Title 21 - Food and Drugs

GENERAL ENFORCEMENT REGULATIONS

ADMINISTRATIVE PRACTICES AND PROCEDURES

GENERAL

FOOD LABELING

COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

NUTRITIONAL QUALITY GUIDELINES FOR FOODS

FOODS FOR SPECIAL DIETARY USE

INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS

INFANT FORMULA

EMERGENCY PERMIT CONTROL

UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL

ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

FORMAL EVIDENTIARY PUBLIC HEARING

PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

DEFINITIONS

REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES

LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES

QUOTAS

RECORDS AND REPORTS OF REGISTRANTS

ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES

PRESCRIPTIONS

MISCELLANEOUS

SCHEDULES OF CONTROLLED SUBSTANCES

REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS

RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES

REQUIREMENTS FOR ELECTRONIC ORDERS AND PRESCRIPTIONS

IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES

IMPORTATION AND EXPORTATION OF LIST I AND LIST II CHEMICALS

RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS

IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE

ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES

DISPOSAL

DEA MAILING ADDRESSES

PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

PUBLIC AVAILABILITY OF INFORMATION

MANDATORY DECLASSIFICATION REVIEW

PUBLIC HEARING BEFORE THE COMMISSIONER

REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

CIVIL MONEY PENALTIES HEARINGS

FOOD ADDITIVES

FOOD ADDITIVE PETITIONS

FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

INDIRECT FOOD ADDITIVES: GENERAL

INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

INDIRECT FOOD ADDITIVES: POLYMERS

INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD

FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

PRIOR-SANCTIONED FOOD INGREDIENTS

SUBSTANCES GENERALLY RECOGNIZED AS SAFE

DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

DIETARY SUPPLEMENTS

GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

PUBLIC INFORMATION

GENERAL

LABELING

PROTECTION OF PRIVACY

ENVIRONMENTAL IMPACT CONSIDERATIONS

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

PRODUCT JURISDICTION

GENERAL

NEW DRUGS

INVESTIGATIONAL NEW DRUG APPLICATION

APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

DIAGNOSTIC RADIOPHARMACEUTICALS

ORPHAN DRUGS

QUALIFYING PATHOGENS

BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE

ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

REGULATION OF COMBINATION PRODUCTS

ORGANIZATION

PROTECTION OF HUMAN SUBJECTS

GENERAL

ANIMAL FOOD LABELING

COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS

CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS

UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL

NEW ANIMAL DRUGS

NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE

NEW ANIMAL DRUG APPLICATIONS

MEDICATED FEED MILL LICENSE

NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

ORAL DOSAGE FORM NEW ANIMAL DRUGS

IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

INTRAMAMMARY DOSAGE FORM NEW ANIMAL DRUGS

NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

EXTRALABEL DRUG USE IN ANIMALS

FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

INSTITUTIONAL REVIEW BOARDS

FOOD ADDITIVES

FOOD ADDITIVE PETITIONS

FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS

IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD

GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

SUBSTANCES GENERALLY RECOGNIZED AS SAFE

FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS

SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

PATENT TERM RESTORATION

BIOLOGICAL PRODUCTS: GENERAL

LICENSING

CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED DEVICES

GENERAL BIOLOGICAL PRODUCTS STANDARDS

ENFORCEMENT POLICY

COLOR ADDITIVES

COLOR ADDITIVE PETITIONS

LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

COLOR ADDITIVE CERTIFICATION

GENERAL

LABELING

MEDICAL DEVICE REPORTING

MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS

IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

MEDICAL DEVICE RECALL AUTHORITY

INVESTIGATIONAL DEVICE EXEMPTIONS

PREMARKET APPROVAL OF MEDICAL DEVICES

LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS

QUALITY SYSTEM REGULATION

MEDICAL DEVICE TRACKING REQUIREMENTS

POSTMARKET SURVEILLANCE

UNIQUE DEVICE IDENTIFICATION

MEDICAL DEVICE CLASSIFICATION PROCEDURES

PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

HEMATOLOGY AND PATHOLOGY DEVICES

IMMUNOLOGY AND MICROBIOLOGY DEVICES

ANESTHESIOLOGY DEVICES

CARDIOVASCULAR DEVICES

DENTAL DEVICES

EAR, NOSE, AND THROAT DEVICES

GASTROENTEROLOGY-UROLOGY DEVICES

GENERAL AND PLASTIC SURGERY DEVICES

GENERAL HOSPITAL AND PERSONAL USE DEVICES

NEUROLOGICAL DEVICES

OBSTETRICAL AND GYNECOLOGICAL DEVICES

OPHTHALMIC DEVICES

ORTHOPEDIC DEVICES

PHYSICAL MEDICINE DEVICES

RADIOLOGY DEVICES

BANNED DEVICES

PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES

MAMMOGRAPHY

DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES