When would FDA withdraw accreditation?

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

§ 1.666 How do I request reaccreditation?

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

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

§ 1.672 What is the duration of direct accreditation?

§ 1.680 How and when will FDA monitor eligible entities?

§ 1.681 How frequently must eligible entities be recertified?

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

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

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

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

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

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

§ 1.700 Who is subject to a user fee under this subpart?

§ 1.705 What user fees are established under this subpart?

§ 1.710 How will FDA notify the public about the fee schedule?

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

§ 1.720 Are user fees under this subpart refundable?

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

§ 1.900 Who is subject to this subpart?

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

§ 1.904 What definitions apply to this subpart?

§ 1.906 What requirements apply to vehicles and transportation equipment?

§ 1.908 What requirements apply to transportation operations?

§ 1.910 What training requirements apply to carriers engaged in transportation operations?

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

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

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

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

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

§ 1.922 Who will respond to a petition requesting a waiver?

§ 1.924 What process applies to a petition requesting a waiver?

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

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

§ 1.930 When will a waiver that we grant become effective?

§ 1.932 Under what circumstances may we modify or revoke a waiver?

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

§ 1.980 Administrative detention of drugs.

§ 2.5 Imminent hazard to the public health.

§ 2.10 Examination and investigation samples.

§ 2.19 Methods of analysis.

§ 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.

§ 2.35 Use of secondhand containers for the shipment or storage of food and animal feed.

§ 2.110 Definition of ammonia under Federal Caustic Poison Act.

§ 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.

§ 3.1 Purpose.

§ 3.2 Definitions.

§ 3.3 Scope.

§ 3.4 Designated agency component.

§ 3.5 Procedures for identifying the designated agency component.

§ 3.6 Product jurisdiction officer.

§ 3.7 Request for designation.

§ 3.8 Letter of designation.

§ 3.9 Effect of letter of designation.

§ 3.10 Stay of review time.

§ 4.1 What is the scope of this subpart?

§ 4.2 How does FDA define key terms and phrases in this subpart?

§ 4.3 What current good manufacturing practice requirements apply to my combination product?

§ 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?

§ 4.100 What is the scope of this subpart?

§ 4.101 How does the FDA define key terms and phrases in this subpart?

§ 4.102 What reports must you submit to FDA for your combination product or constituent part?

§ 4.103 What information must you share with other constituent part applicants for the combination product?

§ 4.104 How and where must you submit postmarketing safety reports for your combination product or constituent part?

§ 4.105 What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?

§ 5.1100 Headquarters.

§ 5.1105 Chief Counsel, Food and Drug Administration.

§ 5.1110 FDA public information offices.

§ 7.1 Scope.

§ 7.3 Definitions.

§ 7.12 Guaranty.

§ 7.13 Suggested forms of guaranty.

§ 7.40 Recall policy.

§ 7.41 Health hazard evaluation and recall classification.

§ 7.42 Recall strategy.

§ 7.45 Food and Drug Administration-requested recall.

§ 7.46 Firm-initiated recall.

§ 7.49 Recall communications.

§ 7.50 Public notification of recall.

§ 7.53 Recall status reports.

§ 7.55 Termination of a recall.

§ 7.59 General industry guidance.

§ 7.84 Opportunity for presentation of views before report of criminal violation.

§ 7.85 Conduct of a presentation of views before report of criminal violation.

§ 7.87 Records related to opportunities for presentation of views conducted before report of criminal violation.

§ 10.1 Scope.

§ 10.3 Definitions.

§ 10.10 Summaries of administrative practices and procedures.

§ 10.19 Waiver, suspension, or modification of procedural requirements.

§ 10.20 Submission of documents to Division of Dockets Management; computation of time; availability for public disclosure.

§ 10.25 Initiation of administrative proceedings.

§ 10.30 Citizen petition.

§ 10.31 Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.

§ 10.33 Administrative reconsideration of action.

§ 10.35 Administrative stay of action.

§ 10.40 Promulgation of regulations for the efficient enforcement of the law.

§ 10.45 Court review of final administrative action; exhaustion of administrative remedies.

§ 10.50 Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.

§ 10.55 Separation of functions; ex parte communications.

§ 10.60 Referral by court.

§ 10.65 Meetings and correspondence.

§ 10.70 Documentation of significant decisions in administrative file.

§ 10.75 Internal agency review of decisions.

§ 10.80 Dissemination of draft Federal Register notices and regulations.

§ 10.85 Advisory opinions.

§ 10.90 Food and Drug Administration regulations, recommendations, and agreements.

§ 10.95 Participation in outside standard-setting activities.

§ 10.100 Public calendar.

§ 10.105 Representation by an organization.

§ 10.110 Settlement proposals.

§ 10.115 Good guidance practices.

§ 10.200 Scope.

§ 10.203 Definitions.

§ 10.204 General.

§ 10.205 Electronic media coverage of public administrative proceedings.

§ 10.206 Procedures for electronic media coverage of agency public administrative proceedings.

§ 11.1 Scope.

§ 11.2 Implementation.

§ 11.3 Definitions.

§ 11.10 Controls for closed systems.

§ 11.30 Controls for open systems.

§ 11.50 Signature manifestations.

§ 11.70 Signature/record linking.

§ 11.100 General requirements.

§ 11.200 Electronic signature components and controls.

§ 11.300 Controls for identification codes/passwords.

§ 12.1 Scope.

§ 12.20 Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.

§ 12.21 Initiation of a hearing involving the issuance, amendment, or revocation of an order.

§ 12.22 Filing objections and requests for a hearing on a regulation or order.

§ 12.23 Notice of filing of objections.

§ 12.24 Ruling on objections and requests for hearing.

§ 12.26 Modification or revocation of regulation or order.

§ 12.28 Denial of hearing in whole or in part.

§ 12.30 Judicial review after waiver of hearing on a regulation.

§ 12.32 Request for alternative form of hearing.

§ 12.35 Notice of hearing; stay of action.

§ 12.37 Effective date of a regulation.

§ 12.38 Effective date of an order.

§ 12.40 Appearance.

§ 12.45 Notice of participation.

§ 12.50 Advice on public participation in hearings.

§ 12.60 Presiding officer.

§ 12.62 Commencement of functions.

§ 12.70 Authority of presiding officer.

§ 12.75 Disqualification of presiding officer.

§ 12.78 Unavailability of presiding officer.

§ 12.80 Filing and service of submissions.

§ 12.82 Petition to participate in forma pauperis.

§ 12.83 Advisory opinions.

§ 12.85 Disclosure of data and information by the participants.

§ 12.87 Purpose; oral and written testimony; burden of proof.

§ 12.89 Participation of nonparties.

§ 12.90 Conduct at oral hearings or conferences.

§ 12.91 Time and place of prehearing conference.

§ 12.92 Prehearing conference procedure.

§ 12.93 Summary decisions.

§ 12.94 Receipt of evidence.

§ 12.95 Official notice.

§ 12.96 Briefs and arguments.

§ 12.97 Interlocutory appeal from ruling of presiding officer.

§ 12.98 Official transcript.

§ 12.99 Motions.

§ 12.100 Administrative record of a hearing.

§ 12.105 Examination of record.

§ 12.120 Initial decision.

§ 12.125 Appeal from or review of initial decision.

§ 12.130 Decision by Commissioner on appeal or review of initial decision.

§ 12.139 Reconsideration and stay of action.

§ 12.140 Review by the courts.

§ 12.159 Copies of petitions for judicial review.

§ 13.1 Scope.

§ 13.5 Notice of a hearing before a Board.

§ 13.10 Members of a Board.

§ 13.15 Separation of functions; ex parte communications; administrative support.

§ 13.20 Submissions to a Board.

§ 13.25 Disclosure of data and information by the participants.

§ 13.30 Proceedings of a Board.

§ 13.40 Administrative record of a Board.

§ 13.45 Examination of administrative record.

§ 13.50 Record for administrative decision.

§ 14.1 Scope.

§ 14.5 Purpose of proceedings before an advisory committee.

§ 14.7 Administrative remedies.

§ 14.10 Applicability to Congress.

§ 14.15 Committees working under a contract with FDA.

§ 14.20 Notice of hearing before an advisory committee.

§ 14.22 Meetings of an advisory committee.

§ 14.25 Portions of advisory committee meetings.

§ 14.27 Determination to close portions of advisory committee meetings.

§ 14.29 Conduct of a hearing before an advisory committee.

§ 14.30 Chairperson of an advisory committee.

§ 14.31 Consultation by an advisory committee with other persons.

§ 14.33 Compilation of materials for members of an advisory committee.

§ 14.35 Written submissions to an advisory committee.

§ 14.39 Additional rules for a particular advisory committee.

§ 14.40 Establishment and renewal of advisory committees.

§ 14.55 Termination of advisory committees.

§ 14.60 Minutes and reports of advisory committee meetings.

§ 14.61 Transcripts of advisory committee meetings.

§ 14.65 Public inquiries and requests for advisory committee records.

§ 14.70 Administrative record of a public hearing before an advisory committee.

§ 14.75 Examination of administrative record and other advisory committee records.

§ 14.80 Qualifications for members of standing policy and technical advisory committees.

§ 14.82 Nominations of voting members of standing advisory committees.

§ 14.84 Nominations and selection of nonvoting members of standing technical advisory committees.

§ 14.86 Rights and responsibilities of nonvoting members of advisory committees.

§ 14.90 Ad hoc advisory committee members.

§ 14.95 Compensation of advisory committee members.

§ 14.100 List of standing advisory committees.

§ 14.120 Establishment of the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC).

§ 14.122 Functions of TEPRSSC.

§ 14.125 Procedures of TEPRSSC.

§ 14.127 Membership of TEPRSSC.

§ 14.130 Conduct of TEPRSSC meeting; availability of TEPRSSC records.

§ 14.140 Establishment of a color additive advisory committee.

§ 14.142 Functions of a color additive advisory committee.

§ 14.145 Procedures of a color additive advisory committee.

§ 14.147 Membership of a color additive advisory committee.

§ 14.155 Fees and compensation pertaining to a color additive advisory committee.

§ 14.160 Establishment of standing technical advisory committees for human prescription drugs.

§ 14.171 Utilization of an advisory committee on the initiative of FDA.

§ 14.172 Utilization of an advisory committee at the request of an interested person.

§ 14.174 Advice and recommendations in writing.

§ 15.1 Scope.

§ 15.20 Notice of a public hearing before the Commissioner.

§ 15.21 Notice of participation; schedule for hearing.

§ 15.25 Written submissions.

§ 15.30 Conduct of a public hearing before the Commissioner.

§ 15.40 Administrative record.

§ 15.45 Examination of administrative record.

§ 16.1 Scope.

§ 16.5 Inapplicability and limited applicability.

§ 16.22 Initiation of regulatory hearing.

§ 16.24 Regulatory hearing required by the act or a regulation.

§ 16.26 Denial of hearing and summary decision.

§ 16.40 Commissioner.

§ 16.42 Presiding officer.

§ 16.44 Communication to presiding officer and Commissioner.

§ 16.60 Hearing procedure.

§ 16.62 Right to counsel.

§ 16.80 Administrative record of a regulatory hearing.

§ 16.85 Examination of administrative record.

§ 16.95 Administrative decision and record for decision.

§ 16.119 Reconsideration and stay of action.

§ 16.120 Judicial review.

§ 17.1 Scope.

§ 17.2 Maximum penalty amounts.

§ 17.3 Definitions.

§ 17.5 Complaint.

§ 17.7 Service of complaint.

§ 17.9 Answer.

§ 17.11 Default upon failure to file an answer.

§ 17.13 Notice of hearing.

§ 17.15 Parties to the hearing.

§ 17.17 Summary decisions.

§ 17.18 Interlocutory appeal from ruling of presiding officer.

§ 17.19 Authority of the presiding officer.

§ 17.20 Ex parte contacts.

§ 17.21 Prehearing conferences.

§ 17.23 Discovery.

§ 17.25 Exchange of witness lists, witness statements, and exhibits.

§ 17.27 Hearing subpoenas.

§ 17.28 Protective order.

§ 17.29 Fees.

§ 17.30 Computation of time.

§ 17.31 Form, filing, and service of papers.

§ 17.32 Motions.

§ 17.33 The hearing and burden of proof.

§ 17.34 Determining the amount of penalties and assessments.

§ 17.35 Sanctions.

§ 17.37 Witnesses.

§ 17.39 Evidence.

§ 17.41 The administrative record.

§ 17.43 Posthearing briefs.

§ 17.45 Initial decision.

§ 17.47 Appeals.

§ 17.48 Harmless error.

§ 17.51 Judicial review.

§ 17.54 Deposit in the Treasury of the United States.

§ 19.1 Scope.

§ 19.5 Reference to Department regulations.

§ 19.6 Code of ethics for government service.

§ 19.10 Food and Drug Administration Conflict of Interest Review Board.

§ 19.21 Duty to report violations.

§ 19.45 Temporary disqualification of former employees.

§ 19.55 Permanent disqualification of former employees.

§ 20.1 Testimony by Food and Drug Administration employees.

§ 20.2 Production of records by Food and Drug Administration employees.

§ 20.3 Certification and authentication of Food and Drug Administration records.

§ 20.20 Policy on disclosure of Food and Drug Administration records.

§ 20.21 Uniform access to records.

§ 20.22 Partial disclosure of records.

§ 20.23 Request for existing records.

§ 20.24 Preparation of new records.

§ 20.25 Retroactive application of regulations.

§ 20.26 Indexes of certain records.

§ 20.27 Submission of records marked as confidential.

§ 20.28 Food and Drug Administration determinations of confidentiality.

§ 20.29 Prohibition on withdrawal of records from Food and Drug Administration files.

§ 20.30 Food and Drug Administration Division of Freedom of Information.

§ 20.31 Retention schedule of requests for Food and Drug Administration records.

§ 20.32 Disclosure of Food and Drug Administration employee names.

§ 20.33 Form or format of response.

§ 20.34 Search for records.

§ 20.40 Filing a request for records.

§ 20.41 Time limitations.

§ 20.42 Aggregation of certain requests.

§ 20.43 Multitrack processing.

§ 20.44 Expedited processing.

§ 20.45 Fees to be charged.

§ 20.46 Waiver or reduction of fees.

§ 20.47 Situations in which confidentiality is uncertain.

§ 20.48 Judicial review of proposed disclosure.

§ 20.49 Denial of a request for records.

§ 20.50 Nonspecific and overly burdensome requests.

§ 20.51 Referral to primary source of records.

§ 20.52 Availability of records at National Technical Information Service.

§ 20.53 Use of private contractor for copying.

§ 20.54 Request for review without copying.

§ 20.55 Indexing trade secrets and confidential commercial or financial information.

§ 20.60 Applicability of exemptions.

§ 20.61 Trade secrets and commercial or financial information which is privileged or confidential.

§ 20.62 Inter- or intra-agency memoranda or letters.

§ 20.63 Personnel, medical, and similar files, disclosure of which constitutes a clearly unwarranted invasion of personal privacy.

§ 20.64 Records or information compiled for law enforcement purposes.

§ 20.65 National defense and foreign policy.

§ 20.66 Internal personnel rules and practices.

§ 20.67 Records exempted by other statutes.

§ 20.80 Applicability of limitations on exemptions.

§ 20.81 Data and information previously disclosed to the public.

§ 20.82 Discretionary disclosure by the Commissioner.

§ 20.83 Disclosure required by court order.

§ 20.84 Disclosure to consultants, advisory committees, State and local government officials commissioned pursuant to 21 U.S.C. 372(a), and other special government employees.

§ 20.85 Disclosure to other Federal government departments and agencies.

§ 20.86 Disclosure in administrative or court proceedings.

§ 20.87 Disclosure to Congress.

§ 20.88 Communications with State and local government officials.

§ 20.89 Communications with foreign government officials.

§ 20.90 Disclosure to contractors.

§ 20.91 Use of data or information for administrative or court enforcement action.

§ 20.100 Applicability; cross-reference to other regulations.

§ 20.101 Administrative enforcement records.

§ 20.102 Court enforcement records.

§ 20.103 Correspondence.

§ 20.104 Summaries of oral discussions.

§ 20.105 Testing and research conducted by or with funds provided by the Food and Drug Administration.

§ 20.106 Studies and reports prepared by or with funds provided by the Food and Drug Administration.

§ 20.107 Food and Drug Administration manuals.

§ 20.108 Agreements between the Food and Drug Administration and other departments, agencies, and organizations.

§ 20.109 Data and information obtained by contract.

§ 20.110 Data and information about Food and Drug Administration employees.

§ 20.111 Data and information submitted voluntarily to the Food and Drug Administration.

§ 20.112 Voluntary drug experience reports submitted by physicians and hospitals.

§ 20.113 Voluntary product defect reports.

§ 20.114 Data and information submitted pursuant to cooperative quality assurance agreements.

§ 20.115 Product codes for manufacturing or sales dates.

§ 20.116 Drug and device registration and listing information.

§ 20.117 New drug information.

§ 20.118 Advisory committee records.

§ 20.119 Lists of names and addresses.

§ 20.120 Records available in Food and Drug Administration Public Reading Rooms.

§ 21.1 Scope.

§ 21.3 Definitions.

§ 21.10 Policy concerning records about individuals.

§ 21.20 Procedures for notice of Food and Drug Administration Privacy Act Record Systems.

§ 21.21 Changes in systems and new systems.

§ 21.30 Records of contractors.

§ 21.31 Records stored by the National Archives and Records Administration.

§ 21.32 Personnel records.

§ 21.33 Medical records.

§ 21.40 Procedures for submitting requests for notification and access.

§ 21.41 Processing of requests.

§ 21.42 Responses to requests.

§ 21.43 Access to requested records.

§ 21.44 Verification of identity.

§ 21.45 Fees.

§ 21.50 Procedures for submitting requests for amendment of records.

§ 21.51 Responses to requests for amendment of records.

§ 21.52 Administrative appeals of refusals to amend records.

§ 21.53 Notation and disclosure of disputed records.

§ 21.54 Amended or disputed records received from other agencies.

§ 21.60 Policy.

§ 21.61 Exempt systems.

§ 21.65 Access to records in exempt systems.

§ 21.70 Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.

§ 21.71 Disclosure of records in Privacy Act Record Systems; accounting required.

§ 21.72 Individual consent to disclosure of records to other persons.

§ 21.73 Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.

§ 21.74 Providing notice that a record is disputed.

§ 21.75 Rights of legal guardians.

§ 25.1 Purpose.

§ 25.5 Terminology.

§ 25.10 Policies and NEPA planning.

§ 25.15 General procedures.

§ 25.16 Public health and safety emergencies.

§ 25.20 Actions requiring preparation of an environmental assessment.

§ 25.21 Extraordinary circumstances.

§ 25.22 Actions requiring the preparation of an environmental impact statement.

§ 25.30 General.

§ 25.31 Human drugs and biologics.

§ 25.32 Foods, food additives, and color additives.

§ 25.33 Animal drugs.

§ 25.34 Devices and electronic products.

§ 25.35 Tobacco product applications.

§ 25.40 Environmental assessments.

§ 25.41 Findings of no significant impact.

§ 25.42 Environmental impact statements.

§ 25.43 Records of decision.

§ 25.44 Lead and cooperating agencies.

§ 25.45 Responsible agency official.

§ 25.50 General information.

§ 25.51 Environmental assessments and findings of no significant impact.

