Labeling for these products can be found at Drugs@FDA or FDA Online Label Repository.

Recognized Standards

Performance Methods and Quality Control

FDA recognizes consensus standards for performance standards, methods standards, and quality control parameter standards including ranges for antimicrobial susceptibility testing.

Susceptibility Test Interpretive Criteria

The table below lists antibacterial drugs and indicates which, if any, susceptibility test interpretive criteria, also known as “breakpoints” (abbreviated as STIC), are recognized or identified by FDA for that drug.

With certain exceptions and additions, identified in the table, FDA recognizes the standard published in:

• Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 31st ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2021. (CLSI M100)

If the table indicates that STIC for a drug are included in CLSI M100 and there are no additions or exceptions, CLSI M100 contains all of the STIC recognized by FDA for that drug.

For specific drug/bacteria combinations, FDA recognizes in part the standards published in:

• Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteriai. 3rd ed. CLSI guideline M45. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.
• Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Susceptibility Testing of Mycobacteria, Norcardia spp. and other Aerobic Actinomycetes. CLSI guideline M62- 1st Edition. Wayne, PA: Clinical and Laboratory Standards Institute; 2018.
• Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI guideline M43-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.

If one of these three standards is recognized in part, that information is provided in the hyperlinked information for the specific drug listed in the table below.

FDA recognition of STIC standard(s) for a drug does not include recognition of epidemiological cutoff values (ECVs) for that drug.

FDA recognition of STIC standard(s) for a drug and bacterial family or genus/species does include recognition of surrogate testing methods included in recognized standards for that drug and bacterial family or genus/species.

Susceptibility Test Interpretive Criteria Recognized or Otherwise Identified by FDA

The hyperlinks included for certain antibacterial drugs in the table below lead to information concerning:

• Recognitions, Exceptions, or Additions to the recognized standard of CLSI M100
• Additional STIC recognized in part from standards CLSI M45, M24-A2, and M43-A
• Additional FDA-identified STIC for certain drug-bacteria combinations not included in a recognized standard

Downloadable File (XLS-16KB)

*No STIC are recognized by FDA for this drug at this time.