10/19/2022

CPG Sec. 680.100 was withdrawn October 19, 2022, and replaced with GFI #258 Use of Tracers in Animal Food, Type A Medicated Articles, and Medicated Feeds. 

04/22/2022

CPG Sec. 300.750 Class III Devices Subject to 515(b) Requirements is obsolete and was withdrawn on 04/22/2022

CPG Sec. 310.200 Sphygmomanometers - Rx Legend is obsolete and was withdrawn on 04/22/2022

CPG Sec. 335.500 Razor Blades, Manicuring Instruments - Not Considered Devices Under 201(h) is obsolete and was withdrawn on 04/22/2022

CPG Sec. 393.100 Enforcement Policy for Certain Laser Light Shows, Displays, and/or Devices. (21 CFR 1040.10 and 1040.11) is obsolete and was withdrawn on 04/22/2022

CPG Sec. 394.500 Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation during Design Development is obsolete and was withdrawn on 04/22/2022

CPG Sec. 398.425 Override of Positive Beam Limitation - 21 CFR 1020.31(g)(5) is obsolete and was withdrawn on 04/22/2022

04/14/2022

Compliance Policy Guide Sec. 625.200 Availability of Bulk Chemicals for Animal Drug Use is obsolete and was withdrawn on 4/14/2022.

02/15/2022

Compliance Policy Guide Sec. 510.800 Beverages--Serving Size Labeling is obsolete and was withdrawn on 2/15/2022.

Compliance Policy Guide Sec. 540.420 Raw Breaded Shrimp--Microbiological Criteria for Evaluating Compliance with Current Good Manufacturing Practice Regulations is obsolete and was withdrawn on 2/15/2022.

Compliance Policy Guide Sec. 562.800 Vending Machine Food—Labeling is obsolete and was withdrawn on 2/15/2022.

12/23/2021

Draft Compliance Policy Guide Sec 540.525 for Decomposition and Histamine in Scombrotoxin (Histamine)-forming Fish and Fishery Products is available for public comment; the updates to this CPG bring the agency’s regulatory position and thinking in line with current science and increase public health protection.

11/4/2021

Compliance Policy Guide Sec 110.100  Certification for Exports was withdrawn November 4, 2021

6/1/2021

Compliance Policy Guide Sec 555.400  Aflatoxins in Human Food was revised to update the format and to include revisions for clarity, references to each of the other aflatoxin CPGs, and a reference to the Memorandum of Understanding between the Agricultural Marketing Service of the USDA and FDA.

Compliance Policy Guide Sec. 570.200 Aflatoxins in Brazil Nuts was revised to update the format and to include revisions for clarity, references to each of the other aflatoxin CPGs, and a reference to the Memorandum of Understanding between the Agricultural Marketing Service of the USDA and FDA.

Compliance Policy Guide Sec. 570.375 Aflatoxins in Peanuts and Peanut Products was revised to update the format and to include revisions for clarity, references to each of the other aflatoxin CPGs, and a reference to the Memorandum of Understanding between the Agricultural Marketing Service of the USDA and FDA.

Compliance Policy Guide Sec. 570.500 Aflatoxins in Pistachio Nuts was revised to update the format and to include revisions for clarity, references to each of the other aflatoxin CPGs, and a reference to the Memorandum of Understanding between the Agricultural Marketing Service of the USDA and FDA.

12/1/2020 
Compliance Policy Guide Sec. 110.650 Weekly Entry Filing Guidance for Industry and FDA Staff was issued

11/20/2020 
Compliance Policy Guide Sec. 560.750 Radionuclides in Imported Foods - Levels of Concern was updated on November 20, 2020, as Compliance Policy Guide Sec. 555.580 Guidance Levels for Radionuclides in Domestic and Imported Foods to reflect the intended application and title as announced in the Federal Register Notice dated July 29, 2004 (69 FR 45336), as well as minor editorial changes.

7/13/2020 
Compliance Policy Guide Sec. 540.750 Use of The Seafood List to Determine Acceptable Seafood Names was revised to clarify existing language to reflect current CPG formatting standards, and to make other editorial revisions on July 14, 2020

6/30/2020
CPG Sec. 670.100 Refusals of Formula Information During Inspection of Feed Mills Manufacturing Feeds Requiring Approved Medicated Feed Applications withdrawn.

