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Updated: 2006-11-30

FDA/ORA Compliance Policy Guides
Chapter 1 Contents

Sub Chapter 100 - General
Sub Chapter 110 - Exports/Imports
Sub Chapter 120 - Fraud
Sub Chapter 130 - Inspections
Sub Chapter 140 - Labeling
Sub Chapter 150 - Laboratory/Analytic
Sub Chapter 160 - Regulatory
Sub Chapter 170 - Specific Problems Non-Food, Drug, or Cosmetic Related
 

Sub Chapter 100 - General
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 Health CPG 7150.05  Page 2
100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients CPG 7153.11  Page 3
100.300 Non-FDA Regulated Products Involving Communicable Disease Hazards CPG 7150.08 Page 3
100.350 FDA Jurisdiction on Indian Reservations CPG 7150.06 Page 4
100.500 Common Carrier as a Relabeler, Repacker, Reprocessor, etc. CPG 7150.03 Page 4
100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices CPG 7150.16 Page 5
100.600 Status of Facial Tissues, Paper Napkins, Paper Towels and Similar Paper Products CPG 7150.02 Page 6
100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier CPG 7150.07  Page 6
100.800 Guaranties Over Printed Signatures CPG 7150.12Page 7
100.900 International Memoranda of Understanding CPG 7150.19 Page 7
100.950 International Partnership Agreements for Compliance Activities... CPG 100.950

 

Sub Chapter 110 - Exports/Imports
110.100 Certification for Exports CPG 7150.01 (Revised 04/14/2000) Page 7
110.200 Export of FDA Regulated Products from U.S. Foreign Trade CPG 7150.11 Page 9
110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
 (Issued 12/11/2003, revised 11/08/2004 and August 2006)
110.310
 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Issued 12/11/2003, revised 06/24/2004; 08/16/2004; 11/02/2004; 11/10/2005)
110.500 Food and Drug Guaranty - Imports CPG 7153.10  Page 9
110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers CPG 7150.14 Page 9
110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States CPG 7153.08 Page 10
110.800 Imports, Post Detention Sampling CPG 7150.04 Page 11
110.900 Imported Products - Lack of English Labeling CPG 7150.15 Page 11

 

Sub Chapter 120 - Fraud
120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities CPG 7150.09 Page 12
120.500 Health Fraud - Factors in Considering Regulatory Action CPG 7150.10 Page 14

 

Sub Chapter 130 - Inspections
130.100 Inspectional Authority; Refusal to Permit Inspection. CPG 7151.01 Page 15
130.200 Inspection of Firms when Legal Action is Pending CPG 7153.01 Page 16
130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections CPG 7151.02 Page 16
130.400 Use of Microfiche and/or Microfilm for Method of Records Retention CPG 7150.13 Page 17

 

Sub Chapter 140 - Labeling
140.100 Seizure of Books that Constitute Misleading Labeling CPG 7153.13 Page 17
140.500 Metric Declarations of Quantity of Contents on Product Labels CPG 7150.17 Page 18

 

Sub Chapter 150 - Laboratory/Analytic
150.100 Requests for Portions of Intermediate or End Products Resulting from FDA Sample Analysis CPG 7150.18 Page 22
150.500 Analytical Methodology Used by FDA - Drugs CPG 7152.01 Page 22

 

Sub Chapter 160 - Regulatory
160.100 Regulatory Actions and Small Business CPG 7153.12 Page 23
160.200 FDA Use of Income Tax Information from IRS in Compliance Activity CPG 7153.09 Page 25
160.300 Requests for Records Under Section 703 Page 25
160.400 Section 305 Meeting - Before Report of Criminal Violation CPG 7153.03 Page 25
160.500 Answering Inquiries on Status of Criminal Records CPG 7153.05 Page 26
160.600 Payment of Expert Witness CPG 7153.07 Page 26
160.700 Reconditioning of Foods Adulterated Under 402(a)(4) CPG 7153.04 Page 27
160.750 Drug and Device Products (Including Biologics and Animal Drugs) Found in Violation of GMPRs - Reconditioning CPG 7153.14 Page 27
160.800 (Revoked 03/08/2005) Y2K Computer Compliance, 4/26/1999
160.850 (Revoked 02/19/2003)
Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures. 		(CPG 7153.17) ref
160.900 Prescription Drug Marketing Act -- Pedigree Requirements under 21 CFR Part 203  

 

Sub Chapter 170
Specific Problems
Non-Food, Drug, or Cosmetic Related
170.100 Turtles - Ban on Interstate and Intrastate Sales and Distribution CPG 7129.01 Page 28
Revised September 11, 2000