USP Non–US Monographs

USP provides standards for articles legally marketed outside the United States if intended to treat neglected diseases. The purpose of these monographs is to support testing by first (e.g., manufacturer), second (e.g., payors), and third (e.g., government control laboratories) parties. Details of the approach are described in the Non–US Guideline. Manufacturers wishing to signal conformance to these monographs may use the following block letters–S–USP. USP Reference Standards to allow testing in accordance with a Non–US monograph may be available in USP's catalogue at a future date.

As new and revised Non–US monographs become available, they will be posted on the USP Web site on a monthly basis on the last Friday of each month. Monographs posted in draft for comment will also indicate the deadline for submitting comments and the e–mail address of the USP staff person to whom comments should be directed. Non–US monographs were formerly known as SALMOUS monographs (Standards for Articles Legally marketed Outside the US).

For additional information, contact Karen A. Russo, Ph.D., ()

Draft Monographs — New Postings

Posting Date: October 30, 2009—No new postings

Next Posting Date: November 30, 2009

Draft Monographs — Previous Postings

Monograph Date Posted Status Liaison History

Artesunate  (134KB)

Aug. 28, 2009 Draft 1, Comment deadline is Nov 30, 2009 Leonel Santos ()

Artesunate Tablets  (107KB)

Aug. 28, 2009 Draft 1, Comment deadline is Nov 30, 2009 Leonel Santos ()

Authorized Monographs — New Postings

Posting Date: October 30, 2009—No new postings

Next Posting Date: November 30, 2009


Authorized Monographs — Previous Postings

Monograph Date Posted Status Liaison History

Abacavir Sulfate  (271KB)

Dec. 28, 2007 Authorized V.1 Leonel Santos ()

Artemether  (89KB)

Jan. 30, 2009 Authorized V.1 Leonel Santos ()

Efavirenz  (270KB)

Dec. 28, 2007 Authorized V.1 Leonel Santos ()

Lumefantrine  (89KB)

Jan. 30, 2009 Authorized V.1 Leonel Santos ()

Lumefantrine and Artemether Tablets  (274KB)

Feb. 27, 2009 Authorized V.1 Leonel Santos ()

Lumefantrine and Artemether Tablets  (274KB)

Feb. 27, 2009 Authorized V.1 Leonel Santos ()

Mefloquine Hydrochloride Tablets  (84KB)

Aug. 28, 2009 Authorized V.1 Leonel Santos ()