3/24/2020
Compliance Policy Guide 110.800 Post Detention Sampling Guidance for Industry was revised to clarify existing language to reflect current CPG formatting standards, and to make other editorial revisions on March 24, 2020

2/20/2020
The following Compliance Policy Guides were withdrawn on February 20, 2020:

Compliance Policy Guide Sec. 605.100 Use of Statements Regarding NADA Approval by FDA in Labeling and Advertising of New Animal Drugs
Compliance Policy Guide Sec. 608.300 Lay Use of *Animal Capture and Euthanasia* Drugs
Compliance Policy Guide Sec. 608.500 Illegal Sales of Veterinary Prescription Drugs Direct Reference Authority for *Warning* Letter Issuance
Compliance Policy Guide Sec. 625.300 Unapproved New Animal Drugs - Follow-up Action to Approved Warning Letter - Direct Reference Seizure Authority
Compliance Policy Guide Sec. 625.400 Reconditioning of New Animal Drugs Seized Under Section 501(a)(5)
Compliance Policy Guide Sec. 625.500 Failure to Register *and/or Drug List*
Compliance Policy Guide Sec. 634.100 Drugs Packaged for Infusion or Injection of Food-Producing Animals
Compliance Policy Guide Sec. 637.100 Plastic Containers for Injectable Animal Drugs
Compliance Policy Guide Sec. 640.100 Anthelmintics
Compliance Policy Guide Sec. 641.100 *Products for Control of Fleas and Ticks* Containing a Pesticide
Compliance Policy Guide Sec. 643.100 Oral Iron Products for Baby Pigs
Compliance Policy Guide Sec. 645.100 Biological Drugs for Animal Use
Compliance Policy Guide Sec. 654.100 Dimethyl Sulfoxide (DMSO) for Animal Use
Compliance Policy Guide Sec. 654.300 Chloramphenicol as an Unapproved New Animal Drug - Direct Reference Seizure Authority
Compliance Policy Guide Sec. 655.200 Adequate Directions for Use - Animal Drugs & Veterinary Devices
Compliance Policy Guide Sec. 655.300 Barking Dog Collar
Compliance Policy Guide Sec. 655.400 The Status of Syringes and Needles for Animal Use
Compliance Policy Guide Sec. 660.100 Failure to Register
Compliance Policy Guide Sec. 670.200 Status of Vitamins and Minerals in Type B and C Medicated Feed and in Non-Medicated Feed
Compliance Policy Guide Sec. 680.200 CGMP Regulations for Medicated Feeds - Daily Inventory Requirements
Compliance Policy Guide Sec. 681.100 Order for Post-Approval Record Reviews
Compliance Policy Guide Sec. 682.100 Use of Drug-Contaminated Products in Animal Feed
Compliance Policy Guide Sec. 682.200 The Use of Antibiotic Drug Residue By-Products in Animal Feed Feed
Compliance Policy Guide Sec. 690.100 Nutritional Supplements for Companion Animals
Compliance Policy Guide Sec. 690.200 Pet Food Labeling
Compliance Policy Guide Sec. 690.400 Water and Gravy in Pet Food
Compliance Policy Guide Sec. 690.600 Rodent Contaminated Pet Foods - *Direct Reference Seizure Authority*

1/30/2020
Compliance Policy Guide Sec. 230.100 Blood and Blood Product Definitions is obsolete and was withdrawn on 1/30/2020

1/30/2020
Compliance Policy Guide Sec. 230.120 Human Blood and Blood Products As Drugs is obsolete and was withdrawn on 1/30/2020.

1/30/2020
Compliance Policy Guide Sec. 270.100 Final Container Labels – Allergenic Extracts Containing Glycerin; Reporting Changes is obsolete and was withdrawn on 1/30/2020.

1/30/2020
Compliance Policy Guide Sec. 275.100 Immune Milk is obsolete and was withdrawn on 1/30/2020.

12/06/2019
Compliance Policy Guide Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor was revised to update regulatory references and terminology for consistency, revised to current CPG formatting standards, and other editorial revisions on December 06, 2019.

7/23/2019
Compliance Policy Guide Sec. 665.200 Checklist Labeling for Custom Mixed Medicated Feeds was withdrawn July 23, 2019.

4/30/2019
Compliance Policy Guide Sec. 675.400 Rendered Animal Feed Ingredients was withdrawn April 30, 2019.

4/30/2019
Compliance Policy Guide Sec. 690.300 Canned Pet Food was withdrawn April 30, 2019.

4/30/2019
Compliance Policy Guide Sec. 690.500 Uncooked Meat for Animal Food was withdrawn April 30, 2019.

03/12/2019
Compliance Policy Guide Sec. 608.200 Prescription Use of Certain Injectable Animal Drugs revised to current CPG formatting standards and reflects minor editorial changes. 

03/12/2019
Compliance Policy Guide Sec. 635.100 Large Volume Parenterals (LVPs) for Animal Use revised to current CPG formatting standards and reflects minor editorial changes. 

03/12/2019
Compliance Policy Guide Sec. 653.100 Animal Grooming Aids revised to current CPG formatting standards, update contact information, and clarify existing language. 

03/12/2019
Compliance Policy Guide Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds revised to current CPG formatting standards, update contact information, and clarify existing language. 

03/12/2019
Compliance Policy Guide Sec. 666.100 Alternate Feeding of Different Medicated Feeds revised to current CPG formatting standards, update contact information, and clarify existing language.

03/12/2019
Compliance Policy Guide Sec. 683.100 Action Levels for Aflatoxins in Animal Food revised to current CPG formatting standards, update contact information, and clarify existing language.

 09/19/2018
Compliance Policy Guide Sec. 575.100 Pesticide Residues and Feed Enforcement Criteria, minor update to CVM contact information.

7/16/2018
Compliance Policy Guide Sec. 230.130 Adequate Space for Determination of Donor Suitability is obsolete and was withdrawn on 7/16/2018.

7/16/2018
Compliance Policy Guide Sec. 230.140 Evaluation and Processing Post Donation Information Reports is obsolete and was withdrawn on 7/16/2018.

7/16/2018
Compliance Policy Guide Sec. 231.100 Platelets, Pooled is obsolete and was withdrawn on 7/16/2018.

7/16/2018
Compliance Policy Guide Sec. 231.120 Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing Platelets and Fresh Frozen Plasma is obsolete and was withdrawn on 7/16/2018.

7/16/2018
Compliance Policy Guide Sec. 231.130 Storage of Platelets for up to five (5) Days is obsolete and was withdrawn on 7/16/2018.

7/16/2018
Compliance Policy Guide Sec. 250.500 Plasma Brokers – Registration and Compliance with Good Manufacturing Practices is obsolete and was withdrawn on 7/16/2018.

1/11/2018
Reviewed all Compliance Policy Guides (CPGs) and made updates to reflect the new ORA program aligned structure. 
*The documents were not reviewed for policy.  Since no policy changes were made, the last revised date remains as the last date the document had a thorough policy review.

11/28/2017
Compliance Policy Guide Sec. 250.100 Source Plasma – Guidelines for Informed Consent Forms is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 251.100 Schedule of Physical Examination for Donors Receiving Immunization Injections is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 252.100 Source Plasma - Regulatory Action Based on Overbleeding is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 252.110 Volume Limits for Automated Collection of Source Plasma is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 254.100 Source Plasma - Use of Units from Donors Subsequently Found to be Reactive to a Serologic Test for Syphilis is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 255.100 Quantitative Testing for Serum Proteins in Plasmapheresis Donors is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 256.100 Plasmapheresis - 48-hour Period Between Plasmapheresis Procedures is obsolete and was withdrawn on 11/28/2017.

11/28/2017
Compliance Policy Guide Sec. 257.100 Deferral of Source Plasma Donors Due To Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis is obsolete and was withdrawn on 11/28/2017.

11/18/2016
Draft Compliance Policy Guide Sec 540.740 Use of the Seafood List to Determine Acceptable Seafood Names issued 11/18/2016.  The Federal Register notice of availability is published at: https://www.gpo.gov/fdsys/pkg/FR-016-11-18/pdf/2016-27843.pdf (81/223 FR 81785).

10/17/2016
Compliance Policy Guide 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 issued on 10/17/2016.

09/14/2016
Compliance Policy Guide Sec. 150.200 Compliance Review of Private Laboratory Analytical Packages (PLAPs) issued on 09/14/2016.

09/21/2015
Draft Compliance Policy Guide Sec. 100.101 Crotalaria spp. Seeds in Grains: Guidance for FDA Staff issued on 09/21/2015. The Federal Register notice of availability is published at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-21/pdf/2015-23619.pdf (80 FR 57000).

