Chapter 1 - General
Manual of Compliance Guides Chapter 1 - General
Sub Chapter 110 - Exports/Imports
Sub Chapter 150 - Laboratory/Analytic
Sub Chapter 100 - General
- CPG Sec.100.100 Responsibility for Reporting Possible or Potential Violations of Law Administered by FDA, Regulations Issued by FDA, Other Possible or Potential Hazards to the Public Health
- CPG Sec. 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients
- CPG Sec.100.250 Food Facility Registration - Human and Animal Food
- CPG Sec. 100.300 Non-FDA Regulated Products Involving Communicable Disease Hazards
- CPG Sec. 100.350 FDA Jurisdiction on Indian Reservations
- CPG Sec. 100.500 - Common Carrier as a Relabeler, Repacker, Reprocessor, etc.
- CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices
- CPG Sec. 100.600 Status of Facial Tissues, Paper Napkins, Paper Towels and Similar Paper Products
- CPG Sec. 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier
- CPG Sec. 100.950 International Partnership Agreements for Compliance Activities
- CPG Sec. 100.800 Guaranties Over Printed Signatures
- CPG Sec. 100.900 International Memoranda of Understanding
- CPG Sec. 101.100 FDA Considerations for Recommending Charges Under 21 U.S.C. §331(a) or (d) for Causing the Introduction of Violative Products into Interstate Commerce Guidance for FDA Staff
Sub Chapter 110 - Exports/Imports
- CPG Sec. 110.100 Certification for Exports
- CPG Sec. 110.200 Export of FDA Regulated Products from U.S. Foreign Trade Zones
- CPG Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Guidance for FDA and CBP Staff)
- CPG Sec. 110.500 Food and Drug Guaranty - Imports
- CPG Sec. 110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers
- CPG Sec. 110.650 Weekly Entry Filing Guidance for Industry and FDA Staff
- CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States
- Compliance Policy Guide Section 110.800 Post Detention Sampling Guidance for Industry
- CPG Sec. 110.900 Imported Products - Lack of English Labeling
Sub Chapter 120 - Fraud
- CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities
- CPG Sec. 120.500 Health Fraud - Factors in Considering Regulatory Action
Sub Chapter 130 - Inspections
- CPG Sec. 130.100 Inspectional Authority; Refusal to Permit Inspection.
- CPG Sec. 130.200 Inspection of Firms when Legal Action is Pending
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention
Sub Chapter 140 - Labeling
- CPG Sec. 140.100 Seizure of Books that Constitute Misleading Labeling
- CPG Sec. 140.500 Metric Declarations of Quantity of Contents on Product Labels
Sub Chapter 150 - Laboratory/Analytics
- CPG Sec. 150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis
- •Compliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs) (PDF - 34KB)
- CPG Sec. 150.500 Analytical Methodology Used by FDA - Drugs
Sub Chapter 160 - Regulatory
- CPG Sec. 160.100 Regulatory Actions and Small Business
- CPG Sec. 160.200 FDA Use of Income Tax Information from IRS in Compliance Activity
- CPG Sec. 160.300 Requests for Records Under Section 703
- CPG Sec. 160.400 *Section 305 Meeting* Before Report of Criminal Violation
- CPG Sec. 160.500 Answering Inquiries on Status of Criminal Referrals
- CPG Sec. 160.600 Payment of Expert Witnesses
- CPG Sec. 160.700 Reconditioning of Foods Adulterated Under 402(a)(4)
- CPG Sec. 160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning