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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
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Sub
Chapter 100 - General
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100.100 |
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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 |
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CPG 7150.05 Page 2 |
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100.200 |
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FDA Jurisdiction Over Products Composed of
Interstate Ingredients |
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CPG 7153.11 Page 3 |
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100.300 |
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Non-FDA Regulated Products Involving
Communicable Disease Hazards |
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CPG 7150.08 Page 3 |
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100.350 |
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FDA Jurisdiction on Indian Reservations |
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CPG 7150.06 Page 4 |
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100.500 |
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Common Carrier as a Relabeler, Repacker,
Reprocessor, etc. |
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CPG 7150.03 Page 4 |
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100.550 |
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Status and Responsibilities of Contract
Sterilizers Engaged in the Sterilization of Drugs and Devices |
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CPG 7150.16 Page 5 |
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100.600 |
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Status of Facial Tissues, Paper Napkins, Paper
Towels and Similar Paper Products |
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CPG 7150.02 Page 6 |
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100.700 |
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GWQAP Pre-Award Evaluation - Inadequate
Information to Evaluate Prospective Supplier |
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CPG 7150.07 Page 6 |
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100.800 |
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Guaranties Over Printed Signatures |
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CPG 7150.12Page 7 |
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100.900 |
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International Memoranda of Understanding |
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CPG 7150.19 Page 7 |
100.950 |
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International Partnership Agreements for
Compliance Activities... |
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CPG 100.950 |
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Sub
Chapter 110 - Exports/Imports
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110.100 |
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Certification for Exports |
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CPG 7150.01 (Revised 04/14/2000) Page 7 |
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110.200 |
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Export of FDA Regulated Products from U.S.
Foreign Trade |
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CPG 7150.11 Page 9 |
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110.300 |
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Registration of Food Facilities Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002
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(Issued 12/11/2003, revised 11/08/2004
and August 2006) |
110.310
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Prior Notice of Imported Food Under the
Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 |
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(Issued 12/11/2003, revised 06/24/2004;
08/16/2004; 11/02/2004; 11/10/2005) |
110.500 |
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Food and Drug Guaranty - Imports |
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CPG 7153.10 Page 9 |
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110.600 |
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FDA Authority Over Products of Foreign Origin
Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers |
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CPG 7150.14 Page 9 |
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110.700 |
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Seizures by the U.S. Customs Service of
Prohibited Articles of Foreign Origin Not Intended for Entry into the United States |
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CPG 7153.08 Page 10 |
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110.800 |
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Imports, Post Detention Sampling |
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CPG 7150.04 Page 11 |
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110.900 |
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Imported Products - Lack of English Labeling |
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CPG 7150.15 Page 11 |
Sub
Chapter 120 - Fraud
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120.100 |
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Fraud, Untrue Statements of Material Facts,
Bribery, and Illegal Gratuities |
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CPG 7150.09 Page 12 |
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120.500 |
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Health Fraud - Factors in Considering Regulatory
Action |
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CPG 7150.10 Page 14 |
Sub
Chapter 130 - Inspections
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130.100 |
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Inspectional Authority; Refusal to Permit
Inspection. |
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CPG 7151.01 Page 15 |
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130.200 |
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Inspection of Firms when Legal Action is Pending |
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CPG 7153.01 Page 16 |
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130.300 |
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FDA Access to Results of Quality Assurance
Program Audits and Inspections |
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CPG 7151.02 Page 16 |
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130.400 |
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Use of Microfiche and/or Microfilm for Method of
Records Retention |
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CPG 7150.13 Page 17 |
Sub
Chapter 140 - Labeling
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140.100 |
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Seizure of Books that Constitute Misleading
Labeling |
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CPG 7153.13 Page 17 |
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140.500 |
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Metric Declarations of Quantity of Contents on
Product Labels |
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CPG 7150.17 Page 18 |
Sub
Chapter 150 - Laboratory/Analytic
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150.100 |
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Requests for Portions of Intermediate or End
Products Resulting from FDA Sample Analysis |
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CPG 7150.18 Page 22 |
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150.500 |
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Analytical Methodology Used by FDA - Drugs |
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CPG 7152.01 Page 22 |
Sub
Chapter 160 - Regulatory
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160.100 |
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Regulatory Actions and Small Business |
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CPG 7153.12 Page 23 |
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160.200 |
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FDA Use of Income Tax Information from IRS in
Compliance Activity |
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CPG 7153.09 Page 25 |
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160.300 |
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Requests for Records Under Section 703 Page 25 |
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160.400 |
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Section 305 Meeting - Before Report of Criminal
Violation |
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CPG 7153.03 Page 25 |
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160.500 |
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Answering Inquiries on Status of Criminal
Records |
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CPG 7153.05 Page 26 |
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160.600 |
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Payment of Expert Witness |
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CPG 7153.07 Page 26 |
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160.700 |
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Reconditioning of Foods Adulterated Under
402(a)(4) |
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CPG 7153.04 Page 27 |
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160.750 |
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Drug and Device Products (Including Biologics
and Animal Drugs) Found in Violation of GMPRs - Reconditioning |
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CPG 7153.14 Page 27 |
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160.800 |
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(Revoked 03/08/2005) Y2K Computer Compliance, 4/26/1999 |
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160.850 |
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(Revoked 02/19/2003)
Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures. |
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(CPG 7153.17) ref |
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160.900 |
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Prescription Drug Marketing Act -- Pedigree Requirements under 21 CFR Part 203 |
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Sub
Chapter 170
Specific Problems
Non-Food, Drug, or Cosmetic Related
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170.100 |
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Turtles - Ban on Interstate and Intrastate Sales
and Distribution |
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CPG 7129.01 Page 28 |
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Revised September 11, 2000 |
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