US, CFR Title 21, Food and Drugs. (Table of Contents per Volume) VOL 1 Chapter I, Subchapter A.- General (Parts 1-99)

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 [RESERVED]
99.- DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES.

VOL 2 Subchapter B.- Food for Human Consumption (Parts 100-169)

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
152.- FRUIT PIES
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

VOL 3 Subchapter B.- Food for Human Consumption Continued (Parts 170-199)

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.- 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.- [RESERVED]

VOL 4 Subchapter C.- Drugs General (Parts 200-299)

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 216.- HUMAN DRUG COMPOUNDING
225.- CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226.- CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250.- SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290.- CONTROLLED DRUGS
299.- DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

VOL 5 Subchapter D.- Drugs for Human Use (Parts 300-499)

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.- [RESERVED]

VOL 6 Subchapter E.- Animal Drugs, Feeds and Related Products (Parts 500-599)

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.- NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED 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.- [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.- [RESERVED]

VOL 7 Subchapter F.- Biologics (Parts 600-680)

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

Subchapter G.- Cosmetics (Parts 700-799)

SUBCHAPTER G—COSMETICS
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.- [RESERVED]

VOL 8 Subchapter H.- Medical Devices (Parts 800-898)

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.- [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

Subchapter I.- Mammography Quality Standards (Parts 900-999)

900.- MAMMOGRAPHY
TOC – TABLE OF CONTENTS

ACCREDITATION
QUALITY STANDARS AND CERTIFICATION STATES AS CERTIFIERS

Subchapter J.- Radiological Health (Parts 1000-1050)

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
1050.- PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

Subchapter K.- Tobacco Products (Parts 1100-1150)

SUBCHAPTER K—TOBACCO PRODUCTS
1100.- TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
1105.- GENERAL
1107.- ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS
1140.- CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
1141.- CIGARETTE PACKAGE AND ADVERTISING WARNINGS
1143.- MINIMUM REQUIRED WARNING STATEMENTS
1150.- USER FEES

Subchapter L.- Regulations under Certain other Acts Administered by FDA (Parts 1210-1299)

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
1251-1269.- [RESERVED]
1270.- HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271.- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299.- [RESERVED]

VOL 9 Chapter II.- Drug Enforcement Administration, Department of Justice (Parts 1300-1399)

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
1321.- DEA MAILING ADDRESSES
1322-1399.- [RESERVED]

Chapter III.- Office of National Drug Control Policy (Parts 1400-1499)

1400.- [RESERVED]
1401.- PUBLIC AVAILABILITY OF INFORMATION 1402.- MANDATORY DECLASSIFICATION REVIEW 1403-1499.- [RESERVED]

US, CFR Title 23, Food and Drugs. (Table of Contents per Volume) VOL 1 Chapter I, Subchapter A.- General (Parts 1-99)

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 [RESERVED]
99.- DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES.

VOL 2 Subchapter B.- Food for Human Consumption (Parts 100-169)

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
152.- FRUIT PIES
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

VOL 3 Subchapter B.- Food for Human Consumption Continued (Parts 170-199)

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.- 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.- [RESERVED]

VOL 4 Subchapter C.- Drugs General (Parts 200-299)

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 216.- HUMAN DRUG COMPOUNDING
225.- CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226.- CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250.- SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290.- CONTROLLED DRUGS
299.- DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

VOL 5 Subchapter D.- Drugs for Human Use (Parts 300-499)

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.- [RESERVED]

VOL 6 Subchapter E.- Animal Drugs, Feeds and Related Products (Parts 500-599)

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.- NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED 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.- [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.- [RESERVED]

VOL 7 Subchapter F.- Biologics (Parts 600-680)

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

Subchapter G.- Cosmetics (Parts 700-799)

SUBCHAPTER G—COSMETICS
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.- [RESERVED]

VOL 8 Subchapter H.- Medical Devices (Parts 800-898)

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.- [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

Subchapter I.- Mammography Quality Standards (Parts 900-999)

900.- MAMMOGRAPHY
TOC – TABLE OF CONTENTS

ACCREDITATION
QUALITY STANDARS AND CERTIFICATION STATES AS CERTIFIERS

Subchapter J.- Radiological Health (Parts 1000-1050)

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
1050.- PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

Subchapter K.- Tobacco Products (Parts 1100-1150)

SUBCHAPTER K—TOBACCO PRODUCTS
1100.- TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
1105.- GENERAL
1107.- ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS
1140.- CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS
1141.- CIGARETTE PACKAGE AND ADVERTISING WARNINGS
1143.- MINIMUM REQUIRED WARNING STATEMENTS
1150.- USER FEES

Subchapter L.- Regulations under Certain other Acts Administered by FDA (Parts 1210-1299)

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
1251-1269.- [RESERVED]
1270.- HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271.- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299.- [RESERVED]

VOL 9 Chapter II.- Drug Enforcement Administration, Department of Justice (Parts 1300-1399)

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
1321.- DEA MAILING ADDRESSES
1322-1399.- [RESERVED]

Chapter III.- Office of National Drug Control Policy (Parts 1400-1499)

1400.- [RESERVED]
1401.- PUBLIC AVAILABILITY OF INFORMATION 1402.- MANDATORY DECLASSIFICATION REVIEW 1403-1499.- [RESERVED]