Title 21

Volume 5 CHAPTER I SUBCHAP D

Subchapter D - Drugs For Human Use

21:5.0.1.1.1PART 300
PART 300 - GENERAL
21:5.0.1.1.1.1SUBPART A
Subpart A [Reserved]
21:5.0.1.1.1.2SUBPART B
Subpart B - Combination Drugs
21:5.0.1.1.1.2.1.1SECTION 300.50
     300.50 Fixed-combination prescription drugs for humans.
21:5.0.1.1.1.3SUBPART C
Subpart C - Substances Generally Prohibited From Drugs
21:5.0.1.1.1.3.1.1SECTION 300.100
     300.100 Chlorofluorocarbon propellants.
21:5.0.1.1.2PART 310
PART 310 - NEW DRUGS
21:5.0.1.1.2.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.2.1.1.1SECTION 310.3
     310.3 Definitions and interpretations.
21:5.0.1.1.2.1.1.2SECTION 310.4
     310.4 Biologics; products subject to license control.
21:5.0.1.1.2.1.1.3SECTION 310.6
     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.
21:5.0.1.1.2.2SUBPART B
Subpart B - Specific Administrative Rulings and Decisions
21:5.0.1.1.2.2.1.1SECTION 310.100
     310.100 New drug status opinions; statement of policy.
21:5.0.1.1.2.2.1.2SECTION 310.103
     310.103 New drug substances intended for hypersensitivity testing.
21:5.0.1.1.2.3SUBPART C
Subpart C - New Drugs Exempted From Prescription-Dispensing Requirements
21:5.0.1.1.2.3.1.1SECTION 310.200
     310.200 Prescription-exemption procedure.
21:5.0.1.1.2.3.1.2SECTION 310.201
     310.201 Exemption for certain drugs limited by new-drug applications to prescription sale.
21:5.0.1.1.2.4SUBPART D
Subpart D - Records and Reports
21:5.0.1.1.2.4.1.1SECTION 310.303
     310.303 Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved.
21:5.0.1.1.2.4.1.2SECTION 310.305
     310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
21:5.0.1.1.2.4.1.3SECTION 310.306
     310.306 Notification of a permanent discontinuance or an interruption in manufacturing of marketed prescription drugs for human use without approved new drug applications.
21:5.0.1.1.2.5SUBPART E
Subpart E - Requirements for Specific New Drugs or Devices
21:5.0.1.1.2.5.1.1SECTION 310.501
     310.501 Patient package inserts for oral contraceptives.
21:5.0.1.1.2.5.1.2SECTION 310.502
     310.502 Certain drugs accorded new drug status through rulemaking procedures.
21:5.0.1.1.2.5.1.3SECTION 310.503
     310.503 Requirements regarding certain radioactive drugs.
21:5.0.1.1.2.5.1.4SECTION 310.509
     310.509 Parenteral drug products in plastic containers.
21:5.0.1.1.2.5.1.5SECTION 310.515
     310.515 Patient package inserts for estrogens.
21:5.0.1.1.2.5.1.6SECTION 310.517
     310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.
21:5.0.1.1.2.5.1.7SECTION 310.518
     310.518 Drug products containing iron or iron salts.
21:5.0.1.1.2.5.1.8SECTION 310.519
     310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.
21:5.0.1.1.2.5.1.9SECTION 310.527
     310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.
21:5.0.1.1.2.5.1.10SECTION 310.528
     310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.
21:5.0.1.1.2.5.1.11SECTION 310.529
     310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.
21:5.0.1.1.2.5.1.12SECTION 310.530
     310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.
21:5.0.1.1.2.5.1.13SECTION 310.531
     310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.
21:5.0.1.1.2.5.1.14SECTION 310.532
     310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.
21:5.0.1.1.2.5.1.15SECTION 310.533
     310.533 Drug products containing active ingredients offered over-the-counter (OTC) for human use as an anticholinergic in cough-cold drug products.
21:5.0.1.1.2.5.1.16SECTION 310.534
     310.534 Drug products containing active ingredients offered over-the-counter (OTC) for human use as oral wound healing agents.
21:5.0.1.1.2.5.1.17SECTION 310.536
     310.536 Drug products containing active ingredients offered over-the-counter (OTC) for use as a nailbiting or thumbsucking deterrent.
21:5.0.1.1.2.5.1.18SECTION 310.537
     310.537 Drug products containing active ingredients offered over-the-counter (OTC) for oral administration for the treatment of fever blisters and cold sores.
21:5.0.1.1.2.5.1.19SECTION 310.538
     310.538 Drug products containing active ingredients offered over-the-counter (OTC) for use for ingrown toenail relief.
21:5.0.1.1.2.5.1.20SECTION 310.540
     310.540 Drug products containing active ingredients offered over-the-counter (OTC) for use as stomach acidifiers.
21:5.0.1.1.2.5.1.21SECTION 310.541
     310.541 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hypophosphatemia.
21:5.0.1.1.2.5.1.22SECTION 310.542
     310.542 Over-the-counter (OTC) drug products containing active ingredients offered for use in the treatment of hyperphosphatemia.
21:5.0.1.1.2.5.1.23SECTION 310.543
     310.543 Drug products containing active ingredients offered over-the-counter (OTC) for human use in exocrine pancreatic insufficiency.
21:5.0.1.1.2.5.1.24SECTION 310.544
     310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent.
21:5.0.1.1.2.5.1.25SECTION 310.545
     310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses.
21:5.0.1.1.2.5.1.26SECTION 310.546
     310.546 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment and/or prevention of nocturnal leg muscle cramps.
21:5.0.1.1.2.5.1.27SECTION 310.547
     310.547 Drug products containing quinine offered over-the-counter (OTC) for the treatment and/or prevention of malaria.
21:5.0.1.1.2.5.1.28SECTION 310.548
     310.548 Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease.
21:5.0.1.1.3PART 312
PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION
21:5.0.1.1.3.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.3.1.1.1SECTION 312.1
     312.1 Scope.
21:5.0.1.1.3.1.1.2SECTION 312.2
     312.2 Applicability.
21:5.0.1.1.3.1.1.3SECTION 312.3
     312.3 Definitions and interpretations.
21:5.0.1.1.3.1.1.4SECTION 312.6
     312.6 Labeling of an investigational new drug.
21:5.0.1.1.3.1.1.5SECTION 312.7
     312.7 Promotion of investigational drugs.
21:5.0.1.1.3.1.1.6SECTION 312.8
     312.8 Charging for investigational drugs under an IND.
21:5.0.1.1.3.1.1.7SECTION 312.10
     312.10 Waivers.
21:5.0.1.1.3.2SUBPART B
Subpart B - Investigational New Drug Application (IND)
21:5.0.1.1.3.2.1.1SECTION 312.20
     312.20 Requirement for an IND.
21:5.0.1.1.3.2.1.2SECTION 312.21
     312.21 Phases of an investigation.
21:5.0.1.1.3.2.1.3SECTION 312.22
     312.22 General principles of the IND submission.
21:5.0.1.1.3.2.1.4SECTION 312.23
     312.23 IND content and format.
21:5.0.1.1.3.2.1.5SECTION 312.30
     312.30 Protocol amendments.
21:5.0.1.1.3.2.1.6SECTION 312.31
     312.31 Information amendments.
21:5.0.1.1.3.2.1.7SECTION 312.32
     312.32 IND safety reporting.
21:5.0.1.1.3.2.1.8SECTION 312.33
     312.33 Annual reports.
21:5.0.1.1.3.2.1.9SECTION 312.38
     312.38 Withdrawal of an IND.
21:5.0.1.1.3.3SUBPART C
Subpart C - Administrative Actions
21:5.0.1.1.3.3.1.1SECTION 312.40
     312.40 General requirements for use of an investigational new drug in a clinical investigation.
21:5.0.1.1.3.3.1.2SECTION 312.41
     312.41 Comment and advice on an IND.
21:5.0.1.1.3.3.1.3SECTION 312.42
     312.42 Clinical holds and requests for modification.
21:5.0.1.1.3.3.1.4SECTION 312.44
     312.44 Termination.
21:5.0.1.1.3.3.1.5SECTION 312.45
     312.45 Inactive status.
21:5.0.1.1.3.3.1.6SECTION 312.47
     312.47 Meetings.
21:5.0.1.1.3.3.1.7SECTION 312.48
     312.48 Dispute resolution.
21:5.0.1.1.3.4SUBPART D
Subpart D - Responsibilities of Sponsors and Investigators
21:5.0.1.1.3.4.1.1SECTION 312.50
     312.50 General responsibilities of sponsors.
21:5.0.1.1.3.4.1.2SECTION 312.52
     312.52 Transfer of obligations to a contract research organization.
21:5.0.1.1.3.4.1.3SECTION 312.53
     312.53 Selecting investigators and monitors.
21:5.0.1.1.3.4.1.4SECTION 312.54
     312.54 Emergency research under § 50.24 of this chapter.
21:5.0.1.1.3.4.1.5SECTION 312.55
     312.55 Informing investigators.
21:5.0.1.1.3.4.1.6SECTION 312.56
     312.56 Review of ongoing investigations.
21:5.0.1.1.3.4.1.7SECTION 312.57
     312.57 Recordkeeping and record retention.
21:5.0.1.1.3.4.1.8SECTION 312.58
     312.58 Inspection of sponsor's records and reports.
21:5.0.1.1.3.4.1.9SECTION 312.59
     312.59 Disposition of unused supply of investigational drug.
21:5.0.1.1.3.4.1.10SECTION 312.60
     312.60 General responsibilities of investigators.
21:5.0.1.1.3.4.1.11SECTION 312.61
     312.61 Control of the investigational drug.
21:5.0.1.1.3.4.1.12SECTION 312.62
     312.62 Investigator recordkeeping and record retention.
21:5.0.1.1.3.4.1.13SECTION 312.64
     312.64 Investigator reports.
21:5.0.1.1.3.4.1.14SECTION 312.66
     312.66 Assurance of IRB review.
21:5.0.1.1.3.4.1.15SECTION 312.68
     312.68 Inspection of investigator's records and reports.
21:5.0.1.1.3.4.1.16SECTION 312.69
     312.69 Handling of controlled substances.
21:5.0.1.1.3.4.1.17SECTION 312.70
     312.70 Disqualification of a clinical investigator.
21:5.0.1.1.3.5SUBPART E
Subpart E - Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
21:5.0.1.1.3.5.1.1SECTION 312.80
     312.80 Purpose.
21:5.0.1.1.3.5.1.2SECTION 312.81
     312.81 Scope.
21:5.0.1.1.3.5.1.3SECTION 312.82
     312.82 Early consultation.
21:5.0.1.1.3.5.1.4SECTION 312.83
     312.83 Treatment protocols.
21:5.0.1.1.3.5.1.5SECTION 312.84
     312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
21:5.0.1.1.3.5.1.6SECTION 312.85
     312.85 Phase 4 studies.
21:5.0.1.1.3.5.1.7SECTION 312.86
     312.86 Focused FDA regulatory research.
21:5.0.1.1.3.5.1.8SECTION 312.87
     312.87 Active monitoring of conduct and evaluation of clinical trials.
21:5.0.1.1.3.5.1.9SECTION 312.88
     312.88 Safeguards for patient safety.
21:5.0.1.1.3.6SUBPART F
Subpart F - Miscellaneous
21:5.0.1.1.3.6.1.1SECTION 312.110
     312.110 Import and export requirements.
21:5.0.1.1.3.6.1.2SECTION 312.120
     312.120 Foreign clinical studies not conducted under an IND.
21:5.0.1.1.3.6.1.3SECTION 312.130
     312.130 Availability for public disclosure of data and information in an IND.
21:5.0.1.1.3.6.1.4SECTION 312.140
     312.140 Address for correspondence.
21:5.0.1.1.3.6.1.5SECTION 312.145
     312.145 Guidance documents.
21:5.0.1.1.3.7SUBPART G
Subpart G - Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
21:5.0.1.1.3.7.1.1SECTION 312.160
     312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
21:5.0.1.1.3.8SUBPART H
Subpart H [Reserved]
21:5.0.1.1.3.9SUBPART I
Subpart I - Expanded Access to Investigational Drugs for Treatment Use
21:5.0.1.1.3.9.1.1SECTION 312.300
     312.300 General.
21:5.0.1.1.3.9.1.2SECTION 312.305
     312.305 Requirements for all expanded access uses.
21:5.0.1.1.3.9.1.3SECTION 312.310
     312.310 Individual patients, including for emergency use.
21:5.0.1.1.3.9.1.4SECTION 312.315
     312.315 Intermediate-size patient populations.
21:5.0.1.1.3.9.1.5SECTION 312.320
     312.320 Treatment IND or treatment protocol.
21:5.0.1.1.4PART 314
PART 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG
21:5.0.1.1.4.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.4.1.1.1SECTION 314.1
     314.1 Scope of this part.
21:5.0.1.1.4.1.1.2SECTION 314.2
     314.2 Purpose.
21:5.0.1.1.4.1.1.3SECTION 314.3
     314.3 Definitions.
21:5.0.1.1.4.2SUBPART B
Subpart B - Applications
21:5.0.1.1.4.2.1.1SECTION 314.50
     314.50 Content and format of an NDA.
21:5.0.1.1.4.2.1.2SECTION 314.52
     314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
21:5.0.1.1.4.2.1.3SECTION 314.53
     314.53 Submission of patent information.
21:5.0.1.1.4.2.1.4SECTION 314.54
     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.
