Preambles to 21 CFR Part 606
Preambles are the notes that FDA publishes when it announces a proposed or final rule. They respond to
comments submitted by industry and the public, and often reveal the intent and FDA's interpretation of the
regulation. All preamble files are in PDF format, and require Adobe Acrobat Reader to view.
- 3 January 2012 (77 FR 16)
FDA is revising the labeling requirements for blood and blood components intended for use in transfusion or
for further manufacture by combining, simplifying, and updating specific regulations applicable to labeling
and circulars of information. These requirements will facilitate the use of a labeling system using
machine-readable information that would be acceptable as a replacement for the ‘‘ABC Codabar’’ system for the
labeling of blood and blood components. This final rule is intended to help ensure the continued safety of
the blood supply and facilitate consistency in labeling.
- 8 February 2008 (73 FR
FDA Is confirming the effective date of 19 February 2008 for the direct final rule that appeared in the
Federal Register of 16 August 2007.
- 11 January 2008 (73 FR
The Food and Drug Administration (FDA) is extending to August 4, 2008, the comment period for the proposed
rule that appeared in the Federal Register of November 8, 2007 (72 FR 63416).
- 8 November 2007 (72 FR
Proposes to revise and update the regulations applicable to blood and blood components, including Source
Plasma and Source Leukocytes, to add donor requirements that are consistent with current practices in the
blood industry, and to more closely align the regulations with current FDA recommendations.
- 24 August ( 275 KB)2007 (72 FR 48798) ( 275 KB)
Requires establishments collecting whole blood or blood components to follow an appropriate system for
identifying blood and blood components previously donated by a donor who tests reactive for evidence of HCV
infection on a subsequent donation. FDA is requiring collecting establishments to quarantine prior in-date
blood and blood components from such a donor. In addition, FDA is revising the HIV "lookback" requirements
for greater consistency with the HCV "lookback" requirements and extending the record retention period to 10
- 16 August 2007 (72 FR
Direct Final Rule removing, revising, or updating specific regulations to be more consistent with current
practices in the blood industry and to remove unnecessary or outdated requirements.
- 16 August 2007 (72 FR
Proposes to amend biologics regulations by removing, revising, or updating specific regulations applicable to
blood, blood components, and source plasma to be more consistent with current practices in the blood industry
and to remove unnecessary or outdated requirements. This proposed rule is a companion to the direct final
rule published in the above notice.
- 24 March 2005 (70 FR
Updates information on FDA mailing addresses.
- 7 April 2004 (69 FR 18255)
Provides a correction to the Federal Register notice from 26 February. The notice itself was corrected, not
the final rule.
- 26 February 2004 (69 FR 9171)
Final rule requiring certain human drug and biological product labels to have bar codes. The rule also
requires the use of machine-readable information on blood and blood component container labels to help reduce
- 27 October 2003 (68 FR 61172)
Corrects a proposed rule from 30 July 2003 that proposed to revise the labeling and storage requirements for
certain human blood and blood components, including Source Plasma (proposed labeling and storage rule). The
proposed regulation included a paragraph that FDA did not intend to publish.
- 30 July 2003 (68 FR 44681)
Proposed rule to revise the labeling and storage requirements for certain human blood and blood components,
including Source Plasma, by combining, simplifying, and updating specific regulations applicable to container
labeling and instruction circulars, and the shipping and storage temperatures for frozen noncellular blood
components. This proposed rule would facilitate the use of a labeling system using machine-readable
information that would be acceptable as a replacement for the ``ABC Codabar'' system for labeling blood and
- 18 June 2003 (68 FR 36527)
Extends to October 14, 2003, the comment period for a proposed rule published in the Federal Register of
March 14, 2003 (68 FR 12406). The proposed rule would amend the agency's pre- and post marketing safety
reporting regulations for human drug and biological products.
- 14 March 2003 (68 FR12500)
Proposed rule to add bar code requirements to all drug and biological products.
- 4 March 2002 (67 FR 9586)
Removed OMB control numbers from §606.170.
- 1 February 2002 (67 FR 4907)
Amends regulations concerning certain statements that have been required on the labels of prescription drugs
generally and on certain narcotic or hypnotic (habit-forming) drugs.
