Guidances directory

All guidance documents2,828 total

• CPG Sec. 100.350 FDA Jurisdiction on Indian ReservationsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• User Instructions - Multi Axis Workstations (Laser Notice 39)Guidance Document · Center for Devices and Radiological Health
• CPG Sec. 655.400 The Status of Syringes and Needles for Animal Use (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 655.300 Barking Dog Collar (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Global Policy and Strategy
• CPG Sec. 655.100 Devices for Use in AnimalsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Global Policy and Strategy
• Color Additive Petitions - Medical DevicesGuidance Document · Center for Devices and Radiological Health
• Master Files Part III - Guidance on Scientific and Technical InformationGuidance Document · Center for Devices and Radiological Health
• CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and ClaimsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 454.100 OTC Ear Drop PreparationsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending MachinesCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 430.300 Labeling Shipping Containers of DrugsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 400.335 Fructose-Containing DrugsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 460.450 Status of Mail-Order Filling of PrescriptionsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application ProgramsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• All US Condom Manufacturers, Importers and RepackagersGuidance Document · Center for Devices and Radiological Health
• Format and Content of the Human Pharmacokinetics and Bioavailability Section of an ApplicationGuidance Document · Center for Drug Evaluation and Research
• GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTSGuidance Document · Center for Drug Evaluation and Research
• Formatting, Assembling and Submitting New Drug and Antibiotic Applications*Guidance Document · Center for Drug Evaluation and Research
• Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic ApplicationsGuidance Document · Center for Drug Evaluation and Research
• Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Policy on Lamp Compatibility (sunlamps)Guidance Document · Center for Devices and Radiological Health
• CPG Sec 590.600 Wigs Compliance Policy Guide 7128.05Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 605.100 - Use of Statements Regarding NADA Approval by FDA in Labeling and Advertising of New Animal Drugs (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 680.200 CGMP Regulations for Medicated Feeds - Daily Inventory Requirements (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 680.400 Medicated Feeds -- Combined BatchesCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated Feed (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 670.100 Refusals of Formula Information During Inspection of Feed Mills Manufacturing Feeds Requiring Approved Medicated Feed Applications (Withdrawn 6/30/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• Walk-In Workstations (Laser Notice 37)Guidance Document · Center for Devices and Radiological Health
• Policy On Maximum Timer Interval and Exposure Schedule For Sunlamp ProductsGuidance Document · Center for Devices and Radiological Health
• CVM GFI #23 Medicated Free Choice Feeds--Manufacturing ControlGuidance Document · Center for Veterinary Medicine
• Policy on Warning Label Required on Sunlamp ProductsGuidance Document · Center for Devices and Radiological Health
• User Instruction Hazard Warnings (Laser Notice 35)Guidance Document · Center for Devices and Radiological Health
• Medical Laser Delivery System Interlocks (Laser Notice 34)Guidance Document · Center for Devices and Radiological Health
• CVM GFI #13 Evaluation of Effectiveness of New Animal Drugs for Use in Free-Choice Feeds-Medicated BlockGuidance Document · Center for Veterinary Medicine
• Plasma Derived from Therapeutic Plasma ExchangeMemorandum · Center for Biologics Evaluation and Research
• CVM GFI #38 Guideline for Effectiveness Evaluation of Topical/Otic Animal DrugsGuidance Document · Center for Veterinary Medicine
• Enforcement Policy on Marketing OTC Combination Products (CPG 7132b16)Guidance Document · Center for Drug Evaluation and Research
• Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug EstablishmentGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #37 Evaluation of Effectiveness of New Animal Drugs for Use in Poultry Feed for PigmentationGuidance Document · Center for Veterinary Medicine
• CPG Sec 430.100 Unit Dose Labeling for Solid and Liquid Oral Dosage FormsGuidance Document · Center for Drug Evaluation and Research,Office of Pharmaceutical Quality
• CVM GFI #24 Drug Combinations for Use in AnimalsGuidance Document · Center for Veterinary Medicine
• CPG Sec. 398.450 Applicability of Positive Beam Limitation (PBL) Requirements When PBL is Provided on "Other than Stationary General Purpose" Radiographic SystemCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 450.550 Control and Accountability of Labeling Associated with Tamper-Resistant Packaging of Over-the-Counter Drug ProductsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 682.200 The Use of Antibiotic Drug Residue By-Products in Animal Feed Feed (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 615.300 Responsibility for Illegal Drug Residues in Meat, Milk and EggsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• Clinical Evaluation of General AnestheticsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 450100 CGMP Enforcement Policy - OTC vs Rx DrugsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 688.100 Unapproved Additives for Exported GrainsCompliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• Procedures for Laboratory Testing of Microwave OvensGuidance Document · Center for Devices and Radiological Health