09/03/2015
Compliance Policy Guide Sec. 435.100 Compressed Medical Gases - Warning Letters for Specific Violations Covering Liquid and Gaseous Oxygen is withdrawn. The Federal Register notice of withdrawal is on display at http://www.gpo.gov/fdsys/pkg/FR-2015-09-03/pdf/2015-21874.pdf (80 FR 53311).

05/26/2015
Compliance Policy Guide Sec. 635.100 Large Volume Parenterals (LVP's) for Animal Use supersedes previously revised version on 03/1995.

05/19/2015
Compliance Policy Guide Sec. 608.400 Compounding of Drugs for Use in Animals is obsolete and was withdrawn on 05/19/2015. The Federal Register notice of withdrawal is on display at: http://www.gpo.gov/fdsys/pkg/FR-2015-05-19/pdf/2015-11982.pdf (80 FR 28624).

12/23/2014
Final Compliance Policy Guide Sec. 540.700 Labeling of Processed and Blended Seafood Products Made Primarily with Fish Protein issued on 12/23/2014. The Federal Register notice of availability is on display at: http://www.gpo.gov/fdsys/pkg/FR-2014-12-23/pdf/2014-30015.pdf (79 FR 77011).

12/16/2014
Draft Compliance Policy Guide Sec. 540.275 Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli issued on 12/16/2014. The Federal Register notice of availability is published at: http://www.gpo.gov/fdsys/pkg/FR-2014-12-16/pdf/2014-29314.pdf (79 FR 74729).

06/03/2014
Final Compliance Policy Guide Sec.100.250 Food Facility Registration-Human and Animal Food issued on 06/03/2014. The Federal Register notice of availability is on display at: http://www.gpo.gov/fdsys/pkg/FR-2014-06-03/pdf/2014-12786 (79 FR 31949).

04/14/2014
Final Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products- Hypoglycin A Toxin issued on 04/15/2014. The Federal Register notice of availability is on display at http://www.gpo.gov/fdsys/pkg/FR-2014-04-15/pdf/2014-08428 (79 FR 21250)

12/04/2013
Compliance Policy Guide 460.200 Pharmacy Compounding is obsolete and was withdrawn. Federal Register notice of withdrawal published on 12/04/2013 (78 FR 72841) @ http://www.gpo.gov/fdsys/pkg/FR-2013-12-04/pdf/2013-28963.pdf.

07/16/2013
Compliance Policy Guide 690.800 Salmonella in Food for Animals is now available. Federal Register notice of availability published on July 16, 2013 (78 FR 42526) @ https://www.federalregister.gov/articles/2013/07/16/2013-16975/compliance-policy-guide-sec-690800-salmonella.

07/16/2013
Compliance Policy Guide Sec. 690.700 Salmonella Contamination of Dry Dog Food is obsolete and was withdrawn. Federal Register notice of withdrawal published on July 16, 2013 (78 FR 42526) @ https://www.federalregister.gov/articles/2013/07/16/2013-16973/salmonella.

02/04/2013
Compliance Policy Guide Sec. 390.100 Definition of “Commerce” -21 CFR 1000.3(d) supersedes previously revised version on 03/2005.

02/01/2013
Compliance Policy Guide Sec. 390.200 Determination by Secretary that Product Fails to Comply or has Defect -21 CFR 1003.11 supersedes previously revised version on 03/1995.

11/14/2012
Compliance Policy Guide Sec.420.500 Interference with Compendial Tests supersedes previously revised version from 1980.

09/10/2012
Draft Compliance Policy Guide Sec. 690.150 Labeling and Marketing of Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats is now available. Federal Register notice of availability published on Sep. 10, 2012 (77 FR 55480) @ http://www.gpo.gov/fdsys/pkg/FR-2012-09-10/pdf/2012-22231.pdf

09/06/2012
Compliance Policy Guide Sec. 335.300 Hypnotherapy Devices - Self Hypnotic Tape Recordings supersedes previously revised version from 2/1995.

09/06/2012
Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and NDA Supplements was withdrawn. Federal Register Notice of withdrawal published on August 30, 2012 (77 FR 52741) @ https://www.federalregister.gov/articles/2012/08/30/2012-21415/compliance-policy-guide-sec-420300-changes-in-compendial-specifications-and-new-drug-application.

09/21/2011
Compliance Policy Guide Sec. 440.100 Marketed New Drugs without Approved NDAs & ANDAs was revised. Federal Register notice of availability published on September 21, 2011 (76 FR 58398) @ http://www.gpo.gov/fdsys/pkg/FR-2011-09-21/html/2011-24316.htm.

05/17/2011
Compliance Policy Guide Sec. 335.700 Surgeons' Gloves and Patient Examination Gloves; Defects - Criteria for Direct Reference Seizure final guidance published. Federal Register notice of availability published on May 17, 2011 (76 FR 28308) @ http://www.gpo.gov/fdsys/pkg/FR-2011-05-17/pdf/2011-12037.pdf.

12/23/2010
Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs has been revised to include date extension to December 31, 2014. Federal Register notice of availability published on Dec. 17, 2012 (77 FR 74668) @http://www.gpo.gov/fdsys/pkg/FR-2012-12-17/html/2012-30297.htm.

12/23/2010
Draft Compliance Policy Guide Sec. 510.800 Beverages Serving Size Labeling is now available. Federal Register notice of availability published on Dec. 23, 2010 (75 FR 80828) @ http://edocket.access.gpo.gov/2010/pdf/2010-32249.pdf.

12/23/2010
Compliance Policy Guide Sec. 527.300 Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity is now available. Federal Register notice of availability published on Dec. 23, 2010 @ http://www.gpo.gov/fdsys/pkg/FR-2010-12-12/pdf/2010-32232.pdf.

12/07/2010
Compliance Policy Guide Sec. 390.500 Definition of High Voltage Vacuum Switch was withdrawn. Federal Register notice of availability published on Dec. 7, 2010 (75 FR 48180) @ http://www.gpo.gov/fdsys/pkg/FR-2010-12-07/pdf/2010-30677.pdf.

07/27/2010
Draft Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed is now available. Federal Register notice of availability published on Aug. 2, 2010 (75 FR 45130) @ http://edocket.access.gpo.gov/2010/pdf/2010-18873.pdf.

03/22/2010
Compliance Policy Guide Sec. 540.375 Canned Salmon -- Adulteration Involving Decomposition is obsolete and was withdrawn March 22, 2010. See 75 FR 13555, Mar. 22, 2010.

12/01/2009
Draft Compliance Policy Guide Sec. 527.300 Dairy Products - Microbial Contaminants and Alkaline Phosphatase Activity (CPG 7106.08) is now available. Federal Register notice of availability published on Dec. 1, 2009 (74 FR 62795) @ http://edocket.access.gpo.gov/2009/pdf/E9-28756.pdf

06/29/2009
Compliance Policy Guide 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
Final Compliance Policy Guide Sec. 540.370 Fish and Fishery Products - Decomposition was issued on January 22, 2009. Federal Register notice of availability published on January 22, 2009 (74 FR 4039) @ http://edocket.access.gpo.gov/2009/pdf/E9-1142.pdf.

12/05/2008
Compliance Policy Guide Sec. 540.700 Processed and/or Blended Seafood Products (CPG 7108.16) was revised in November and is now in effect. Revisions were made in the Policy section of the guide.

10/2008
Draft Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 is now available.

07/18/2008
Compliance Policy Guide Sec. 540.575 Fish - Fresh and Frozen - Adulteration Involving Decomposition (CPG 7108.05) is obsolete and withdrawn on July 18, 2008. Federal Register notice of withdrawal published on July 18, 2008 (73 FR 41361) @ http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-16456.htm.

07/18/2008
Draft Compliance Policy Guide Sec. 540.370 Fish and Fishery Products -- Decomposition. This CPG provides guidance to FDA staff regarding decomposition in fish and fishery products. Federal Register notice of availability published on July 18, 2008 (73FR 41361) @ http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-16456.pdf.

06/06/2008
Compliance Policy Guide Sec 560.700 Processing of Imported Frozen Products of Multiple Sizes (e.g., Shrimp, Prawns, Etc.) (CPG 7119.10) is obsolete and was withdrawn on June 6, 2008. Federal Register notice of withdrawal published on June 6, 2008 (73 FR 32338) @ http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-12766.pdf.

04/11/2008
Compliance Policy Guide Sec. 500.500 Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style Sauces is now available. The CPG provides 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.

02/06/2008
Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenesis now available. The CPG provides guidance to FDA Staff on FDA's enforcement policy for Listeria monocytogenes (L. monocytogenes) in foods.

01/08/2008
Compliance Policy Guide Sec. 555.700 Revocation of Tolerances for Cancelled Pesticides is obsolete and was withdrawn January 8, 2008. See 73 FR 1357, Jan. 8, 2008.

01/08/2008
Draft of Revised Compliance Policy Guide Sec. 575.100 Pesticide Chemical Residues in Food - Enforcement Criteria is now available. This revised draft CPG provides guidance for FDA staff regarding FDA's current thinking on its enforcement policy for pesticide chemical residues in food.

07/13/2007
Compliance Policy Guide 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).

11/30/2006
Compliance Policy Guide Sec. 160.900 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 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)).
Guidance replaces Compliance Policy Guide CPG Sec 110-300, Guidance for FDA Staff Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002;
Guidance replaces Compliance Policy Guide Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs (CPG 7132c.02)

07/07/2006
Compliance Policy Guide Sec. 608.100 Human-Labeled Drugs Distributed and Used in Animal Medicine is obsolete and was withdrawn July 7, 2006. See 71 FR 38650, Jul. 7, 2006.

07/07/2006
Compliance Policy Guide Sec. 616.100 Streptomycin Residues in Cattle Tissues is obsolete and was withdrawn July 7, 2006. See 71 FR 38650, Jul. 7, 2006. This CPG was superceded by 21 CFR 556.200.

12/12/2005
Revised Compliance Policy Guide CPG Sec. 230.150 - Blood Donor Classification Statement, Paid or Volunteer Donor
Revised Compliance Policy Guide CPG Sec. 300.750 - Class III Devices Subject to 515(b) Requirements (CPG 7124.18)
Revoked Compliance Policy Guide CPG Sec. 460.700 - Controlled Release Dosage Form Drugs - Rate of Release of Active Ingredients (CPG 7132a.02)

11/10/2005
Revised Compliance Policy Guide 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), Compliance Policy Guide Sec. 615.100 Extra-Label Use of New Animal Drugs in Food-Producing Animals (CPG 7125.06)

05/19/2005
Revised Compliance Policy Guide Sec. 315.100 Illegal Interstate Commercial Shipment of Dentures (CPG 7124.07)

04/25/2005
Revised Compliance Policy Guide Sec. 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective Supplier

04/25/2005
Revised Compliance Policy Guide Sec. 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic Products

04/13/2005
Revised Compliance Policy Guide Sec. 560.400 Imported Milk and Cream - Federal Import Milk Act CPG 7119.05

03/18/2005
Revised Compliance Policy Guide Sec. 300.500 Reprocessing of Single Use Devices (CPG 7124.16)

03/10/2005
Revised the following 8 Compliance Policy Guides, making 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 Compliance Policy Guide Sec. 355.100 Cellutron Machine

03/08/2005
Revoked Compliance Policy Guide Sec. 160.800 Y2K Computer Compliance

03/04/2005
Revised Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

11/16/2004
Compliance Policy Guide Sec. 400.210 Radiofrequency Identification Feasibility Studies and Pilot Programs

11/02/2004
Revised Compliance Policy Guide 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 Compliance Policy Guide 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 Compliance Policy Guide Sec. 394.500 Importation of Television Products, Microwave Ovens, and Inherent Class I Laser Products for Investigation and Evaluation

07/29/2004
Replaced/Re-titled Compliance Policy Guide Sec. 560.750 Guidance Levels for Radionuclides in Domestic and Imported Foods (CPG 7119.14)

03/12/2004
Revised Compliance Policy Guide Sec. 490.100 Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval CPG 7132c.08 to update content of August 2000 paper edition.

02/09/2004
Edited two pages to conform text (reference) on Internet pages to August 2000 paper edition Compliance Policy Guide Sec. 515.700 Chocolate & Chocolate Liquor - Adulteration with Insect and Rodent Filth CPG 7105.11;
Compliance Policy Guide Sec. 515.775 Cocoa Powder, Press Cake - Adulteration with Insect and Rodent Filth CPG 7105.13

01/05/2004
Revoked Compliance Policy Guide Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse (CPG 7124.06)

12/10/2003
Compliance Policy Guide 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.htm

07/08/2003
Revised Compliance Policy Guide Sec. 608.400 Compounding of Drugs for Use in Animals (CPG 7125.40)

02/19/2003
Revoked Compliance Policy Guide Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17). See: 68 FR 8775 02/25/2003.

