04/04/2013

Draft Compliance Policy Guide Sec.100.250 Food Facility Registration- Human and Animal Food is now available. Federal Register notice of availability published on April 4, 2013 (78 FR 20326 ) @ https://www.federalregister.gov/articles/2013/04/04/2013-07809/food-facility-registration-human-and-animal-food-compliance-policy-guides-draft-availability

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

11/14/2012

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

11/08/2012

Draft Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products – Hypoglycin A Toxin is now available. Federal Register notice of availability published on November 8, 2012 (77 FR 67013) @ https://www.federalregister.gov/articles/2012/11/08/2012-27225/draft-compliance-policy-guide-sec-550050-canned-ackee-frozen-ackee-and-other-ackee

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Compliance Policy Guide Sec. 420.300 Changes in Compendial Specifications and NDA Supplements was withdrawn.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, 2012.   Federal Register notice of availability published on Dec. 23, 2010 (75 FR 80827) @ http://edocket.access.gpo.gov/2010/pdf/2010-32274.pdf. 

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://origin.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 
 

11/03/2004
Revised Compliance Policy Guide Sec. 110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
 

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)

12/15/2003
Compliance Policy Guide 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.htm.

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
Reissued Compliance Policy Guide Sec. 460.200 Pharmacy Compounding

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)