History of Changes to GMP Regulations

This page links you to previous Federal Register notices affecting the following GMP regulations:

21 CFR Part 110 (Food)
21 CFR Parts 210 and 211 (Drug)
21 CFR Part 212 (Proposed for Positron Emission Tomography Drugs)
21 CFR Part 606 (Blood)
21 CFR Part 820 (Medical Device)

21 CFR Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food

Change of Address; Technical Amendment (6 November 2001)

21 CFR Parts 210 and 211 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General and Current Good Manufacturing Practice For Finished Pharmaceuticals

Human drugs, medical devices, and biological products:  Human cells, tissues, and cellular and tissue-based products; donors eligibility determination [HTML] [PDF] (25 May 2004)

Records and Reports Concerning Experience With Approved New Animal Drugs:  Withdrawal of interim final rule and issuance of final rule [HTML] [PDF] (31 March 2003)

Records and Reports Concerning Experience With Approved New Animal Drugs; Delay of Effective Date.   [HTML] [PDF] Effective date delayed indefinitely (31 July 2002)

Bar Code Label Requirements for Human Drug Products; Notice of Public Meeting   [HTML]  [PDF]   (18 June 2002) 

Records and Reports Concerning Experience With Approved New Animal Drugs (4 February 2002)

Change of Address; Technical Amendment (6 November 2001)

Suitability Determination for Donors of Human Cellular and Tissue-Based Products ( Proposed changes to 21 CFR Parts 210, 211, and 820 from September 30, 1999) Reopening of comment period  (18 April 2000)

Code of Federal Regulations; Technical Amendment (10 April 2000)

Suitability Determination for Donors of Human Cellular and Tissue Based Products - Proposed Revision to 21 CFR Parts 210 and 211 (30 September 1999)

Final Rule 4 November 1998 to 21 CFR Part 211 Regarding Tamper Evident Packaging Requirements For OTC Drugs

Revision of Certain Labeling Controls - Proposed Revision to 21 CFR Parts 210 and 211 (29 July 1997)

Proposed Revision to 21 CFR Parts 210 and 211 (3 May 1996) to clarify certain manufacturing, quality control, and documentation requirements, ensure that the regulation more accurately encompasses cGMP, and updates the requirements for process validation.

21 CFR Part 212 (Proposed) - Current Good Manufacturing Practice For Positron Emission Tomography Drugs

Draft Proposed Rule for Current Good Manufacturing Practice for Positron Emission Tomography Drug Products  

Human drugs: Current good manufacturing practices—Positron emission tomography drug products, [TEXT]  [PDF] (1 April 2002)

Draft Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drug Products; Availability [TEXT]  [PDF] (1 April 2002)Current Good Manufacturing Practices for Positron Emission Tomography Drug Products; Preliminary Draft Regulations; Availability [HTML] or [Acrobat] (22 September 1999)

21 CFR Part 606 - Current Good Manufacturing Practice For Blood and Blood Components

Bar Code Label Requirement for Human Drug Products and Biological Products; Correction [HTML] [PDF] (7 April 2004)

Bar Code Label Requirement for Human Drug Products and Biological Products [HTML] [PDF] (26 February 2004) 

Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma; Correction [HTML] [PDF] (27 October 2003)

Proposed Rule:  Blood and Blood Components, Including Source Plasma; Labeling and Storage Requirements; Revisions [HTML]  [PDF]  (30 July 2003)

Safety Reporting Requirements for Human Drug and Biological Products; Extension of Comment Period [HTML]  [PDF] (18 June 2003)

Bar Code Label Requirement For Human Drug Products and Blood Proposed Rule (14 March 2003)

FDA Information on this proposed rule

Safety Reporting Requirements for Human Drug and Biological Products  Proposed Rule (14 March 2003)

FDA Information on this proposed rule

Amendment of Regulations Regarding certain Label Statements on Prescription Drugs (1 February 2002)

Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma; Confirmation in Part and Technical Amendment (10 January 2001)

FEDERAL REGISTER Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection ("Lookback"); Proposed Rule (16 November  2000)

Reporting of Biologic Product Deviations in Manufacturing Final Rule amending 21 CFR Part 606 (Published 7 November 2000) Correction made on 9 November 2000 

Amendment of Regulations Regarding Certain Label Statements on Prescription Drugs - Proposed Revision to 21 CFR Part 606 (Published 10 April 2000, revised 21 April 2000)

21 CFR Part 820 - Medical Device Quality System Regulation

Medical Device Reporting; Premarket Approval of Medical Devices; Quality System Regulation; Technical Amendment [HTML] [PDF] (31 March 2006)

Human drugs, medical devices, and biological products:  Human cells, tissues, and cellular and tissue-based products; donors eligibility determination [HTML] [PDF] (25 May 2004)

Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment   [HTML] [PDF] (10 March 2004)

Suitability Determination for Donors of Human Cellular and Tissue-Based Products ( Proposed changes to 21 CFR Parts 210, 211, and 820 from September 30, 1999) Reopening of comment period  (18 April 2000)

Proposed Revision to 21 CFR Part 820 (30 September  1999)  concerning Suitability Determination for Donors of Human Cellular and Tissue Based Products

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