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← All Titles Title 21 — Food and Drugs

1 General Enforcement Regulations
2 General Administrative Rulings And Decisions
3 Product Jurisdiction
4 Regulation Of Combination Products
5 Organization
7 Enforcement Policy
10 Administrative Practices And Procedures
11 Electronic Records; Electronic Signatures
12 Formal Evidentiary Public Hearing
13 Public Hearing Before A Public Board Of Inquiry
14 Public Hearing Before A Public Advisory Committee
15 Public Hearing Before The Commissioner
16 Regulatory Hearing Before The Food And Drug Administration
17 Civil Money Penalties Hearings
19 Standards Of Conduct And Conflicts Of Interest
20 Public Information
21 Protection Of Privacy
25 Environmental Impact Considerations
26 Mutual Recognition Of Pharmaceutical Good Manufacturing Practice Reports, Medical Device Quality System Audit Reports, And Certain Medical Device Product Evaluation Reports: United States And The European Community
50 Protection Of Human Subjects
54 Financial Disclosure By Clinical Investigators
56 Institutional Review Boards
58 Good Laboratory Practice For Nonclinical Laboratory Studies
60 Patent Term Restoration
70 Color Additives
71 Color Additive Petitions
73 Listing Of Color Additives Exempt From Certification
74 Listing Of Color Additives Subject To Certification
80 Color Additive Certification
81 General Specifications And General Restrictions For Provisional Color Additives For Use In Foods, Drugs, And Cosmetics
82 Listing Of Certified Provisionally Listed Colors And Specifications
83-98 98 [Reserved]
99 Dissemination Of Information On Unapproved/New Uses For Marketed Drugs, Biologics, And Devices
100 General
101 Food Labeling
102 Common Or Usual Name For Nonstandardized Foods
104 Nutritional Quality Guidelines For Foods
105 Foods For Special Dietary Use
106 Infant Formula Requirements Pertaining To Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records And Reports, And Notifications
107 Infant Formula
108 Emergency Permit Control
109 Unavoidable Contaminants In Food For Human Consumption And Food-Packaging Material
110 Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food
111 Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements
112 Standards For The Growing, Harvesting, Packing, And Holding Of Produce For Human Consumption
113 Thermally Processed Low-Acid Foods Packaged In Hermetically Sealed Containers
114 Acidified Foods
115 Shell Eggs
117 Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Human Food
118 Production, Storage, And Transportation Of Shell Eggs
119 Dietary Supplements That Present A Significant Or Unreasonable Risk
120 Hazard Analysis And Critical Control Point (Haccp) Systems
121 Mitigation Strategies To Protect Food Against Intentional Adulteration
123 Fish And Fishery Products
129 Processing And Bottling Of Bottled Drinking Water
130 Food Standards: General
131 Milk And Cream
133 Cheeses And Related Cheese Products
135 Frozen Desserts
136 Bakery Products
137 Cereal Flours And Related Products
139 Macaroni And Noodle Products
145 Canned Fruits
146 Canned Fruit Juices
150 Fruit Butters, Jellies, Preserves, And Related Products
155 Canned Vegetables
156 Vegetable Juices
158 Frozen Vegetables
160 Eggs And Egg Products
161 Fish And Shellfish
163 Cacao Products
164 Tree Nut And Peanut Products
165 Beverages
166 Margarine
168 Sweeteners And Table Sirups
169 Food Dressings And Flavorings
170 Food Additives
171 Food Additive Petitions
172 Food Additives Permitted For Direct Addition To Food For Human Consumption
173 Secondary Direct Food Additives Permitted In Food For Human Consumption
174 Indirect Food Additives: General
175 Indirect Food Additives: Adhesives And Components Of Coatings
176 Indirect Food Additives: Paper And Paperboard Components
177 Indirect Food Additives: Polymers
178 Indirect Food Additives: Adjuvants, Production Aids, And Sanitizers
179 Irradiation In The Production, Processing And Handling Of Food
180 Food Additives Permitted In Food Or In Contact With Food On An Interim Basis Pending Additional Study
181 Prior-Sanctioned Food Ingredients
182 Substances Generally Recognized As Safe
184 Direct Food Substances Affirmed As Generally Recognized As Safe
186 Indirect Food Substances Affirmed As Generally Recognized As Safe
189 Substances Prohibited From Use In Human Food
190 Dietary Supplements
191-199 199 [Reserved]
200 General
201 Labeling
202 Prescription Drug Advertising
203 Prescription Drug Marketing
205 Guidelines For State Licensing Of Wholesale Prescription Drug Distributors
