Pending Monographs

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 propose new monographs or to propose revision to existing text. Once FDA approval is granted, USP then works with the sponsor to move the new monograph or revision to existing text 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 3.0 (effective June 1, 2015).

USP will be reevaluating all of the Draft Monographs and Authorized Pending Monographs that are currently posted below. If no longer relevant, these monographs will be eliminated. Where there is a desire to move these monographs forward to official status, they will be developed, balloted, and published in accordance with the revised Pending Monograph Guideline, including publication in Pharmacopeial Forum (PF) where required under the Guideline. This process is expected to take several months.

Beginning June 26, 2015, the tables of pending proposals currently posted on the Pending Monograph webpage will be updated monthly to indicate which monographs were removed from the website and whether they were eliminated or proposed in PF.

For additional information, contact Michael Goede (myg@usp.org).

Latest Updates to Draft Monographs (updated 26–Aug–2016; next posting 30–Sep–2016)

MonographDate PostedStatusLiaisonHistory
No changes to post    

Latest Updates to Authorized Monographs (updated 26–Aug–2016; next posting 30–Sep–2016)

MonographDate PostedStatusLiaisonHistory
No changes to post    

Draft Monographs — Previous Postings

MonographDate PostedStatusLiaisonHistory
Abiraterone AcetateSep. 27, 2013Draft 1Feiwen Mao (fm@usp.org) 
Azacitidine for InjectionJun. 28, 2013Draft 1, comment period ends Sep. 30, 2013.Ramanujam Prasad  (rsp@usp.org)
Brimonidine TartrateMar. 28, 2014Draft 1Feiwen Mao (fm@usp.org) 
Colesevelam HydrochlorideAug. 31, 2012Draft 1, comment period ended Nov. 30, 2012. Awaiting Expert Committee approval.Sujatha Ramakrishna (sxr@usp.org) 
DecitabineJun. 4, 2014Draft 1Feiwen Mao (fm@usp.org) 
Ibandronate SodiumNov. 24, 2010Draft proposal cancelled because of significant negative comments receivedElena Gonikberg (eg@usp.org)Draft posted on Nov. 24, 2010, comment period ended Feb 28, 2011. Cancelled on Mar. 25, 2016 
Iron Sucrose InjectionN/AWithdrawn at sponsor's request.Sujatha Ramakrishna (sxr@usp.org)
 
Lamivudine, Zidovudine, and Nevirapine TabletsNov. 30, 2012Draft 2, comment period ended Feb. 28, 2013. Awaiting Expert Committee approval.Amanda Martin-Esker (ame@usp.org)
LatanoprostMar. 30, 2012Draft 1, comment period ended Jun. 30, 2012. Awaiting Expert Committee approval.Feiwen Mao (fm@usp.org)
Latanoprost Ophthalmic SolutionMar. 30, 2012Draft 1, comment period ended Jun. 30, 2012. Awaiting Expert Committee approval.Feiwen Mao (fm@usp.org)
Oxiconazole NitrateDec. 27, 2013Draft 1Shankari Shivaprasad (sns@usp.org)
PaliperidoneMay 25, 2012Pending Revision Cancelled. No impact on official USP–Nf monograph.Ravi Ravichandran (rr@usp.org)Revision cancelled on Nov. 20, 2015
Rabeprazole SodiumFeb. 22, 2013Elena Gonikberg (eg@usp.org)Proposed in PF 41(2) [Mar.–May 2015]
RanolazineOct. 25, 2013Draft 1Sujatha Ramakrishna (sxr@usp.org)
Ribavirin TabletsN/A See Pending Monographs Advancing to USP – NF section below Leonel Santos (lxs@usp.org) Ribavirin Tablets Draft 1
Tolterodine TartrateN/AWithdrawn at sponsor's request.Elena Gonikberg (eg@usp.org)
Valacyclovir HydrochlorideMay 28, 2010 See Pending Monographs Advancing to USP–NF section below. Behnam Davani (bd@usp.org) Valacyclovir Hydrochloride 
Ziprasidone HydrochlorideDec. 28, 2011Official Dec. 1, 2012, via Revision Bulletin.Ravi Ravichandran (rr@usp.org)Published in Revision Bulletin, Nov. 30, 2012
Zoledronic AcidAug. 27, 2010Draft proposal cancelled because of significant negative comments receivedElena Gonikberg (eg@usp.org)Draft posted on Aug. 27, 2010, comment period ended Nov. 30, 2010. Cancelled Mar. 25, 2016 

Authorized Pending Monographs — Previous Postings

MonographDate PostedStatusLiaisonHistory
Abacavir Oral SolutionFeb. 29, 2008Authorized V.1Behnam Davani (bd@usp.org)
Abacavir SulfateMar. 26, 2010Authorized V.2Leonel Santos (lxs@usp.org) Abacavir Sulfate V.1
Abacavir Tablets Oct. 30, 2009Authorized V.1Leonel Santos (lxs@usp.org)
Acamprosate CalciumPending Revision Cancelled May 27, 2016Authorized V.1Heather Joyce (hrj@usp.org)Cancelled May 27, 2016
Almotriptan MalatePending Revision Cancelled. No impact on official USP-NF monograph.Authorized V.2Heather Joyce (hrj@usp.org)Cancelled May 27, 2016
Almotriptan TabletsPending Revision Cancelled. No impact on official USP-NF monograph.Authorized V.1Heather Joyce (hrj@usp.org)Cancelled May 27, 2016
Amlodipine and Benazepril Hydrochloride Capsules      Aug. 26, 2011 Authorized V.1Sujatha Ramakrishna (sxr@usp.org)
AnastrozoleOct. 30, 2009Authorized V.1Feiwen Mao
(fm@usp.org)
AripiprazoleOct. 26, 2012Pending Revision Cancelled. No impact on official USP–NF monographHeather Joyce (hrj@usp.org)Mar. 25, 2016
AprepitantJun. 29,
2012
Published in USP 39–NF 34, official May 1, 2016Elena Gonikberg (eg@usp.org)Revision incorporated in USP–NF
Atomoxetine HydrochlorideDec. 28, 2011Authorized V.1Heather Joyce (hrj@usp.org)Cancelled July 29, 2016
Atorvastatin CalciumFeb. 24, 2012See Pending Monographs Advancing to USP–NF section below.Elena Gonikberg (eg@usp.org)Atorvastatin Calcium V.1
AzacitidineJun. 29,
2012
Authorized V.1Feiwen Mao (fm@usp.org)
BemotrizinolJan. 30,
2009
Authorized V.2Feiwen Mao (fm@usp.org) Bemotrizinol V.1
BosentanDec. 28, 2012Authorized V.1Domenick Vicchio (dwv@usp.org)
Bupropion HydrobromidePending Revision CancelledAuthorized V.1Heather Joyce (hrj@usp.org)Cancelled May 27, 2016
CabergolineApr. 26, 2013See Pending Monographs Advancing to USP–NF section below.Heather Joyce (hrj@usp.org)Cabergoline V.1
Cefditoren Pivoxil Jun. 26,
2009
Authorized V.1Ahalya Wise (aww@usp.org)
ClimbazoleOct. 28, 2011Authorized V.1Feiwen Mao (fm@usp.org)
DalfampridineDec. 27, 2013Authorized V.1Heather Joyce (hrj@usp.org)New proposal published in PF 42(1)[Jan.-Feb. 2016]
Didanosine Tablets for Oral SuspensionFeb. 24, 2012Authorized V.1Behnam Davani (bd@usp)
Donepezil Hydrochloride TabletsFeb. 29, 2008Incorporated in USP 35–NF 30, First SupplementHeather Joyce (hrj@usp.org) Official via Revision Bulletin (posted 29–Jul–2011; official 01–Aug–2011)
Drometrizole TrisiloxaneApr. 29, 2011Authorized V.1Feiwen Mao (fm@usp.org)
Efavirenz Feb. 29, 2008Authorized V.1Behnam Davani (bd@usp.org)
Efavirenz Capsules Oct. 30, 2009Authorized V.1Leonel Santos (lxs@usp.org)
Efavirenz TabletsOct. 30, 2009Authorized V.1Leonel Santos (lxs@usp.org)
Emtricitabine Dec. 29, 2010Authorized V.1, updated Feb. 27, 2015 to correct chemical name in Table 1Shankari Shivaprasad (sns@usp.org)
Emtricitabine Capsules Dec. 29, 2010Authorized V.1Shankari Shivaprasad (sns@usp.org)
Eprosartan MesylateApr. 26, 2013Authorized V.1Sujatha Ramakrishna (sxr@usp.org)
Escitalopram Tablets Pending Revision Cancelled. No impact on official USP-NF monographAuthorized V.1Heather Joyce (hrj@usp.org)Cancelled May 27, 2016
Escitalopram Oral SolutionApr. 27, 2012See Pending Monographs Advancing to USP–NF section below.Heather Joyce (hrj@usp.org) Escitaopram Oral Solution V.1
Escitalopram OxalatePending Revision Cancelled. No impact on official USP-NF monographAuthorized V.2Heather Joyce (hrj@usp.org)Cancelled May 27, 2016
Esomeprazole Magnesium   Dec. 29, 2010Official Dec. 1, 2015Elena Gonikberg (eg@usp.org)Published in Revision Bulletin, Nov. 20, 2015
EszopicloneSep. 30, 2011Authorized V.1Heather Joyce (hrj@usp.org)Cancelled July 29, 2016
Ethylhexyl TriazoneFeb. 29, 2008Authorized V.1Feiwen Mao (fm@usp.org)
EtonogestrelDec. 27, 2013Authorized V.1Domenick Vicchio (dwv@usp.org) 
Exemestane Dec. 29, 2010Authorized V.1Feiwen Mao (fm@usp.org)
Famciclovir TabletsApr. 30, 2010Authorized V.1Behnam Davani (bd@usp.org)
Frovatriptan SuccinateDec. 27, 2013Authorized V.1Heather Joyce (hrj@usp.org)Proposed in PF 41(5) [Sep.–Oct. 2015]
GatifloxacinApr. 30, 2010Authorized V.2Behnam Davani (bd@usp.org) Gatifloxacin V.1
IctasolApr. 29, 2011Authorized V.1Feiwen Mao (fm@usp.org) 
 