11/14/2002
Revised Compliance Policy Guide Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18)

11/12/2002
Revoked Compliance Policy Guide 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)

10/07/2002
Revoked Compliance Policy Guide 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)

08/07/2002
Revoked Compliance Policy Guide 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)

06/20/2002
Revoked Compliance Policy Guide Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13)

06/20/2002
Revoked Compliance Policy Guide Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products (CPG 7133.16)

05/29/2002
Compliance Policy Guide Sec. 460.200 Pharmacy Compounding (Withdrawn December 4, 2013)

05/16/2002
Corrected Compliance Policy Guide Sec 575.100 Pesticide Residues...Heptachlor table

05/16/2002
Compliance Policy Guide Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor (Issued 05/07/2002)

03/29/2002
Revised as Draft Compliance Policy Guide Sec. 345.100 Male Condom Defects (CPG 7124.21)

12/18/2001
Revised as Draft Compliance Policy Guide Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18) [Final 11/14/2002]

10/2001
Compliance Policy Guide Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin

10/2001
Reformatted Compliance Policy Guide Sec. 570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05)

04/2001
Final Compliance Policy Guide Sec. 615.115 Extra-Label Use of Medicated Feeds for Minor Species

04/2001
Compliance Policy Guide Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens

03/2001
Reformatted Compliance Policy Guide Sec. 220.100 Interstate Shipment of Biological Products for Use in Medical Emergencies (CPG 7134.11)

03/2001
Reformatted Compliance Policy Guide Sec. 270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting Changes (CPG 7134.06)

12/2000
Draft Compliance Policy Guide Sec.230.150 Blood Donor Incentives

08/10/2000
Revised Compliance Policy Guide Sec. 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (CPG 7108.17)

08/17/2000
Revised Compliance Policy Guide Sec. 230.110 Registration of Blood Banks and Other Firms Collecting, Manufacturing, Preparing or Processing Human Blood or Blood Products (CPG 7134.01)

08/14/2000
Compliance Policy Guide Sec. 280.100 Stability Requirements for Licensed In Vitro Diagnostic Products.

08/14/2000
Compliance Policy Guide Sec. 280.110 Microbiological Control Requirements in Licensed Anti-Human Globulin and Blood Grouping Reagents

08/10/2000
Revised Compliance Policy Guide Sec. 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (CPG 7108.17)

06/29/2000
Compliance Policy Guide 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

05/01/2000
Revised Compliance Policy Guide Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18)

04/14/2000
Revised Compliance Policy Guide Sec. 110.100 Certification for Exports (CPG 7150.01)

03/28/2000
Deleted Compliance Policy Guide Sec. 215.100 IND Filings: Completion of Applicable...

03/22/2000
Reissued Compliance Policy Guide Sec. 257.100 Deferral of Source Plasma Donors Due to Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

03/06/2000
Compliance Policy Guide Sec. 252.110 Volume Limits for Automated Collection of Source Plasma

01/24/2000
Deleted (Revoked) Compliance Policy Guide Sec. 305.100 Acupuncture Devices and Accessories (CPG 7124.11)

08/04/1999
Draft Compliance Policy Guide Sec. 615.115 Use of Medicated Feeds for Minor Species

07/09/1999
Compliance Policy Guide Sec. 230.140 Evaluation and Processing Post Donation Information Reports

05/13/1999
Compliance Policy Guide Sec. 160.850 Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17)

04/26/1999
Compliance Policy Guide Sec. 160.800 Y2K Computer Compliance

03/23/1999
Compliance Policy Guide Sec. 555.425 Foods, Adulteration Involving Hard or Sharp Foreign Objects

01/08/1999
Deleted Compliance Policy Guide Sec. 460.200 Manufacture, Distribution, and Promotion of Adulterated, Misbranded, or Unapproved New Drugs for Human Use by State-Licensed Pharmacies (CPG 7132.16)

12/21/1998
Compliance Policy Guide Sec. 257.100 Deferral of Source Plasma Donors Due To Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

11/13/1998
Revised Compliance Policy Guide Sec. 675.400 Rendered Animal Feed Ingredients (CPG 7126.24)