206 Imprinting Of Solid Oral Dosage Form Drug Products For Human Use
207 Requirements For Foreign And Domestic Establishment Registration And Listing For Human Drugs, Including Drugs That Are Regulated Under A Biologics License Application, And Animal Drugs, And The National Drug Code
208 Medication Guides For Prescription Drug Products
209 Requirement For Authorized Dispensers And Pharmacies To Distribute A Side Effects Statement
210 Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
211 Current Good Manufacturing Practice For Finished Pharmaceuticals
212 Current Good Manufacturing Practice For Positron Emission Tomography Drugs
213 Xxx
216 Human Drug Compounding
225 Current Good Manufacturing Practice For Medicated Feeds
226 Current Good Manufacturing Practice For Type A Medicated Articles
230 Xxx
250 Special Requirements For Specific Human Drugs
251 Section 804 Importation Program
290 Controlled Drugs
299 Drugs; Official Names And Established Names
300 General
310 New Drugs
312 Investigational New Drug Application
314 Applications For Fda Approval To Market A New Drug
315 Diagnostic Radiopharmaceuticals
316 Orphan Drugs
317 Qualifying Pathogens
320 Bioavailability And Bioequivalence Requirements
328 Over-The-Counter Drug Products Intended For Oral Ingestion That Contain Alcohol
329 Nonprescription Human Drug Products Subject To Section 760 Of The Federal Food, Drug, And Cosmetic Act
330 Over-The-Counter (Otc) Human Drugs Which Are Generally Recognized As Safe And Effective And Not Misbranded
331 Antacid Products For Over-The-Counter (Otc) Human Use
332 Antiflatulent Products For Over-The-Counter Human Use
333 Topical Antimicrobial Drug Products For Over-The-Counter Human Use
335 Antidiarrheal Drug Products For Over-The-Counter Human Use
336 Antiemetic Drug Products For Over-The-Counter Human Use
338 Nighttime Sleep-Aid Drug Products For Over-The-Counter Human Use
340 Stimulant Drug Products For Over-The-Counter Human Use
341 Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products For Over-The-Counter Human Use
343 Internal Analgesic, Antipyretic, And Antirheumatic Drug Products For Over-The-Counter Human Use
344 Topical Otic Drug Products For Over-The-Counter Human Use
346 Anorectal Drug Products For Over-The-Counter Human Use
347 Skin Protectant Drug Products For Over-The-Counter Human Use
348 External Analgesic Drug Products For Over-The-Counter Human Use
349 Ophthalmic Drug Products For Over-The-Counter Human Use
350 Antiperspirant Drug Products For Over-The-Counter Human Use
352 Sunscreen Drug Products For Over-The-Counter Human Use [Stayed Indefinitely]
355 Anticaries Drug Products For Over-The-Counter Human Use
357 Miscellaneous Internal Drug Products For Over-The-Counter Human Use
358 Miscellaneous External Drug Products For Over-The-Counter Human Use
361 Prescription Drugs For Human Use Generally Recognized As Safe And Effective And Not Misbranded: Drugs Used In Research
369 Interpretative Statements Re Warnings On Drugs And Devices For Over-The-Counter Sale
370-499 499 [Reserved]
500 General
501 Animal Food Labeling
502 Common Or Usual Names For Nonstandardized Animal Foods
507 Current Good Manufacturing Practice, Hazard Analysis, And Risk-Based Preventive Controls For Food For Animals
509 Unavoidable Contaminants In Animal Food And Food-Packaging Material
510 New Animal Drugs
511 New Animal Drugs For Investigational Use
514 New Animal Drug Applications
515 Medicated Feed Mill License
516 New Animal Drugs For Minor Use And Minor Species
520 Oral Dosage Form New Animal Drugs
522 Implantation Or Injectable Dosage Form New Animal Drugs
524 Ophthalmic And Topical Dosage Form New Animal Drugs
526 Intramammary Dosage Form New Animal Drugs
528 Intentional Genomic Alterations In Animals
529 Certain Other Dosage Form New Animal Drugs
530 Extralabel Drug Use In Animals
556 Tolerances For Residues Of New Animal Drugs In Food
558 New Animal Drugs For Use In Animal Feeds
564 Part 564 [Reserved]
570 Food Additives
571 Food Additive Petitions
573 Food Additives Permitted In Feed And Drinking Water Of Animals
579 Irradiation In The Production, Processing, And Handling Of Animal Feed And Pet Food
582 Substances Generally Recognized As Safe
584 Food Substances Affirmed As Generally Recognized As Safe In Feed And Drinking Water Of Animals
589 Substances Prohibited From Use In Animal Food Or Feed
590-599 599 [Reserved]
600 Biological Products: General
601 Licensing
606 Current Good Manufacturing Practice For Blood And Blood Components