§ 25.52 Environmental impact statements.

§ 25.60 Environmental effects abroad of major agency actions.

§ 26.1 Definitions.

§ 26.2 Purpose.

§ 26.3 Scope.

§ 26.4 Product coverage.

§ 26.5 Length of transition period.

§ 26.6 Equivalence assessment.

§ 26.7 Participation in the equivalence assessment and determination.

§ 26.8 Other transition activities.

§ 26.9 Equivalence determination.

§ 26.10 Regulatory authorities not listed as currently equivalent.

§ 26.11 Start of operational period.

§ 26.12 Nature of recognition of inspection reports.

§ 26.13 Transmission of postapproval inspection reports.

§ 26.14 Transmission of preapproval inspection reports.

§ 26.15 Monitoring continued equivalence.

§ 26.16 Suspension.

§ 26.17 Role and composition of the Joint Sectoral Committee.

§ 26.18 Regulatory collaboration.

§ 26.19 Information relating to quality aspects.

§ 26.20 Alert system.

§ 26.21 Safeguard clause.

§ 26.31 Purpose.

§ 26.32 Scope.

§ 26.33 Product coverage.

§ 26.34 Regulatory authorities.

§ 26.35 Length and purpose of transition period.

§ 26.36 Listing of CAB's.

§ 26.37 Confidence building activities.

§ 26.38 Other transition period activities.

§ 26.39 Equivalence assessment.

§ 26.40 Start of the operational period.

§ 26.41 Exchange and endorsement of quality system evaluation reports.

§ 26.42 Exchange and endorsement of product evaluation reports.

§ 26.43 Transmission of quality system evaluation reports.

§ 26.44 Transmission of product evaluation reports.

§ 26.45 Monitoring continued equivalence.

§ 26.46 Listing of additional CAB's.

§ 26.47 Role and composition of the Joint Sectoral Committee.

§ 26.48 Harmonization.

§ 26.49 Regulatory cooperation.

§ 26.50 Alert system and exchange of postmarket vigilance reports.

§ 26.60 Definitions.

§ 26.61 Purpose of this part.

§ 26.62 General obligations.

§ 26.63 General coverage of this part.

§ 26.64 Transitional arrangements.

§ 26.65 Designating authorities.

§ 26.66 Designation and listing procedures.

§ 26.67 Suspension of listed conformity assessment bodies.

§ 26.68 Withdrawal of listed conformity assessment bodies.

§ 26.69 Monitoring of conformity assessment bodies.

§ 26.70 Conformity assessment bodies.

§ 26.71 Exchange of information.

§ 26.72 Sectoral contact points.

§ 26.73 Joint Committee.

§ 26.74 Preservation of regulatory authority.

§ 26.75 Suspension of recognition obligations.

§ 26.76 Confidentiality.

§ 26.77 Fees.

§ 26.78 Agreements with other countries.

§ 26.79 Territorial application.

§ 26.80 Entry into force, amendment, and termination.

§ 26.81 Final provisions.

§ 50.1 Scope.

§ 50.3 Definitions.

§ 50.20 General requirements for informed consent.

§ 50.23 Exception from general requirements.

§ 50.24 Exception from informed consent requirements for emergency research.

§ 50.25 Elements of informed consent.

§ 50.27 Documentation of informed consent.

§ 50.50 IRB duties.

§ 50.51 Clinical investigations not involving greater than minimal risk.

§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.

§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.

§ 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

§ 50.55 Requirements for permission by parents or guardians and for assent by children.

§ 50.56 Wards.

§ 54.1 Purpose.

§ 54.2 Definitions.

§ 54.3 Scope.

§ 54.4 Certification and disclosure requirements.

§ 54.5 Agency evaluation of financial interests.

§ 54.6 Recordkeeping and record retention.

§ 56.101 Scope.

§ 56.102 Definitions.

§ 56.103 Circumstances in which IRB review is required.

§ 56.104 Exemptions from IRB requirement.

§ 56.105 Waiver of IRB requirement.

§ 56.106 Registration.

§ 56.107 IRB membership.

§ 56.108 IRB functions and operations.

§ 56.109 IRB review of research.

§ 56.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

§ 56.111 Criteria for IRB approval of research.

§ 56.112 Review by institution.

§ 56.113 Suspension or termination of IRB approval of research.

§ 56.114 Cooperative research.

§ 56.115 IRB records.

§ 56.120 Lesser administrative actions.

§ 56.121 Disqualification of an IRB or an institution.

§ 56.122 Public disclosure of information regarding revocation.

§ 56.123 Reinstatement of an IRB or an institution.

§ 56.124 Actions alternative or additional to disqualification.

§ 58.1 Scope.

§ 58.3 Definitions.

§ 58.10 Applicability to studies performed under grants and contracts.

§ 58.15 Inspection of a testing facility.

§ 58.29 Personnel.

§ 58.31 Testing facility management.

§ 58.33 Study director.

§ 58.35 Quality assurance unit.

§ 58.41 General.

§ 58.43 Animal care facilities.

§ 58.45 Animal supply facilities.

§ 58.47 Facilities for handling test and control articles.

§ 58.49 Laboratory operation areas.

§ 58.51 Specimen and data storage facilities.

§ 58.61 Equipment design.

§ 58.63 Maintenance and calibration of equipment.

§ 58.81 Standard operating procedures.

§ 58.83 Reagents and solutions.

§ 58.90 Animal care.

§ 58.105 Test and control article characterization.

§ 58.107 Test and control article handling.

§ 58.113 Mixtures of articles with carriers.

§ 58.120 Protocol.

§ 58.130 Conduct of a nonclinical laboratory study.

§ 58.185 Reporting of nonclinical laboratory study results.

§ 58.190 Storage and retrieval of records and data.

§ 58.195 Retention of records.

§ 58.200 Purpose.

§ 58.202 Grounds for disqualification.

§ 58.204 Notice of and opportunity for hearing on proposed disqualification.

§ 58.206 Final order on disqualification.

§ 58.210 Actions upon disqualification.

§ 58.213 Public disclosure of information regarding disqualification.

§ 58.215 Alternative or additional actions to disqualification.

§ 58.217 Suspension or termination of a testing facility by a sponsor.

§ 58.219 Reinstatement of a disqualified testing facility.

§ 60.1 Scope.

§ 60.2 Purpose.

§ 60.3 Definitions.

§ 60.10 FDA assistance on eligibility.

§ 60.20 FDA action on regulatory review period determinations.

§ 60.22 Regulatory review period determinations.

§ 60.24 Revision of regulatory review period determinations.

§ 60.26 Final action on regulatory review period determinations.

§ 60.28 Time frame for determining regulatory review periods.

§ 60.30 Filing, format, and content of petitions.

§ 60.32 Applicant response to petition.

§ 60.34 FDA action on petitions.

§ 60.36 Standard of due diligence.

§ 60.40 Request for hearing.

§ 60.42 Notice of hearing.

§ 60.44 Hearing procedures.

§ 60.46 Administrative decision.

§ 70.3 Definitions.

§ 70.5 General restrictions on use of color additives.

§ 70.10 Color additives in standardized foods and new drugs.

§ 70.11 Related substances.

§ 70.19 Fees for listing.

§ 70.20 Packaging requirements for straight colors (other than hair dyes).

§ 70.25 Labeling requirements for color additives (other than hair dyes).

§ 70.40 Safety factors to be considered.

§ 70.42 Criteria for evaluating the safety of color additives.

§ 70.45 Allocation of color additives.

§ 70.50 Application of the cancer clause of section 721 of the act.

§ 70.51 Advisory committee on the applicability of the anticancer clause.

§ 70.55 Request for scientific studies.

§ 71.1 Petitions.

§ 71.2 Notice of filing of petition.

§ 71.4 Samples; additional information.

§ 71.6 Extension of time for studying petitions; substantive amendments; withdrawal of petitions without prejudice.

§ 71.15 Confidentiality of data and information in color additive petitions.

§ 71.18 Petition for exemption from certification.

§ 71.20 Publication of regulation.

§ 71.22 Deception as a basis for refusing to issue regulations; deceptive use of a color additive for which a regulation has issued.

§ 71.25 Condition for certification.

§ 71.26 Revocation of exemption from certification.

§ 71.27 Listing and exemption from certification on the Commissioner's initiative.

§ 71.30 Procedure for filing objections to regulations.

§ 71.37 Exemption of color additives for investigational use.

§ 73.1 Diluents in color additive mixtures for food use exempt from certification.

§ 73.30 Annatto extract.

§ 73.35 Astaxanthin.

§ 73.37 Astaxanthin dimethyldisuccinate.

§ 73.40 Dehydrated beets (beet powder).

§ 73.50 Ultramarine blue.

§ 73.70 Calcium carbonate.

§ 73.75 Canthaxanthin.

§ 73.85 Caramel.

§ 73.90 β-Apo-8′-carotenal.

§ 73.95 β-Carotene.

§ 73.100 Cochineal extract; carmine.

§ 73.125 Sodium copper chlorophyllin.

§ 73.140 Toasted partially defatted cooked cottonseed flour.

§ 73.160 Ferrous gluconate.

§ 73.165 Ferrous lactate.

§ 73.169 Grape color extract.

§ 73.170 Grape skin extract (enocianina).

§ 73.185 Haematococcus algae meal.

§ 73.200 Synthetic iron oxide.

§ 73.250 Fruit juice.

§ 73.260 Vegetable juice.

§ 73.275 Dried algae meal.

§ 73.295 Tagetes (Aztec marigold) meal and extract.

§ 73.300 Carrot oil.

§ 73.315 Corn endosperm oil.

§ 73.340 Paprika.

§ 73.345 Paprika oleoresin.

§ 73.350 Mica-based pearlescent pigments.

§ 73.352 Paracoccus pigment.

§ 73.355 Phaffia yeast.

§ 73.450 Riboflavin.

§ 73.500 Saffron.

§ 73.520 Soy leghemoglobin.

§ 73.530 Spirulina extract.

§ 73.575 Titanium dioxide.

§ 73.585 Tomato lycopene extract; tomato lycopene concentrate.

§ 73.600 Turmeric.

§ 73.615 Turmeric oleoresin.

§ 73.1001 Diluents in color additive mixtures for drug use exempt from certification.

§ 73.1010 Alumina (dried aluminum hydroxide).

§ 73.1015 Chromium-cobalt-aluminum oxide.

§ 73.1025 Ferric ammonium citrate.

§ 73.1030 Annatto extract.

§ 73.1070 Calcium carbonate.

§ 73.1075 Canthaxanthin.

§ 73.1085 Caramel.

§ 73.1095 β-Carotene.

§ 73.1100 Cochineal extract; carmine.

§ 73.1125 Potassium sodium copper chloropyhllin (chlorophyllin-copper complex).

§ 73.1150 Dihydroxyacetone.

§ 73.1162 Bismuth oxychloride.

§ 73.1200 Synthetic iron oxide.

§ 73.1298 Ferric ammonium ferrocyanide.

§ 73.1299 Ferric ferrocyanide.

§ 73.1326 Chromium hydroxide green.

§ 73.1327 Chromium oxide greens.

§ 73.1329 Guanine.

§ 73.1350 Mica-based pearlescent pigments.

§ 73.1375 Pyrogallol.

§ 73.1400 Pyrophyllite.

§ 73.1410 Logwood extract.

§ 73.1496 Mica.

§ 73.1530 Spirulina extract.

§ 73.1550 Talc.

§ 73.1575 Titanium dioxide.

§ 73.1645 Aluminum powder.

§ 73.1646 Bronze powder.

§ 73.1647 Copper powder.

§ 73.1991 Zinc oxide.

§ 73.2030 Annatto.

§ 73.2085 Caramel.

§ 73.2087 Carmine.

§ 73.2095 β-Carotene.

§ 73.2110 Bismuth citrate.

§ 73.2120 Disodium EDTA-copper.

§ 73.2125 Potassium sodium copper chlorophyllin (chlorophyllin-copper complex).

§ 73.2150 Dihydroxyacetone.

§ 73.2162 Bismuth oxychloride.

§ 73.2180 Guaiazulene.

§ 73.2190 Henna.

§ 73.2250 Iron oxides.

§ 73.2298 Ferric ammonium ferrocyanide.

§ 73.2299 Ferric ferrocyanide.

§ 73.2326 Chromium hydroxide green.

§ 73.2327 Chromium oxide greens.

§ 73.2329 Guanine.

§ 73.2396 Lead acetate.

§ 73.2400 Pyrophyllite.

§ 73.2496 Mica.

§ 73.2500 Silver.

§ 73.2575 Titanium dioxide.

§ 73.2645 Aluminum powder.

§ 73.2646 Bronze powder.

§ 73.2647 Copper powder.

§ 73.2725 Ultramarines.

§ 73.2775 Manganese violet.

§ 73.2991 Zinc oxide.

§ 73.2995 Luminescent zinc sulfide.

§ 73.3100 1,4-Bis[(2-hydroxyethyl)amino]-9,10-anthracenedione bis(2-methyl-2-propenoic)ester copolymers.

§ 73.3105 1,4-Bis[(2-methylphenyl)amino]-9,10-anthracenedione.

§ 73.3106 1,4-Bis[4-(2-methacryloxyethyl) phenylamino]anthraquinone copolymers.

§ 73.3107 Carbazole violet.

§ 73.3110 Chlorophyllin-copper complex, oil soluble.

§ 73.3110a Chromium-cobalt-aluminum oxide.

§ 73.3111 Chromium oxide greens.

§ 73.3112 C.I. Vat Orange 1.

§ 73.3115 2-[[2,5-Diethoxy-4-[(4-methylphenyl)thiol]phenyl]azo]-1,3,5-benzenetriol.

§ 73.3117 16,23-Dihydrodinaphtho[2,3-a:2′,3′-i] naphth [2′,3′:6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone.

§ 73.3118 N,N′-(9,10-Dihydro-9,10-dioxo-1,5-anthracenediyl) bisbenzamide.

§ 73.3119 7,16-Dichloro-6,15-dihydro-5,9,14,18-anthrazinetetrone.

§ 73.3120 16,17-Dimethoxydinaphtho [1,2,3-cd:3′,2′,1′-lm] perylene-5,10-dione.

§ 73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers.

§ 73.3122 4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one.

§ 73.3123 6-Ethoxy-2-(6-ethoxy-3-oxobenzo[b]thien-2(3H)-ylidene) benzo[b]thiophen-3 (2H)-one.

§ 73.3124 Phthalocyanine green.

§ 73.3125 Iron oxides.

§ 73.3126 Titanium dioxide.

§ 73.3127 Vinyl alcohol/methyl methacrylate-dye reaction products.

§ 73.3128 Mica-based pearlescent pigments.

§ 73.3129 Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate.

§ 74.101 FD&C Blue No. 1.

§ 74.102 FD&C Blue No. 2.

§ 74.203 FD&C Green No. 3.

§ 74.250 Orange B.

§ 74.302 Citrus Red No. 2.

§ 74.303 FD&C Red No. 3.

§ 74.340 FD&C Red No. 40.

§ 74.705 FD&C Yellow No. 5.

§ 74.706 FD&C Yellow No. 6.

§ 74.1101 FD&C Blue No. 1

§ 74.1102 FD&C Blue No. 2.

§ 74.1104 D&C Blue No. 4.

§ 74.1109 D&C Blue No. 9.

§ 74.1203 FD&C Green No. 3.

§ 74.1205 D&C Green No. 5.

§ 74.1206 D&C Green No. 6.

§ 74.1208 D&C Green No. 8.

§ 74.1254 D&C Orange No. 4.

§ 74.1255 D&C Orange No. 5.

§ 74.1260 D&C Orange No. 10.

§ 74.1261 D&C Orange No. 11.

§ 74.1303 FD&C Red No. 3.

§ 74.1304 FD&C Red No. 4.

§ 74.1306 D&C Red No. 6.

§ 74.1307 D&C Red No. 7.

§ 74.1317 D&C Red No. 17.

§ 74.1321 D&C Red No. 21.

§ 74.1322 D&C Red No. 22.

§ 74.1327 D&C Red No. 27.

§ 74.1328 D&C Red No. 28.

§ 74.1330 D&C Red No. 30.

§ 74.1331 D&C Red No. 31.

§ 74.1333 D&C Red No. 33.

§ 74.1334 D&C Red No. 34.

§ 74.1336 D&C Red No. 36.

§ 74.1339 D&C Red No. 39.

§ 74.1340 FD&C Red No. 40.

§ 74.1602 D&C Violet No. 2.

§ 74.1705 FD&C Yellow No. 5.

§ 74.1706 FD&C Yellow No. 6.

§ 74.1707 D&C Yellow No. 7.

§ 74.1707a Ext. D&C Yellow No. 7.

§ 74.1708 D&C Yellow No. 8.

§ 74.1710 D&C Yellow No. 10.

§ 74.1711 D&C Yellow No. 11.

§ 74.2052 D&C Black No. 2.

§ 74.2053 D&C Black No. 3.

§ 74.2101 FD&C Blue No. 1.

§ 74.2104 D&C Blue No. 4.

§ 74.2151 D&C Brown No. 1.

§ 74.2203 FD&C Green No. 3.

§ 74.2205 D&C Green No. 5.

§ 74.2206 D&C Green No. 6.

§ 74.2208 D&C Green No. 8.

§ 74.2254 D&C Orange No. 4.

§ 74.2255 D&C Orange No. 5.

§ 74.2260 D&C Orange No. 10.

§ 74.2261 D&C Orange No. 11.

§ 74.2304 FD&C Red No. 4.

§ 74.2306 D&C Red No. 6.

§ 74.2307 D&C Red No. 7

§ 74.2317 D&C Red No. 17.

§ 74.2321 D&C Red No. 21.

§ 74.2322 D&C Red No. 22.

§ 74.2327 D&C Red No. 27.

§ 74.2328 D&C Red No. 28.

§ 74.2330 D&C Red No. 30.

§ 74.2331 D&C Red No. 31.

§ 74.2333 D&C Red No. 33.

§ 74.2334 D&C Red No. 34.

§ 74.2336 D&C Red No. 36.

§ 74.2340 FD&C Red No. 40.

§ 74.2602 D&C Violet No. 2.

§ 74.2602a Ext. D&C Violet No. 2.

§ 74.2705 FD&C Yellow No. 5.

§ 74.2706 FD&C Yellow No. 6.

§ 74.2707 D&C Yellow No. 7.

§ 74.2707a Ext. D&C Yellow No. 7.

§ 74.2708 D&C Yellow No. 8.

§ 74.2710 D&C Yellow No. 10.

§ 74.2711 D&C Yellow No. 11.

§ 74.3045 [Phthalocyaninato(2-)] copper.

§ 74.3054 D&C Black No. 4.

§ 74.3102 FD&C Blue No. 2.

§ 74.3106 D&C Blue No. 6.

§ 74.3206 D&C Green No. 6.

§ 74.3230 D&C Red No. 17.

§ 74.3602 D&C Violet No. 2.

§ 74.3708 D&C Yellow No. 8.

§ 74.3710 D&C Yellow No. 10.

§ 80.10 Fees for certification services.

§ 80.21 Request for certification.

§ 80.22 Samples to accompany requests for certification.

§ 80.31 Certification.

§ 80.32 Limitations of certificates.

§ 80.34 Authority to refuse certification service.

§ 80.35 Color additive mixtures; certification and exemption from certification.

§ 80.37 Treatment of batch pending certification.

§ 80.38 Treatment of batch after certification.

§ 80.39 Records of distribution.

§ 81.1 Provisional lists of color additives.

§ 81.10 Termination of provisional listings of color additives.

§ 81.30 Cancellation of certificates.

§ 81.32 Limitation of certificates.

§ 82.3 Definitions.

§ 82.5 General specifications for straight colors.

§ 82.6 Certifiable mixtures.

§ 82.50 General.

§ 82.51 Lakes (FD&C).

§ 82.101 FD&C Blue No. 1.

§ 82.102 FD&C Blue No. 2.

§ 82.203 FD&C Green No. 3.

§ 82.304 FD&C Red No. 4.

§ 82.705 FD&C Yellow No. 5.

§ 82.706 FD&C Yellow No. 6.

§ 82.1050 General.

§ 82.1051 Lakes (D&C).

§ 82.1104 D&C Blue No. 4.

§ 82.1205 D&C Green No. 5.

§ 82.1206 D&C Green No. 6.

§ 82.1254 D&C Orange No. 4.

§ 82.1255 D&C Orange No. 5.

§ 82.1260 D&C Orange No. 10.

§ 82.1261 D&C Orange No. 11.

§ 82.1306 D&C Red No. 6.

§ 82.1307 D&C Red No. 7.

§ 82.1317 D&C Red No. 17.

§ 82.1321 D&C Red No. 21.

§ 82.1322 D&C Red No. 22.

§ 82.1327 D&C Red No. 27.

§ 82.1328 D&C Red No. 28.

§ 82.1330 D&C Red No. 30.

§ 82.1331 D&C Red No. 31.

§ 82.1333 D&C Red No. 33.

§ 82.1334 D&C Red No. 34.

§ 82.1336 D&C Red No. 36.

§ 82.1602 D&C Violet No. 2.

§ 82.1707 D&C Yellow No. 7.

§ 82.1708 D&C Yellow No. 8.

§ 82.1710 D&C Yellow No. 10.

§ 82.2050 General.

§ 82.2051 Lakes (Ext. D&C).

§ 82.2707a Ext. D&C Yellow No. 7.

§ 99.1 Scope.

§ 99.3 Definitions.

§ 99.101 Information that may be disseminated.

§ 99.103 Mandatory statements and information.

§ 99.105 Recipients of information.

§ 99.201 Manufacturer's submission to the agency.

§ 99.203 Request to extend the time for completing planned studies.

§ 99.205 Application for exemption from the requirement to file a supplemental application.

§ 99.301 Agency action on a submission.

§ 99.303 Extension of time for completing planned studies.

§ 99.305 Exemption from the requirement to file a supplemental application.

§ 99.401 Corrective actions and cessation of dissemination of information.

§ 99.403 Termination of approvals of applications for exemption.

§ 99.405 Applicability of labeling, adulteration, and misbranding authority.

§ 99.501 Recordkeeping and reports.

§ 100.1 Petitions requesting exemption from preemption for State or local requirements.

§ 100.2 State enforcement of Federal regulations.

§ 100.100 Misleading containers.

§ 100.155 Salt and iodized salt.

§ 101.1 Principal display panel of package form food.

§ 101.2 Information panel of package form food.

§ 101.3 Identity labeling of food in packaged form.

§ 101.4 Food; designation of ingredients.

§ 101.5 Food; name and place of business of manufacturer, packer, or distributor.

§ 101.7 Declaration of net quantity of contents.

§ 101.8 Vending machines.

§ 101.9 Nutrition labeling of food.

§ 101.10 Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims.

§ 101.11 Nutrition labeling of standard menu items in covered establishments.

§ 101.12 Reference amounts customarily consumed per eating occasion.

§ 101.13 Nutrient content claims - general principles.

§ 101.14 Health claims: general requirements.

§ 101.15 Food; prominence of required statements.

§ 101.17 Food labeling warning, notice, and safe handling statements.

§ 101.18 Misbranding of food.

§ 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives.

§ 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice.

§ 101.36 Nutrition labeling of dietary supplements.

§ 101.42 Nutrition labeling of raw fruit, vegetables, and fish.

§ 101.43 Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish.

§ 101.44 What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States?

§ 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish.

§ 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.”

§ 101.56 Nutrient content claims for “light” or “lite.”

§ 101.60 Nutrient content claims for the calorie content of foods.

§ 101.61 Nutrient content claims for the sodium content of foods.

§ 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods.

§ 101.65 Implied nutrient content claims and related label statements.

§ 101.67 Use of nutrient content claims for butter.

§ 101.69 Petitions for nutrient content claims.

§ 101.70 Petitions for health claims.

§ 101.71 Health claims: claims not authorized.

§ 101.72 Health claims: calcium, vitamin D, and osteoporosis.

§ 101.73 Health claims: dietary lipids and cancer.

§ 101.74 Health claims: sodium and hypertension.

§ 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.

§ 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer.

§ 101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.

§ 101.78 Health claims: fruits and vegetables and cancer.

§ 101.79 Health claims: Folate and neural tube defects.

§ 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.

§ 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).

§ 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD).

§ 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).

§ 101.91 Gluten-free labeling of food.

§ 101.93 Certain types of statements for dietary supplements.

§ 101.95 “Fresh,” “freshly frozen,” “fresh frozen,” “frozen fresh.”

§ 101.100 Food; exemptions from labeling.

§ 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments.

§ 102.5 General principles.

§ 102.19 Petitions.

§ 102.22 Protein hydrolysates.

§ 102.23 Peanut spreads.

§ 102.26 Frozen “heat and serve” dinners.

§ 102.28 Foods packaged for use in the preparation of “main dishes” or “dinners.”

§ 102.33 Beverages that contain fruit or vegetable juice.

§ 102.37 Mixtures of edible fat or oil and olive oil.

§ 102.39 Onion rings made from diced onion.

§ 102.41 Potato chips made from dried potatoes.

§ 102.45 Fish sticks or portions made from minced fish.

§ 102.46 Pacific whiting.

§ 102.47 Bonito.

§ 102.49 Fried clams made from minced clams.

§ 102.50 Crabmeat.

§ 102.54 Seafood cocktails.

§ 102.55 Nonstandardized breaded composite shrimp units.

§ 102.57 Greenland turbot ().

§ 104.5 General principles.

§ 104.20 Statement of purpose.

§ 104.47 Frozen “heat and serve” dinner.

§ 105.3 Definitions and interpretations.

§ 105.62 Hypoallergenic foods.

§ 105.65 Infant foods.

§ 105.66 Label statements relating to usefulness in reducing or maintaining body weight.

§ 106.1 Status and applicability of the regulations in part 106.

§ 106.3 Definitions.

§ 106.5 Current good manufacturing practice.

§ 106.6 Production and in-process control system.

§ 106.10 Controls to prevent adulteration by workers.

§ 106.20 Controls to prevent adulteration caused by facilities.

§ 106.30 Controls to prevent adulteration caused by equipment or utensils.

§ 106.35 Controls to prevent adulteration due to automatic (mechanical or electronic) equipment.

§ 106.40 Controls to prevent adulteration caused by ingredients, containers, and closures.

§ 106.50 Controls to prevent adulteration during manufacturing.

§ 106.55 Controls to prevent adulteration from microorganisms.

§ 106.60 Controls to prevent adulteration during packaging and labeling of infant formula.

§ 106.70 Controls on the release of finished infant formula.

§ 106.80 Traceability.

§ 106.90 Audits of current good manufacturing practice.

§ 106.91 General quality control.

§ 106.92 Audits of quality control procedures.

§ 106.94 Audit plans and procedures.

§ 106.96 Requirements for quality factors for infant formulas.

§ 106.100 Records.

§ 106.110 New infant formula registration.

§ 106.120 New infant formula submission.

§ 106.121 Quality factor assurances for infant formulas.

§ 106.130 Verification submission.

§ 106.140 Submission concerning a change in infant formula that may adulterate the product.

§ 106.150 Notification of an adulterated or misbranded infant formula.

§ 106.160 Incorporation by reference.

§ 107.1 Status and applicability of the regulations in part 107.

§ 107.3 Definitions.

§ 107.10 Nutrient information.

§ 107.20 Directions for use.

§ 107.30 Exemptions.

§ 107.50 Terms and conditions.

§ 107.100 Nutrient specifications.

§ 107.200 Food and Drug Administration-required recall.

§ 107.210 Firm-initiated product removals.

§ 107.220 Scope and effect of infant formula recalls.

§ 107.230 Elements of an infant formula recall.

§ 107.240 Notification requirements.

§ 107.250 Termination of an infant formula recall.

§ 107.260 Revision of an infant formula recall.

§ 107.270 Compliance with this subpart.

§ 107.280 Records retention.

§ 108.3 Definitions.

§ 108.5 Determination of the need for a permit.

§ 108.6 Revocation of determination of need for permit.

§ 108.7 Issuance or denial of permit.

§ 108.10 Suspension and reinstatement of permit.

§ 108.12 Manufacturing, processing, or packing without a permit, or in violation of a permit.

§ 108.19 Establishment of requirements for exemption from section 404 of the act.

§ 108.25 Acidified foods.

§ 108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers.

§ 109.3 Definitions and interpretations.

§ 109.4 Establishment of tolerances, regulatory limits, and action levels.

§ 109.6 Added poisonous or deleterious substances.

§ 109.7 Unavoidability.

§ 109.15 Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

§ 109.16 Ornamental and decorative ceramicware.

§ 109.30 Tolerances for polychlorinated biphenyls (PCB's).

§ 110.3 Definitions.

§ 110.5 Current good manufacturing practice.

§ 110.10 Personnel.

§ 110.19 Exclusions.

§ 110.20 Plant and grounds.

§ 110.35 Sanitary operations.

§ 110.37 Sanitary facilities and controls.

§ 110.40 Equipment and utensils.

§ 110.80 Processes and controls.

§ 110.93 Warehousing and distribution.

§ 110.110 Natural or unavoidable defects in food for human use that present no health hazard.

§ 111.1 Who is subject to this part?

§ 111.3 What definitions apply to this part?

§ 111.5 Do other statutory provisions and regulations apply?

§ 111.8 What are the requirements under this subpart B for written procedures?

§ 111.10 What requirements apply for preventing microbial contamination from sick or infected personnel and for hygienic practices?

§ 111.12 What personnel qualification requirements apply?

§ 111.13 What supervisor requirements apply?

§ 111.14 Under this subpart B, what records must you make and keep?

§ 111.15 What sanitation requirements apply to your physical plant and grounds?

§ 111.16 What are the requirements under this subpart C for written procedures?

§ 111.20 What design and construction requirements apply to your physical plant?

§ 111.23 Under this subpart C, what records must you make and keep?

§ 111.25 What are the requirements under this subpart D for written procedures?

§ 111.27 What requirements apply to the equipment and utensils that you use?

§ 111.30 What requirements apply to automated, mechanical, or electronic equipment?

§ 111.35 Under this subpart D, what records must you make and keep?

§ 111.55 What are the requirements to implement a production and process control system?

§ 111.60 What are the design requirements for the production and process control system?

§ 111.65 What are the requirements for quality control operations?

§ 111.70 What specifications must you establish?

§ 111.73 What is your responsibility for determining whether established specifications are met?

§ 111.75 What must you do to determine whether specifications are met?

§ 111.77 What must you do if established specifications are not met?

§ 111.80 What representative samples must you collect?

§ 111.83 What are the requirements for reserve samples?

§ 111.87 Who conducts a material review and makes a disposition decision?

§ 111.90 What requirements apply to treatments, in-process adjustments, and reprocessing when there is a deviation or unanticipated occurrence or when a specification established in accordance with § 111.70 is not met?

§ 111.95 Under this subpart E, what records must you make and keep?

§ 111.103 What are the requirements under this subpart F for written procedures?

§ 111.105 What must quality control personnel do?

§ 111.110 What quality control operations are required for laboratory operations associated with the production and process control system?

§ 111.113 What quality control operations are required for a material review and disposition decision?

§ 111.117 What quality control operations are required for equipment, instruments, and controls?

§ 111.120 What quality control operations are required for components, packaging, and labels before use in the manufacture of a dietary supplement?

§ 111.123 What quality control operations are required for the master manufacturing record, the batch production record, and manufacturing operations?

§ 111.127 What quality control operations are required for packaging and labeling operations?

§ 111.130 What quality control operations are required for returned dietary supplements?

§ 111.135 What quality control operations are required for product complaints?

§ 111.140 Under this subpart F, what records must you make and keep?

§ 111.153 What are the requirements under this subpart G for written procedures?

§ 111.155 What requirements apply to components of dietary supplements?

§ 111.160 What requirements apply to packaging and labels received?

§ 111.165 What requirements apply to a product received for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier)?

§ 111.170 What requirements apply to rejected components, packaging, and labels, and to rejected products that are received for packaging or labeling as a dietary supplement?

§ 111.180 Under this subpart G, what records must you make and keep?

§ 111.205 What is the requirement to establish a master manufacturing record?

§ 111.210 What must the master manufacturing record include?

§ 111.255 What is the requirement to establish a batch production record?

§ 111.260 What must the batch record include?

§ 111.303 What are the requirements under this subpart J for written procedures?

§ 111.310 What are the requirements for the laboratory facilities that you use?

§ 111.315 What are the requirements for laboratory control processes?

§ 111.320 What requirements apply to laboratory methods for testing and examination?

§ 111.325 Under this subpart J, what records must you make and keep?

§ 111.353 What are the requirements under this subpart K for written procedures?

§ 111.355 What are the design requirements for manufacturing operations?

§ 111.360 What are the requirements for sanitation?

§ 111.365 What precautions must you take to prevent contamination?

§ 111.370 What requirements apply to rejected dietary supplements?

§ 111.375 Under this subpart K, what records must you make and keep?

§ 111.403 What are the requirements under this subpart L for written procedures?

§ 111.410 What requirements apply to packaging and labels?

§ 111.415 What requirements apply to filling, assembling, packaging, labeling, and related operations?

§ 111.420 What requirements apply to repackaging and relabeling?

§ 111.425 What requirements apply to a packaged and labeled dietary supplement that is rejected for distribution?

§ 111.430 Under this subpart L, what records must you make and keep?

§ 111.453 What are the requirements under this subpart for M written procedures?

§ 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?

§ 111.460 What requirements apply to holding in-process material?

§ 111.465 What requirements apply to holding reserve samples of dietary supplements?

§ 111.470 What requirements apply to distributing dietary supplements?

§ 111.475 Under this subpart M, what records must you make and keep?

§ 111.503 What are the requirements under this subpart N for written procedures?

§ 111.510 What requirements apply when a returned dietary supplement is received?

§ 111.515 When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

§ 111.520 When may a returned dietary supplement be salvaged?

§ 111.525 What requirements apply to a returned dietary supplement that quality control personnel approve for reprocessing?

§ 111.530 When must an investigation be conducted of your manufacturing processes and other batches?

§ 111.535 Under this subpart N, what records must you make and keep?

§ 111.553 What are the requirements under this subpart O for written procedures?

§ 111.560 What requirements apply to the review and investigation of a product complaint?

§ 111.570 Under this subpart O, what records must you make and keep?

§ 111.605 What requirements apply to the records that you make and keep?

§ 111.610 What records must be made available to FDA?

§ 112.1 What food is covered by this part?

§ 112.2 What produce is not covered by this part?

§ 112.3 What definitions apply to this part?

§ 112.4 Which farms are subject to the requirements of this part?

§ 112.5 Which farms are eligible for a qualified exemption and associated modified requirements based on average monetary value of all food sold and direct farm marketing?

§ 112.6 What modified requirements apply to me if my farm is eligible for a qualified exemption in accordance with § 112.5?

§ 112.7 What records must I establish and keep if my farm is eligible for a qualified exemption in accordance with § 112.5?

§ 112.11 What general requirements apply to persons who are subject to this part?

§ 112.12 Are there any alternatives to the requirements established in this part?

§ 112.21 What requirements apply regarding qualifications and training for personnel who handle (contact) covered produce or food contact surfaces?

§ 112.22 What minimum requirements apply for training personnel who conduct a covered activity?

§ 112.23 What requirements apply regarding supervisors?

§ 112.30 Under this subpart, what requirements apply regarding records?

§ 112.31 What measures must I take to prevent ill or infected persons from contaminating covered produce with microorganisms of public health significance?

§ 112.32 What hygienic practices must personnel use?

§ 112.33 What measures must I take to prevent visitors from contaminating covered produce and food contact surfaces with microorganisms of public health significance?

§ 112.41 What requirements apply to the quality of agricultural water?

§ 112.42 What requirements apply to my agricultural water sources, water distribution system, and pooling of water?

§ 112.43 What requirements apply to treating agricultural water?

§ 112.44 What specific microbial quality criteria apply to agricultural water used for certain intended uses?

§ 112.45 What measures must I take if my agricultural water does not meet the requirements of § 112.41 or § 112.44?

§ 112.46 How often must I test agricultural water that is subject to the requirements of § 112.44?

§ 112.47 Who must perform the tests required under § 112.46 and what methods must be used?

§ 112.48 What measures must I take for water that I use during harvest, packing, and holding activities for covered produce?

§ 112.49 What alternatives may I establish and use in lieu of the requirements of this subpart?

§ 112.50 Under this subpart, what requirements apply regarding records?

§ 112.51 What requirements apply for determining the status of a biological soil amendment of animal origin?

§ 112.52 How must I handle, convey, and store biological soil amendments of animal origin?

§ 112.53 What prohibitions apply regarding use of human waste?

§ 112.54 What treatment processes are acceptable for a biological soil amendment of animal origin that I apply in the growing of covered produce?

§ 112.55 What microbial standards apply to the treatment processes in § 112.54?

§ 112.56 What application requirements and minimum application intervals apply to biological soil amendments of animal origin?

§ 112.60 Under this subpart, what requirements apply regarding records?

§ 112.81 How do the requirements of this subpart apply to areas where covered activities take place?

§ 112.83 What requirements apply regarding grazing animals, working animals, and animal intrusion?

§ 112.84 Does this regulation require covered farms to take actions that would constitute a “taking” of threatened or endangered species; to take measures to exclude animals from outdoor growing areas; or to destroy animal habitat or otherwise clear farm borders around outdoor growing areas or drainages?

§ 112.111 What measures must I take if I grow, harvest, pack or hold both covered and excluded produce?

§ 112.112 What measures must I take immediately prior to and during harvest activities?

§ 112.113 How must I handle harvested covered produce during covered activities?

§ 112.114 What requirements apply to dropped covered produce?

§ 112.115 What measures must I take when packaging covered produce?

§ 112.116 What measures must I take when using food-packing (including food packaging) material?

§ 112.121 What equipment and tools are subject to the requirements of this subpart?

§ 112.122 What buildings are subject to the requirements of this subpart?

§ 112.123 What general requirements apply regarding equipment and tools subject to this subpart?

§ 112.124 What requirements apply to instruments and controls used to measure, regulate, or record?

§ 112.125 What requirements apply to equipment that is subject to this subpart used in the transport of covered produce?

§ 112.126 What requirements apply to my buildings?

§ 112.127 What requirements apply regarding domesticated animals in and around a fully-enclosed building?

§ 112.128 What requirements apply regarding pest control in buildings?

§ 112.129 What requirements apply to toilet facilities?

§ 112.130 What requirements apply for hand-washing facilities?