- 6 August 2001 (66 FR 40886)
Changed definition of, and requirements for, compatibility testing
- 11 June 2001 (66 FR 31176)
Second notice on same day. Requires blood and plasma establishments to notify donors, including tautologously
donors, whenever the donor is deferred or determined not to be suitable for current or future donations of
blood and blood components. A donor is deferred based on results of tests for communicable disease agents or
determined not to be suitable for donation based on failure to satisfy suitability criteria. Blood and plasma
establishments also are required to notify the referring physician of an tautologous donor when the
tautologous donor is deferred based on tests for evidence of infection with a communicable disease agent(s).
A standard operating procedure and record keeping are also required.
- 11 June 2001 (66 FR 31162)
First of 2 notices on same day
Updated hepatitis B virus and HIV testing requirements by adding testing requirements for hepatitis C virus,
human T-lymphotropic virus, and by adding requirements for supplemental (I.e., additional, more specific)
testing approved for such use by FDA when a donation is found to be reactive for any of the required
screening tests for evidence of infection due to communicable disease agents. The agency is also requiring
certain test kits to use reference panels, when available, to verify the acceptable sensitivity and
specificity of each lot.
- 10 January 2001 (66 FR 1834)
Confirms direct final rule issued on August 19, 1999 except for compatibility testing issues in part 606 (and
other parts of other regs.) This rule changes compatibility testing definition and requirements to reflect
- 16 November 2000 (65 FR 69405)
Proposed rule which suggests amending the biologics regulations to require that blood establishments
(including plasma establishments) prepare and follow written procedures for appropriate action when it is
determined that blood and blood components at increased risk of transmitting hepatitis C virus (HCV)
infection have been collected from a donor who tested repeatedly reactive for evidence of HCV infection at a
later date. This proposed rule would require blood establishments to quarantine prior collections from such a
donor, perform further testing on the donor, and notify transfusion recipients, as appropriate, when such a
donor is identified at the time of a repeat donation or after performing a review of historical testing
records to identify donations at increased risk of transmitting HCV. In addition, FDA is proposing to extend
the record retention period to 10 years to create opportunities for disease prevention many years after
recipient exposure to such a donor.
- 9 November 2000 (65 FR 67477)
Corrects the effective date of the November 7 rule.
- 7 November 2000 (65 FR 66635)
Requires establishments involved in the manufacture of blood and blood components, including licensed
manufacturers, unlicensed registered establishments and transfusion services, to report biological product
deviations in manufacturing. Also requires licensed manufacturers, unlicensed registered establishments and
transfusion services who had control over the product when a deviation occurred to report to FDA the
biological product if the product has been distributed. The final rule also establishes a 45 day reporting
- 19 August 1999 (64 FR 45366)
Removes, revises, and updates specific regulations applicable to blood, blood components, and Source Plasma
to be more consistent with current practices in the blood industry and remove unnecessary or outdated
- 6 April 1998 (63 FR 16685)
Corrected spelling error
- 15 October 1997 (62 FR 53538)
Deletes requirements for a biologics establishment to name a “responsible head” or “designated qualified
person” to exercise control of the establishment in all matters relating to compliance with regulatory
requirements and to represent the establishment in its dealings with FDA.
- 9 September 1996 (61 FR 47422)
Requires that blood establishments (including plasma establishments) prepare and follow written procedures
for appropriate action when it is determined that Whole Blood, blood components (including recovered plasma),
Source Plasma, and Source Leukocytes at increased risk for transmitting HIV infection have been
- 6 May 1994 (59 FR 23636)
Corrects certain omissions from the designators for blood specifications and makes other minor, technical
- 13 April 1992 (57 FR 12862)
Technical amendment correcting an error.
- 2 April 1992 (57 FR 11263)
Technical amendment correcting an error.
- 31 March 1992 (57 FR 10814)
Fixed typographical and other inadvertent errors.
- 26 March 1990 (55 FR 11014)
Updated titles and mailing symbols of certain organizational units.
- 5 January 1988 (53 FR 116)
Required HIV testing for all blood and blood components.
- 30 August 1985 (50 FR 35469)
Updated labeling regulations for blood and blood components that is collected or manufactured in a blood band
- 8 June 1984 (49 FR 23833)
Updated organizational references and clarified delegations of authority regarding biological products.
- 12 February 1980 (45 FR 9261)>
Amended to require less frequent performance checks and calibrations for the hematocrit centrifuge and vacuum
- 2 December 1975 (40 FR 55849)
Made changes in wording and in chart
- 18 November 1975 (40 FR 53532) ( 580 KB)
Original final rule
- 28 May 1974 (39 FR 18614)
Original Proposed rule.
Last Update: 12 March 2013