• Exemption from Reporting and Record keeping Requirements for Certain Sunlamp Product ManufacturersGuidance Document · Center for Devices and Radiological Health
• CPG Sec. 430.200 Repacking of Drug Products - Testing/Examination under CGMPsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• Investigational Medical Laser Significant Risk Device (Laser Notice 31)Guidance Document · Center for Devices and Radiological Health
• Clinical Evaluation of Antiepileptic Drugs (adults and children)Guidance Document · Center for Drug Evaluation and Research
• CPG Sec. 110.100 Certification for Exports (Withdrawn 11/04/2021)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 578.350 Wheat for Human Consumption - ReconditioningCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 578.100 Starches - Common or Usual NamesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 690.400 Water and Gravy in Pet Food (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy StockCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 460.100 Hospital Pharmacies - Status as Drug ManufacturerCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 540.475 Snapper - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 562.450 Identity of Foods - Use of Terms Such as Fresh, Frozen, Dried, Canned, Etc.Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical InvestigatorsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 442.100 New Drugs - ExportGuidance Document · Center for Drug Evaluation and Research
• CPG Sec 560.500 Jams, Jellies and Related Products - ImportsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 560.450 Imported Low-Acid Canned Foods (Manufacturer Not Registered and/or No Scheduled Process Filed)Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 420.400 Performance of Tests for Compendial Requirements on Compendial ProductsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 400.900 Class I Recalls of Prescription DrugsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 400.800 Collection and Charitable Distribution of DrugsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 400.600 Drugs - Declaration of Quantity of Active Ingredient by Both Metric and Apothecary SystemsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 400.325 Candy "Pills" Representation as DrugCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 525.750 Spices - DefinitionsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 515.500 Barley Sugar - Definition, and Barley Sugar CandyCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 515.350 Candy - Mixed with Trinkets and Sold in Vending MachinesCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 515.300 Honey - Source DeclarationCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 510.300 Unfermented Beverages - Use of Word "Champagne"Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 510.200 Brandy Containing Methyl Alcohol - Food AdditiveCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 500.100 Additives - Labeling with Adequate Directions for Many UsesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 578400 Treated Grain Seed - Mercury ResidueCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555500 All Food Sanitation (Including Bacteriological) Inspections - Classification of EstablishmentCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 555450 Foods - Adulteration Involving Infestation and 1080 RodenticideCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 390100 Definition of “Commerce” - 21 CFR 10003(d) 2Compliance Policy Guide (CPG) · Center for Devices and Radiological Health
• CPG Sec. 690.200 Pet Food Labeling (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 682.100 Use of Drug-Contaminated Products in Animal Feed (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 460.500 Prescription Drugs for Ship's Medicine ChestsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 460.425 Prescription Status when Telephoned to Recording MachineCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 460.400 Computerized Prescription Recordkeeping by PharmaciesCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 660.100 Failure to Register (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 655.200 Adequate Directions for Use - Animal Drugs & Veterinary Devices (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec 540.285 Crabmeat Products - Labeling; Crabmeat Products with Added Fish or Other Seafood Ingredients - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 527.450 Milk & Milk Products Containing PenicillinCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 420.300 Changes in Compendial Specifications and NDA Supplements withdrawn on 8/30/12Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 420.200 Compendium Revisions and DeletionsCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 130.100 Inspectional Authority; Refusal to Permit Inspection.Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 625.200 Availability of Bulk Chemicals for Animal Drug Use (Withdrawn 4/14/2022)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 110.500 Food and Drug Guaranty - ImportsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec 555.200 Adulterated Food Mixed with Good FoodCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec. 398.400 Automatic Adjustment of the X-ray Field Size to the Selected Spot-Film Size - 21 CFR 1020.31(g)(1)Guidance Document · Office of Regulatory Affairs
• CPG Sec 525.650 Labeling of SeasoningsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 550.625 Oranges - Artificial ColoringCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 550.575 MarmaladeCompliance Policy Guide (CPG) · Human Foods Program