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