Pending Monographs
USP provides Pending Monographs for certain drug products, drug substances, and excipients that have been submitted or are intended to be submitted to the U.S. Food and Drug Administration (FDA) for approval to be marketed in the United States, but have not yet received such approval. Under this approach, sponsors of Requests for Revision such as manufacturers of generic or over-the-counter (OTC) products and others can work with USP to create a Pending Monograph as authorized text. Once FDA approval is granted, USP then works with the sponsor to move that monograph into official USP–NF status, along with an official USP Reference Standard where appropriate. Details of the approach are described in the Pending Monographs Guideline Version 2.7 (effective November 1, 2011).
As new and revised Pending Monographs become available, they are posted on the USP website on a monthly basis on the last Friday of each month. Monographs posted in draft for comment include the deadline for submitting comments and the email address of the USP staff person to whom comments should be directed. Following review of comments and approval by the relevant Expert Committee, the Authorized Pending Standard is posted to this website.
- Download a Power Point presentation on the Pending Monographs Guideline
- View Pending Monograph Frequently Asked Questions
For additional information, contact Karen A. Russo, Ph.D. (kar@usp.org)
Draft Monographs — New Postings
Posting Date: December 28, 2011
Monograph | Date Posted | Status | Liaison | History |
| Ziprasidone Hydrochloride | Dec. 28, 2011 | Draft 1. Comment period ends Mar. 31, 2012. | Hari Ramanathan (hr@usp.org) | — |
Next Posting Date: January 27, 2012
Draft Monographs — Previous Postings
Monograph | Date Posted | Status | Liaison | History |
Mar. 25, 2011 | Draft 1, comment period ended | Elena Gonikberg (eg@usp.org) |
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Apr. 30, 2010 | Draft 1, comment period ended Jul. 31, 2010. Awaiting Expert Committee approval. | Hari Ramanathan (hr@usp.org) |
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Dec. 29, 2010 | Draft 1, comment period ended Mar. 31, 2011. Awaiting Expert Committee approval. | Elena Gonikberg (eg@usp.org) |
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| Didanosine Tablets for Oral Suspension | Sept. 30, 2011 | Draft 1, comment period ends Dec. 31, 2011. | Leonel Santos (lxs@usp.org) | — |
| Escitalopram Oral Solution | Aug. 26, 2011 | Draft 1, comment period ended Nov. 30, 2011. Awaiting Expert Committee approval. | Hari Ramanathan (hr@usp.org) | — |
Nov. 24, 2010 | Draft 1, comment period ended Feb. 28, 2011. Awaiting Expert Committee approval. | Elena Gonikberg (eg@usp.org) |
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Iron Sucrose Injection | N/A | Withdrawn at sponsor's request. | Sujatha Ramakrishna (sxr@usp.org) | |
| Perindopril Erbumine | Aug. 26, 2011 | Draft 1, comment period ended Nov. 30, 2011. Awaiting Expert Committee Approval | Sujatha Ramakrishna (sxr@usp.org) | — |
Ribavirin Tablets | N/A | Leonel Santos (lxs@usp.org) | ||
Tolterodine Tartrate | N/A | Withdrawn at sponsor's request. | Elena Gonikberg (eg@usp.org) |
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Valacyclovir Hydrochloride | May 28, 2010 | Hari Ramanathan (hr@usp.org) | ||
Aug. 27, 2010 | Draft 1, comment period ended Nov. 30, 2010. Awaiting Expert Committee approval. | Elena Gonikberg (eg@usp.org) |
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Feb. 25, 2011 | Draft 1, comment period ended May 31, 2011. Awaiting Expert Committee approval. | Hari Ramanathan (hr@usp.org) |
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Authorized Pending Monographs — No New Postings
Posting Date: December 28, 2011
Monograph | Date Posted | Status | Liaison | History |
| Atomexetine Hydrochloride | Dec. 28, 2011 | Authorized V.1 | Hari Ramanathan (hr@usp.org) | — |
Next Posting Date: January 27, 2012
Authorized Pending Monographs — Previous Postings
Monograph | Date Posted | Status | Liaison | History |
Feb. 29, 2008 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Mar. 26, 2010 | Authorized V.2 | Leonel Santos (lxs@usp.org) | ||
Oct. 30, 2009 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Dec. 29, 2010 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Sept. 30, 2011 | Authorized V.2 | Hari Ramanathan | ||
Apr. 30, 2010 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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| Amlodipine and Benazepril Hydrochloride Capsules | Aug. 26, 2011 | Authorized V.1 | Sujatha Ramakrishna (sxr@usp.org) | — |
Oct. 30, 2009 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Jan. 30, 2009 | Authorized V.2 | Feiwen Mao (fm@usp.org) | ||
| Bicalutamide | N/A | Feiwen Mao (fm@usp.org) | Bicalutamide | |
Jun. 26, 2009 | Authorized V.1 | Ahalya Wise (aww@usp.org) |
