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Six-Month Implementation Guideline

Type of Posting: General Announcement

Posting Date: 09–Nov–2009

This product, USP 32–NF 27, is current from May 1, 2009, through April 30, 2010, as described below.

The United States Pharmacopeia–National Formulary and its Supplements become official six months after being released to the public. The USP–NF, which is released on November 1 of each year, becomes official on May 1 of the following year.

This change was adopted to give users more time to bring their methods and procedures into compliance with new and revised USP–NF requirements.

The table below describes the new official dates. The 2008 USP 31–NF 26, and the Supplements and Interim Revision Announcements (IRAs) to that edition, will be official until May 1, 2009, at which time the USP 32–NF 27 becomes official.

Publication

Release Date

Official Date

Official Until

USP 32-NF 27

Nov. 1, 2008

May 1, 2009

May 1, 2010 (except as superseded by Supplements, IRAs, and Revision Bulletins)

First Supplement

Feb. 1, 2009

Aug. 1, 2009

May 1, 2010 (except as superseded by Second Supplement, IRAs, and Revision Bulletins)

Second Supplement

June 1, 2009

Dec. 1, 2009

May 1, 2010 (except as superseded by IRAs and Revision Bulletins)

USP 33-NF 28

Nov. 1, 2009

May 1, 2010

May 1, 2011 (except as superseded by Supplements, IRAs, and Revision Bulletins)

IRAs will continue to become official on the first day of the second month of the Pharmacopeial Forum (PF) issue in which they are published as final. For instance, IRAs published as final in the May-June PF (issue 3) will become official on June 1. This table gives the details of the IRAs that will apply to USP 31-NF 26 and USP 32-NF 27.

IRA*

Release Date

Official Date

Revises

Jan. 1, 2009 IRA, PF 35(1)

Jan. 1, 2009

Feb. 1, 2009

USP 31-NF 26 and its Supplements

Mar. 1, 2009 IRA, PF 35(2)

Mar. 1, 2009

April 1, 2009

USP 31-NF 26 and its Supplements

May 1, 2009 IRA, PF 35(3)

May 1, 2009

June 1, 2009

USP 32-NF 27

1 July 2009 IRA, PF 35(4)

1 July 2009

Aug. 1, 2009

USP 32-NF 27 and First Supplement

Sept. 1, 2009 IRA, PF 35(5)

Sept. 1, 2009

Oct. 1, 2009

USP 32-NF 27 and First Supplement

Nov. 1, 2009 IRA, PF 35(6)

Nov. 1, 2009

Dec. 1, 2009

USP 32-NF 27 and its Supplements

Jan. 1, 2010 IRA, PF 36(1)

Jan. 1, 2010

Feb. 1, 2010

USP 32-NF 27 and its Supplements

Mar. 1, 2010 IRA, PF 36(2)

Mar. 1, 2010

April 1, 2010

USP 32-NF 27 and its Supplements

*NOTE—Beginning January 1, 2007, USP will cease identifying IRAs numerically (First, Second, etc.) and instead will designate them by the date on which they are published.

Revision Bulletins published on the USP website will continue to become official immediately upon publication, unless the Revision Bulletin specifies otherwise.

Revisions that contain a specific official date shall continue to become official upon such specified date, which supersedes the general official date for the publication.

For more information about the change in official dates, please visit the USP website.

Notice and Warning

Concerning U.S. Patent or Trademark Rights

The inclusion in The United States Pharmacopeia or in the National Formulary of a monograph on any drug in respect to which patent or trademark rights may exist shall not be deemed, and is not intended as, a grant of, or authority to exercise, any right or privilege protected by such patent or trademark. All such rights and privileges are vested in the patent or trademark owner, and no other person may exercise the same without express permission, authority, or license secured from such patent or trademark owner.

Concerning Use of USP or NF Text

Use of the USP–NF is subject to the terms and conditions of the USP–NF License Agreement. Attention is called to the fact that the USP–NF is fully copyrighted. Authors and others wishing to use portions of the text or images in any manner not expressly permitted by the License Agreement should request permission to do so from the Secretary of the USPC Board of Trustees.

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