IscotrizinolFeb. 28, 2014Authorized V.1Feiwen Mao (fm@usp.org) 
Imiquimod CreamApr. 29, 2011Authorized V.1Behnam Davani (bd@usp.org)
LamivudineOct. 30, 2009Authorized V.1Behnam Davani (bd@usp.org)
Lamivudine Oral SolutionMar. 26, 2010Authorized V.1Behnam Davani (bd@usp.org)
Lamivudine and Stavudine Tablets  Feb. 25, 2011Authorized V.1Behnam Davani (bd@usp.org)
Lamivudine Tablets  Aug. 29, 2008Authorized V.1Behnam Davani (bd@usp.org)
Lamivudine, Zidovudine, And Nevirapine Tablets  Mar. 26, 2010Authorized V.1Behnam Davani (bd@usp.org)
Lamivudine and Zidovudine Tablets  Feb. 25, 2011Authorized V.1Behnam Davani (bd@usp.org)
LamotrigineNov. 23, 2007Pending Revision Cancelled. No impact on official USP–Nf monograph.Ravi Ravichandran (rr@usp.org)Proposal was cancelled on June 26, 2015
LevofloxacinJan. 30,
2009
Authorized V.2Behnam Davani (bd@usp.org) Levofloxacin V.1
Levofloxacin TabletsApr. 29, 2011Authorized V.1Behnam Davani (bd@usp.org)
LinezolidMar. 29, 2013Authorized V. 1Ahalva Wise (aww@usp.org)
Linezolid TabletsMar. 29, 2013Authorized V.1Ahalva Wise (aww@usp.org)
LopinavirAug. 28, 2009Authorized V.1Leonel Santos (lxs@usp.org)
Lopinavir and Ritonavir TabletsApr. 30, 2010Authorized V.1Leonel Santos (lxs@usp.org)
MetaxaloneAug. 30, 2013Pending Revision Cancelled. No impact on official USP–Nf monograph.Donald Min (ddm@usp.org) 
Revision was cancelled on Nov. 20, 2015
MifepristoneAug. 29, 2008Authorized V.1.1Mary Waddell (msw@usp.org) Mifepristone V.1
Mycophenolate Mofetil CapsulesJun. 26,
2009
Authorized V.1Feiwen Mao (fm@usp.org)
Mycophenolate Mofetil TabletsJun. 26,
2009
Authorized V.1Feiwen Mao (fm@usp.org)
Nitazoxanide Dec. 29, 2010Authorized V.1Leonel Santos (lxs@usp.org)
Olopatadine HydrochlorideN/AWithdrawn. Sponsor is no longer seeking FDA approval.Feiwen Mao (fm@usp.org)
Olopatadine Hydrochloride Ophthalmic SolutionN/AWithdrawn. Sponsor is no longer seeking FDA approval.Feiwen Mao (fm@usp.org)
OxaliplatinFeb. 29, 2008Authorized V.1.1Feiwen Mao (fm@usp.org) Oxaliplatin V.1
Perindopril ErbumineApr. 27, 2012Authorized V.1Sujatha Ramakrishna (sxr@usp.org)
Piroctone OlamineFeb. 29, 2008Authorized V.1Feiwen Mao (fm@usp.org)
Risperidone Orally Disintegrating Tablets  Apr. 30, 2010Official in USP 35–NF 30Ravi Ravichandran (rr@usp.org)Revision incorporated in USP–NF
Rivastigmine Tartrate Oral Solution Dec. 29, 2010Authorized V.1Elena Gonikberg (eg@usp.org)
Ropivacaine  Dec. 28, 2009Authorized V.1Morgan Puderbaugh (mxp@usp.org)
Sodium PicosulfateAug. 28, 2009Published USP 37–NF 32, Second Supplement, official Dec. 1, 2015Elena Gonikberg (eg@usp.org)Revision incorporated in USP–NF
Stavudine, Lamivudine, And Nevirapine Tablets  Mar. 26, 2010Authorized V.1Behnam Davani (bd@usp.org) 
Tenofovir Disoproxil FumarateAug. 26, 2011Authorized V.1Leonel Santos (lxs@usp.org)
Tenofovir Disoproxil Fumarate TabletsAug. 26, 2011Authorized V.1Leonel Santos (lxs@usp.org)
Terbinafine TabletsOct. 30, 2009Authorized V.1Leonel Santos (lxs@usp.org)
Travoprost Ophthalmic Solution Jun. 24, 2011Authorized V.1Feiwen Mao (fm@usp.org)
VoriconazoleApr. 29, 2011Authorized V.1Leonel Santos (lxs@usp.org)
ZolmitriptanJun. 29,
2012
Pending Revision Cancelled. No impact on official USP–Nf monograph.Ravi Ravichandran (rr@usp.org)Revision cancelled on Nov. 20, 2015

