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FDA/ORA
Compliance Policy Guides Manual
August 2000 (This page updated August 16, 2004) |
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Revision/Update History
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Year |
2004 |
2003 |
2002 |
2001 |
2000 |
1999 |
1998 |
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2004 |
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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 |
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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 |
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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) |
2001 |
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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] |
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New: Oct., 2001 - Sec. 510.150
Apple Juice, Apple Juice Concentrates, and Apple Juice Products - Adulteration with
Patulin |
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Reformat: Oct., 2001 - Sec.
570.425 Tree Nuts - Adulteration Involving Rejects (Insect Infestation, Moldy, Rancid,
Otherwise Decomposed, Blanks, and Shriveled) (CPG 7112.05) |
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Final: April 2001 - Sec.
615.115 Extra-Label Use of Medicated Feeds for Minor Species |
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New: April 2001 - Sec. 555.250 Statement of Policy for Labeling and Preventing
Cross-contact of Common Food Allergens |
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Reformat: March, 2001 - Sec.
220.100 Interstate Shipment of Biological Products for Use in Medical Emergencies (CPG
7134.11) |
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Reformat: March, 2001 - Sec.
270.100 Final Container Labels - Allergenic Extracts Containing Glycerin; Reporting
Changes (CPG 7134.06) |
2000 |
Top |
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Draft CPG - December 2000, Sec.230.150 Blood Donor Incentives |
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Revised 08/10/2000, Sec.540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or
Smoked (CPG 7108.17) |
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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 |
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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) |
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New 08/14/2000, Sec. 280.100 Stability
Requirements for Licensed In Vitro Diagnostic Products. |
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New 08/14/2000, Sec. 280.110 Microbiological
Control Requirements in Licensed Anti-Human Globulin and Blood Grouping Reagents |
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Revised 08/10/2000 Sec. 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or
Smoked (CPG 7108.17) |
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Revised 05/01/2000, Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) (CPG 7125.18) |
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Revised 04/14/2000, Sec. 110.100 Certification for Exports (CPG 7150.01) |
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Deleted 03/28/2000, Sec. 215.100 IND Filings: Completion of Applicable... |
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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 |
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New 03/06/2000, Sec. 252.110 Volume
Limits for Automated Collection of Source Plasma |
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Deleted (Revoked) 01/24/2000, Sec. 305.100 Acupuncture Devices and Accessories (CPG 7124.11) |
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1999 |
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Draft CPG 08/04/1999, Sec. 615.115 Use of Medicated Feeds for Minor Species |
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New 07/09/1999, Sec. 230.140 Evaluation and Processing Post Donation Information Reports |
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New 05/13/1999, Sec. 160.850 Enforcement Policy: 21 CFR Part
11; Electronic Records; Electronic Signatures (CPG
7153.17) |
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New 04/26/1999, Sec. 160.800 Y2K Computer Compliance |
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New 03/23/1999, Sec. 555.425 Foods,
Adulteration Involving Hard or Sharp Foreign Objects |
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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) |
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1998 |
Top |
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Revised 11/13/98, Revised Sec. 675.400 Rendered Animal Feed Ingredients (CPG 7126.24) |
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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 |
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*Material between asterisks was changed |
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