USP Non-U.S. Standards

Standards for Articles Legally Marketed Outside the U.S.

USP provides standards for articles legally marketed outside the United States (SALMOUS) 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 SALMOUS 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 SALMOUS monograph may be available in USP's catalogue at a future date.

As new and revised SALMOUS 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.

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

Draft Monographs

Artemether  (224KB) –The comment period for this draft monograph closed on September 30, 2007. The relevant Expert Committee will review the comments received and finalize the monograph. Following approval by the Committee, the final monograph will be posted to this Web site. Leonel Santos()

Lumefantrine  (269KB) –The comment period for this draft monograph closed on September 30, 2007. The relevant Expert Committee will review the comments received and finalize the monograph. Following approval by the Committee, the final monograph will be posted to this Web site. Leonel Santos()

Lumefantrine and Artemether Tablets  (227KB) – The comment period for this draft monograph closed on September 30, 2007. The relevant Expert Committee will review the comments received and finalize the monograph. Following approval by the Committee, the final monograph will be posted to this Web site. Leonel Santos()

Authorized Monographs

Abacavir Sulfate  (271KB) (NEW), Authorized USP SALMOUS Standard, V.1, November 1, 2007, Leonel Santos ()

Efavirenz  (270KB) (NEW) – Authorized USP SALMOUS Standard, V.1, November 1, 2007, Leonel Santos ()