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
AdapaleneOfficial December 1, 2012. This monograph was published in USP 36–NF 31.Feiwen Mao (fm@usp.org)
Atorvastatin CalciumOfficial June 1, 2013. This monograph will be published in USP 37.Sujatha Ramakrishna (sxr@usp.org)
BicalutamideOfficial Mar 3, 2012. This monograph was published in USP 34–NF 29, Second Supplement.Feiwen Mao (fm@usp.org)
CabergolineOfficial August 1, 2013. This monograph will be published in USP 37–NF 32, First Supplement.Heather Joyce (hrj@usp.org)
CarvedilolOfficial May 1, 2009. This monograph was published in USP 32–NF 27, First Supplement.Sujatha Ramakrishna (sxr@usp.org)
Carvedilol TabletsOfficial May 1, 2009. This monograph was published in USP 32–NF 27, First Supplement.Sujatha Ramakrishna (sxr@usp.org)
Cetirizine HydrochlorideOfficial May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First SupplementDomenick Vicchio (dwv@usp.org)
Cetirizine Hydrochloride Oral SolutionOfficial May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First SupplementDomenick Vicchio (dwv@usp.org)
Donepezil HydrochlorideRevision Bulletin posted April 29, 2011. Official May 1, 2011. This monograph was published in USP 35–NF 30.Heather Joyce (hrj@usp.org)
Escitalopram Oral SolutionOfficial May 1, 2014. This monograph will be published in USP 37–NF 32.Heather Joyce (hrj@usp.org)
FamciclovirOfficial February 1, 2013. This monograph was published in USP 36–31, First Supplement.Behnam Davani (bd@usp.org)
ImiquimodOfficial October 1, 2013. This monograph will be published in USP 37.Behnam Davani (bd@usp.org)
Irinotecan HydrochlorideOfficial May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First SupplementFeiwen Mao (fm@usp.org)
Galantamine HydrobromideOfficial December 15, 2008. The revised official monograph was published in USP 32–NF 27, Second Supplement.Heather Joyce (hrj@usp.org)
LevetiracetamOfficial May 1, 2010. This monograph was published in USP 33–NF 28, Reissue, First Supplement.Ravi Ravichandran (rr@usp.org)
Losartan PotassiumOfficial January 1, 2012. This monograph was published in USP 35–NF 30, Second Supplement.Sujatha Ramakrishna (sxr@usp.org)
Oxaliplatin Injection Official October 1 , 2012. This monograph was published in USP 36–NF 31, First Supplement.Feiwen Mao (fm@usp.org)
Pantoprazole SodiumOfficial June 1, 2008. This monograph was published in USP 32–NF 27.Elena Gonikberg (eg@usp.org)
Pantoprazole Sodium Delayed Release TabletsOfficial June 1, 2008. This monograph was published in USP 32–NF 27.Elena Gonikberg (eg@usp.org)
Ribavirin TabletsOfficial September 1, 2010. This monograph was published in USP 33–NF 28, Reissue, Second SupplementLeonel Santos (lxs@usp.org)
Rocuronium BromideOfficial August 1, 2009. The revised official monograph was published in USP 33–NF 28 Reissue.Ravi Ravichandran (rr@usp.org)
TemozolomideOfficial June 1, 2013. The revised official monograph was published in USP 37–NF 32R.S. Prasad (rsp@usp.org)
Valacyclovir HydrochlorideOfficial December 1, 2010. This monograph was published in USP 34–NF 29, Second Supplement.Leonel Santos (lxs@usp.org)
Venlafaxine Extended-Release CapsulesOfficial July 1, 2012. This monograph was published in USP 35–NF 30, Second Supplement.Ravi Ravichandran (rr@usp.org)
Ziprasidone HydrochlorideOfficial December 1, 2012. This monograph was published in USP 36–NF 31, Second Supplement.Mary P. Koleck  (mpk@usp.org)