Inspections, Compliance, Enforcement, and Criminal Investigations
Compliance Policy Guidance Manual
| Year | 2009 - 2008 - 2007 - 2006 - 2005 - 2004 - 2003 - 2002 - 2001 - 2000 - 1999 - 1998 |
| 2009 | Top |
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06/29/2009: Compliance Policy Guide (CPG) entitled, "CPG Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" was revised on May 6, 2009, and is now in effect. Federal Register notice of availability published on May 6, 2009 (74 FR 20955) @ http://www.fda.gov/OHRMS/DOCKETS/98fr/E9-10556.htm. 01/22/2009 |
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| 2008 | Top |
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12/05/2008 10/31/2008: 07/18/2008 New Draft "CPG Sec. 540.370, Fish and Fishery Products -- Decomposition." The purpose of this Compliance Policy Guide (CPG) is to provide guidance relating to FDA's direct reference enforcement policy on decomposition in fish and fishery products. 06/06/2008 4/11/2008 The purpose of this Compliance Policy Guide (CPG) is to provide guidance to help FDA personnel determine whether to take enforcement action based upon the presence of 3-MCPD in acid-HP and Asian-style sauces in interstate commerce or offered for import into the United States. 2/6/2008 The purpose of this draft Compliance Policy Guide is to provide guidance to FDA Staff on FDA's enforcement policy for Listeria monocytogenes (L. monocytogenes) in foods. 1/9/2008 The purpose of this revised draft CPG Sec. 575.100 is to provide guidance for FDA staff regarding FDA's current thinking on its enforcement policy for pesticide chemical residues in food. |
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| 2007 | Top |
| 07/13/2007 Compliance Policy Guide (CPG) entitled, "Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)" was revised on June 2, 2007, and is now in effect. This CPG was amended to incorporate the current references and cites to the Device Quality System Regulation (21 CFR Part 820). |
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| 2006 | Top |
| 11/30/2006 Compliance Policy Guide (CPG) 160.900 entitled "Prescription Drug Marketing Act--Pedigree Requirements under 21 CFR Part 203" [PDF Size 42 kb]. This CPG describes how the agency intends to prioritize its enforcement efforts in the first year after the December 1, 2006, effective date of 21 CFR Sec. 203.3(u) and 203.50. In addition, the FDA is announcing the availability of a "Guidance for Industry: Prescription Drug Marketing Act Pedigree Requirements Questions and Answers" (PDMA Q & A). The PDMA Q & A guidance is issued in response to the many questions received regarding the Prescription Drug Marketing Act PDMA pedigree requirements. FDA is implementing the PDMA Q&A guidance immediately, because the agency has determined that prior public input is not feasible or appropriate. However, FDA is opening a docket on the PDMA Q & A for interested persons to submit comments and questions. FDA intends to review the comments and questions and to revise the PDMA Q & A when appropriate. The agency believes that it is important to maintain FDA's written responses to the significant questions concerning the PDMA pedigree requirements in a single guidance document that is periodically updated as the agency receives and responds to additional questions. We intend to use the following four indicators to help users of the guidance identify future additions or revisions: (1) The updated guidance will be identified as a revision of the previously issued document, (2) the revision date of the guidance will appear on its cover, (3) the edition number of the guidance will be included in its title, and (4) questions and answers that have been added to the guidance, or prior answers that have been in any way modified, will be identified as such in the body of the guidance. The two guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the PDMA. 11/02/2006 Compliance Policy Guide (CPG) entitled, "Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)" was revised on October 3, 2006, and is now in effect. Revisions were made throughout the CPG, most significantly, to conform to the device registration regulations. If a contract sterilizer only distributes sterilized devices to the manufacturer or other registered firm and does not ship the sterilized devices into commercial distribution, then it is not required to register with the Center for Devices and Radiological Health (21 CFR 807.20(c)(2)). Additionally, a contract sterilizer located in a foreign country is only required to register if it imports, or offers for import, the sterilized devices into the United States (21 CFR 807.40(a)). New Guidance That Replaces CPG Sec 110-300, Compliance Policy Guide Guidance for FDA Staff Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" New Guidance which Replaces CPG Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (CPG 7132c.02) |