21:5.0.1.1.4.2.1.5SECTION 314.55
     314.55 Pediatric use information.
21:5.0.1.1.4.2.1.6SECTION 314.60
     314.60 Amendments to an unapproved NDA, supplement, or resubmission.
21:5.0.1.1.4.2.1.7SECTION 314.65
     314.65 Withdrawal by the applicant of an unapproved application.
21:5.0.1.1.4.2.1.8SECTION 314.70
     314.70 Supplements and other changes to an approved NDA.
21:5.0.1.1.4.2.1.9SECTION 314.71
     314.71 Procedures for submission of a supplement to an approved application.
21:5.0.1.1.4.2.1.10SECTION 314.72
     314.72 Change in ownership of an application.
21:5.0.1.1.4.2.1.11SECTION 314.80
     314.80 Postmarketing reporting of adverse drug experiences.
21:5.0.1.1.4.2.1.12SECTION 314.81
     314.81 Other postmarketing reports.
21:5.0.1.1.4.2.1.13SECTION 314.90
     314.90 Waivers.
21:5.0.1.1.4.3SUBPART C
Subpart C - Abbreviated Applications
21:5.0.1.1.4.3.1.1SECTION 314.92
     314.92 Drug products for which abbreviated applications may be submitted.
21:5.0.1.1.4.3.1.2SECTION 314.93
     314.93 Petition to request a change from a listed drug.
21:5.0.1.1.4.3.1.3SECTION 314.94
     314.94 Content and format of an ANDA.
21:5.0.1.1.4.3.1.4SECTION 314.95
     314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
21:5.0.1.1.4.3.1.5SECTION 314.96
     314.96 Amendments to an unapproved ANDA.
21:5.0.1.1.4.3.1.6SECTION 314.97
     314.97 Supplements and other changes to an approved ANDA.
21:5.0.1.1.4.3.1.7SECTION 314.98
     314.98 Postmarketing reports.
21:5.0.1.1.4.3.1.8SECTION 314.99
     314.99 Other responsibilities of an applicant of an ANDA.
21:5.0.1.1.4.4SUBPART D
Subpart D - FDA Action on Applications and Abbreviated Applications
21:5.0.1.1.4.4.1.1SECTION 314.100
     314.100 Timeframes for reviewing applications and abbreviated applications.
21:5.0.1.1.4.4.1.2SECTION 314.101
     314.101 Filing an NDA and receiving an ANDA.
21:5.0.1.1.4.4.1.3SECTION 314.102
     314.102 Communications between FDA and applicants.
21:5.0.1.1.4.4.1.4SECTION 314.103
     314.103 Dispute resolution.
21:5.0.1.1.4.4.1.5SECTION 314.104
     314.104 Drugs with potential for abuse.
21:5.0.1.1.4.4.1.6SECTION 314.105
     314.105 Approval of an NDA and an ANDA.
21:5.0.1.1.4.4.1.7SECTION 314.106
     314.106 Foreign data.
21:5.0.1.1.4.4.1.8SECTION 314.107
     314.107 Date of approval of a 505(b)(2) application or ANDA.
21:5.0.1.1.4.4.1.9SECTION 314.108
     314.108 New drug product exclusivity.
21:5.0.1.1.4.4.1.10SECTION 314.110
     314.110 Complete response letter to the applicant.
21:5.0.1.1.4.4.1.11SECTION 314.120
     314.120 [Reserved]
21:5.0.1.1.4.4.1.12SECTION 314.122
     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.
21:5.0.1.1.4.4.1.13SECTION 314.125
     314.125 Refusal to approve an NDA.
21:5.0.1.1.4.4.1.14SECTION 314.126
     314.126 Adequate and well-controlled studies.
21:5.0.1.1.4.4.1.15SECTION 314.127
     314.127 Refusal to approve an ANDA.
21:5.0.1.1.4.4.1.16SECTION 314.150
     314.150 Withdrawal of approval of an application or abbreviated application.
21:5.0.1.1.4.4.1.17SECTION 314.151
     314.151 Withdrawal of approval of an abbreviated new drug application under section 505(j)(5) of the act.
21:5.0.1.1.4.4.1.18SECTION 314.152
     314.152 Notice of withdrawal of approval of an application or abbreviated application for a new drug.
21:5.0.1.1.4.4.1.19SECTION 314.153
     314.153 Suspension of approval of an abbreviated new drug application.
21:5.0.1.1.4.4.1.20SECTION 314.160
     314.160 Approval of an application or abbreviated application for which approval was previously refused, suspended, or withdrawn.
21:5.0.1.1.4.4.1.21SECTION 314.161
     314.161 Determination of reasons for voluntary withdrawal of a listed drug.
21:5.0.1.1.4.4.1.22SECTION 314.162
     314.162 Removal of a drug product from the list.
21:5.0.1.1.4.4.1.23SECTION 314.170
     314.170 Adulteration and misbranding of an approved drug.
21:5.0.1.1.4.5SUBPART E
Subpart E - Hearing Procedures for New Drugs
21:5.0.1.1.4.5.1.1SECTION 314.200
     314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing.
21:5.0.1.1.4.5.1.2SECTION 314.201
     314.201 Procedure for hearings.
21:5.0.1.1.4.5.1.3SECTION 314.235
     314.235 Judicial review.
21:5.0.1.1.4.6SUBPART F
Subpart F [Reserved]
21:5.0.1.1.4.7SUBPART G
Subpart G - Miscellaneous Provisions
21:5.0.1.1.4.7.1.1SECTION 314.410
     314.410 Imports and exports of new drugs.
21:5.0.1.1.4.7.1.2SECTION 314.420
     314.420 Drug master files.
21:5.0.1.1.4.7.1.3SECTION 314.430
     314.430 Availability for public disclosure of data and information in an application or abbreviated application.
21:5.0.1.1.4.7.1.4SECTION 314.440
     314.440 Addresses for applications and abbreviated applications.
21:5.0.1.1.4.7.1.5SECTION 314.445
     314.445 Guidance documents.
21:5.0.1.1.4.8SUBPART H
Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses
21:5.0.1.1.4.8.1.1SECTION 314.500
     314.500 Scope.
21:5.0.1.1.4.8.1.2SECTION 314.510
     314.510 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
21:5.0.1.1.4.8.1.3SECTION 314.520
     314.520 Approval with restrictions to assure safe use.
21:5.0.1.1.4.8.1.4SECTION 314.530
     314.530 Withdrawal procedures.
21:5.0.1.1.4.8.1.5SECTION 314.540
     314.540 Postmarketing safety reporting.
21:5.0.1.1.4.8.1.6SECTION 314.550
     314.550 Promotional materials.
21:5.0.1.1.4.8.1.7SECTION 314.560
     314.560 Termination of requirements.
21:5.0.1.1.4.9SUBPART I
Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible
21:5.0.1.1.4.9.1.1SECTION 314.600
     314.600 Scope.
21:5.0.1.1.4.9.1.2SECTION 314.610
     314.610 Approval based on evidence of effectiveness from studies in animals.
21:5.0.1.1.4.9.1.3SECTION 314.620
     314.620 Withdrawal procedures.
21:5.0.1.1.4.9.1.4SECTION 314.630
     314.630 Postmarketing safety reporting.
21:5.0.1.1.4.9.1.5SECTION 314.640
     314.640 Promotional materials.
21:5.0.1.1.4.9.1.6SECTION 314.650
     314.650 Termination of requirements.
21:5.0.1.1.5PART 315
PART 315 - DIAGNOSTIC RADIOPHARMACEUTICALS
21:5.0.1.1.5.0.1.1SECTION 315.1
     315.1 Scope.
21:5.0.1.1.5.0.1.2SECTION 315.2
     315.2 Definition.
21:5.0.1.1.5.0.1.3SECTION 315.3
     315.3 General factors relevant to safety and effectiveness.
21:5.0.1.1.5.0.1.4SECTION 315.4
     315.4 Indications.
21:5.0.1.1.5.0.1.5SECTION 315.5
     315.5 Evaluation of effectiveness.
21:5.0.1.1.5.0.1.6SECTION 315.6
     315.6 Evaluation of safety.
21:5.0.1.1.6PART 316
PART 316 - ORPHAN DRUGS
21:5.0.1.1.6.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.6.1.1.1SECTION 316.1
     316.1 Scope of this part.
21:5.0.1.1.6.1.1.2SECTION 316.2
     316.2 Purpose.
21:5.0.1.1.6.1.1.3SECTION 316.3
     316.3 Definitions.
21:5.0.1.1.6.1.1.4SECTION 316.4
     316.4 Address for submissions.
21:5.0.1.1.6.2SUBPART B
Subpart B - Written Recommendations for Investigations of Orphan Drugs
21:5.0.1.1.6.2.1.1SECTION 316.10
     316.10 Content and format of a request for written recommendations.
21:5.0.1.1.6.2.1.2SECTION 316.12
     316.12 Providing written recommendations.
21:5.0.1.1.6.2.1.3SECTION 316.14
     316.14 Refusal to provide written recommendations.
21:5.0.1.1.6.3SUBPART C
Subpart C - Designation of an Orphan Drug
21:5.0.1.1.6.3.1.1SECTION 316.20
     316.20 Content and format of a request for orphan-drug designation.
21:5.0.1.1.6.3.1.2SECTION 316.21
     316.21 Verification of orphan-drug status.
21:5.0.1.1.6.3.1.3SECTION 316.22
     316.22 Permanent-resident agent for foreign sponsor.
21:5.0.1.1.6.3.1.4SECTION 316.23
     316.23 Timing of requests for orphan-drug designation; designation of already approved drugs.
21:5.0.1.1.6.3.1.5SECTION 316.24
     316.24 Deficiency letters and granting orphan-drug designation.
21:5.0.1.1.6.3.1.6SECTION 316.25
     316.25 Refusal to grant orphan-drug designation.
21:5.0.1.1.6.3.1.7SECTION 316.26
     316.26 Amendment to orphan-drug designation.
21:5.0.1.1.6.3.1.8SECTION 316.27
     316.27 Change in ownership of orphan-drug designation.
21:5.0.1.1.6.3.1.9SECTION 316.28
     316.28 Publication of orphan-drug designations.
21:5.0.1.1.6.3.1.10SECTION 316.29
     316.29 Revocation of orphan-drug designation.
21:5.0.1.1.6.3.1.11SECTION 316.30
     316.30 Annual reports of holder of orphan-drug designation.
21:5.0.1.1.6.4SUBPART D
Subpart D - Orphan-drug Exclusive Approval
21:5.0.1.1.6.4.1.1SECTION 316.31
     316.31 Scope of orphan-drug exclusive approval.
21:5.0.1.1.6.4.1.2SECTION 316.34
     316.34 FDA recognition of exclusive approval.
21:5.0.1.1.6.4.1.3SECTION 316.36
     316.36 Insufficient quantities of orphan drugs.
21:5.0.1.1.6.5SUBPART E
Subpart E - Open Protocols for Investigations
21:5.0.1.1.6.5.1.1SECTION 316.40
     316.40 Treatment use of a designated orphan drug.
21:5.0.1.1.6.6SUBPART F
Subpart F - Availability of Information
21:5.0.1.1.6.6.1.1SECTION 316.50
     316.50 Guidance documents.
21:5.0.1.1.6.6.1.2SECTION 316.52
     316.52 Availability for public disclosure of data and information in requests and applications.
21:5.0.1.1.7PART 317
PART 317 - QUALIFYING PATHOGENS
21:5.0.1.1.7.0.1.1SECTION 317.1
     317.1 [Reserved]
21:5.0.1.1.7.0.1.2SECTION 317.2
     317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.
21:5.0.1.1.8PART 320
PART 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
21:5.0.1.1.8.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.8.1.1.1SECTION 320.1
     320.1 Definitions.
21:5.0.1.1.8.2SUBPART B
Subpart B - Procedures for Determining the Bioavailability or Bioequivalence of Drug Products
21:5.0.1.1.8.2.1.1SECTION 320.21
     320.21 Requirements for submission of bioavailability and bioequivalence data.
21:5.0.1.1.8.2.1.2SECTION 320.22
     320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
21:5.0.1.1.8.2.1.3SECTION 320.23
     320.23 Basis for measuring in vivo bioavailability or demonstrating bioequivalence.
21:5.0.1.1.8.2.1.4SECTION 320.24
     320.24 Types of evidence to measure bioavailability or establish bioequivalence.
21:5.0.1.1.8.2.1.5SECTION 320.25
     320.25 Guidelines for the conduct of an in vivo bioavailability study.
21:5.0.1.1.8.2.1.6SECTION 320.26
     320.26 Guidelines on the design of a single-dose in vivo bioavailability or bioequivalence study.
21:5.0.1.1.8.2.1.7SECTION 320.27
     320.27 Guidelines on the design of a multiple-dose in vivo bioavailability study.
21:5.0.1.1.8.2.1.8SECTION 320.28
     320.28 Correlation of bioavailability with an acute pharmacological effect or clinical evidence.
21:5.0.1.1.8.2.1.9SECTION 320.29
     320.29 Analytical methods for an in vivo bioavailability or bioequivalence study.
21:5.0.1.1.8.2.1.10SECTION 320.30
     320.30 Inquiries regarding bioavailability and bioequivalence requirements and review of protocols by the Food and Drug Administration.