§ 112.131 What must I do to control and dispose of sewage?

§ 112.132 What must I do to control and dispose of trash, litter, and waste in areas used for covered activities?

§ 112.133 What requirements apply to plumbing?

§ 112.134 What must I do to control animal excreta and litter from domesticated animals that are under my control?

§ 112.140 Under this subpart, what requirements apply regarding records?

§ 112.141 What commodities are subject to this subpart?

§ 112.142 What requirements apply to seeds or beans used to grow sprouts?

§ 112.143 What measures must I take for growing, harvesting, packing, and holding sprouts?

§ 112.144 What testing must I do during growing, harvesting, packing, and holding sprouts?

§ 112.145 What requirements apply to testing the environment for Listeria species or L. monocytogenes?

§ 112.146 What actions must I take if the growing, harvesting, packing, or holding environment tests positive for Listeria species or L. monocytogenes?

§ 112.147 What must I do to collect and test samples of spent sprout irrigation water or sprouts for pathogens?

§ 112.148 What actions must I take if the samples of spent sprout irrigation water or sprouts test positive for a pathogen?

§ 112.150 Under this subpart, what requirements apply regarding records?

§ 112.151 What methods must I use to test the quality of water to satisfy the requirements of § 112.46?

§ 112.152 What methods must I use to test the growing, harvesting, packing, and holding environment for Listeria species or L. monocytogenes to satisfy the requirements of § 112.144(a)?

§ 112.153 What methods must I use to test spent sprout irrigation water (or sprouts) from each production batch of sprouts for pathogens to satisfy the requirements of § 112.144(b) and (c)?

§ 112.161 What general requirements apply to records required under this part?

§ 112.162 Where must I store records?

§ 112.163 May I use existing records to satisfy the requirements of this part?

§ 112.164 How long must I keep records?

§ 112.165 What formats are acceptable for the records I keep?

§ 112.166 What requirements apply for making records available and accessible to FDA?

§ 112.167 Can records that I provide to FDA be disclosed to persons outside of FDA?

§ 112.171 Who may request a variance from the requirements of this part?

§ 112.172 How may a State, tribe, or foreign country request a variance from one or more requirements of this part?

§ 112.173 What must be included in the Statement of Grounds in a petition requesting a variance?

§ 112.174 What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?

§ 112.175 Who responds to a petition requesting a variance?

§ 112.176 What process applies to a petition requesting a variance?

§ 112.177 Can an approved variance apply to any person other than those identified in the petition requesting that variance?

§ 112.178 Under what circumstances may FDA deny a petition requesting a variance?

§ 112.179 When does a variance approved by FDA become effective?

§ 112.180 Under what circumstances may FDA modify or revoke an approved variance?

§ 112.181 What procedures apply if FDA determines that an approved variance should be modified or revoked?

§ 112.182 What are the permissible types of variances that may be granted?

§ 112.192 What is the applicability and status of this part?

§ 112.193 What are the provisions for coordination of education and enforcement?

§ 112.201 Under what circumstances can FDA withdraw a qualified exemption in accordance with the requirements of § 112.5?

§ 112.202 What procedure will FDA use to withdraw an exemption?

§ 112.203 What information must FDA include in an order to withdraw a qualified exemption?

§ 112.204 What must I do if I receive an order to withdraw a qualified exemption applicable to my farm?

§ 112.205 Can I appeal or request a hearing on an order to withdraw a qualified exemption applicable to my farm?

§ 112.206 What is the procedure for submitting an appeal?

§ 112.207 What is the procedure for requesting an informal hearing?

§ 112.208 What requirements are applicable to an informal hearing?

§ 112.209 Who is the presiding officer for an appeal and for an informal hearing?

§ 112.210 What is the timeframe for issuing a decision on an appeal?

§ 112.211 When is an order to withdraw a qualified exemption applicable to a farm revoked?

§ 112.213 If my qualified exemption is withdrawn, under what circumstances would FDA reinstate my qualified exemption?

§ 113.3 Definitions.

§ 113.5 Current good manufacturing practice.

§ 113.10 Personnel.

§ 113.40 Equipment and procedures.

§ 113.60 Containers.

§ 113.81 Product preparation.

§ 113.83 Establishing scheduled processes.

§ 113.87 Operations in the thermal processing room.

§ 113.89 Deviations in processing, venting, or control of critical factors.

§ 113.100 Processing and production records.

§ 114.3 Definitions.

§ 114.5 Current good manufacturing practice.

§ 114.10 Personnel.

§ 114.80 Processes and controls.

§ 114.83 Establishing scheduled processes.

§ 114.89 Deviations from scheduled processes.

§ 114.90 Methodology.

§ 114.100 Records.

§ 115.50 Refrigeration of shell eggs held for retail distribution.

§ 117.1 Applicability and status.

§ 117.3 Definitions.

§ 117.4 Qualifications of individuals who manufacture, process, pack, or hold food.

§ 117.5 Exemptions.

§ 117.7 Applicability of subparts C, D, and G of this part to a facility solely engaged in the storage of unexposed packaged food.

§ 117.8 Applicability of subpart B of this part to the off-farm packing and holding of raw agricultural commodities.

§ 117.9 Records required for this subpart.

§ 117.10 Personnel.

§ 117.20 Plant and grounds.

§ 117.35 Sanitary operations.

§ 117.37 Sanitary facilities and controls.

§ 117.40 Equipment and utensils.

§ 117.80 Processes and controls.

§ 117.93 Warehousing and distribution.

§ 117.95 Holding and distribution of human food by-products for use as animal food.

§ 117.110 Defect action levels.

§ 117.126 Food safety plan.

§ 117.130 Hazard analysis.

§ 117.135 Preventive controls.

§ 117.136 Circumstances in which the owner, operator, or agent in charge of a manufacturing/processing facility is not required to implement a preventive control.

§ 117.137 Provision of assurances required under § 117.136(a)(2), (3), and (4).

§ 117.139 Recall plan.

§ 117.140 Preventive control management components.

§ 117.145 Monitoring.

§ 117.150 Corrective actions and corrections.

§ 117.155 Verification.

§ 117.160 Validation.

§ 117.165 Verification of implementation and effectiveness.

§ 117.170 Reanalysis.

§ 117.180 Requirements applicable to a preventive controls qualified individual and a qualified auditor.

§ 117.190 Implementation records required for this subpart.

§ 117.201 Modified requirements that apply to a qualified facility.

§ 117.206 Modified requirements that apply to a facility solely engaged in the storage of unexposed packaged food.

§ 117.251 Circumstances that may lead FDA to withdraw a qualified facility exemption.

§ 117.254 Issuance of an order to withdraw a qualified facility exemption.

§ 117.257 Contents of an order to withdraw a qualified facility exemption.

§ 117.260 Compliance with, or appeal of, an order to withdraw a qualified facility exemption.

§ 117.264 Procedure for submitting an appeal.

§ 117.267 Procedure for requesting an informal hearing.

§ 117.270 Requirements applicable to an informal hearing.

§ 117.274 Presiding officer for an appeal and for an informal hearing.

§ 117.277 Timeframe for issuing a decision on an appeal.

§ 117.280 Revocation of an order to withdraw a qualified facility exemption.

§ 117.284 Final agency action.

§ 117.287 Reinstatement of a qualified facility exemption that was withdrawn.

§ 117.301 Records subject to the requirements of this subpart.

§ 117.305 General requirements applying to records.

§ 117.310 Additional requirements applying to the food safety plan.

§ 117.315 Requirements for record retention.

§ 117.320 Requirements for official review.

§ 117.325 Public disclosure.

§ 117.330 Use of existing records.

§ 117.335 Special requirements applicable to a written assurance.

§ 117.405 Requirement to establish and implement a supply-chain program.

§ 117.410 General requirements applicable to a supply-chain program.

§ 117.415 Responsibilities of the receiving facility.

§ 117.420 Using approved suppliers.

§ 117.425 Determining appropriate supplier verification activities (including determining the frequency of conducting the activity).

§ 117.430 Conducting supplier verification activities for raw materials and other ingredients.

§ 117.435 Onsite audit.

§ 117.475 Records documenting the supply-chain program.

§ 118.1 Persons covered by the requirements in this part.

§ 118.3 Definitions.

§ 118.4 Salmonella Enteritidis (SE) prevention measures.

§ 118.5 Environmental testing for Salmonella Enteritidis (SE).

§ 118.6 Egg testing for Salmonella Enteritidis (SE).

§ 118.7 Sampling methodology for Salmonella Enteritidis (SE).

§ 118.8 Testing methodology for Salmonella Enteritidis (SE).

§ 118.9 Administration of the Salmonella Enteritidis (SE) prevention plan.

§ 118.10 Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.

§ 118.11 Registration requirements for shell egg producers covered by the requirements of this part.

§ 118.12 Enforcement and compliance.

§ 119.1 Dietary supplements containing ephedrine alkaloids.

§ 120.1 Applicability.

§ 120.3 Definitions.

§ 120.5 Current good manufacturing practice.

§ 120.6 Sanitation standard operating procedures.

§ 120.7 Hazard analysis.

§ 120.8 Hazard Analysis and Critical Control Point (HACCP) plan.

§ 120.9 Legal basis.

§ 120.10 Corrective actions.

§ 120.11 Verification and validation.

§ 120.12 Records.

§ 120.13 Training.

§ 120.14 Application of requirements to imported products.

§ 120.20 General.

§ 120.24 Process controls.

§ 120.25 Process verification for certain processors.

§ 121.1 Applicability.

§ 121.3 Definitions.

§ 121.4 Qualifications of individuals who perform activities under subpart C of this part.

§ 121.5 Exemptions.

§ 121.126 Food defense plan.

§ 121.130 Vulnerability assessment to identify significant vulnerabilities and actionable process steps.

§ 121.135 Mitigation strategies for actionable process steps.

§ 121.138 Mitigation strategies management components.

§ 121.140 Food defense monitoring.

§ 121.145 Food defense corrective actions.

§ 121.150 Food defense verification.

§ 121.157 Reanalysis.

§ 121.301 Records subject to the requirements of this subpart.

§ 121.305 General requirements applying to records.

§ 121.310 Additional requirements applying to the food defense plan.

§ 121.315 Requirements for record retention.

§ 121.320 Requirements for official review.

§ 121.325 Public disclosure.

§ 121.330 Use of existing records.

§ 121.401 Compliance.

§ 123.3 Definitions.

§ 123.5 Current good manufacturing practice.

§ 123.6 Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.

§ 123.7 Corrective actions.

§ 123.8 Verification.

§ 123.9 Records.

§ 123.10 Training.

§ 123.11 Sanitation control procedures.

§ 123.12 Special requirements for imported products.

§ 123.15 General.

§ 123.16 Process controls.

§ 123.20 General.

§ 123.28 Source controls.

§ 129.1 Current good manufacturing practice.

§ 129.3 Definitions.

§ 129.20 Plant construction and design.

§ 129.35 Sanitary facilities.

§ 129.37 Sanitary operations.

§ 129.40 Equipment and procedures.

§ 129.80 Processes and controls.

§ 130.3 Definitions and interpretations.

§ 130.5 Procedure for establishing a food standard.

§ 130.6 Review of Codex Alimentarius food standards.

§ 130.8 Conformity to definitions and standards of identity.

§ 130.9 Sulfites in standardized food.

§ 130.10 Requirements for foods named by use of a nutrient content claim and a standardized term.

§ 130.11 Label designations of ingredients for standardized foods.

§ 130.12 General methods for water capacity and fill of containers.

§ 130.14 General statements of substandard quality and substandard fill of container.

§ 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity.

§ 130.20 Food additives proposed for use in foods for which definitions and standards of identity are established.

§ 131.3 Definitions.

§ 131.25 Whipped cream products containing flavoring or sweetening.

§ 131.110 Milk.

§ 131.111 Acidified milk.

§ 131.112 Cultured milk.

§ 131.115 Concentrated milk.

§ 131.120 Sweetened condensed milk.

§ 131.125 Nonfat dry milk.

§ 131.127 Nonfat dry milk fortified with vitamins A and D.

§ 131.130 Evaporated milk.

§ 131.147 Dry whole milk.

§ 131.149 Dry cream.

§ 131.150 Heavy cream.

§ 131.155 Light cream.

§ 131.157 Light whipping cream.

§ 131.160 Sour cream.

§ 131.162 Acidified sour cream.

§ 131.170 Eggnog.

§ 131.180 Half-and-half.

§ 131.200 Yogurt.

§ 131.203 Lowfat yogurt.

§ 131.206 Nonfat yogurt.

§ 133.3 Definitions.

§ 133.5 Methods of analysis.

§ 133.10 Notice to manufacturers, packers, and distributors of pasteurized blended cheese, pasteurized process cheese, cheese food, cheese spread, and related foods.

§ 133.102 Asiago fresh and asiago soft cheese.

§ 133.103 Asiago medium cheese.

§ 133.104 Asiago old cheese.

§ 133.106 Blue cheese.

§ 133.108 Brick cheese.

§ 133.109 Brick cheese for manufacturing.

§ 133.111 Caciocavallo siciliano cheese.

§ 133.113 Cheddar cheese.

§ 133.114 Cheddar cheese for manufacturing.

§ 133.116 Low sodium cheddar cheese.

§ 133.118 Colby cheese.

§ 133.119 Colby cheese for manufacturing.

§ 133.121 Low sodium colby cheese.

§ 133.123 Cold-pack and club cheese.

§ 133.124 Cold-pack cheese food.

§ 133.125 Cold-pack cheese food with fruits, vegetables, or meats.

§ 133.127 Cook cheese, koch kaese.

§ 133.128 Cottage cheese.

§ 133.129 Dry curd cottage cheese.

§ 133.133 Cream cheese.

§ 133.134 Cream cheese with other foods.

§ 133.136 Washed curd and soaked curd cheese.

§ 133.137 Washed curd cheese for manufacturing.

§ 133.138 Edam cheese.

§ 133.140 Gammelost cheese.

§ 133.141 Gorgonzola cheese.

§ 133.142 Gouda cheese.

§ 133.144 Granular and stirred curd cheese.

§ 133.145 Granular cheese for manufacturing.

§ 133.146 Grated cheeses.

§ 133.147 Grated American cheese food.

§ 133.148 Hard grating cheeses.

§ 133.149 Gruyere cheese.

§ 133.150 Hard cheeses.

§ 133.152 Limburger cheese.

§ 133.153 Monterey cheese and monterey jack cheese.

§ 133.154 High-moisture jack cheese.

§ 133.155 Mozzarella cheese and scamorza cheese.

§ 133.156 Low-moisture mozzarella and scamorza cheese.

§ 133.157 Part-skim mozzarella and scamorza cheese.

§ 133.158 Low-moisture part-skim mozzarella and scamorza cheese.

§ 133.160 Muenster and munster cheese.

§ 133.161 Muenster and munster cheese for manufacturing.

§ 133.162 Neufchatel cheese.

§ 133.164 Nuworld cheese.

§ 133.165 Parmesan and reggiano cheese.

§ 133.167 Pasteurized blended cheese.

§ 133.168 Pasteurized blended cheese with fruits, vegetables, or meats.

§ 133.169 Pasteurized process cheese.

§ 133.170 Pasteurized process cheese with fruits, vegetables, or meats.

§ 133.171 Pasteurized process pimento cheese.

§ 133.173 Pasteurized process cheese food.

§ 133.174 Pasteurized process cheese food with fruits, vegetables, or meats.

§ 133.175 Pasteurized cheese spread.

§ 133.176 Pasteurized cheese spread with fruits, vegetables, or meats.

§ 133.178 Pasteurized neufchatel cheese spread with other foods.

§ 133.179 Pasteurized process cheese spread.

§ 133.180 Pasteurized process cheese spread with fruits, vegetables, or meats.

§ 133.181 Provolone cheese.

§ 133.182 Soft ripened cheeses.

§ 133.183 Romano cheese.

§ 133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold cheese from sheep's milk.

§ 133.185 Samsoe cheese.

§ 133.186 Sap sago cheese.

§ 133.187 Semisoft cheeses.

§ 133.188 Semisoft part-skim cheeses.

§ 133.189 Skim milk cheese for manufacturing.

§ 133.190 Spiced cheeses.

§ 133.191 Part-skim spiced cheeses.

§ 133.193 Spiced, flavored standardized cheeses.

§ 133.195 Swiss and emmentaler cheese.

§ 133.196 Swiss cheese for manufacturing.

§ 135.3 Definitions.

§ 135.110 Ice cream and frozen custard.

§ 135.115 Goat's milk ice cream.

§ 135.130 Mellorine.

§ 135.140 Sherbet.

§ 135.160 Water ices.

§ 136.3 Definitions.

§ 136.110 Bread, rolls, and buns.

§ 136.115 Enriched bread, rolls, and buns.

§ 136.130 Milk bread, rolls, and buns.

§ 136.160 Raisin bread, rolls, and buns.

§ 136.180 Whole wheat bread, rolls, and buns.

§ 137.105 Flour.

§ 137.155 Bromated flour.

§ 137.160 Enriched bromated flour.

§ 137.165 Enriched flour.

§ 137.170 Instantized flours.

§ 137.175 Phosphated flour.

§ 137.180 Self-rising flour.

§ 137.185 Enriched self-rising flour.

§ 137.190 Cracked wheat.

§ 137.195 Crushed wheat.

§ 137.200 Whole wheat flour.

§ 137.205 Bromated whole wheat flour.

§ 137.211 White corn flour.

§ 137.215 Yellow corn flour.

§ 137.220 Durum flour.

§ 137.225 Whole durum flour.

§ 137.250 White corn meal.

§ 137.255 Bolted white corn meal.

§ 137.260 Enriched corn meals.

§ 137.265 Degerminated white corn meal.

§ 137.270 Self-rising white corn meal.

§ 137.275 Yellow corn meal.

§ 137.280 Bolted yellow corn meal.

§ 137.285 Degerminated yellow corn meal.

§ 137.290 Self-rising yellow corn meal.

§ 137.300 Farina.

§ 137.305 Enriched farina.

§ 137.320 Semolina.

§ 137.350 Enriched rice.

§ 139.110 Macaroni products.

§ 139.115 Enriched macaroni products.

§ 139.117 Enriched macaroni products with fortified protein.

§ 139.120 Milk macaroni products.

§ 139.121 Nonfat milk macaroni products.

§ 139.122 Enriched nonfat milk macaroni products.

§ 139.125 Vegetable macaroni products.

§ 139.135 Enriched vegetable macaroni products.

§ 139.138 Whole wheat macaroni products.

§ 139.140 Wheat and soy macaroni products.

§ 139.150 Noodle products.

§ 139.155 Enriched noodle products.

§ 139.160 Vegetable noodle products.

§ 139.165 Enriched vegetable noodle products.

§ 139.180 Wheat and soy noodle products.

§ 145.3 Definitions.

§ 145.110 Canned applesauce.

§ 145.115 Canned apricots.

§ 145.116 Artificially sweetened canned apricots.

§ 145.120 Canned berries.

§ 145.125 Canned cherries.

§ 145.126 Artificially sweetened canned cherries.

§ 145.130 Canned figs.

§ 145.131 Artificially sweetened canned figs.

§ 145.134 Canned preserved figs.

§ 145.135 Canned fruit cocktail.

§ 145.136 Artificially sweetened canned fruit cocktail.

§ 145.140 Canned seedless grapes.

§ 145.145 Canned grapefruit.

§ 145.170 Canned peaches.

§ 145.171 Artificially sweetened canned peaches.

§ 145.175 Canned pears.

§ 145.176 Artificially sweetened canned pears.

§ 145.180 Canned pineapple.

§ 145.181 Artificially sweetened canned pineapple.

§ 145.185 Canned plums.

§ 145.190 Canned prunes.

§ 146.3 Definitions.

§ 146.114 Lemon juice.

§ 146.120 Frozen concentrate for lemonade.

§ 146.121 Frozen concentrate for artificially sweetened lemonade.

§ 146.126 Frozen concentrate for colored lemonade.

§ 146.132 Grapefruit juice.

§ 146.135 Orange juice.

§ 146.137 Frozen orange juice.

§ 146.140 Pasteurized orange juice.

§ 146.141 Canned orange juice.

§ 146.145 Orange juice from concentrate.

§ 146.146 Frozen concentrated orange juice.

§ 146.148 Reduced acid frozen concentrated orange juice.

§ 146.150 Canned concentrated orange juice.

§ 146.151 Orange juice for manufacturing.

§ 146.152 Orange juice with preservative.

§ 146.153 Concentrated orange juice for manufacturing.

§ 146.154 Concentrated orange juice with preservative.

§ 146.185 Pineapple juice.

§ 146.187 Canned prune juice.

§ 150.110 Fruit butter.

§ 150.140 Fruit jelly.

§ 150.160 Fruit preserves and jams.

§ 152.126 Frozen cherry pie.

§ 155.3 Definitions.

§ 155.120 Canned green beans and canned wax beans.

§ 155.130 Canned corn.

§ 155.131 Canned field corn.

§ 155.170 Canned peas.

§ 155.172 Canned dry peas.

§ 155.190 Canned tomatoes.

§ 155.191 Tomato concentrates.

§ 155.194 Catsup.

§ 155.200 Certain other canned vegetables.

§ 155.201 Canned mushrooms.

§ 156.3 Definitions.

§ 156.145 Tomato juice.

§ 158.3 Definitions.

§ 158.170 Frozen peas.

§ 160.100 Eggs.

§ 160.105 Dried eggs.

§ 160.110 Frozen eggs.

§ 160.115 Liquid eggs.

§ 160.140 Egg whites.

§ 160.145 Dried egg whites.

§ 160.150 Frozen egg whites.

§ 160.180 Egg yolks.

§ 160.185 Dried egg yolks.

§ 160.190 Frozen egg yolks.

§ 161.30 Declaration of quantity of contents on labels for canned oysters.

§ 161.130 Oysters.

§ 161.136 Olympia oysters.

§ 161.145 Canned oysters.

§ 161.170 Canned Pacific salmon.

§ 161.173 Canned wet pack shrimp in transparent or nontransparent containers.

§ 161.175 Frozen raw breaded shrimp.

§ 161.176 Frozen raw lightly breaded shrimp.

§ 161.190 Canned tuna.

§ 163.5 Methods of analysis.

§ 163.110 Cacao nibs.

§ 163.111 Chocolate liquor.

§ 163.112 Breakfast cocoa.

§ 163.113 Cocoa.

§ 163.114 Lowfat cocoa.

§ 163.117 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.

§ 163.123 Sweet chocolate.

§ 163.124 White chocolate.

§ 163.130 Milk chocolate.

§ 163.135 Buttermilk chocolate.

§ 163.140 Skim milk chocolate.

§ 163.145 Mixed dairy product chocolates.

§ 163.150 Sweet cocoa and vegetable fat coating.

§ 163.153 Sweet chocolate and vegetable fat coating.

§ 163.155 Milk chocolate and vegetable fat coating.

§ 164.110 Mixed nuts.

§ 164.120 Shelled nuts in rigid or semirigid containers.

§ 164.150 Peanut butter.

§ 165.3 Definitions.

§ 165.110 Bottled water.

§ 166.40 Labeling of margarine.

§ 166.110 Margarine.

§ 168.110 Dextrose anhydrous.

§ 168.111 Dextrose monohydrate.

§ 168.120 Glucose sirup.

§ 168.121 Dried glucose sirup.

§ 168.122 Lactose.

§ 168.130 Cane sirup.

§ 168.140 Maple sirup.

§ 168.160 Sorghum sirup.

§ 168.180 Table sirup.

§ 169.3 Definitions.

§ 169.115 French dressing.

§ 169.140 Mayonnaise.

§ 169.150 Salad dressing.

§ 169.175 Vanilla extract.

§ 169.176 Concentrated vanilla extract.

§ 169.177 Vanilla flavoring.

§ 169.178 Concentrated vanilla flavoring.

§ 169.179 Vanilla powder.

§ 169.180 Vanilla-vanillin extract.

§ 169.181 Vanilla-vanillin flavoring.

§ 169.182 Vanilla-vanillin powder.

§ 170.3 Definitions.

§ 170.6 Opinion letters on food additive status.

§ 170.10 Food additives in standardized foods.

§ 170.15 Adoption of regulation on initiative of Commissioner.

§ 170.17 Exemption for investigational use and procedure for obtaining authorization to market edible products from experimental animals.

§ 170.18 Tolerances for related food additives.

§ 170.19 Pesticide chemicals in processed foods.

§ 170.20 General principles for evaluating the safety of food additives.

§ 170.22 Safety factors to be considered.

§ 170.30 Eligibility for classification as generally recognized as safe (GRAS).

§ 170.35 Affirmation of generally recognized as safe (GRAS) status.

§ 170.38 Determination of food additive status.

§ 170.39 Threshold of regulation for substances used in food-contact articles.

§ 170.45 Fluorine-containing compounds.

§ 170.50 Glycine (aminoacetic acid) in food for human consumption.

§ 170.60 Nitrites and/or nitrates in curing premixes.

§ 170.100 Submission of a premarket notification for a food contact substance (FCN) to the Food and Drug Administration (FDA).

§ 170.101 Information in a premarket notification for a food contact substance (FCN).

§ 170.102 Confidentiality of information in a premarket notification for a food contact substance (FCN).

§ 170.103 Withdrawal without prejudice of a premarket notification for a food contact substance (FCN).

§ 170.104 Action on a premarket notification for a food contact substance (FCN).

§ 170.105 The Food and Drug Administration's (FDA's) determination that a premarket notification for a food contact substance (FCN) is no longer effective.

§ 170.106 Notification for a food contact substance formulation (NFCSF).

§ 170.203 Definitions.

§ 170.205 Opportunity to submit a GRAS notice.

§ 170.210 How to send your GRAS notice to FDA.

§ 170.215 Incorporation into a GRAS notice.

§ 170.220 General requirements applicable to a GRAS notice.

§ 170.225 Part 1 of a GRAS notice: Signed statements and certification.

§ 170.230 Part 2 of a GRAS notice: Identity, method of manufacture, specifications, and physical or technical effect.

§ 170.235 Part 3 of a GRAS notice: Dietary exposure.

§ 170.240 Part 4 of a GRAS notice: Self-limiting levels of use.

§ 170.245 Part 5 of a GRAS notice: Experience based on common use in food before 1958.

§ 170.250 Part 6 of a GRAS notice: Narrative.

§ 170.255 Part 7 of a GRAS notice: List of supporting data and information in your GRAS notice.

§ 170.260 Steps you may take before FDA responds to your GRAS notice.

§ 170.265 What FDA will do with a GRAS notice.

§ 170.270 Procedures that apply when the intended conditions of use of a notified substance include use in a product or products subject to regulation by the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture.

§ 170.275 Public disclosure of a GRAS notice.

§ 170.280 Submission of a supplement.

§ 170.285 Disposition of pending GRAS affirmation petitions.

§ 171.1 Petitions.

§ 171.6 Amendment of petition.

§ 171.7 Withdrawal of petition without prejudice.

§ 171.8 Threshold of regulation for substances used in food-contact articles.

§ 171.100 Regulation based on petition.

§ 171.102 Effective date of regulation.

§ 171.110 Procedure for objections and hearings.

§ 171.130 Procedure for amending and repealing tolerances or exemptions from tolerances.

§ 172.5 General provisions for direct food additives.

§ 172.105 Anoxomer.

§ 172.110 BHA.

§ 172.115 BHT.

§ 172.120 Calcium disodium EDTA.

§ 172.130 Dehydroacetic acid.

§ 172.133 Dimethyl dicarbonate.

§ 172.135 Disodium EDTA.

§ 172.140 Ethoxyquin.

§ 172.145 Heptylparaben.

§ 172.150 4-Hydroxymethyl-2,6-di--butylphenol.

§ 172.155 Natamycin (pimaricin).

§ 172.160 Potassium nitrate.

§ 172.165 Quaternary ammonium chloride combination.

§ 172.167 Silver nitrate and hydrogen peroxide solution.

§ 172.170 Sodium nitrate.

§ 172.175 Sodium nitrite.

§ 172.177 Sodium nitrite used in processing smoked chub.

§ 172.180 Stannous chloride.

§ 172.185 TBHQ.

§ 172.190 THBP.

§ 172.210 Coatings on fresh citrus fruit.

§ 172.215 Coumarone-indene resin.

§ 172.225 Methyl and ethyl esters of fatty acids produced from edible fats and oils.

§ 172.230 Microcapsules for flavoring substances.

§ 172.235 Morpholine.

§ 172.250 Petroleum naphtha.

§ 172.255 Polyacrylamide.

§ 172.260 Oxidized polyethylene.

§ 172.270 Sulfated butyl oleate.

§ 172.275 Synthetic paraffin and succinic derivatives.

§ 172.280 Terpene resin.

§ 172.310 Aluminum nicotinate.

§ 172.315 Nicotinamide-ascorbic acid complex.

§ 172.320 Amino acids.

§ 172.325 Bakers yeast protein.

§ 172.330 Calcium pantothenate, calcium chloride double salt.

§ 172.335 D-Pantothenamide.

§ 172.340 Fish protein isolate.

§ 172.345 Folic acid (folacin).

§ 172.350 Fumaric acid and salts of fumaric acid.

§ 172.365 Kelp.

§ 172.370 Iron-choline citrate complex.

§ 172.372 -Acetyl-L-methionine.

§ 172.375 Potassium iodide.

§ 172.379 Vitamin D.

§ 172.380 Vitamin D.

§ 172.381 Vitamin D.

§ 172.385 Whole fish protein concentrate.

§ 172.395 Xylitol.

§ 172.399 Zinc methionine sulfate.

§ 172.410 Calcium silicate.

§ 172.430 Iron ammonium citrate.

§ 172.480 Silicon dioxide.

§ 172.490 Yellow prussiate of soda.

§ 172.510 Natural flavoring substances and natural substances used in conjunction with flavors.

§ 172.515 Synthetic flavoring substances and adjuvants.

§ 172.520 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.

§ 172.530 Disodium guanylate.

§ 172.535 Disodium inosinate.

§ 172.540 DL-Alanine.

§ 172.560 Modified hop extract.

§ 172.575 Quinine.

§ 172.580 Safrole-free extract of sassafras.

§ 172.585 Sugar beet extract flavor base.

§ 172.590 Yeast-malt sprout extract.

§ 172.610 Arabinogalactan.

§ 172.615 Chewing gum base.

§ 172.620 Carrageenan.

§ 172.623 Carrageenan with polysorbate 80.

§ 172.626 Salts of carrageenan.

§ 172.655 Furcelleran.

§ 172.660 Salts of furcelleran.

§ 172.665 Gellan gum.

§ 172.695 Xanthan gum.

§ 172.710 Adjuvants for pesticide use dilutions.

§ 172.712 1,3-Butylene glycol.

§ 172.715 Calcium lignosulfonate.

§ 172.720 Calcium lactobionate.

§ 172.723 Epoxidized soybean oil.

§ 172.725 Gibberellic acid and its potassium salt.

§ 172.730 Potassium bromate.

§ 172.735 Glycerol ester of rosin.

§ 172.736 Glycerides and polyglycides of hydrogenated vegetable oils.

§ 172.755 Stearyl monoglyceridyl citrate.

§ 172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).

§ 172.770 Ethylene oxide polymer.

§ 172.775 Methacrylic acid-divinylbenzene copolymer.

§ 172.780 Acacia (gum arabic).

§ 172.785 -specific bacteriophage preparation.

§ 172.800 Acesulfame potassium.

§ 172.802 Acetone peroxides.

§ 172.803 Advantame.

§ 172.804 Aspartame.

§ 172.806 Azodicarbonamide.

§ 172.808 Copolymer condensates of ethylene oxide and propylene oxide.

§ 172.809 Curdlan.

§ 172.810 Dioctyl sodium sulfosuccinate.

§ 172.811 Glyceryl tristearate.

§ 172.812 Glycine.

§ 172.814 Hydroxylated lecithin.

§ 172.816 Methyl glucoside-coconut oil ester.

§ 172.818 Oxystearin.

§ 172.820 Polyethylene glycol (mean molecular weight 200-9,500).

§ 172.822 Sodium lauryl sulfate.

§ 172.824 Sodium mono- and dimethyl naphthalene sulfonates.

§ 172.826 Sodium stearyl fumarate.

§ 172.828 Acetylated monoglycerides.

§ 172.829 Neotame.

§ 172.830 Succinylated monoglycerides.

§ 172.831 Sucralose.

§ 172.832 Monoglyceride citrate.

§ 172.833 Sucrose acetate isobutyrate (SAIB).

§ 172.834 Ethoxylated mono- and diglycerides.

§ 172.836 Polysorbate 60.

§ 172.838 Polysorbate 65.

§ 172.840 Polysorbate 80.

§ 172.841 Polydextrose.

§ 172.842 Sorbitan monostearate.

§ 172.844 Calcium stearoyl-2-lactylate.

§ 172.846 Sodium stearoyl lactylate.

§ 172.848 Lactylic esters of fatty acids.

§ 172.850 Lactylated fatty acid esters of glycerol and propylene glycol.

§ 172.852 Glyceryl-lacto esters of fatty acids.

§ 172.854 Polyglycerol esters of fatty acids.

§ 172.856 Propylene glycol mono- and diesters of fats and fatty acids.

§ 172.858 Propylene glycol alginate.

§ 172.859 Sucrose fatty acid esters.

§ 172.860 Fatty acids.

§ 172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or both oils.

§ 172.862 Oleic acid derived from tall oil fatty acids.

§ 172.863 Salts of fatty acids.

§ 172.864 Synthetic fatty alcohols.

§ 172.866 Synthetic glycerin produced by the hydrogenolysis of carbohydrates.

§ 172.867 Olestra.

§ 172.868 Ethyl cellulose.

§ 172.869 Sucrose oligoesters.

§ 172.870 Hydroxypropyl cellulose.

§ 172.872 Methyl ethyl cellulose.

§ 172.874 Hydroxypropyl methylcellulose.

§ 172.876 Castor oil.

§ 172.878 White mineral oil.

§ 172.880 Petrolatum.

§ 172.882 Synthetic isoparaffinic petroleum hydrocarbons.

§ 172.884 Odorless light petroleum hydrocarbons.

§ 172.886 Petroleum wax.

§ 172.888 Synthetic petroleum wax.

§ 172.890 Rice bran wax.

§ 172.892 Food starch-modified.

§ 172.894 Modified cottonseed products intended for human consumption.

§ 172.896 Dried yeasts.

§ 172.898 Bakers yeast glycan.

§ 173.5 Acrylate-acrylamide resins.

§ 173.10 Modified polyacrylamide resin.

§ 173.20 Ion-exchange membranes.

§ 173.21 Perfluorinated ion exchange membranes.

§ 173.25 Ion-exchange resins.

§ 173.40 Molecular sieve resins.

§ 173.45 Polymaleic acid and its sodium salt.

§ 173.50 Polyvinylpolypyrrolidone.

§ 173.55 Polyvinylpyrrolidone.

§ 173.60 Dimethylamine-epichlorohydrin copolymer.

§ 173.65 Divinylbenzene copolymer.

§ 173.70 Chloromethylated aminated styrene-divinylbenzene resin.

§ 173.73 Sodium polyacrylate.

§ 173.75 Sorbitan monooleate.

§ 173.110 Amyloglucosidase derived from

§ 173.115 Alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis.

§ 173.120 Carbohydrase and cellulase derived from

§ 173.130 Carbohydrase derived from

§ 173.135 Catalase derived from

§ 173.140 Esterase-lipase derived from

§ 173.145 Alpha-Galactosidase derived from var.

§ 173.150 Milk-clotting enzymes, microbial.

§ 173.160

§ 173.165

§ 173.170 Aminoglycoside 3′-phosphotransferase II.

§ 173.210 Acetone.

§ 173.220 1,3-Butylene glycol.

§ 173.228 Ethyl acetate.

§ 173.230 Ethylene dichloride.

§ 173.240 Isopropyl alcohol.

§ 173.250 Methyl alcohol residues.

§ 173.255 Methylene chloride.

§ 173.270 Hexane.

§ 173.275 Hydrogenated sperm oil.

§ 173.280 Solvent extraction process for citric acid.

§ 173.290 Trichloroethylene.

§ 173.300 Chlorine dioxide.

§ 173.310 Boiler water additives.

§ 173.315 Chemicals used in washing or to assist in the peeling of fruits and vegetables.

§ 173.320 Chemicals for controlling microorganisms in cane-sugar and beet-sugar mills.

§ 173.322 Chemicals used in delinting cottonseed.

§ 173.325 Acidified sodium chlorite solutions.

§ 173.340 Defoaming agents.

§ 173.342 Chlorofluorocarbon 113 and perfluorohexane.

§ 173.345 Chloropentafluoroethane.

§ 173.350 Combustion product gas.

§ 173.355 Dichlorodifluoromethane.

§ 173.356 Hydrogen peroxide.

§ 173.357 Materials used as fixing agents in the immobilization of enzyme preparations.

§ 173.360 Octafluorocyclobutane.

§ 173.368 Ozone.

§ 173.370 Peroxyacids.

§ 173.375 Cetylpyridinium chloride.

§ 173.385 Sodium methyl sulfate.

§ 173.395 Trifluoromethane sulfonic acid.

§ 173.400 Dimethyldialkylammonium chloride.

§ 173.405 Sodium dodecylbenzenesulfonate.

§ 174.5 General provisions applicable to indirect food additives.

§ 174.6 Threshold of regulation for substances used in food-contact articles.

§ 175.105 Adhesives.

§ 175.125 Pressure-sensitive adhesives.

§ 175.210 Acrylate ester copolymer coating.

§ 175.230 Hot-melt strippable food coatings.

§ 175.250 Paraffin (synthetic).

§ 175.260 Partial phosphoric acid esters of polyester resins.

§ 175.270 Poly(vinyl fluoride) resins.

§ 175.300 Resinous and polymeric coatings.

§ 175.320 Resinous and polymeric coatings for polyolefin films.

§ 175.350 Vinyl acetate/crotonic acid copolymer.

§ 175.360 Vinylidene chloride copolymer coatings for nylon film.

§ 175.365 Vinylidene chloride copolymer coatings for polycarbonate film.

§ 175.380 Xylene-formaldehyde resins condensed with 4,4′-isopropylidenediphenol-epichlorohydrin epoxy resins.

§ 175.390 Zinc-silicon dioxide matrix coatings.

§ 176.110 Acrylamide-acrylic acid resins.

§ 176.120 Alkyl ketene dimers.

§ 176.130 Anti-offset substances.

