Guidances directory

All guidance documents2,854 total

• CPG Sec 505.350 Honey Bread, Honey BunsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 505.300 "Butter-Nut" BreadCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 505.200 "Butter" Featured in Product NameCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• Guide for Establishing and Maintaining a Calibration Constancy Intercomparison System for Microwave Oven Compliance Survey Instruments (FDA 88-8264)] (PDF Only)Guidance Document · Center for Devices and Radiological Health
• Quality Control Guide for Sunlamp Products (FDA 88-8234)Guidance Document · Center for Devices and Radiological Health
• CPG Sec 578450 Wheat Flour-Adulteration with Insect Fragments and Rodent HairsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Recommendations for the Management of Donor and Units that are Initially Reactive for Hepatitis B Surface Antigen (HBsAg)Memorandum · Center for Biologics Evaluation and Research
• CPG Sec 565.200 Red Meat Adulterated with PCBsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Class II and IIIA Laser Light Show Projectors and Shows (Laser Notice 40)Guidance Document · Center for Devices and Radiological Health
• CPG Sec. 160.600 Payment of Expert WitnessesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 460.600 Content Uniformity Testing of Tablets and CapsulesCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 567.200 Pork and Beans and Similar Bean Products - LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec. 345.200 Diaphragms - Rx DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 325.100 Karaya Gum Powder and Related Devices for Use by OstomatesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 320.100 Ear Piercing DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k))Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 300.100 Inspection of Manufacturers of Device ComponentsCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
• CPG Sec. 425.500 Computerized Drug Processing; Identification of "Persons" on Batch Production and Control RecordsGuidance Document · Center for Drug Evaluation and Research
• CPG Sec. 425.400 Computerized Drug Processing; Input/Output CheckingCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 425.200 Computerized Drug Processing; Vendor ResponsibilityCompliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 425.100 Computerized Drug Processing; CGMP Applicability to Hardware and Software*Compliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec. 410.100 *Finished Dosage Form Drug Products in Bulk Containers - Applications of Current Good Manufacturing Practice Regulations*Compliance Policy Guide (CPG) · Center for Drug Evaluation and Research
• CPG Sec 567.300 *Bouillon, Bouillon Cubes, Granulated Bouillon*Compliance Policy Guide (CPG) · Human Foods Program
• CPG Sec 567.100 Antipasto, Common or Usual NameCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec. 100.300 *Non-FDA Regulated Products Involving Communicable Disease Hazards*Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG Sec. 100.100 Responsibility for Reporting Possible or Potential Violations of Laws Administered by FDA, Regulations Issued by FDA, Other Possible or Potential Hazards to the Public HealthCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• 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