21:5.0.1.1.8.2.1.11SECTION 320.31
     320.31 Applicability of requirements regarding an “Investigational New Drug Application.”
21:5.0.1.1.8.2.1.12SECTION 320.32
     320.32 Procedures for establishing or amending a bioequivalence requirement.
21:5.0.1.1.8.2.1.13SECTION 320.33
     320.33 Criteria and evidence to assess actual or potential bioequivalence problems.
21:5.0.1.1.8.2.1.14SECTION 320.34
     320.34 Requirements for batch testing and certification by the Food and Drug Administration.
21:5.0.1.1.8.2.1.15SECTION 320.35
     320.35 Requirements for in vitro testing of each batch.
21:5.0.1.1.8.2.1.16SECTION 320.36
     320.36 Requirements for maintenance of records of bioequivalence testing.
21:5.0.1.1.8.2.1.17SECTION 320.38
     320.38 Retention of bioavailability samples.
21:5.0.1.1.8.2.1.18SECTION 320.63
     320.63 Retention of bioequivalence samples.
21:5.0.1.1.9PART 328
PART 328 - OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
21:5.0.1.1.9.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.9.1.1.1SECTION 328.1
     328.1 Scope.
21:5.0.1.1.9.1.1.2SECTION 328.3
     328.3 Definitions.
21:5.0.1.1.9.2SUBPART B
Subpart B - Ingredients
21:5.0.1.1.9.2.1.1SECTION 328.10
     328.10 Alcohol.
21:5.0.1.1.9.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.9.3.1.1SECTION 328.50
     328.50 Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.
21:5.0.1.1.10PART 329
PART 329 - NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT
21:5.0.1.1.10.0.1.1SECTION 329.100
     329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.
21:5.0.1.1.11PART 330
PART 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
21:5.0.1.1.11.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.11.1.1.1SECTION 330.1
     330.1 General conditions for general recognition as safe, effective and not misbranded.
21:5.0.1.1.11.1.1.2SECTION 330.2
     330.2 Pregnancy-nursing warning.
21:5.0.1.1.11.1.1.3SECTION 330.3
     330.3 Imprinting of solid oral dosage form drug products.
21:5.0.1.1.11.1.1.4SECTION 330.5
     330.5 Drug categories.
21:5.0.1.1.11.2SUBPART B
Subpart B - Administrative Procedures
21:5.0.1.1.11.2.1.1SECTION 330.10
     330.10 Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs.
21:5.0.1.1.11.2.1.2SECTION 330.11
     330.11 NDA deviations from applicable monograph.
21:5.0.1.1.11.2.1.3SECTION 330.12
     330.12 Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).
21:5.0.1.1.11.2.1.4SECTION 330.13
     330.13 Conditions for marketing ingredients recommended for over-the-counter (OTC) use under the OTC drug review.
21:5.0.1.1.11.2.1.5SECTION 330.14
     330.14 Additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded.
21:5.0.1.1.11.2.1.6SECTION 330.15
     330.15 Timelines for FDA review and action on time and extent applications and safety and effectiveness data submissions.
21:5.0.1.1.12PART 331
PART 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
21:5.0.1.1.12.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.12.1.1.1SECTION 331.1
     331.1 Scope.
21:5.0.1.1.12.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.12.2.1.1SECTION 331.10
     331.10 Antacid active ingredients.
21:5.0.1.1.12.2.1.2SECTION 331.11
     331.11 Listing of specific active ingredients.
21:5.0.1.1.12.2.1.3SECTION 331.15
     331.15 Combination with nonantacid active ingredients.
21:5.0.1.1.12.3SUBPART C
Subpart C - Testing Procedures
21:5.0.1.1.12.3.1.1SECTION 331.20
     331.20 Determination of percent contribution of active ingredients.
21:5.0.1.1.12.3.1.2SECTION 331.21
     331.21 Test modifications.
21:5.0.1.1.12.4SUBPART D
Subpart D - Labeling
21:5.0.1.1.12.4.1.1SECTION 331.30
     331.30 Labeling of antacid products.
21:5.0.1.1.12.4.1.2SECTION 331.80
     331.80 Professional labeling.
21:5.0.1.1.13PART 332
PART 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.13.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.13.1.1.1SECTION 332.1
     332.1 Scope.
21:5.0.1.1.13.1.1.2SECTION 332.3
     332.3 Definitions.
21:5.0.1.1.13.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.13.2.1.1SECTION 332.10
     332.10 Antiflatulent active ingredients.
21:5.0.1.1.13.2.1.2SECTION 332.15
     332.15 Combination with non-antiflatulent active ingredients.
21:5.0.1.1.13.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.13.3.1.1SECTION 332.30
     332.30 Labeling of antiflatulent drug products.
21:5.0.1.1.13.3.1.2SECTION 332.31
     332.31 Professional labeling.
21:5.0.1.1.14PART 333
PART 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.14.1SUBPART A
Subpart A [Reserved]
21:5.0.1.1.14.2SUBPART B
Subpart B - First Aid Antibiotic Drug Products
21:5.0.1.1.14.2.1.1SECTION 333.101
     333.101 Scope.
21:5.0.1.1.14.2.1.2SECTION 333.103
     333.103 Definitions.
21:5.0.1.1.14.2.1.3SECTION 333.110
     333.110 First aid antibiotic active ingredients.
21:5.0.1.1.14.2.1.4SECTION 333.120
     333.120 Permitted combinations of active ingredients.
21:5.0.1.1.14.2.1.5SECTION 333.150
     333.150 Labeling of first aid antibiotic drug products.
21:5.0.1.1.14.2.1.6SECTION 333.160
     333.160 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.14.3SUBPART C
Subpart C - Topical Antifungal Drug Products
21:5.0.1.1.14.3.1.1SECTION 333.201
     333.201 Scope.
21:5.0.1.1.14.3.1.2SECTION 333.203
     333.203 Definitions.
21:5.0.1.1.14.3.1.3SECTION 333.210
     333.210 Antifungal active ingredients.
21:5.0.1.1.14.3.1.4SECTION 333.250
     333.250 Labeling of antifungal drug products.
21:5.0.1.1.14.3.1.5SECTION 333.280
     333.280 Professional labeling.
21:5.0.1.1.14.4SUBPART D
Subpart D - Topical Acne Drug Products
21:5.0.1.1.14.4.1.1SECTION 333.301
     333.301 Scope.
21:5.0.1.1.14.4.1.2SECTION 333.303
     333.303 Definitions.
21:5.0.1.1.14.4.1.3SECTION 333.310
     333.310 Acne active ingredients.
21:5.0.1.1.14.4.1.4SECTION 333.320
     333.320 Permitted combinations of active ingredients.
21:5.0.1.1.14.4.1.5SECTION 333.350
     333.350 Labeling of acne drug products.
21:5.0.1.1.15PART 335
PART 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.15.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.15.1.1.1SECTION 335.1
     335.1 Scope.
21:5.0.1.1.15.1.1.2SECTION 335.3
     335.3 Definitions.
21:5.0.1.1.15.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.15.2.1.1SECTION 335.10
     335.10 Antidiarrheal active ingredients.
21:5.0.1.1.15.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.15.3.1.1SECTION 335.50
     335.50 Labeling of antidiarrheal drug products.
21:5.0.1.1.16PART 336
PART 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.16.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.16.1.1.1SECTION 336.1
     336.1 Scope.
21:5.0.1.1.16.1.1.2SECTION 336.3
     336.3 Definition.
21:5.0.1.1.16.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.16.2.1.1SECTION 336.10
     336.10 Antiemetic active ingredients.
21:5.0.1.1.16.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.16.3.1.1SECTION 336.50
     336.50 Labeling of antiemetic drug products.
21:5.0.1.1.16.3.1.2SECTION 336.80
     336.80 Professional labeling.
21:5.0.1.1.17PART 338
PART 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.17.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.17.1.1.1SECTION 338.1
     338.1 Scope.
21:5.0.1.1.17.1.1.2SECTION 338.3
     338.3 Definition.
21:5.0.1.1.17.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.17.2.1.1SECTION 338.10
     338.10 Nighttime sleep-aid active ingredients.
21:5.0.1.1.17.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.17.3.1.1SECTION 338.50
     338.50 Labeling of nighttime sleep-aid drug products.
21:5.0.1.1.18PART 340
PART 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.18.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.18.1.1.1SECTION 340.1
     340.1 Scope.
21:5.0.1.1.18.1.1.2SECTION 340.3
     340.3 Definition.
21:5.0.1.1.18.2SUBPART B
Subpart B - Active Ingredient
21:5.0.1.1.18.2.1.1SECTION 340.10
     340.10 Stimulant active ingredient.
21:5.0.1.1.18.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.18.3.1.1SECTION 340.50
     340.50 Labeling of stimulant drug products.
21:5.0.1.1.19PART 341
PART 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.19.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.19.1.1.1SECTION 341.1
     341.1 Scope.
21:5.0.1.1.19.1.1.2SECTION 341.3
     341.3 Definitions.
21:5.0.1.1.19.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.19.2.1.1SECTION 341.12
     341.12 Antihistamine active ingredients.
21:5.0.1.1.19.2.1.2SECTION 341.14
     341.14 Antitussive active ingredients.
21:5.0.1.1.19.2.1.3SECTION 341.16
     341.16 Bronchodilator active ingredients.
21:5.0.1.1.19.2.1.4SECTION 341.18
     341.18 Expectorant active ingredient.
21:5.0.1.1.19.2.1.5SECTION 341.20
     341.20 Nasal decongestant active ingredients.
21:5.0.1.1.19.2.1.6SECTION 341.40
     341.40 Permitted combinations of active ingredients.
21:5.0.1.1.19.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.19.3.1.1SECTION 341.70
     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).
21:5.0.1.1.19.3.1.2SECTION 341.72
     341.72 Labeling of antihistamine drug products.
21:5.0.1.1.19.3.1.3SECTION 341.74
     341.74 Labeling of antitussive drug products.
21:5.0.1.1.19.3.1.4SECTION 341.76
     341.76 Labeling of bronchodilator drug products.
21:5.0.1.1.19.3.1.5SECTION 341.78
     341.78 Labeling of expectorant drug products.
21:5.0.1.1.19.3.1.6SECTION 341.80
     341.80 Labeling of nasal decongestant drug products.
21:5.0.1.1.19.3.1.7SECTION 341.85
     341.85 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.19.3.1.8SECTION 341.90
     341.90 Professional labeling.
21:5.0.1.1.20PART 343
PART 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.20.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.20.1.1.1SECTION 343.1
     343.1 Scope.
21:5.0.1.1.20.1.1.2SECTION 343.3
     343.3 Definitions.
21:5.0.1.1.20.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.20.2.1.1SECTION 343.10
     343.10 [Reserved]
21:5.0.1.1.20.2.1.2SECTION 343.12
     343.12 Cardiovascular active ingredients.
21:5.0.1.1.20.2.1.3SECTION 343.13
     343.13 Rheumatologic active ingredients.
21:5.0.1.1.20.2.1.4SECTION 343.20
     343.20 [Reserved]
21:5.0.1.1.20.2.1.5SECTION 343.22
     343.22 Permitted combinations of active ingredients for cardiovascular-rheumatologic use.
21:5.0.1.1.20.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.20.3.1.1SECTION 343.50-343.60
     343.50-343.60 [Reserved]
21:5.0.1.1.20.3.1.2SECTION 343.80
     343.80 Professional labeling.
21:5.0.1.1.20.4SUBPART D
Subpart D - Testing Procedures
21:5.0.1.1.20.4.1.1SECTION 343.90
     343.90 Dissolution and drug release testing.
21:5.0.1.1.21PART 344
PART 344 - TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.21.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.21.1.1.1SECTION 344.1
     344.1 Scope.
21:5.0.1.1.21.1.1.2SECTION 344.3
     344.3 Definitions.
21:5.0.1.1.21.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.21.2.1.1SECTION 344.10
     344.10 Earwax removal aid active ingredient.
21:5.0.1.1.21.2.1.2SECTION 344.12
     344.12 Ear drying aid active ingredient.
21:5.0.1.1.21.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.21.3.1.1SECTION 344.50
     344.50 Labeling of earwax removal aid drug products.
21:5.0.1.1.21.3.1.2SECTION 344.52
     344.52 Labeling of ear drying aid drug products.
21:5.0.1.1.22PART 346
PART 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.22.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.22.1.1.1SECTION 346.1
     346.1 Scope.
21:5.0.1.1.22.1.1.2SECTION 346.3
     346.3 Definitions.
21:5.0.1.1.22.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.22.2.1.1SECTION 346.10
     346.10 Local anesthetic active ingredients.
21:5.0.1.1.22.2.1.2SECTION 346.12
     346.12 Vasoconstrictor active ingredients.
21:5.0.1.1.22.2.1.3SECTION 346.14
     346.14 Protectant active ingredients.
21:5.0.1.1.22.2.1.4SECTION 346.16
     346.16 Analgesic, anesthetic, and antipruritic active ingredients.
21:5.0.1.1.22.2.1.5SECTION 346.18
     346.18 Astringent active ingredients.
21:5.0.1.1.22.2.1.6SECTION 346.20
     346.20 Keratolytic active ingredients.
21:5.0.1.1.22.2.1.7SECTION 346.22
     346.22 Permitted combinations of anorectal active ingredients.
21:5.0.1.1.22.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.22.3.1.1SECTION 346.50
     346.50 Labeling of anorectal drug products.
21:5.0.1.1.22.3.1.2SECTION 346.52
     346.52 Labeling of permitted combinations of anorectal active ingredients.
21:5.0.1.1.23PART 347
PART 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.23.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.23.1.1.1SECTION 347.1