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| Climbazole | Oct. 28, 2011 | Authorized V.1 | Feiwen Mao (fm@usp.org) | — |
Donepezil Hydrochloride | NA | Hari Ramanathan (hr@usp.org) | ||
Feb. 29, 2008 | Authorized V.2 | Ravi Ravichandran (rr@usp.org) | ||
Apr. 29, 2011 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Feb. 29, 2008 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Oct. 30, 2009 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Oct. 30, 2009 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Dec. 29, 2010 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Dec. 29, 2010 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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May 29, 2009 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Apr. 30, 2010 | Authorized V.2 | Hari Ramanathan (hr@usp.org) | ||
Dec. 29, 2010 | Authorized V.1 | Elena Gonikberg (eg@usp.org) |
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| Eszopiclone | Sep. 30, 2011 | Authorized V.1 | Hari Ramanathan (hr@usp.org) | — |
Feb. 29, 2008 | Authorized V.1 | Feiwen Mao (fm@usp.org) | ||
Dec. 29, 2010 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Apr. 30, 2010 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Apr. 30, 2010 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Apr. 30, 2010 | Authorized V.2 | Hari Ramanathan (hr@usp.org) | ||
Apr. 29, 2011 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Apr. 29, 2011 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Apr. 29, 2011 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Oct. 30, 2009 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Mar. 26, 2010 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Feb. 25, 2011 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Aug. 29, 2008 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Mar. 26, 2010 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Feb. 25, 2011 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Nov. 23, 2007 | Authorized V.1 | Ravi Ravichandran (rr@usp.org) |
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Jan. 30, 2009 | Authorized V.2 | Morgan Puderbaugh (mxp@usp.org) | ||
Apr. 29, 2011 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Losartan Potassium | N/A | Sujatha Ramakrishna (sxr@usp.org) | Losartan Potassium V.1 | |
Aug. 28, 2009 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Apr. 30, 2010 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Aug. 29, 2008 | Authorized V.1.1 | Karen A. Russo (kar@usp.org) | ||
Jun. 26, 2009 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Jun. 26, 2009 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Dec. 29, 2010 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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Olopatadine Hydrochloride | N/A | Withdrawn. Sponsor is no longer seeking FDA approval. | Feiwen Mao (fm@usp.org) |
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Olopatadine Hydrochloride Ophthalmic Solution | N/A | Withdrawn. Sponsor is no longer seeking FDA approval. | Feiwen Mao (fm@usp.org) |
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Feb. 29, 2008 | Authorized V.1.1 | Feiwen Mao (fm@usp.org) | ||
Apr. 29, 2011 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Feb. 29, 2008 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Apr. 30, 2010 | Authorized V.1 | Ravi Ravichandran (rr@usp.org) |
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Dec. 29, 2010 | Authorized V.1 | Elena Gonikberg (eg@usp.org) |
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Dec. 28, 2009 | Authorized V.1 | Morgan Puderbaugh (mxp@usp.org) |
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Aug. 28, 2009 | Authorized V.1 | Elena Gonikberg (eg@usp.org) |
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Mar. 26, 2010 | Authorized V.1 | Behnam Davani (bd@usp.org) |
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Apr. 30, 2010 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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| Tenofovir Disporoxil Fumarate | Aug. 26, 2011 | Authorized V.1 | Leonel Santos (lxs@usp.org) | — |
| Tenofovir Disporoxil Fumarate Tablets | Aug. 26, 2011 | Authorized V.1 | Leonel Santos (lxs@usp.org) | — |
Oct. 30, 2009 | Authorized V.1 | Hari Ramanathan (hr@usp.org) |
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June 24, 2011 | Authorized V.1 | Feiwen Mao (fm@usp.org) |
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Venlafaxine Extended-Release Capsules | N/A | Hari Ramanathan (hr@usp.org) | ||
Apr. 29, 2011 | Authorized V.1 | Leonel Santos (lxs@usp.org) |
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Pending Monographs Advancing to USP–NF
The sponsors of the following Pending monographs have received full FDA approval. The Pending monographs in their entirety or specific sections are now eligible to become official USP text. The monographs listed below have either advanced to official status or are in the process of advancing to official status.
