Antibiotics Standards

Substandard antibiotics can exacerbate antimicrobial resistance (AMR), a global health crisis in which widely used antibiotics are becoming ineffective against the microbes they previously killed. AMR knows no boundaries, and resistance can spread across borders and countries. A lack of robust quality control standards and testing contribute to the proliferation of poor-quality antibiotics.

USP provides standards for identity, strength, quality, and purity that can assist manufacturers and national control laboratories testing these essential medicines. Furthermore, USP supports initiatives that encourage development of new antimicrobial drugs. Assuring the quality of medicines is essential for new drugs to work as effectively and for as long as possible.

New: USP Antibiotics Manufacturing and Testing Infographic

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USP-NF Documentary Standards and USP Reference Standards

Support for the development of new antibiotic standards and monograph method modernization


Below are the antibiotic-related monographs and chapters published and official in the United States Pharmacopeia-National Formulary (USP-NF) that support the quality of antibiotic medicines. We also offer Reference Standards, highly characterized physical specimens that are suitable for use in compendial testing. These reference standards, in combination with their associated documentary standard(s), help ensure the identity, strength, quality, and purity of antibiotic medicines.

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USP continues to increase the number of antibiotic-related monographs in the United States Pharmacopeia-National Formulary (USP–NF). A complete listing of monographs under development can be found in USP’s Pharmacopeial Forum (PF), a free bimonthly online journal where proposed monographs and general chapters are published for public review and comment before potentially becoming official. To learn more, visit the Pharmacopeial Forum.

Your participation in our standards-setting process is vital to the development of relevant USP–NF monographs. USP seeks sponsors to help develop the following monographs

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Learn how you can donate material or methods by visiting our biologics standards engagement page or by contacting us at



Antimicrobial resistance (AMR)

News releases

Online courses

Classroom/Laboratory Courses


Browse our antibiotic-related products

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Reference Standards Release Notification Service

USP also continues to develop Reference Standards. To learn more, sign up for our Reference Standards Release Notification Service: