|
FDA/ORA
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 |
Contact
FDA