Guidances directory

All guidance documents2,854 total

• 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• CPG Sec. 690.200 Pet Food Labeling (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 682.100 Use of Drug-Contaminated Products in Animal Feed (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs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• CPG Sec. 660.100 Failure to Register (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
• CPG Sec. 655.200 Adequate Directions for Use - Animal Drugs & Veterinary Devices (Withdrawn 2/20/2020)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs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
• CPG Sec 550.550 Maraschino CherriesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 520.200 Canned Foods - Seam DefectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec. 251.100 Schedule of Physical Examination for Donors Receiving Immunization Injections (Obsolete, Withdrawn on 11/28/2017)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
• CPG 230.120- Human Blood and Blood Products as DrugsCompliance Policy Guide (CPG) · Office of Regulatory Affairs
• Alternate Wording For Caution Statement (Laser Notice 30)Guidance Document · Center for Devices and Radiological Health
• Quality Control Practices for Compliance with the Federal Mercury Vapor Lamp Performance StandardGuidance Document · Center for Devices and Radiological Health
• Open Door Operation of Microwave Ovens as a Result of Oven MiswiringIndustry Letter · Center for Devices and Radiological Health
• Exemption of Certain Lasers Used By DOE, NOAA and US Dept of Commerce (Laser Notice 25)Memorandum · Center for Devices and Radiological Health
• Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979: Guidance for IndustryGuidance Document · Center for Veterinary Medicine Human Foods Program Office of Inspections and Investigations Center for Biologics Evaluation and Research Center for Devices and Radiological Health Center for Drug Evaluation and Research
• General Guidelines for OTC Combination ProductsGuidance Document · Center for Drug Evaluation and Research
• Upgrading Category III Antiperspirants to Category I (43 FR 46728-46731)Guidance Document · Center for Drug Evaluation and Research
• 21 CFR 211 PREAMBLEPreamble · Department of Health and Human Services, Food and Drug Administration
• Guidance ('Guidelines') for Evaluation of Hysteroscopic Sterilization DevicesGuidance Document · Center for Devices and Radiological Health
• Laser Light Shows Subject to Laser Product Performance Standard (Laser Notice 22)Guidance Document · Center for Devices and Radiological Health
• Antidepressant Drugs--Clinical EvaluationGuidance Document · Center for Drug Evaluation and Research
• Hypnotic Drugs--Clinical EvaluationGuidance Document · Center for Drug Evaluation and Research
• Procedures for Field Testing Microwave OvensGuidance Document · Center for Devices and Radiological Health
• Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16)Guidance Document · Center for Devices and Radiological Health
• Review Guidelines for Oxygen Generators and Oxygen Equipment for Emergency UseGuidance Document · Center for Devices and Radiological Health
• Lasers Manufactured and Used In-House (Laser Notice 14)Guidance Document · Center for Devices and Radiological Health
• Manufacture and Certification of Laser Kits (Laser Notice 13)Guidance Document · Center for Devices and Radiological Health
• Remote Interlock Connectors (Laser Notice 11)Guidance Document · Center for Devices and Radiological Health
• Certain Military Lasers Exempt From 21 CFR 104010 & 11 (Laser Notice 9)Memorandum · Center for Devices and Radiological Health
• Viewing Optics - Sighting Telescope (Laser Notice 8)Guidance Document · Center for Devices and Radiological Health
• Quality Control Practices for Compliance with the Federal Laser Performance StandardGuidance Document · Center for Devices and Radiological Health
• Laser Energy Source (Laser Notice 2)Guidance Document · Center for Devices and Radiological Health
• Guidance for the Submission of Cabinet X-Ray System Reports Pursuant to 21-CFR 102040Guidance Document · Center for Devices and Radiological Health
• CPG Sec 335300 Hypnotherapy Devices - Self-Hypnotic Tape RecordingsCompliance Policy Guide (CPG) · Office of Regulatory Affairs