     347.1 Scope.
21:5.0.1.1.23.1.1.2SECTION 347.3
     347.3 Definitions.
21:5.0.1.1.23.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.23.2.1.1SECTION 347.10
     347.10 Skin protectant active ingredients.
21:5.0.1.1.23.2.1.2SECTION 347.12
     347.12 Astringent active ingredients.
21:5.0.1.1.23.2.1.3SECTION 347.20
     347.20 Permitted combinations of active ingredients.
21:5.0.1.1.23.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.23.3.1.1SECTION 347.50
     347.50 Labeling of skin protectant drug products.
21:5.0.1.1.23.3.1.2SECTION 347.52
     347.52 Labeling of astringent drug products.
21:5.0.1.1.23.3.1.3SECTION 347.60
     347.60 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.24PART 348
PART 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.24.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.24.1.1.1SECTION 348.1
     348.1 Scope.
21:5.0.1.1.24.1.1.2SECTION 348.3
     348.3 Definitions.
21:5.0.1.1.24.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.24.2.1.1SECTION 348.10
     348.10 Analgesic, anesthetic, and antipruritic active ingredients.
21:5.0.1.1.24.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.24.3.1.1SECTION 348.50
     348.50 Labeling of external analgesic drug products.
21:5.0.1.1.25PART 349
PART 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.25.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.25.1.1.1SECTION 349.1
     349.1 Scope.
21:5.0.1.1.25.1.1.2SECTION 349.3
     349.3 Definitions.
21:5.0.1.1.25.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.25.2.1.1SECTION 349.10
     349.10 Ophthalmic astringent.
21:5.0.1.1.25.2.1.2SECTION 349.12
     349.12 Ophthalmic demulcents.
21:5.0.1.1.25.2.1.3SECTION 349.14
     349.14 Ophthalmic emollients.
21:5.0.1.1.25.2.1.4SECTION 349.16
     349.16 Ophthalmic hypertonicity agent.
21:5.0.1.1.25.2.1.5SECTION 349.18
     349.18 Ophthalmic vasoconstrictors.
21:5.0.1.1.25.2.1.6SECTION 349.20
     349.20 Eyewashes.
21:5.0.1.1.25.2.1.7SECTION 349.30
     349.30 Permitted combinations of active ingredients.
21:5.0.1.1.25.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.25.3.1.1SECTION 349.50
     349.50 Labeling of ophthalmic drug products.
21:5.0.1.1.25.3.1.2SECTION 349.55
     349.55 Labeling of ophthalmic astringent drug products.
21:5.0.1.1.25.3.1.3SECTION 349.60
     349.60 Labeling of ophthalmic demulcent drug products.
21:5.0.1.1.25.3.1.4SECTION 349.65
     349.65 Labeling of ophthalmic emollient drug products.
21:5.0.1.1.25.3.1.5SECTION 349.70
     349.70 Labeling of ophthalmic hypertonicity drug products.
21:5.0.1.1.25.3.1.6SECTION 349.75
     349.75 Labeling of ophthalmic vasoconstrictor drug products.
21:5.0.1.1.25.3.1.7SECTION 349.78
     349.78 Labeling of eyewash drug products.
21:5.0.1.1.25.3.1.8SECTION 349.79
     349.79 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.25.3.1.9SECTION 349.80
     349.80 Professional labeling.
21:5.0.1.1.26PART 350
PART 350 - ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.26.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.26.1.1.1SECTION 350.1
     350.1 Scope.
21:5.0.1.1.26.1.1.2SECTION 350.3
     350.3 Definition.
21:5.0.1.1.26.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.26.2.1.1SECTION 350.10
     350.10 Antiperspirant active ingredients.
21:5.0.1.1.26.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.26.3.1.1SECTION 350.50
     350.50 Labeling of antiperspirant drug products.
21:5.0.1.1.26.4SUBPART D
Subpart D - Guidelines for Effectiveness Testing
21:5.0.1.1.26.4.1.1SECTION 350.60
     350.60 Guidelines for effectiveness testing of antiperspirant drug products.
21:5.0.1.1.27PART 352
PART 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
21:5.0.1.1.27.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.27.1.1.1SECTION 352.1
     352.1 Scope.
21:5.0.1.1.27.1.1.2SECTION 352.3
     352.3 Definitions.
21:5.0.1.1.27.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.27.2.1.1SECTION 352.10
     352.10 Sunscreen active ingredients.
21:5.0.1.1.27.2.1.3SECTION 352.20
     352.20 Permitted combinations of active ingredients.
21:5.0.1.1.27.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.27.3.1.1SECTION 352.50
     352.50 Principal display panel of all sunscreen drug products.
21:5.0.1.1.27.3.1.2SECTION 352.52
     352.52 Labeling of sunscreen drug products.
21:5.0.1.1.27.3.1.3SECTION 352.60
     352.60 Labeling of permitted combinations of active ingredients.
21:5.0.1.1.27.4SUBPART D
Subpart D - Testing Procedures
21:5.0.1.1.27.4.1.1SECTION 352.70
     352.70 Standard sunscreen.
21:5.0.1.1.27.4.1.2SECTION 352.71
     352.71 Light source (solar simulator).
21:5.0.1.1.27.4.1.3SECTION 352.72
     352.72 General testing procedures.
21:5.0.1.1.27.4.1.4SECTION 352.73
     352.73 Determination of SPF value.
21:5.0.1.1.27.4.1.5SECTION 352.76
     352.76 Determination if a product is water resistant or very water resistant.
21:5.0.1.1.27.4.1.6SECTION 352.77
     352.77 Test modifications.
21:5.0.1.1.28PART 355
PART 355 - ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.28.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.28.1.1.1SECTION 355.1
     355.1 Scope.
21:5.0.1.1.28.1.1.2SECTION 355.3
     355.3 Definitions.
21:5.0.1.1.28.2SUBPART B
Subpart B - Active Ingredients
21:5.0.1.1.28.2.1.1SECTION 355.10
     355.10 Anticaries active ingredients.
21:5.0.1.1.28.2.1.2SECTION 355.20
     355.20 Packaging conditions.
21:5.0.1.1.28.3SUBPART C
Subpart C - Labeling
21:5.0.1.1.28.3.1.1SECTION 355.50
     355.50 Labeling of anticaries drug products.
21:5.0.1.1.28.3.1.2SECTION 355.55
     355.55 Principal display panel of all fluoride rinse drug products.
21:5.0.1.1.28.3.1.3SECTION 355.60
     355.60 Professional labeling.
21:5.0.1.1.28.4SUBPART D
Subpart D - Testing Procedures
21:5.0.1.1.28.4.1.1SECTION 355.70
     355.70 Testing procedures for fluoride dentifrice drug products.
21:5.0.1.1.29PART 357
PART 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.29.1SUBPART A
Subpart A [Reserved]