Monograph | Status | Liaison |
Bicalutamide | Sponsor obtained FDA approval. The organic impurities (chromatographic purity) and assay procedures of the Authorized V.1 Pending monograph have been proposed as a revision to the official USP Bicalutamide monograph and appeared in PF 36(5) for public comment. The remaining FDA approved procedures are consistent with the current official monograph. | Feiwen Mao (fm@usp.org) |
Carvedilol | Official May 1, 2009. This monograph was published in USP32–NF27, First Supplement. | Sujatha Ramakrishna (sxr@usp.org) |
Carvedilol Tablets | Official May 1, 2009. This monograph was published in USP32–NF27, First Supplement. | Sujatha Ramakrishna (sxr@usp.org) |
Cetirizine Hydrochloride | Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement | Domenick Vicchio (dwv@usp.org) |
Cetirizine Hydrochloride Oral Solution | Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement | Domenick Vicchio (dwv@usp.org) |
Donepezil Hydrochloride | Revision Bulletin posted April 29, 2011. Official May 1, 2011. This monograph will be published in USP35–NF30. | Hari Ramanathan (hr@usp.org) |
Irinotecan Hydrochloride | Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement | Feiwen Mao (fm@usp.org) |
Galantamine Hydrobromide | Official December 15, 2008. The revised official monograph was published in USP32–NF27, Second Supplement. | Ravi Ravichandran (rr@usp.org) |
Levetiracetam | Official May 1, 2010. This monograph was published in USP33–NF28, Reissue, First Supplement. | Ravi Ravichandran (rr@usp.org) |
| Losartan Potassium | See Authorized Pending Monographs above. | Sujatha Ramakrishna (sxr@usp.org) |
Pantoprazole Sodium | Official June 1, 2008. This monograph was published in USP32–NF27. | Elena Gonikberg (eg@usp.org) |
Pantoprazole Sodium Delayed Release Tablets | Official June 1, 2008. This monograph was published in USP32–NF27. | Elena Gonikberg (eg@usp.org) |
Ribavirin Tablets | Official September 1, 2010. This monograph was published in USP33–NF28, Reissue, Second Supplement | Leonel Santos (lxs@usp.org) |
Rocuronium Bromide | Official August 1, 2009. The revised official monograph was published in USP33–NF28 Reissue. | Ravi Ravichandran (rr@usp.org) |
Valacyclovir Hydrochloride | Revision Bulletin posted November 24, 2010. Official December 1, 2010. This monograph was published in USP34–NF29, Second Supplement. | Leonel Santos (lxs@usp.org ) |
| Venlafaxine Extended-Release Capsules | Revision Bulletin will be posted December 20, 2011. Official January 1, 2012. This monograph will be published in USP–NF30, Second Supplement. | Hari Ramanathan (hr@usp.org) |
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