ORA Compliance Reference: Tracking Revisions and Updates

Revisions and Update List This page was updated: November 3, 2004
Contents:	Recent	2003	2002	2001	2000	1999
Recent: 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Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 10/29/2004 Draft CPG (Not for Implementation), Sec. 560.400 "Imported Milk and Cream--Federal Import Milk Act (CPG 7119.05)." When finalized it will replace the existing CPG at Sec. 560.400. Comments due 30 days after date of publication in the Federal Register dated October 29, 2004 10/03/2004 Revised list to add 1 new member, Disqualified/Totally Restricted List for Clinical Investigators 08/31/2004 Edited Debarment List - at Uddin, Mohammad, added "NMI" to indicate that FDA records show no middle initial for this person. 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) 07/23/2004 Updated links to FDA Regulations (2004) on the Bioresearch Monitoring Information Page; links to laws enforced by FDA and related regulation on the Welcome to Compliance References page 06/24/2004 Revised CPG Sec. 110.310 - Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 06/16/2004 AIP Procedures - procedures March 5, 1998 06/10/2004 Revised to update citations Sec. 690.300 Canned Pet Food (CPG 7126.18) 06/15/2004 Correction in classification (Class) - Charles River Laboratories, West Chester, OH 05/12/2004 John B. Najarian on Restricted List for Clinical Investigators 05/06/2004 March 2004 edition of the Regulatory Procedures Manual (RPM) published. New edition of FDA RPM is effective May 6^th, 2004. All chapters have been changed except Chapter 9 "Import Operations/Actions." 04/09/2004 Corrected entry for Arthur Riba on Restricted List for Clinical Investigators 04/05/2004 Revised Application Integrity Policy List to add Plus Orthopedics, San Diego, California. 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 02/23/2004 Revised list to add 1 new member, 02/23/2004: Restricted List for Clinical Investigators; Revised list to add 1 new member, 02/23/2004: Disqualified/Totally Restricted List for Clinical Investigators 02/13/2004 Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Updated February 9, 2004 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 Draft CPG 1/14/2004 Draft CPG (Not for Implementation), Sec. 560.750 "Guidance Levels for Radionuclides in Domestic and Imported Foods, Availability; and Draft Supporting Document, Supporting Document for Guidance Levels for Radionuclides in Domestic and Imported Foods." [TXT] [PDF (39kb)] When finalized it will replace the existing CPG. Comments due March 15, 2004 --The Draft Guidance Word version (39.5kb) --The Draft Guidance PDF (17.2kb) --Supporting Statement for Guidance Levels - Word version (151kb) --Supporting Statement for Guidance Levels - PDF (59.3kb) Revoked 1/5/2004 Sec. 370.200 RIA Analysis of Hair to Detect the Presence of Drugs of Abuse CPG 7124.06 2003 Revisions and Updates: 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. Revised: Application Integrity Policy Committee Contact Persons list on 12/18/2003 Revised Application Integrity Policy List to add AGA Medical Corporation, Golden Valley, Minnesota Revised CPGM list on 12/18/2003 by • added new Drugs program 7356.002M, "Inspections of Licensed Biological Therapeutic Drug Products" • added new Veterinary Medicine program 7371.009, "BSE/Ruminant Feed Ban Inspections" • added on-line links for Drug programs: 7346.832 "Pre-Approval Inspections/Investigations"; 7346.843, “Post-Approval Audit Inspections”; 7356.002A, "Sterile Drug Process Inspections"; 7356.002B, “Repackers and Relabelers”, 7356.002C, “Radioactive drugs” and 7356.002E, “Compressed medical gases” • Corrected title of drug program 7356.002 "Drug Manufacturing Inspections" • corrected CPGM list by removing previously withdrawn Device programs 7385.002 "Ionizing Radiation Use Control Laboratory Support", 7385.003 "Federal Facility Use Control and Equipment Performance Survey Program", and 7386.006G "WEAC Testing of Medical Devices for Conformance to Voluntary Standards" • corrected Device program numbers 7382.014 to 7385.014 and 7385.004 to 7386.009. New CPG 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. Revised Debarment List, 10/22/2003 - One person added. Published 10/23/03. Revised list to add 2 new members, 10/17/2003: Disqualified/Totally Restricted List for Clinical Investigators. Published 10/21/03. Revised Debarment List, 10/10/2003 - debarment terminated for one person; three people added. Published 10/10/03. Added pdf version of Guideline for the Monitoring of Clinical Investigations, Jan., 1988. (PDF 16KB). Published 9/30/03. Revised list to add 2 new members, 09/09/2003: Restricted List for Clinical Investigators. Published 09/10/03. Revised 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 08/11/2003. Published 09/04/03. Revised Debarment List, 8/8/2003 - one person added. Published 8/15/03. Revised Sec. 608.400 - Compounding of Drugs for Use in Animals. Published 7/14/03. Revised 3 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 01/27/3. Published 7/2/03. New CPGM link to Compliance Programs published by CBER: Inspection of Source Plasma Establishments and Inspections of Licensed Vaccines. Published 6/6/03. Updated ORA page on Electronic Records/Signatures, 21 CFR Part 11. Published 6/6/03. Revised Debarment List, 5/9/2003 - one person added. Published 5/30/03. 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. Published 5/30/03. Revised list to update Dr. J.L. Williams, 5/15/2003: Disqualified/Totally Restricted List for Clinical Investigators. Published 5/23/03. Replaced Reference: Good Laboratory Practice (GLP) Final Rule, 12/22/1978 (PDF 6585KB). Published 5/23/03. Revised - Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990, Updated 03/06/2003. Published 5/1/03. Revised Application Integrity Policy List to remove Gliatech, Inc., Beachwood, OH; and Solvay Pharmaceuticals, Inc., Beaudette, MN, and Marietta, GA, April 2003. Revised list to add new member, 04/10/2003: Disqualified/Totally Restricted List for Clinical Investigators. Revised Debarment List on 04/09/2003 - One person removed (Hernandez, Delfina); One correction inserted (Lai, Elaine). Revised: Application Integrity Policy Committee Contact Persons list. Updated 3/31/2003. Revised 03/23/2003, HTML/online links changed for Biologics Compliance Programs 7342.006, 7342.008. and 7345.001 (CBER). No content was changed. New CPGM, 03/19/2003: Biologics Compliance Program March 2003, 7341.002, Inspection of Tissue Establishments (CBER). 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. Revised list to add new member, 02/10/2003: Disqualified/Totally Restricted List for Clinical Investigators. Revised Debarment List on 01/13/2003 - 2 people added. 2002 Revisions and Updates Revised list to add new member, 10/28/2002: Disqualified/Totally Restricted List for Clinical Investigators. Edited lists 12/16/2002: 1) Inactive Labs List and 2)Active Tox Labs List Revised Debarment List on 12/03/2002 - one person added Typographical errors (1 per page) 11/27/2002: CPGuides Manual - Sec 555.425 -Foods - Adulteration Involving Hard or Sharp Foreign Objects; and Sec. 515.350 Candy - Mixed with Trinkets and Sold in Vending Machines (CPG 7105.04) Edited links 11/27/2002: 21 CFR Part 11 Guidance Documents Dockets Established - Topics for Guidance Development Revised 11/14/2002: Sec. 555.600 Filth from Insects, Rodents, and Other Pests in Foods (CPG 7120.18) Updated 11/14/2002: 4 lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990 Revoked effective 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) Revised 11/13/2002 Debarment List - 3 people added Revised 2 lists to add new or update member(s), 10/16/2002: Disqualified/Totally Restricted List for Clinical Investigators and Restricted List for Clinical Investigators Revoked effective 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) per Federal Register, 09/05/2002 (67 FR 56850) Revised Subchapter Import for Export in Chapter 9 of Regulatory Procedures Manual. 09/13/2002. New - CryoLife, Inc., Kennesaw, GA, 08/13/2002. Order for Retention, Recall, and/or Destruction [PDF] size 279KB [HTML] New - Four Lists of Nonclinical Laboratories Inspected Since Fiscal Year 1990. Updated 08/2002 Revised list to add new member, 08/7/2002: Disqualified/Totally Restricted List for Clinical Investigators 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 Revised list to add new member, 06/27/2002: Restricted List for Clinical Investigators Revised list to add new member, 06/27/2002: Disqualified/Totally Restricted List for Clinical Investigators Reissued 05/29/2002, Sec. 460.200 Pharmacy Compounding Revoked effective on 06/20/2002, Sec. 391.100 Advertisement Literature for High-Intensity Mercury Vapor Discharge Lamps (CPG 7133.13) Revoked effective on 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 CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor issued 05/07/2002 Revised BioResearch Monitoring Information references added or updated 05/16/2002 Revised Debarment List on 05/07/2002 - person added Revised Compliance Program Manual 04/26/2002 page - page text and links were updated Edited Debarment List on 04/09/2002 Revised as Draft 05/29/2002 - Sec. 345.100 Male Condom Defects (CPG 7124.21) for comment Edited page to remove dates that may become obsolete, 04/2/2002: Application Integrity Policy Information. Revised list to add new member, 04/02/2002: Disqualified/Totally Restricted List for Clinical Investigators Revised list to add new member, 02/20/2002: Application Integrity Policy List Revised lists to align members to groups, 01/15/2002: a) Restricted List for Clinical Investigators b) Disqualified/Totally Restricted List for Clinical Investigators Top of Page
2001 Revisions and Updates Revised as Draft Dec 18, 2001 - Sec. 555.600 Filth from Insects, Rodents, and Other Pests in Foods (CPG 7120.18) New CPG Oct., 2001 - Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with Patulin Reformat CPG Oct., 2001 - Sec. 570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid, Otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05) Final CPG April 2001 - Sec. 615.115 Extra-Label Use of Medicated Feeds for Minor Species New CPG April 2001, Sec. 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens New RPM Chapter 5, March, 2001, Subchapter Civil Money Penalties, Reduction of Civil Money Penalties for Small Entities New RPM Chapter 9, January 2001, Communication Concerning Assessment of Civil Monetary Penalties by U.S. Customs Service in Cases Involving Imported Food New RPM Chapter 9, January 2001, Secured Storage Top of Page
2000 Revisions and Updates Draft CPG - December 2000, Sec. 230.150 Blood Donor Incentives Revised 8/10/2000, Sec. 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (CPG 7108.17) New 06/29/2000, Sec. 100.950 International Parnership Agreements for Compliance Activities - Agreements among the USFDA, Foreign Government Agencies, and Foreign or Domestic Trade Associations and/or Other Organizations Deleted 07/03/2000, Sec. 405.100 Prescriptions Prepared from Certified Antibiotics (CPG 7122.01) Deleted 07/03/2000, Sec. 405.200 Export of Uncertified Antibiotics (CPG 7122.02) Deleted 07/03/2000, Sec. 405.210 Returned Antibiotics Exported Under 801(d) of the Act (CPG 7122.03) Revised 05/01/2000, Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18) Revised 04/14/2000, Section 110.100, Certification for Exports (CPG7150.01) Deleted 03/28/2000, Section 215.100, IND Filings: Completion of Applicable... Reissued 03/22/2000, Section 257.100, Deferral of Source Plasma Donors Due to Red Cell Loss During Collection of Source Plasma by Automated Plasmapheresis New 03/06/2000, Section 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) Top of Page
1999 Revisions and Updates Draft CPG - 08/04/1999, Section 615.115 Use of Medicated Feeds for Minor Species July 9, 1999, Compliance Policy Guide 230.140, Biologics, Evaluation and Processing Post Donation Information Reports The "Draft Civil Money Penalty Reduction Policy for Small Entities" published in the Federal Register (FR) on May 18, 1999. See final copy of the RPM Subchapter March 20, 2001 New 5/13/1999, Compliance Policy Guide, Enforcement Policy: 21 CFR Part 11; Electronic Records; Electronic Signatures (CPG 7153.17) New, 4/26/1999, Compliance Policy Guide, Y2K Computer Compliance Draft Revised CPG, 4/9/1999, Regulatory Policy on the Disposition of Publications that Constitute Labeling (CPG 7153.13) (Level I guidance document (see 62FR8961 2/27/97)) Not for Implementation Top of Page