Skip page top navigation to main text HHS Logo/Office of Regulatory Affairs Banner and Link to ORA Home page  ORA Start Page  |   Search  |   News  |   About ORA  |   FDA - Centers  |  
 Compliance Policy Guides
 FDA Banner/Link to FDA Home Page
About ORA   | Site Map | Compliance Ref  |  Federal-State  |  Inspection Ref  |  Import Program  |  Science Ref  |   V1.3
 Skip Subsection TOC to Main Text

Compliance Policy Guides Manual

August 2000 (This page updated July 08, 2003)


Revision/Update History

Year 2003 2002 2001 2000 1999 1998
2003 Top
Revised 07/08/2003:
Sec. 608.400 Compounding of Drugs for Use in Animals (CPG 7125.40) 
2002 Top
Revised 11/14/2002:
Sec. 555.600 Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18) 
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)
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)
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)
Reissued 05/29/2002:
Sec. 460.200 Pharmacy Compounding
Revoked 06/20/2002:
Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13)
Revoked 06/20/2002:
Sec. 396.100 Applicability of the Sunlamp Performance Standard To UVA Tanning Products (CPG 7133.16)
Corrected 05/16/2002:
Sec 575.100 Pesticide Residues...Heptachlor table
New 05/16/2002: 
Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor (Issued 05/07/2002)
Revised as Draft Mar 29, 2002:
Sec. 345.100 Male Condom Defects (CPG 7124.21)
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

This page updated on July 08, 2003 tc