§ 176.150 Chelating agents used in the manufacture of paper and paperboard.

§ 176.160 Chromium (Cr III) complex of -ethyl--heptadecylfluoro-octane sulfonyl glycine.

§ 176.170 Components of paper and paperboard in contact with aqueous and fatty foods.

§ 176.180 Components of paper and paperboard in contact with dry food.

§ 176.200 Defoaming agents used in coatings.

§ 176.210 Defoaming agents used in the manufacture of paper and paperboard.

§ 176.230 3,5-Dimethyl-1,3,5,2-tetrahydrothiadiazine-2-thione.

§ 176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.

§ 176.260 Pulp from reclaimed fiber.

§ 176.300 Slimicides.

§ 176.320 Sodium nitrate-urea complex.

§ 176.350 Tamarind seed kernel powder.

§ 177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.

§ 177.1020 Acrylonitrile/butadiene/styrene co-polymer.

§ 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer.

§ 177.1040 Acrylonitrile/styrene copoly-mer.

§ 177.1050 Acrylonitrile/styrene copoly-mer modified with butadiene/styrene elastomer.

§ 177.1060 -Alkylglutarimide/acrylic copolymers.

§ 177.1200 Cellophane.

§ 177.1210 Closures with sealing gaskets for food containers.

§ 177.1211 Cross-linked polyacrylate copolymers.

§ 177.1240 1,4-Cyclohexylene dimethylene terephthalate and 1,4-cyclohexylene dimethylene isophthalate copolymer.

§ 177.1310 Ethylene-acrylic acid copolymers.

§ 177.1312 Ethylene-carbon monoxide copolymers.

§ 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymers.

§ 177.1320 Ethylene-ethyl acrylate copolymers.

§ 177.1330 Ionomeric resins.

§ 177.1340 Ethylene-methyl acrylate copolymer resins.

§ 177.1345 Ethylene/1,3-phenylene oxyethylene isophthalate/ terephthalate copolymer.

§ 177.1350 Ethylene-vinyl acetate copolymers.

§ 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.

§ 177.1380 Fluorocarbon resins.

§ 177.1390 Laminate structures for use at temperatures of 250 °F and above.

§ 177.1395 Laminate structures for use at temperatures between 120 °F and 250 °F.

§ 177.1400 Hydroxyethyl cellulose film, water-insoluble.

§ 177.1420 Isobutylene polymers.

§ 177.1430 Isobutylene-butene copolymers.

§ 177.1440 4,4′-Isopropylidenediphenol-epichlorohydrin resins minimum molecular weight 10,000.

§ 177.1460 Melamine-formaldehyde resins in molded articles.

§ 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate copolymers.

§ 177.1500 Nylon resins.

§ 177.1520 Olefin polymers.

§ 177.1550 Perfluorocarbon resins.

§ 177.1555 Polyarylate resins.

§ 177.1556 Polyaryletherketone resins.

§ 177.1560 Polyarylsulfone resins.

§ 177.1570 Poly-1-butene resins and butene/ethylene copolymers.

§ 177.1580 Polycarbonate resins.

§ 177.1585 Polyestercarbonate resins.

§ 177.1590 Polyester elastomers.

§ 177.1595 Polyetherimide resin.

§ 177.1600 Polyethylene resins, carboxyl modified.

§ 177.1610 Polyethylene, chlorinated.

§ 177.1615 Polyethylene, fluorinated.

§ 177.1620 Polyethylene, oxidized.

§ 177.1630 Polyethylene phthalate polymers.

§ 177.1632 Poly(phenyleneterephthalamide) resins.

§ 177.1635 Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene).

§ 177.1637 Poly(oxy-1,2-ethanediyloxycarbonyl-2,6-naphthalenediylcarbonyl) resins.

§ 177.1640 Polystyrene and rubber-modified polystyrene.

§ 177.1650 Polysulfide polymer-polyepoxy resins.

§ 177.1655 Polysulfone resins.

§ 177.1660 Poly (tetramethylene terephthalate).

§ 177.1670 Polyvinyl alcohol film.

§ 177.1680 Polyurethane resins.

§ 177.1810 Styrene block polymers.

§ 177.1820 Styrene-maleic anhydride copolymers.

§ 177.1830 Styrene-methyl methacrylate copolymers.

§ 177.1850 Textryls.

§ 177.1900 Urea-formaldehyde resins in molded articles.

§ 177.1950 Vinyl chloride-ethylene copolymers.

§ 177.1960 Vinyl chloride-hexene-1 copolymers.

§ 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.

§ 177.1980 Vinyl chloride-propylene copolymers.

§ 177.1990 Vinylidene chloride/methyl acrylate copolymers.

§ 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate polymers.

§ 177.2210 Ethylene polymer, chlorosulfonated.

§ 177.2250 Filters, microporous polymeric.

§ 177.2260 Filters, resin-bonded.

§ 177.2280 4,4′-Isopropylidenediphenolepichlorohydrin thermosetting epoxy resins.

§ 177.2355 Mineral reinforced nylon resins.

§ 177.2400 Perfluorocarbon cured elastomers.

§ 177.2410 Phenolic resins in molded articles.

§ 177.2415 Poly(aryletherketone) resins.

§ 177.2420 Polyester resins, cross-linked.

§ 177.2430 Polyether resins, chlorinated.

§ 177.2440 Polyethersulfone resins.

§ 177.2450 Polyamide-imide resins.

§ 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.

§ 177.2465 Polymethylmethacrylate/poly(trimethoxysilylpropyl)methacrylate copolymers.

§ 177.2470 Polyoxymethylene copolymer.

§ 177.2480 Polyoxymethylene homopolymer.

§ 177.2490 Polyphenylene sulfide resins.

§ 177.2500 Polyphenylene sulfone resins.

§ 177.2510 Polyvinylidene fluoride resins.

§ 177.2550 Reverse osmosis membranes.

§ 177.2600 Rubber articles intended for repeated use.

§ 177.2710 Styrene-divinylbenzene resins, cross-linked.

§ 177.2800 Textiles and textile fibers.

§ 177.2910 Ultra-filtration membranes.

§ 178.1005 Hydrogen peroxide solution.

§ 178.1010 Sanitizing solutions.

§ 178.2010 Antioxidants and/or stabilizers for polymers.

§ 178.2550 4-Hydroxymethyl-2,6-di--butylphenol.

§ 178.2650 Organotin stabilizers in vinyl chloride plastics.

§ 178.3010 Adjuvant substances used in the manufacture of foamed plastics.

§ 178.3120 Animal glue.

§ 178.3125 Anticorrosive agents.

§ 178.3130 Antistatic and/or antifogging agents in food-packaging materials.

§ 178.3280 Castor oil, hydrogenated.

§ 178.3290 Chromic chloride complexes.

§ 178.3295 Clarifying agents for polymers.

§ 178.3297 Colorants for polymers.

§ 178.3300 Corrosion inhibitors used for steel or tinplate.

§ 178.3400 Emulsifiers and/or surface-active agents.

§ 178.3450 Esters of stearic and palmitic acids.

§ 178.3480 Fatty alcohols, synthetic.

§ 178.3500 Glycerin, synthetic.

§ 178.3505 Glyceryl tri-(12-acetoxystearate).

§ 178.3520 Industrial starch-modified.

§ 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.

§ 178.3570 Lubricants with incidental food contact.

§ 178.3600 Methyl glucoside-coconut oil ester.

§ 178.3610 α-Methylstyrene-vinyltoluene resins, hydrogenated.

§ 178.3620 Mineral oil.

§ 178.3650 Odorless light petroleum hydrocarbons.

§ 178.3690 Pentaerythritol adipate-stearate.

§ 178.3700 Petrolatum.

§ 178.3710 Petroleum wax.

§ 178.3720 Petroleum wax, synthetic.

§ 178.3725 Pigment dispersants.

§ 178.3730 Piperonyl butoxide and pyrethrins as components of bags.

§ 178.3740 Plasticizers in polymeric substances.

§ 178.3750 Polyethylene glycol (mean molecular weight 200-9,500).

§ 178.3760 Polyethylene glycol (400) monolaurate.

§ 178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen process) montan wax acids.

§ 178.3780 Polyhydric alcohol esters of long chain monobasic acids.

§ 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics.

§ 178.3800 Preservatives for wood.

§ 178.3850 Reinforced wax.

§ 178.3860 Release agents.

§ 178.3870 Rosins and rosin derivatives.

§ 178.3900 Sodium pentachlorophenate.

§ 178.3910 Surface lubricants used in the manufacture of metallic articles.

§ 178.3930 Terpene resins.

§ 178.3940 Tetraethylene glycol di-(2-ethylhexoate).

§ 178.3950 Tetrahydrofuran.

§ 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing.

§ 179.25 General provisions for food irradiation.

§ 179.26 Ionizing radiation for the treatment of food.

§ 179.30 Radiofrequency radiation for the heating of food, including microwave frequencies.

§ 179.39 Ultraviolet radiation for the processing and treatment of food.

§ 179.41 Pulsed light for the treatment of food.

§ 179.43 Carbon dioxide laser for etching food.

§ 179.45 Packaging materials for use during the irradiation of prepackaged foods.

§ 180.1 General.

§ 180.22 Acrylonitrile copolymers.

§ 180.25 Mannitol.

§ 180.30 Brominated vegetable oil.

§ 180.37 Saccharin, ammonium saccharin, calcium saccharin, and sodium saccharin.

§ 181.1 General.

§ 181.5 Prior sanctions.

§ 181.22 Certain substances employed in the manufacture of food-packaging materials.

§ 181.23 Antimycotics.

§ 181.24 Antioxidants.

§ 181.25 Driers.

§ 181.26 Drying oils as components of finished resins.

§ 181.27 Plasticizers.

§ 181.28 Release agents.

§ 181.29 Stabilizers.

§ 181.30 Substances used in the manufacture of paper and paperboard products used in food packaging.

§ 181.32 Acrylonitrile copolymers and resins.

§ 181.33 Sodium nitrate and potassium nitrate.

§ 181.34 Sodium nitrite and potassium nitrite.

§ 182.1 Substances that are generally recognized as safe.

§ 182.10 Spices and other natural seasonings and flavorings.

§ 182.20 Essential oils, oleoresins (solvent-free), and natural extractives (including distillates).

§ 182.40 Natural extractives (solvent-free) used in conjunction with spices, seasonings, and flavorings.

§ 182.50 Certain other spices, seasonings, essential oils, oleoresins, and natural extracts.

§ 182.60 Synthetic flavoring substances and adjuvants.

§ 182.70 Substances migrating from cotton and cotton fabrics used in dry food packaging.

§ 182.90 Substances migrating to food from paper and paperboard products.

§ 182.99 Adjuvants for pesticide chemicals.

§ 182.1045 Glutamic acid.

§ 182.1047 Glutamic acid hydrochloride.

§ 182.1057 Hydrochloric acid.

§ 182.1073 Phosphoric acid.

§ 182.1087 Sodium acid pyrophosphate.

§ 182.1125 Aluminum sulfate.

§ 182.1127 Aluminum ammonium sulfate.

§ 182.1129 Aluminum potassium sulfate.

§ 182.1131 Aluminum sodium sulfate.

§ 182.1180 Caffeine.

§ 182.1217 Calcium phosphate.

§ 182.1235 Caramel.

§ 182.1320 Glycerin.

§ 182.1480 Methylcellulose.

§ 182.1500 Monoammonium glutamate.

§ 182.1516 Monopotassium glutamate.

§ 182.1711 Silica aerogel.

§ 182.1745 Sodium carboxymethylcellulose.

§ 182.1748 Sodium caseinate.

§ 182.1778 Sodium phosphate.

§ 182.1781 Sodium aluminum phosphate.

§ 182.1810 Sodium tripolyphosphate.

§ 182.2122 Aluminum calcium silicate.

§ 182.2227 Calcium silicate.

§ 182.2437 Magnesium silicate.

§ 182.2727 Sodium aluminosilicate.

§ 182.2729 Sodium calcium aluminosilicate, hydrated.

§ 182.2906 Tricalcium silicate.

§ 182.3013 Ascorbic acid.

§ 182.3041 Erythorbic acid.

§ 182.3089 Sorbic acid.

§ 182.3109 Thiodipropionic acid.

§ 182.3149 Ascorbyl palmitate.

§ 182.3169 Butylated hydroxyanisole.

§ 182.3173 Butylated hydroxytoluene.

§ 182.3189 Calcium ascorbate.

§ 182.3225 Calcium sorbate.

§ 182.3280 Dilauryl thiodipropionate.

§ 182.3616 Potassium bisulfite.

§ 182.3637 Potassium metabisulfite.

§ 182.3640 Potassium sorbate.

§ 182.3731 Sodium ascorbate.

§ 182.3739 Sodium bisulfite.

§ 182.3766 Sodium metabisulfite.

§ 182.3795 Sodium sorbate.

§ 182.3798 Sodium sulfite.

§ 182.3862 Sulfur dioxide.

§ 182.3890 Tocopherols.

§ 182.6085 Sodium acid phosphate.

§ 182.6197 Calcium diacetate.

§ 182.6203 Calcium hexametaphosphate.

§ 182.6215 Monobasic calcium phosphate.

§ 182.6285 Dipotassium phosphate.

§ 182.6290 Disodium phosphate.

§ 182.6757 Sodium gluconate.

§ 182.6760 Sodium hexametaphosphate.

§ 182.6769 Sodium metaphosphate.

§ 182.6778 Sodium phosphate.

§ 182.6787 Sodium pyrophosphate.

§ 182.6789 Tetra sodium pyrophosphate.

§ 182.6810 Sodium tripolyphosphate.

§ 182.7255 Chondrus extract.

§ 182.8013 Ascorbic acid.

§ 182.8159 Biotin.

§ 182.8217 Calcium phosphate.

§ 182.8223 Calcium pyrophosphate.

§ 182.8250 Choline bitartrate.

§ 182.8252 Choline chloride.

§ 182.8778 Sodium phosphate.

§ 182.8890 Tocopherols.

§ 182.8892 α-Tocopherol acetate.

§ 182.8985 Zinc chloride.

§ 182.8988 Zinc gluconate.

§ 182.8991 Zinc oxide.

§ 182.8994 Zinc stearate.

§ 182.8997 Zinc sulfate.

§ 184.1 Substances added directly to human food affirmed as generally recognized as safe (GRAS).

§ 184.1005 Acetic acid.

§ 184.1007 Aconitic acid.

§ 184.1009 Adipic acid.

§ 184.1011 Alginic acid.

§ 184.1012 α-Amylase enzyme preparation from Bacillus stearothermophilus.

§ 184.1021 Benzoic acid.

§ 184.1024 Bromelain.

§ 184.1025 Caprylic acid.

§ 184.1027 Mixed carbohydrase and protease enzyme product.

§ 184.1033 Citric acid.

§ 184.1034 Catalase (bovine liver).

§ 184.1061 Lactic acid.

§ 184.1063 Enzyme-modified lecithin.

§ 184.1065 Linoleic acid.

§ 184.1069 Malic acid.

§ 184.1077 Potassium acid tartrate.

§ 184.1081 Propionic acid.

§ 184.1090 Stearic acid.

§ 184.1091 Succinic acid.

§ 184.1095 Sulfuric acid.

§ 184.1097 Tannic acid.

§ 184.1099 Tartaric acid.

§ 184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.

§ 184.1115 Agar-agar.

§ 184.1120 Brown algae.

§ 184.1121 Red algae.

§ 184.1133 Ammonium alginate.

§ 184.1135 Ammonium bicarbonate.

§ 184.1137 Ammonium carbonate.

§ 184.1138 Ammonium chloride.

§ 184.1139 Ammonium hydroxide.

§ 184.1140 Ammonium citrate, dibasic.

§ 184.1141a Ammonium phosphate, monobasic.

§ 184.1141b Ammonium phosphate, dibasic.

§ 184.1143 Ammonium sulfate.

§ 184.1148 Bacterially-derived carbohydrase enzyme preparation.

§ 184.1150 Bacterially-derived protease enzyme preparation.

§ 184.1155 Bentonite.

§ 184.1157 Benzoyl peroxide.

§ 184.1165 n-Butane and iso-butane.

§ 184.1185 Calcium acetate.

§ 184.1187 Calcium alginate.

§ 184.1191 Calcium carbonate.

§ 184.1193 Calcium chloride.

§ 184.1195 Calcium citrate.

§ 184.1199 Calcium gluconate.

§ 184.1201 Calcium glycerophosphate.

§ 184.1205 Calcium hydroxide.

§ 184.1206 Calcium iodate.

§ 184.1207 Calcium lactate.

§ 184.1210 Calcium oxide.

§ 184.1212 Calcium pantothenate.

§ 184.1221 Calcium propionate.

§ 184.1229 Calcium stearate.

§ 184.1230 Calcium sulfate.

§ 184.1240 Carbon dioxide.

§ 184.1245 -carotene.

§ 184.1250 Cellulase enzyme preparation derived from Trichoderma longibrachiatum.

§ 184.1257 Clove and its derivatives.

§ 184.1259 Cocoa butter substitute.

§ 184.1260 Copper gluconate.

§ 184.1261 Copper sulfate.

§ 184.1262 Corn silk and corn silk extract.

§ 184.1265 Cuprous iodide.

§ 184.1271 L-Cysteine.

§ 184.1272 L-Cysteine monohydrochloride.

§ 184.1277 Dextrin.

§ 184.1278 Diacetyl.

§ 184.1282 Dill and its derivatives.

§ 184.1287 Enzyme-modified fats.

§ 184.1293 Ethyl alcohol.

§ 184.1295 Ethyl formate.

§ 184.1296 Ferric ammonium citrate.

§ 184.1297 Ferric chloride.

§ 184.1298 Ferric citrate.

§ 184.1301 Ferric phosphate.

§ 184.1304 Ferric pyrophosphate.

§ 184.1307 Ferric sulfate.

§ 184.1307a Ferrous ascorbate.

§ 184.1307b Ferrous carbonate.

§ 184.1307c Ferrous citrate.

§ 184.1307d Ferrous fumarate.

§ 184.1308 Ferrous gluconate.

§ 184.1311 Ferrous lactate.

§ 184.1315 Ferrous sulfate.

§ 184.1316 Ficin.

§ 184.1317 Garlic and its derivatives.

§ 184.1318 Glucono delta-lactone.

§ 184.1321 Corn gluten.

§ 184.1322 Wheat gluten.

§ 184.1323 Glyceryl monooleate.

§ 184.1324 Glyceryl monostearate.

§ 184.1328 Glyceryl behenate.

§ 184.1329 Glyceryl palmitostearate.

§ 184.1330 Acacia (gum arabic).

§ 184.1333 Gum ghatti.

§ 184.1339 Guar gum.

§ 184.1343 Locust (carob) bean gum.

§ 184.1349 Karaya gum (sterculia gum).

§ 184.1351 Gum tragacanth.

§ 184.1355 Helium.

§ 184.1366 Hydrogen peroxide.

§ 184.1370 Inositol.

§ 184.1372 Insoluble glucose isomerase enzyme preparations.

§ 184.1375 Iron, elemental.

§ 184.1386 Isopropyl citrate.

§ 184.1387 Lactase enzyme preparation from Candida pseudotropicalis.

§ 184.1388 Lactase enzyme preparation from Kluyveromyces lactis.

§ 184.1400 Lecithin.