607 Establishment Registration And Product Listing For Manufacturers Of Human Blood And Blood Products And Licensed Devices
610 General Biological Products Standards
630 Requirements For Blood And Blood Components Intended For Transfusion Or For Further Manufacturing Use
640 Additional Standards For Human Blood And Blood Products
660 Additional Standards For Diagnostic Substances For Laboratory Tests
680 Additional Standards For Miscellaneous Products
700 General
701 Cosmetic Labeling
710 Voluntary Registration Of Cosmetic Product Establishments
720 Voluntary Filing Of Cosmetic Product Ingredient Composition Statements
740 Cosmetic Product Warning Statements
741-799 799 [Reserved]
800 General
801 Labeling
803 Medical Device Reporting
806 Medical Devices; Reports Of Corrections And Removals
807 Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
808 Exemptions From Federal Preemption Of State And Local Medical Device Requirements
809 In Vitro Diagnostic Products For Human Use
810 Medical Device Recall Authority
812 Investigational Device Exemptions
813 Part 813 [Reserved]
814 Premarket Approval Of Medical Devices
820 Quality System Regulation
821 Medical Device Tracking Requirements
822 Postmarket Surveillance
830 Unique Device Identification
860 Medical Device Classification Procedures
861 Procedures For Performance Standards Development
862 Clinical Chemistry And Clinical Toxicology Devices
864 Hematology And Pathology Devices
866 Immunology And Microbiology Devices
868 Anesthesiology Devices
870 Cardiovascular Devices
872 Dental Devices
874 Ear, Nose, And Throat Devices
876 Gastroenterology-Urology Devices
878 General And Plastic Surgery Devices
880 General Hospital And Personal Use Devices
882 Neurological Devices
884 Obstetrical And Gynecological Devices
886 Ophthalmic Devices
888 Orthopedic Devices
890 Physical Medicine Devices
892 Radiology Devices
895 Banned Devices
898 Performance Standard For Electrode Lead Wires And Patient Cables
900 Mammography
1000 General
1002 Records And Reports
1003 Notification Of Defects Or Failure To Comply
1004 Repurchase, Repairs, Or Replacement Of Electronic Products
1005 Importation Of Electronic Products
1010 Performance Standards For Electronic Products: General
1020 Performance Standards For Ionizing Radiation Emitting Products
1030 Performance Standards For Microwave And Radio Frequency Emitting Products
1040 Performance Standards For Light-Emitting Products
1100 General
1105 General
1107 Exemption Requests And Substantial Equivalence Reports
1114 Premarket Tobacco Product Applications
1140 Cigarettes, Smokeless Tobacco, And Covered Tobacco Products
1141 Required Warnings For Cigarette Packages And Advertisements
1143 Minimum Required Warning Statements
1150 User Fees
1210 Regulations Under The Federal Import Milk Act
1230 Regulations Under The Federal Caustic Poison Act
1240 Control Of Communicable Diseases
1250 Interstate Conveyance Sanitation
1251-1270 1270 [Reserved]
1271 Human Cells, Tissues, And Cellular And Tissue-Based Products
1272-1299 1299 [Reserved]
1300 Definitions
1301 Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances
1302 Labeling And Packaging Requirements For Controlled Substances
1303 Quotas
1304 Records And Reports Of Registrants
1305 Orders For Schedule I And Ii Controlled Substances
1306 Prescriptions
1307 Miscellaneous
1308 Schedules Of Controlled Substances
1309 Registration Of Manufacturers, Distributors, Importers And Exporters Of List I Chemicals
1310 Records And Reports Of Listed Chemicals And Certain Machines; Importation And Exportation Of Certain Machines
1311 Requirements For Electronic Orders And Prescriptions
1312 Importation And Exportation Of Controlled Substances
1313 Importation And Exportation Of List I And List Ii Chemicals
1314 Retail Sale Of Scheduled Listed Chemical Products
1315 Importation And Production Quotas For Ephedrine, Pseudoephedrine, And Phenylpropanolamine
1316 Administrative Functions, Practices, And Procedures
1317 Disposal
1318 Controls To Satisfy The Requirements Of The Act Applicable To The Manufacturing Of Marihuana
1321 Dea Mailing Addresses
1322-1399 1399 [Reserved]
1400 Part 1400 [Reserved]
1401 Public Availability Of Information
1402 Mandatory Declassification Review
1403-1499 1499 [Reserved]

Title 21 · FDA

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21 C.F.R. Part 213 · Updated April 1, 2025

View on eCFR ↗

Source: eCFR Title 21 Part 213 . Updated April 1, 2025.

Part of the Legal Reference Project: Federal Rules · Readable Regs · State Rules

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