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| 2005 | Top |
| 12/12/05 Revised CPG Sec. 230.150 - Blood Donor Classification Statement, Paid or Volunteer Donor Revised CPG Sec. 300.750 - Class III Devices Subject to 515(b) Requirements (CPG 7124.18) Revoked CPG Sec. 460.700 - Controlled Release Dosage Form Drugs - Rate of Release of Active Ingredients (CPG 7132a.02) 11/10/2005: Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 08/08/2005: Revoked by Federal Register notice on 09/24/1998 (63 FR 51074), CPG Sec. 615.100 Extra-Label Use of New Animal Drugs in Food-Producing Animals (CPG 7125.06) 05/19/2005 Revised CPG Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG 7124.07) 04/25/2005 Revised CPG 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier 04/25/2005 Revised CPG 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic Products 04/13/2005 Revised CPG Sec. 560.400 Imported Milk and Cream - Federal Import Milk Act CPG 7119.05 03/18/2005 Revised CPG Sec. 300.500 - Reprocessing of Single Use Devices (CPG 7124.16) 03/10/2005 Revised 8 CPGs to make corrections/minor changes: Sec. 390.100; Sec. 390.400; Sec. 393.100; Sec. 396.300; Sec. 398.100; Sec. 398.325; Sec. 398.425; Sec. 398.700; 03/10/2005 Revoked CPG: Sec. 355.100 - Cellutron Machine 03/08/2005 Revoked 03/08/2005, Compliance Policy Guide, Sec. 160.800 Y2K Computer Compliance 03/04/2005 Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 |
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| 2004 | Top |
| 11/16/2004 New CPG Sec. 400.210- Radiofrequency Identification Feasibility Studies and Pilot Programs 11/03/2004 Revised CPG Sec. 110.300 - Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 11/02/2004 Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 08/16/2004 Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 07/29/2004 Revised CPG Sec. 394.500 - Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation 07/29/2004 Replaced/Retitled CPG Sec. 560.750 Guidance Levels for Radionuclides in Domestic and Imported Foods (CPG 7119.14) 3/12/2004 Revised to update content of August 2000 paper edition: Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval CPG 7132c.08 2/9/2004 Edited two pages to conform text (reference) on Internet pages to August 2000 paper edition CPG Sec. 515.700 Chocolate & Chocolate Liquor - Adulteration with Insect and Rodent Filth CPG 7105.11 CPG Sec. 515.775 Cocoa Powder, Press Cake - Adulteration with Insect and Rodent Filth CPG 7105.13 Revoked 1/5/2004 Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse CPG 7124.06 |
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| 2003 | Top |
| Issued 12/15/2003 New CPG Sec. 110.300 - "Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" is available at: http://www.cfsan.fda.gov/~furls/cpgreg.html. |
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| Issued 12/10/2003 Sec. 110.310 - "Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002" is available at: http://www.cfsan.fda.gov/~pn/cpgpn.html |
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| Revised 07/08/2003: Sec. 608.400 Compounding of Drugs for Use in Animals (CPG 7125.40) |
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| Revoked effective 02/19/2003: Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17). See: 68 FR 8775 02/25/2003. |
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| 2002 | Top |
| Revised 11/14/2002: Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18) |
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| Revoked effective on 11/12/2002: Sec. 398.475 Minimum X-Ray Field Size for Spot-Film Operation of Fluoroscopic Systems with Fixed SID and Without Stepless Adjustment of the Field Size (CPG 7133.17) |
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| Revoked effective on 10/07/2002: Sec. 300.700 Direct Reference Authority for Class III Medical Devices Without a Premarket Notification (510(k)) or an Approved Premarket Approval Application (PMA) (CPG 7124.30) |
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| Revoked effective on 08/07/2002: Sec. 315.200 Status of Dental Supplies such as Denture Cleaners, Adhesives, Cushions, and Repair Materials as a Device or Cosmetic (CPG 7124.05) See 67 FR 45129, 07/08/2002 (products are regulated as devices by regulation) |
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| Reissued 05/29/2002: Sec. 460.200 Pharmacy Compounding |
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| Revoked 06/20/2002: Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13) |
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| Revoked 06/20/2002: ;Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products (CPG 7133.16) |
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| Corrected 05/16/2002: Sec 575.100 Pesticide Residues...Heptachlor table |
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| New 05/16/2002: Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor (Issued 05/07/2002) |
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| Revised as Draft Mar 29, 2002: Sec. 345.100 Male Condom Defects (CPG 7124.21) |
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| 2001 | Top |
| Revised as Draft Dec 18, 2001 - Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18) [Final 11/14/2002] | |
| New: Oct., 2001 - Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin | |
| Reformat: Oct., 2001 - Sec. 570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05) | |
| Final: April 2001 - Sec. 615.115 Extra-Label Use of Medicated Feeds for Minor Species | |
| New: April 2001 - Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens | |
| Reformat: March, 2001 - Sec. 220.100 Interstate Shipment of Biological Products for Use in Medical Emergencies (CPG 7134.11) | |
| Reformat: March, 2001 - Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes (CPG 7134.06) | |
| 2000 | Top |
| Draft CPG - December 2000, Sec.230.150 Blood Donor Incentives | |
| Revised 08/10/2000, Sec.540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (CPG 7108.17) | |
| New 06/29/2000, Sec. 100.950 International Partnership Agreements for Compliance Activities - Agreements among the USFDA, Foreign Government Agencies, and Foreign or Domestic Trade Associations and/or Other Organizations | |
| Revised 08/17/2000, Sec. 230.110 Registration of Blood Banks and Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01) | |
| New 08/14/2000, Sec. 280.100 Stability Requirements for Licensed In Vitro Diagnostic Products. | |
| New 08/14/2000, Sec. 280.110 Microbiological Control Requirements in Licensed Anti-Human Globulin and Blood Grouping Reagents | |
| Revised 08/10/2000 Sec. 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (CPG 7108.17) | |
| Revised 05/01/2000, Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18) | |
| Revised 04/14/2000, Sec. 110.100 Certification for Exports (CPG 7150.01) | |
| Deleted 03/28/2000, Sec. 215.100 IND Filings: Completion of Applicable... | |
| Reissued 03/22/2000, Sec. 257.100 Deferral of Source Plasma Donors Due to Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis | |
| New 03/06/2000, Sec. 252.110 Volume Limits for Automated Collection of Source Plasma | |
| Deleted (Revoked) 01/24/2000, Sec. 305.100 Acupuncture Devices and Accessories (CPG 7124.11) | |
| 1999 | Top |
| Draft CPG 08/04/1999, Sec. 615.115 Use of Medicated Feeds for Minor Species | |
| New 07/09/1999, Sec. 230.140 Evaluation and Processing Post Donation Information Reports | |
| New 05/13/1999, Sec. 160.850 Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17) | |
| New 04/26/1999, Sec. 160.800 Y2K Computer Compliance | |
| New 03/23/1999, Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects | |
| Deleted 01/8/1999, Sec. 460.200 Manufacture, Distribution, and Promotion of Adulterated, Misbranded, or Unapproved New Drugs for Human Use by State-Licensed Pharmacies (CPG 7132.16) | |
| 1998 | Top |
| Revised 11/13/98, Revised Sec. 675.400 Rendered Animal Feed Ingredients (CPG 7126.24) | |
| New 12/21/98, New Sec. 257.100 Deferral of Source Plasma Donors Due To Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis |
*Material between asterisks was changed