§ 184.1408 Licorice and licorice derivatives.

§ 184.1409 Ground limestone.

§ 184.1415 Animal lipase.

§ 184.1420 Lipase enzyme preparation derived from Rhizopus niveus.

§ 184.1425 Magnesium carbonate.

§ 184.1426 Magnesium chloride.

§ 184.1428 Magnesium hydroxide.

§ 184.1431 Magnesium oxide.

§ 184.1434 Magnesium phosphate.

§ 184.1440 Magnesium stearate.

§ 184.1443 Magnesium sulfate.

§ 184.1443a Malt.

§ 184.1444 Maltodextrin.

§ 184.1445 Malt syrup (malt extract).

§ 184.1446 Manganese chloride.

§ 184.1449 Manganese citrate.

§ 184.1452 Manganese gluconate.

§ 184.1461 Manganese sulfate.

§ 184.1472 Menhaden oil.

§ 184.1490 Methylparaben.

§ 184.1498 Microparticulated protein product.

§ 184.1505 Mono- and diglycerides.

§ 184.1521 Monosodium phosphate derivatives of mono- and diglycerides.

§ 184.1530 Niacin.

§ 184.1535 Niacinamide.

§ 184.1537 Nickel.

§ 184.1538 Nisin preparation.

§ 184.1540 Nitrogen.

§ 184.1545 Nitrous oxide.

§ 184.1553 Peptones.

§ 184.1555 Rapeseed oil.

§ 184.1560 Ox bile extract.

§ 184.1563 Ozone.

§ 184.1583 Pancreatin.

§ 184.1585 Papain.

§ 184.1588 Pectins.

§ 184.1595 Pepsin.

§ 184.1610 Potassium alginate.

§ 184.1613 Potassium bicarbonate.

§ 184.1619 Potassium carbonate.

§ 184.1622 Potassium chloride.

§ 184.1625 Potassium citrate.

§ 184.1631 Potassium hydroxide.

§ 184.1634 Potassium iodide.

§ 184.1635 Potassium iodate.

§ 184.1639 Potassium lactate.

§ 184.1643 Potassium sulfate.

§ 184.1655 Propane.

§ 184.1660 Propyl gallate.

§ 184.1666 Propylene glycol.

§ 184.1670 Propylparaben.

§ 184.1676 Pyridoxine hydrochloride.

§ 184.1685 Rennet (animal-derived) and chymosin preparation (fermentation-derived).

§ 184.1695 Riboflavin.

§ 184.1697 Riboflavin-5′-phosphate (sodium).

§ 184.1698 Rue.

§ 184.1699 Oil of rue.

§ 184.1702 Sheanut oil.

§ 184.1721 Sodium acetate.

§ 184.1724 Sodium alginate.

§ 184.1733 Sodium benzoate.

§ 184.1736 Sodium bicarbonate.

§ 184.1742 Sodium carbonate.

§ 184.1751 Sodium citrate.

§ 184.1754 Sodium diacetate.

§ 184.1763 Sodium hydroxide.

§ 184.1764 Sodium hypophosphite.

§ 184.1768 Sodium lactate.

§ 184.1769a Sodium metasilicate.

§ 184.1784 Sodium propionate.

§ 184.1792 Sodium sesquicarbonate.

§ 184.1801 Sodium tartrate.

§ 184.1804 Sodium potassium tartrate.

§ 184.1807 Sodium thiosulfate.

§ 184.1835 Sorbitol.

§ 184.1845 Stannous chloride (anhydrous and dihydrated).

§ 184.1848 Starter distillate.

§ 184.1851 Stearyl citrate.

§ 184.1854 Sucrose.

§ 184.1857 Corn sugar.

§ 184.1859 Invert sugar.

§ 184.1865 Corn syrup.

§ 184.1866 High fructose corn syrup.

§ 184.1875 Thiamine hydrochloride.

§ 184.1878 Thiamine mononitrate.

§ 184.1890 α-Tocopherols.

§ 184.1901 Triacetin.

§ 184.1903 Tributyrin.

§ 184.1911 Triethyl citrate.

§ 184.1914 Trypsin.

§ 184.1923 Urea.

§ 184.1924 Urease enzyme preparation from Lactobacillus fermentum.

§ 184.1930 Vitamin A.

§ 184.1945 Vitamin B.

§ 184.1950 Vitamin D.

§ 184.1973 Beeswax (yellow and white).

§ 184.1976 Candelilla wax.

§ 184.1978 Carnauba wax.

§ 184.1979 Whey.

§ 184.1979a Reduced lactose whey.

§ 184.1979b Reduced minerals whey.

§ 184.1979c Whey protein concentrate.

§ 184.1983 Bakers yeast extract.

§ 184.1984 Zein.

§ 184.1985 Aminopeptidase enzyme preparation derived from lactococcus lactis.

§ 186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).

§ 186.1093 Sulfamic acid.

§ 186.1256 Clay (kaolin).

§ 186.1275 Dextrans.

§ 186.1300 Ferric oxide.

§ 186.1316 Formic acid.

§ 186.1374 Iron oxides.

§ 186.1551 Hydrogenated fish oil.

§ 186.1555 Japan wax.

§ 186.1557 Tall oil.

§ 186.1673 Pulp.

§ 186.1750 Sodium chlorite.

§ 186.1756 Sodium formate.

§ 186.1770 Sodium oleate.

§ 186.1771 Sodium palmitate.

§ 186.1797 Sodium sulfate.

§ 186.1839 Sorbose.

§ 189.1 Substances prohibited from use in human food.

§ 189.5 Prohibited cattle materials.

§ 189.110 Calamus and its derivatives.

§ 189.113 Cinnamyl anthranilate.

§ 189.120 Cobaltous salts and its derivatives.

§ 189.130 Coumarin.

§ 189.135 Cyclamate and its derivatives.

§ 189.140 Diethylpyrocarbonate (DEPC).

§ 189.145 Dulcin.

§ 189.155 Monochloroacetic acid.

§ 189.165 Nordihydroguaiaretic acid (NDGA).

§ 189.175 P-4000.

§ 189.180 Safrole.

§ 189.190 Thiourea.

§ 189.191 Chlorofluorocarbon propellants.

§ 189.220 Flectol H.

§ 189.240 Lead solders.

§ 189.250 Mercaptoimidazoline and 2-mercaptoimidazoline.

§ 189.280 4,4′-Methylenebis (2-chloroanaline).

§ 189.300 Hydrogenated 4,4′-isopropylidene-diphenolphosphite ester resins.

§ 189.301 Tin-coated lead foil capsules for wine bottles.

§ 190.6 Requirement for premarket notification.

§ 200.5 Mailing of important information about drugs.

§ 200.7 Supplying pharmacists with indications and dosage information.

§ 200.10 Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers.

§ 200.11 Use of octadecylamine in steam lines of drug establishments.

§ 200.15 Definition of term “insulin.”

§ 200.50 Ophthalmic preparations and dispensers.

§ 200.51 Aqueous-based drug products for oral inhalation.

§ 200.200 Prescription drugs; reminder advertisements and reminder labeling to provide price information to consumers.

§ 201.1 Drugs; name and place of business of manufacturer, packer, or distributor.

§ 201.2 Drugs and devices; National Drug Code numbers.

§ 201.5 Drugs; adequate directions for use.

§ 201.6 Drugs; misleading statements.

§ 201.10 Drugs; statement of ingredients.

§ 201.15 Drugs; prominence of required label statements.

§ 201.16 Drugs; Spanish-language version of certain required statements.

§ 201.17 Drugs; location of expiration date.

§ 201.18 Drugs; significance of control numbers.

§ 201.19 Drugs; use of term “infant”.

§ 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.

§ 201.21 Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.

§ 201.22 Prescription drugs containing sulfites; required warning statements.

§ 201.23 Required pediatric studies.

§ 201.24 Labeling for systemic antibacterial drug products.

§ 201.25 Bar code label requirements.

§ 201.26 Exceptions or alternatives to labeling requirements for human drug products held by the Strategic National Stockpile.

§ 201.50 Statement of identity.

§ 201.51 Declaration of net quantity of contents.

§ 201.55 Statement of dosage.

§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1).

§ 201.58 Waiver of labeling requirements.

§ 201.60 Principal display panel.

§ 201.61 Statement of identity.

§ 201.62 Declaration of net quantity of contents.

§ 201.63 Pregnancy/breast-feeding warning.

§ 201.64 Sodium labeling.

§ 201.66 Format and content requirements for over-the-counter (OTC) drug product labeling.

§ 201.70 Calcium labeling.

§ 201.71 Magnesium labeling.

§ 201.72 Potassium labeling.

§ 201.80 Specific requirements on content and format of labeling for human prescription drug and biological products; older drugs not described in § 201.56(b)(1).

§ 201.100 Prescription drugs for human use.

§ 201.105 Veterinary drugs.

§ 201.115 New drugs or new animal drugs.

§ 201.116 Drugs having commonly known directions.

§ 201.117 Inactive ingredients.

§ 201.119 In vitro diagnostic products.

§ 201.120 Prescription chemicals and other prescription components.

§ 201.122 Drugs for processing, repacking, or manufacturing.

§ 201.125 Drugs for use in teaching, law enforcement, research, and analysis.

§ 201.127 Drugs; expiration of exemptions.

§ 201.128 Meaning of “intended uses”.

§ 201.129 Drugs; exemption for radioactive drugs for research use.

§ 201.150 Drugs; processing, labeling, or repacking.

§ 201.161 Medical gases.

§ 201.200 Disclosure of drug efficacy study evaluations in labeling and advertising.

§ 201.300 Notice to manufacturers, packers, and distributors of glandular preparations.

§ 201.301 Notice to manufacturers, packers, and distributors of estrogenic hormone preparations.

§ 201.302 Notice to manufacturers, packers, and distributors of drugs for internal use which contain mineral oil.

§ 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.

§ 201.304 Tannic acid and barium enema preparations.

§ 201.305 Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use; warnings.

§ 201.306 Potassium salt preparations intended for oral ingestion by man.

§ 201.307 Sodium phosphates; package size limitation, warnings, and directions for over-the-counter sale.

§ 201.308 Ipecac syrup; warnings and directions for use for over-the-counter sale.

§ 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary warning statement.

§ 201.310 Phenindione; labeling of drug preparations intended for use by man.

§ 201.311 [Reserved]

§ 201.312 Magnesium sulfate heptahydrate; label declaration on drug products.

§ 201.313 Estradiol labeling.

§ 201.314 Labeling of drug preparations containing salicylates.

§ 201.315 Over-the-counter drugs for minor sore throats; suggested warning.

§ 201.316 Drugs with thyroid hormone activity for human use; required warning.

§ 201.317 Digitalis and related cardiotonic drugs for human use in oral dosage forms; required warning.

§ 201.319 Water-soluble gums, hydrophilic gums, and hydrophilic mucilloids (including, but not limited to agar, alginic acid, calcium polycarbophil, carboxymethylcellulose sodium, carrageenan, chondrus, glucomannan ((B-1,4 linked) polymannose acetate), guar gum, karaya gum, kelp, methylcellulose, plantago seed (psyllium), polycarbophil tragacanth, and xanthan gum) as active ingredients; required warnings and directions.

§ 201.320 Warning statements for drug products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.

§ 201.323 Aluminum in large and small volume parenterals used in total parenteral nutrition.

§ 201.325 Over-the-counter drugs for vaginal contraceptive and spermicide use containing nonoxynol 9 as the active ingredient; required warnings and labeling information.

§ 201.326 Over-the-counter drug products containing internal analgesic/antipyretic active ingredients; required warnings and other labeling.

§ 201.327 Over-the-counter sunscreen drug products; required labeling based on effectiveness testing.

§ 201.328 Labeling of medical gas containers.

§ 202.1 Prescription-drug advertisements.

§ 203.1 Scope.

§ 203.2 Purpose.

§ 203.3 Definitions.

§ 203.10 Restrictions on reimportation.

§ 203.11 Applications for reimportation to provide emergency medical care.

§ 203.12 An appeal from an adverse decision by the district office.

§ 203.20 Sales restrictions.

§ 203.22 Exclusions.

§ 203.23 Returns.

§ 203.30 Sample distribution by mail or common carrier.

§ 203.31 Sample distribution by means other than mail or common carrier (direct delivery by a representative or detailer).

§ 203.32 Drug sample storage and handling requirements.

§ 203.33 Drug sample forms.

§ 203.34 Policies and procedures; administrative systems.

§ 203.35 Standing requests.

§ 203.36 Fulfillment houses, shipping and mailing services, comarketing agreements, and third-party recordkeeping.

§ 203.37 Investigation and notification requirements.

§ 203.38 Sample lot or control numbers; labeling of sample units.

§ 203.39 Donation of drug samples to charitable institutions.

§ 203.50 Requirements for wholesale distribution of prescription drugs.

§ 203.60 Request and receipt forms, reports, and records.

§ 203.70 Application for a reward.

§ 205.1 Scope.

§ 205.2 Purpose.

§ 205.3 Definitions.

§ 205.4 Wholesale drug distributor licensing requirement.

§ 205.5 Minimum required information for licensure.

§ 205.6 Minimum qualifications.

§ 205.7 Personnel.

§ 205.8 Violations and penalties.

§ 205.50 Minimum requirements for the storage and handling of prescription drugs and for the establishment and maintenance of prescription drug distribution records.

§ 206.1 Scope.

§ 206.3 Definitions.

§ 206.7 Exemptions.

§ 206.10 Code imprint required.

§ 207.1 What definitions and interpretations of terms apply to this part?

§ 207.3 Bulk drug substance.

§ 207.5 What is the purpose of this part?

§ 207.9 Who does this part cover?

§ 207.13 Who is exempt from the registration and listing requirements?

§ 207.17 Who must register?

§ 207.21 When must initial registration information be provided?

§ 207.25 What information is required for registration?

§ 207.29 What are the requirements for reviewing and updating registration information?

§ 207.33 What is the National Drug Code (NDC), how is it assigned, and what are its requirements?

§ 207.35 What changes require a new NDC?

§ 207.37 What restrictions pertain to the use of the NDC?

§ 207.41 Who must list drugs and what drugs must they list?

§ 207.45 When, after initial registration of an establishment, must drug listing information be submitted?

§ 207.49 What listing information must a registrant submit for a drug it manufactures?

§ 207.53 What listing information must a registrant submit for a drug that it repacks or relabels?

§ 207.54 What listing information must a registrant submit for a drug that it salvages?

§ 207.55 What additional drug listing information may FDA require?

§ 207.57 What information must registrants submit when updating listing information and when?

§ 207.61 How is registration and listing information provided to FDA?

§ 207.65 How can a waiver of the electronic submission requirement be obtained?

§ 207.69 What are the requirements for an official contact and a United States agent?

§ 207.77 What legal status is conferred by registration and listing?

§ 207.81 What registration and listing information will FDA make available for public disclosure?

§ 208.1 Scope and purpose.

§ 208.3 Definitions.

§ 208.20 Content and format of a Medication Guide.

§ 208.24 Distributing and dispensing a Medication Guide.

§ 208.26 Exemptions and deferrals.

§ 209.1 Scope and purpose.

§ 209.2 Definitions.

§ 209.10 Content and format of the side effects statement.

§ 209.11 Dispensing and distributing the side effects statement.

§ 210.1 Status of current good manufacturing practice regulations.

§ 210.2 Applicability of current good manufacturing practice regulations.

§ 210.3 Definitions.

§ 211.1 Scope.

§ 211.3 Definitions.

§ 211.22 Responsibilities of quality control unit.

§ 211.25 Personnel qualifications.

§ 211.28 Personnel responsibilities.

§ 211.34 Consultants.

§ 211.42 Design and construction features.

§ 211.44 Lighting.

§ 211.46 Ventilation, air filtration, air heating and cooling.

§ 211.48 Plumbing.

§ 211.50 Sewage and refuse.

§ 211.52 Washing and toilet facilities.

§ 211.56 Sanitation.

§ 211.58 Maintenance.

§ 211.63 Equipment design, size, and location.

§ 211.65 Equipment construction.

§ 211.67 Equipment cleaning and maintenance.

§ 211.68 Automatic, mechanical, and electronic equipment.

§ 211.72 Filters.

§ 211.80 General requirements.

§ 211.82 Receipt and storage of untested components, drug product containers, and closures.

§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.

§ 211.86 Use of approved components, drug product containers, and closures.

§ 211.87 Retesting of approved components, drug product containers, and closures.

§ 211.89 Rejected components, drug product containers, and closures.

§ 211.94 Drug product containers and closures.

§ 211.100 Written procedures; deviations.

§ 211.101 Charge-in of components.

§ 211.103 Calculation of yield.

§ 211.105 Equipment identification.

§ 211.110 Sampling and testing of in-process materials and drug products.

§ 211.111 Time limitations on production.

§ 211.113 Control of microbiological contamination.

§ 211.115 Reprocessing.

§ 211.122 Materials examination and usage criteria.

§ 211.125 Labeling issuance.

§ 211.130 Packaging and labeling operations.

§ 211.132 Tamper-evident packaging requirements for over-the-counter (OTC) human drug products.

§ 211.134 Drug product inspection.

§ 211.137 Expiration dating.

§ 211.142 Warehousing procedures.

§ 211.150 Distribution procedures.

§ 211.160 General requirements.

§ 211.165 Testing and release for distribution.

§ 211.166 Stability testing.

§ 211.167 Special testing requirements.

§ 211.170 Reserve samples.

§ 211.173 Laboratory animals.

§ 211.176 Penicillin contamination.

§ 211.180 General requirements.

§ 211.182 Equipment cleaning and use log.

§ 211.184 Component, drug product container, closure, and labeling records.

§ 211.186 Master production and control records.

§ 211.188 Batch production and control records.

§ 211.192 Production record review.

§ 211.194 Laboratory records.

§ 211.196 Distribution records.

§ 211.198 Complaint files.

§ 211.204 Returned drug products.

§ 211.208 Drug product salvaging.

§ 212.1 What are the meanings of the technical terms used in these regulations?

§ 212.2 What is current good manufacturing practice for PET drugs?

§ 212.5 To what drugs do the regulations in this part apply?

§ 212.10 What personnel and resources must I have?

§ 212.20 What activities must I perform to ensure drug quality?

§ 212.30 What requirements must my facilities and equipment meet?

§ 212.40 How must I control the components I use to produce PET drugs and the containers and closures I package them in?

§ 212.50 What production and process controls must I have?

§ 212.60 What requirements apply to the laboratories where I test components, in-process materials, and finished PET drug products?

§ 212.61 What must I do to ensure the stability of my PET drug products through expiry?

§ 212.70 What controls and acceptance criteria must I have for my finished PET drug products?

§ 212.71 What actions must I take if a batch of PET drug product does not conform to specifications?

§ 212.80 What are the requirements associated with labeling and packaging PET drug products?

§ 212.90 What actions must I take to control the distribution of PET drug products?

§ 212.100 What do I do if I receive a complaint about a PET drug product produced at my facility?

§ 212.110 How must I maintain records of my production of PET drugs?

§ 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act.

§ 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness.

§ 225.1 Current good manufacturing practice.

§ 225.10 Personnel.

§ 225.20 Buildings.

§ 225.30 Equipment.

§ 225.35 Use of work areas, equipment, and storage areas for other manufacturing and storage purpose.

§ 225.42 Components.

§ 225.58 Laboratory controls.

§ 225.65 Equipment cleanout procedures.

§ 225.80 Labeling.

§ 225.102 Master record file and production records.

§ 225.110 Distribution records.

§ 225.115 Complaint files.

§ 225.120 Buildings and grounds.

§ 225.130 Equipment.

§ 225.135 Work and storage areas.

§ 225.142 Components.

§ 225.158 Laboratory assays.

§ 225.165 Equipment cleanout procedures.

§ 225.180 Labeling.

§ 225.202 Formula, production, and distribution records.

§ 226.1 Current good manufacturing practice.

§ 226.10 Personnel.

§ 226.20 Buildings.

§ 226.30 Equipment.

§ 226.40 Production and control procedures.

§ 226.42 Components.

§ 226.58 Laboratory controls.

§ 226.80 Packaging and labeling.

§ 226.102 Master-formula and batch-production records.

§ 226.110 Distribution records.

§ 226.115 Complaint files.

§ 250.11 Thyroid-containing drug preparations intended for treatment of obesity in humans.

§ 250.12 Stramonium preparations labeled with directions for use in self-medication regarded as misbranded.

§ 250.100 Amyl nitrite inhalant as a prescription drug for human use.

§ 250.101 Amphetamine and methamphetamine inhalers regarded as prescription drugs.

§ 250.102 Drug preparations intended for human use containing certain “coronary vasodilators”.

§§ 250.103-250.104 [Reserved]

§ 250.105 Gelsemium-containing preparations regarded as prescription drugs.

§§ 250.106-250.107 [Reserved]

§ 250.108 Potassium permanganate preparations as prescription drugs.

§ 250.201 Preparations for the treatment of pernicious anemia.

§ 250.250 Hexachlorophene, as a component of drug and cosmetic products.

§ 290.1 Controlled substances.

§ 290.2 Exemption from prescription requirements.

§ 290.5 Drugs; statement of required warning.

§ 290.6 Spanish-language version of required warning.

§ 290.10 Definition of emergency situation.

§ 299.3 Definitions and interpretations.

§ 299.4 Established names for drugs.

§ 299.5 Drugs; compendial name.

§ 300.50 Fixed-combination prescription drugs for humans.

§ 300.100 Chlorofluorocarbon propellants.

§ 310.3 Definitions and interpretations.

§ 310.4 Biologics; products subject to license control.

§ 310.6 Applicability of “new drug” or safety or effectiveness findings in drug efficacy study implementation notices and notices of opportunity for hearing to identical, related, and similar drug products.

§ 310.100 New drug status opinions; statement of policy.

§ 310.103 New drug substances intended for hypersensitivity testing.

§ 310.200 Prescription-exemption procedure.

§ 310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.

§ 310.303 Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved.

§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.

§ 310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.

§ 310.501 Patient package inserts for oral contraceptives.

§ 310.502 Certain drugs accorded new drug status through rulemaking procedures.

§ 310.503 Requirements regarding certain radioactive drugs.

§ 310.509 Parenteral drug products in plastic containers.

§ 310.515 Patient package inserts for estrogens.

§ 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.

§ 310.518 Drug products containing iron or iron salts.

§ 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.

§ 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.

§ 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.

§ 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.

§ 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.

§ 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.

§ 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.

§ 310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.

§ 310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.

§ 310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.

§ 310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.

§ 310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.

§ 310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.

§ 310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.

§ 310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.

§ 310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.

§ 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.

§ 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.

§ 310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.

§ 310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.

§ 310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.

§ 312.1 Scope.

§ 312.2 Applicability.

§ 312.3 Definitions and interpretations.

§ 312.6 Labeling of an investigational new drug.

§ 312.7 Promotion of investigational drugs.

§ 312.8 Charging for investigational drugs under an IND.

§ 312.10 Waivers.

§ 312.20 Requirement for an IND.

§ 312.21 Phases of an investigation.

§ 312.22 General principles of the IND submission.

§ 312.23 IND content and format.

§ 312.30 Protocol amendments.

§ 312.31 Information amendments.

§ 312.32 IND safety reporting.

§ 312.33 Annual reports.

§ 312.38 Withdrawal of an IND.

§ 312.40 General requirements for use of an investigational new drug in a clinical investigation.

§ 312.41 Comment and advice on an IND.

§ 312.42 Clinical holds and requests for modification.

§ 312.44 Termination.

§ 312.45 Inactive status.

§ 312.47 Meetings.

§ 312.48 Dispute resolution.

§ 312.50 General responsibilities of sponsors.

§ 312.52 Transfer of obligations to a contract research organization.

§ 312.53 Selecting investigators and monitors.

§ 312.54 Emergency research under § 50.24 of this chapter.

§ 312.55 Informing investigators.

§ 312.56 Review of ongoing investigations.

§ 312.57 Recordkeeping and record retention.

§ 312.58 Inspection of sponsor's records and reports.

§ 312.59 Disposition of unused supply of investigational drug.

§ 312.60 General responsibilities of investigators.

§ 312.61 Control of the investigational drug.

§ 312.62 Investigator recordkeeping and record retention.

§ 312.64 Investigator reports.

§ 312.66 Assurance of IRB review.

§ 312.68 Inspection of investigator's records and reports.

§ 312.69 Handling of controlled substances.

§ 312.70 Disqualification of a clinical investigator.

§ 312.80 Purpose.

§ 312.81 Scope.

§ 312.82 Early consultation.

§ 312.83 Treatment protocols.

§ 312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.

§ 312.85 Phase 4 studies.

§ 312.86 Focused FDA regulatory research.

§ 312.87 Active monitoring of conduct and evaluation of clinical trials.

§ 312.88 Safeguards for patient safety.

§ 312.110 Import and export requirements.

§ 312.120 Foreign clinical studies not conducted under an IND.

§ 312.130 Availability for public disclosure of data and information in an IND.

§ 312.140 Address for correspondence.

§ 312.145 Guidance documents.

§ 312.160 Drugs for investigational use in laboratory research animals or in vitro tests.

§ 312.300 General.

§ 312.305 Requirements for all expanded access uses.

§ 312.310 Individual patients, including for emergency use.

§ 312.315 Intermediate-size patient populations.

§ 312.320 Treatment IND or treatment protocol.

§ 314.1 Scope of this part.

§ 314.2 Purpose.

§ 314.3 Definitions.

§ 314.50 Content and format of an NDA.

§ 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

§ 314.53 Submission of patent information.

§ 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.

§ 314.55 Pediatric use information.

§ 314.60 Amendments to an unapproved NDA, supplement, or resubmission.

§ 314.65 Withdrawal by the applicant of an unapproved application.

§ 314.70 Supplements and other changes to an approved NDA.

§ 314.71 Procedures for submission of a supplement to an approved application.

§ 314.72 Change in ownership of an application.

§ 314.80 Postmarketing reporting of adverse drug experiences.

§ 314.81 Other postmarketing reports.

§ 314.90 Waivers.

§ 314.92 Drug products for which abbreviated applications may be submitted.

§ 314.93 Petition to request a change from a listed drug.

§ 314.94 Content and format of an ANDA.

§ 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.

§ 314.96 Amendments to an unapproved ANDA.

§ 314.97 Supplements and other changes to an approved ANDA.

§ 314.98 Postmarketing reports.

§ 314.99 Other responsibilities of an applicant of an ANDA.

§ 314.100 Timeframes for reviewing applications and abbreviated applications.

§ 314.101 Filing an NDA and receiving an ANDA.

§ 314.102 Communications between FDA and applicants.

§ 314.103 Dispute resolution.

§ 314.104 Drugs with potential for abuse.

§ 314.105 Approval of an NDA and an ANDA.

§ 314.106 Foreign data.

§ 314.107 Date of approval of a 505(b)(2) application or ANDA.

§ 314.108 New drug product exclusivity.

§ 314.110 Complete response letter to the applicant.

§ 314.120 [Reserved]

§ 314.122 Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.

§ 314.125 Refusal to approve an NDA.

§ 314.126 Adequate and well-controlled studies.

§ 314.127 Refusal to approve an ANDA.

§ 314.150 Withdrawal of approval of an application or abbreviated application.

§ 314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.

§ 314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.

§ 314.153 Suspension of approval of an abbreviated new drug application.

§ 314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.

§ 314.161 Determination of reasons for voluntary withdrawal of a listed drug.

§ 314.162 Removal of a drug product from the list.

§ 314.170 Adulteration and misbranding of an approved drug.

§ 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.

§ 314.201 Procedure for hearings.

§ 314.235 Judicial review.

§ 314.410 Imports and exports of new drugs.

§ 314.420 Drug master files.

§ 314.430 Availability for public disclosure of data and information in an application or abbreviated application.

§ 314.440 Addresses for applications and abbreviated applications.

§ 314.445 Guidance documents.

§ 314.500 Scope.

§ 314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.

§ 314.520 Approval with restrictions to assure safe use.

§ 314.530 Withdrawal procedures.

§ 314.540 Postmarketing safety reporting.

§ 314.550 Promotional materials.

§ 314.560 Termination of requirements.

§ 314.600 Scope.

§ 314.610 Approval based on evidence of effectiveness from studies in animals.

§ 314.620 Withdrawal procedures.

§ 314.630 Postmarketing safety reporting.

§ 314.640 Promotional materials.

§ 314.650 Termination of requirements.

§ 315.1 Scope.

§ 315.2 Definition.

§ 315.3 General factors relevant to safety and effectiveness.

§ 315.4 Indications.

§ 315.5 Evaluation of effectiveness.

§ 315.6 Evaluation of safety.

§ 316.1 Scope of this part.

§ 316.2 Purpose.

§ 316.3 Definitions.

§ 316.4 Address for submissions.

§ 316.10 Content and format of a request for written recommendations.

§ 316.12 Providing written recommendations.

§ 316.14 Refusal to provide written recommendations.

§ 316.20 Content and format of a request for orphan-drug designation.

§ 316.21 Verification of orphan-drug status.

§ 316.22 Permanent-resident agent for foreign sponsor.

§ 316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.

§ 316.24 Deficiency letters and granting orphan-drug designation.

§ 316.25 Refusal to grant orphan-drug designation.

§ 316.26 Amendment to orphan-drug designation.

§ 316.27 Change in ownership of orphan-drug designation.

§ 316.28 Publication of orphan-drug designations.

§ 316.29 Revocation of orphan-drug designation.

§ 316.30 Annual reports of holder of orphan-drug designation.

§ 316.31 Scope of orphan-drug exclusive approval.

§ 316.34 FDA recognition of exclusive approval.

§ 316.36 Insufficient quantities of orphan drugs.

§ 316.40 Treatment use of a designated orphan drug.

§ 316.50 Guidance documents.

§ 316.52 Availability for public disclosure of data and information in requests and applications.

§ 317.1 [Reserved]

§ 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.

§ 320.1 Definitions.

§ 320.21 Requirements for submission of bioavailability and bioequivalence data.

§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.

§ 320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.

§ 320.24 Types of evidence to measure bioavailability or establish bioequivalence.

§ 320.25 Guidelines for the conduct of an in vivo bioavailability study.

§ 320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.

§ 320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.

§ 320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.

§ 320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.

§ 320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.

§ 320.31 Applicability of requirements regarding an “Investigational New Drug Application.”

§ 320.32 Procedures for establishing or amending a bioequivalence requirement.

§ 320.33 Criteria and evidence to assess actual or potential bioequivalence problems.

§ 320.34 Requirements for batch testing and certification by the Food and Drug Administration.

§ 320.35 Requirements for in vitro testing of each batch.

§ 320.36 Requirements for maintenance of records of bioequivalence testing.

§ 320.38 Retention of bioavailability samples.

§ 320.63 Retention of bioequivalence samples.

§ 328.1 Scope.

§ 328.3 Definitions.

§ 328.10 Alcohol.

§ 328.50 Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.

§ 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.

§ 330.1 General conditions for general recognition as safe, effective and not misbranded.

§ 330.2 Pregnancy-nursing warning.

§ 330.3 Imprinting of solid oral dosage form drug products.

§ 330.5 Drug categories.

§ 330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.

§ 330.11 NDA deviations from applicable monograph.

§ 330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

§ 330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.

§ 330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.

§ 330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.

§ 331.1 Scope.

§ 331.10 Antacid active ingredients.

§ 331.11 Listing of specific active ingredients.

§ 331.15 Combination with nonantacid active ingredients.

§ 331.20 Determination of percent contribution of active ingredients.

§ 331.21 Test modifications.

§ 331.30 Labeling of antacid products.

§ 331.80 Professional labeling.

§ 332.1 Scope.

§ 332.3 Definitions.

§ 332.10 Antiflatulent active ingredients.

§ 332.15 Combination with non-antiflatulent active ingredients.

§ 332.30 Labeling of antiflatulent drug products.

§ 332.31 Professional labeling.

§ 333.101 Scope.

§ 333.103 Definitions.

§ 333.110 First aid antibiotic active ingredients.

§ 333.120 Permitted combinations of active ingredients.

§ 333.150 Labeling of first aid antibiotic drug products.

§ 333.160 Labeling of permitted combinations of active ingredients.

§ 333.201 Scope.

§ 333.203 Definitions.

§ 333.210 Antifungal active ingredients.

§ 333.250 Labeling of antifungal drug products.

§ 333.280 Professional labeling.

§ 333.301 Scope.

§ 333.303 Definitions.

§ 333.310 Acne active ingredients.

§ 333.320 Permitted combinations of active ingredients.

§ 333.350 Labeling of acne drug products.

§ 335.1 Scope.

§ 335.3 Definitions.

§ 335.10 Antidiarrheal active ingredients.

§ 335.50 Labeling of antidiarrheal drug products.

§ 336.1 Scope.

§ 336.3 Definition.

§ 336.10 Antiemetic active ingredients.

§ 336.50 Labeling of antiemetic drug products.

§ 336.80 Professional labeling.

§ 338.1 Scope.

§ 338.3 Definition.

§ 338.10 Nighttime sleep-aid active ingredients.

§ 338.50 Labeling of nighttime sleep-aid drug products.

§ 340.1 Scope.

§ 340.3 Definition.

§ 340.10 Stimulant active ingredient.

§ 340.50 Labeling of stimulant drug products.

§ 341.1 Scope.

§ 341.3 Definitions.

§ 341.12 Antihistamine active ingredients.

§ 341.14 Antitussive active ingredients.

§ 341.16 Bronchodilator active ingredients.

§ 341.18 Expectorant active ingredient.

§ 341.20 Nasal decongestant active ingredients.

§ 341.40 Permitted combinations of active ingredients.

§ 341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product).

§ 341.72 Labeling of antihistamine drug products.

§ 341.74 Labeling of antitussive drug products.

§ 341.76 Labeling of bronchodilator drug products.

§ 341.78 Labeling of expectorant drug products.

§ 341.80 Labeling of nasal decongestant drug products.

§ 341.85 Labeling of permitted combinations of active ingredients.

§ 341.90 Professional labeling.

§ 343.1 Scope.

§ 343.3 Definitions.

§ 343.10 [Reserved]

§ 343.12 Cardiovascular active ingredients.

§ 343.13 Rheumatologic active ingredients.

§ 343.20 [Reserved]

§ 343.22 Permitted combinations of active ingredients for cardiovascular-rheumatologic use.

§§ 343.50-343.60 [Reserved]

§ 343.80 Professional labeling.

§ 343.90 Dissolution and drug release testing.

§ 344.1 Scope.

§ 344.3 Definitions.

§ 344.10 Earwax removal aid active ingredient.

§ 344.12 Ear drying aid active ingredient.

§ 344.50 Labeling of earwax removal aid drug products.

§ 344.52 Labeling of ear drying aid drug products.

§ 346.1 Scope.

§ 346.3 Definitions.

§ 346.10 Local anesthetic active ingredients.

§ 346.12 Vasoconstrictor active ingredients.

§ 346.14 Protectant active ingredients.

§ 346.16 Analgesic, anesthetic, and antipruritic active ingredients.

§ 346.18 Astringent active ingredients.

§ 346.20 Keratolytic active ingredients.

§ 346.22 Permitted combinations of anorectal active ingredients.

§ 346.50 Labeling of anorectal drug products.

§ 346.52 Labeling of permitted combinations of anorectal active ingredients.

§ 347.1 Scope.

§ 347.3 Definitions.

§ 347.10 Skin protectant active ingredients.

§ 347.12 Astringent active ingredients.

§ 347.20 Permitted combinations of active ingredients.

§ 347.50 Labeling of skin protectant drug products.

§ 347.52 Labeling of astringent drug products.

§ 347.60 Labeling of permitted combinations of active ingredients.

§ 348.1 Scope.

§ 348.3 Definitions.

§ 348.10 Analgesic, anesthetic, and antipruritic active ingredients.

§ 348.50 Labeling of external analgesic drug products.

§ 349.1 Scope.

§ 349.3 Definitions.

§ 349.10 Ophthalmic astringent.

§ 349.12 Ophthalmic demulcents.

§ 349.14 Ophthalmic emollients.

§ 349.16 Ophthalmic hypertonicity agent.

§ 349.18 Ophthalmic vasoconstrictors.

§ 349.20 Eyewashes.

§ 349.30 Permitted combinations of active ingredients.

§ 349.50 Labeling of ophthalmic drug products.

§ 349.55 Labeling of ophthalmic astringent drug products.

§ 349.60 Labeling of ophthalmic demulcent drug products.

§ 349.65 Labeling of ophthalmic emollient drug products.

§ 349.70 Labeling of ophthalmic hypertonicity drug products.

§ 349.75 Labeling of ophthalmic vasoconstrictor drug products.

§ 349.78 Labeling of eyewash drug products.

§ 349.79 Labeling of permitted combinations of active ingredients.

§ 349.80 Professional labeling.

§ 350.1 Scope.

§ 350.3 Definition.

§ 350.10 Antiperspirant active ingredients.

§ 350.50 Labeling of antiperspirant drug products.

§ 350.60 Guidelines for effectiveness testing of antiperspirant drug products.

§ 352.1 Scope.

§ 352.3 Definitions.

§ 352.10 Sunscreen active ingredients.

§ 352.20 Permitted combinations of active ingredients.

§ 352.50 Principal display panel of all sunscreen drug products.

§ 352.52 Labeling of sunscreen drug products.

§ 352.60 Labeling of permitted combinations of active ingredients.

§ 352.70 Standard sunscreen.

§ 352.71 Light source (solar simulator).

§ 352.72 General testing procedures.

§ 352.73 Determination of SPF value.

§ 352.76 Determination if a product is water resistant or very water resistant.

§ 352.77 Test modifications.

§ 355.1 Scope.

§ 355.3 Definitions.

§ 355.10 Anticaries active ingredients.

§ 355.20 Packaging conditions.

§ 355.50 Labeling of anticaries drug products.

§ 355.55 Principal display panel of all fluoride rinse drug products.

§ 355.60 Professional labeling.

§ 355.70 Testing procedures for fluoride dentifrice drug products.

§ 357.101 Scope.

§ 357.103 Definition.

§ 357.110 Anthelmintic active ingredient.

§ 357.150 Labeling of anthelmintic drug products.

§ 357.152 Package inserts for anthelmintic drug products.

§ 357.180 Professional labeling.

§ 357.201 Scope.

§ 357.203 Definition.

§ 357.210 Cholecystokinetic active ingredients.

§ 357.250 Labeling of cholecystokinetic drug products.

§ 357.280 Professional labeling.