21:5.0.1.1.29.2SUBPART B
Subpart B - Anthelmintic Drug Products
21:5.0.1.1.29.2.1.1SECTION 357.101
     357.101 Scope.
21:5.0.1.1.29.2.1.2SECTION 357.103
     357.103 Definition.
21:5.0.1.1.29.2.1.3SECTION 357.110
     357.110 Anthelmintic active ingredient.
21:5.0.1.1.29.2.1.4SECTION 357.150
     357.150 Labeling of anthelmintic drug products.
21:5.0.1.1.29.2.1.5SECTION 357.152
     357.152 Package inserts for anthelmintic drug products.
21:5.0.1.1.29.2.1.6SECTION 357.180
     357.180 Professional labeling.
21:5.0.1.1.29.3SUBPART C
Subpart C - Cholecystokinetic Drug Products
21:5.0.1.1.29.3.1.1SECTION 357.201
     357.201 Scope.
21:5.0.1.1.29.3.1.2SECTION 357.203
     357.203 Definition.
21:5.0.1.1.29.3.1.3SECTION 357.210
     357.210 Cholecystokinetic active ingredients.
21:5.0.1.1.29.3.1.4SECTION 357.250
     357.250 Labeling of cholecystokinetic drug products.
21:5.0.1.1.29.3.1.5SECTION 357.280
     357.280 Professional labeling.
21:5.0.1.1.29.4SUBPART D
Subparts D-H [Reserved]
21:5.0.1.1.29.5SUBPART I
Subpart I - Deodorant Drug Products for Internal Use
21:5.0.1.1.29.5.1.1SECTION 357.801
     357.801 Scope.
21:5.0.1.1.29.5.1.2SECTION 357.803
     357.803 Definitions.
21:5.0.1.1.29.5.1.3SECTION 357.810
     357.810 Active ingredients for deodorant drug products for internal use.
21:5.0.1.1.29.5.1.4SECTION 357.850
     357.850 Labeling of deodorant drug products for internal use.
21:5.0.1.1.30PART 358
PART 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
21:5.0.1.1.30.1SUBPART A
Subpart A [Reserved]
21:5.0.1.1.30.2SUBPART B
Subpart B - Wart Remover Drug Products
21:5.0.1.1.30.2.1.1SECTION 358.101
     358.101 Scope.
21:5.0.1.1.30.2.1.2SECTION 358.103
     358.103 Definitions.
21:5.0.1.1.30.2.1.3SECTION 358.110
     358.110 Wart remover active ingredients.
21:5.0.1.1.30.2.1.4SECTION 358.150
     358.150 Labeling of wart remover drug products.
21:5.0.1.1.30.3SUBPART C
Subpart C [Reserved]
21:5.0.1.1.30.4SUBPART D
Subpart D - Ingrown Toenail Relief Drug Products
21:5.0.1.1.30.4.1.1SECTION 358.301
     358.301 Scope.
21:5.0.1.1.30.4.1.2SECTION 358.303
     358.303 Definitions.
21:5.0.1.1.30.4.1.3SECTION 358.310
     358.310 Ingrown toenail relief active ingredient.
21:5.0.1.1.30.4.1.4SECTION 358.350
     358.350 Labeling of ingrown toenail relief drug products.
21:5.0.1.1.30.5SUBPART E
Subpart E [Reserved]
21:5.0.1.1.30.6SUBPART F
Subpart F - Corn and Callus Remover Drug Products
21:5.0.1.1.30.6.1.1SECTION 358.501
     358.501 Scope.
21:5.0.1.1.30.6.1.2SECTION 358.503
     358.503 Definitions.
21:5.0.1.1.30.6.1.3SECTION 358.510
     358.510 Corn and callus remover active ingredients.
21:5.0.1.1.30.6.1.4SECTION 358.550
     358.550 Labeling of corn and callus remover drug products.
21:5.0.1.1.30.7SUBPART G
Subpart G - Pediculicide Drug Products
21:5.0.1.1.30.7.1.1SECTION 358.601
     358.601 Scope.
21:5.0.1.1.30.7.1.2SECTION 358.603
     358.603 Definition.
21:5.0.1.1.30.7.1.3SECTION 358.610
     358.610 Pediculicide active ingredients.
21:5.0.1.1.30.7.1.4SECTION 358.650
     358.650 Labeling of pediculicide drug products.
21:5.0.1.1.30.8SUBPART H
Subpart H - Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis
21:5.0.1.1.30.8.1.1SECTION 358.701
     358.701 Scope.
21:5.0.1.1.30.8.1.2SECTION 358.703
     358.703 Definitions.
21:5.0.1.1.30.8.1.3SECTION 358.710
     358.710 Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis.
21:5.0.1.1.30.8.1.4SECTION 358.720
     358.720 Permitted combinations of active ingredients.
21:5.0.1.1.30.8.1.5SECTION 358.750
     358.750 Labeling of drug products for the control of dandruff, seborrheic dermatitis, or psoriasis.
21:5.0.1.1.30.8.1.6SECTION 358.760
     358.760 Labeling of permitted combinations of active ingredients for the control of dandruff.
21:5.0.1.1.31PART 361
PART 361 - PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
21:5.0.1.1.31.0.1.1SECTION 361.1
     361.1 Radioactive drugs for certain research uses.
21:5.0.1.1.32PART 369
PART 369 - INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
21:5.0.1.1.32.1SUBPART A
Subpart A - Definitions and Interpretations
21:5.0.1.1.32.1.1.1SECTION 369.1
     369.1 Purpose of issuance.
21:5.0.1.1.32.1.1.2SECTION 369.2
     369.2 Definitions.
21:5.0.1.1.32.1.1.3SECTION 369.3
     369.3 Warnings required on drugs exempted from prescription-dispensing requirements of section 503(b)(1)(C).
21:5.0.1.1.32.1.1.4SECTION 369.4
     369.4 Warnings suggested for drugs by formal or informal statements of policy.
21:5.0.1.1.32.1.1.5SECTION 369.6
     369.6 [Reserved]
21:5.0.1.1.32.1.1.6SECTION 369.7
     369.7 Warnings required by official compendia.
21:5.0.1.1.32.1.1.7SECTION 369.8
     369.8 Warning statements in relation to conditions for use.
21:5.0.1.1.32.1.1.8SECTION 369.9
     369.9 General warnings re accidental ingestion by children.
21:5.0.1.1.32.1.1.9SECTION 369.10
     369.10 Conspicuousness of warning statements.
21:5.0.1.1.32.2SUBPART B
Subpart B - Warning and Caution Statements for Drugs
21:5.0.1.1.32.2.1.1SECTION 369.20
     369.20 Drugs; recommended warning and caution statements.
21:5.0.1.1.32.2.1.2SECTION 369.21
     369.21 Drugs; warning and caution statements required by regulations.
21:5.0.1.1.33PART 370-499
PARTS 370-499 [RESERVED]