Notice of Updates

For information regarding prior changes to the STIC webpages, see https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-09007.pdf

https://www.federalregister.gov/documents/2020/10/22/2020-23439/21st-century-cures-act-annual-compilation-of-notices-of-updates-from-the-susceptibility-test

Updates to Standards Recognition

As of May 18, 2022, the following standards are no longer recognized:

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.

As of May 18, 2022, with certain exceptions, FDA recognizes the standard published in:

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 32nd ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2022.

Updates by Drug:

Drug	Route of Administration	Action Taken	Therapeutic Category	Date
Amoxicillin and clavulanate	Oral	FDA does not recognize M100 standard and provides STIC for Haemophilus influenzae.	Antibacterial	5/17/22
Azithromycin	Oral, Injection	For Neisseria gonorrhoeae, FDA has reviewed STIC and concludes no changes are needed at this time. Rationale	Antibacterial	10/14/21
Cefadroxil	Oral	FDA removed the statement “Susceptibility of Enterobacteriaceae to cefadroxil may be deduced from testing cefazolin.” Rationale	Antibacterial	4/27/22
Cefazolin	Injection	For Enterobacterales, FDA has reviewed STIC and the updated standard is recognized. Rationale	Antibacterial	10/14/21
Cefazolin	Injection	FDA does not recognize M100 standard for cefazolin as a surrogate to predict susceptibility of oral cephalosporins when used for the treatment of uncomplicated UTI caused by Escherichia coli, Klebsiella pneumoniae and Proteus mirabilis. Rationale	Antibacterial	10/20/22
Cefiderocol	Injection	FDA recognizes M100 disk diffusion standards for Enterobacterales.	Antibacterial	1/31/23
Cefiderocol	Injection	FDA has updated STIC and added STIC for Acinetobacter baumannii complex.	Antibacterial	9/25/20
Cefoxitin	Injection	FDA recognizes M100 standard for Staphylococcus aureus complex and Staphylococcus lugdunensis; FDA recognizes M100 disk diffusion standard for Staphylococcus epidermidis and other Staphylococci spp.	Antibacterial	10/04/22
Ceftaroline fosamil	Injection	For Staphylococcus aureus, FDA has reviewed STIC and concludes no changes are needed at this time. Rationale	Antibacterial	4/16/20
Ceftolozane Tazobactam	Injection	FDA recognizes M100 standard for Haemphilus influenzae.	Antibacterial	10/14/21
Ceftolozane and tazobactam	Injection	FDA recognizes M100 disk diffusion standard for Enterobacterales.	Antibacterial	5/17/22
Ciprofloxacin	Oral, Injection	For Salmonella spp., the updated standard is recognized.	Antibacterial	2/28/20
Colistimethate	Injection	FDA does not recognize M100 standard for Enterobacterales, Pseudomonas aeruginosa, or Acinetobacter spp. Rationale	Antibacterial	1/17/23
Daptomycin	Injection	FDA updated STIC. Rationale.	Antibacterial	8/25/20
Delafloxacin	Injection, Oral	FDA identified STIC for Staphylococcus lugdunensis for Acute Bacterial Skin and Skin Structure Infections.	Antibacterial	10/06/20
Imipenem-Cilastatin-Relebactam	Injection	FDA identified STIC for Acinetobacter calcoaceticus-baumannii complex and Haemophilus influenzae.	Antibacterial	6/4/20
Imipenem-Cilastatin-Relebactam	Injection	FDA recognizes M100 standard for Enterobacteriaceae, Pseudomonas aeruginosa, and anaerobes.	Antibacterial	10/14/21
Lefamulin	Oral, Injection	FDA recognizes M100 standard for Staphylococcus aureus, Streptococcus pneumoniae, and Haemophilus influenzae.	Antibacterial	10/14/21
Lefamulin	Oral, Injection	FDA does not recognize M100 disk diffusion standard and provides STIC for Streptococcus pneumoniae and Haemophilus influenzae.	Antibacterial	5/17/22
Levofloxacin	Oral, Injection	Salmonella spp., the updated standard is recognized.	Antibacterial	2/28/20
Ofloxacin	Oral	For Salmonella spp., the updated standard is recognized.	Antibacterial	2/28/20
Omadacycline	Injection, Oral	FDA updated disk breakpoints for Streptococcus pneumoniae for community acquired bacterial pneumonia.	Antibacterial	8/25/20
Oxacillin	Injection	FDA concurs with the revised CLSI STIC for Staphylococcus by species level. Rationale; FDA references Cefoxitin STIC for Staphylococcus spp. as a surrogate test.	Antibacterial	10/04/22
Piperacillin and Tazobactam	Injection	FDA has updated STIC for Enterobacterales. FDA has recognized M100 standard for susceptible and resistant breakpoints and updated an intermediate breakpoint. FDA does not recognize M100 standard for a susceptible dose dependent breakpoint. Rationale.	Antibacterial	1/17/23
Polymixin B	Injection	FDA does not recognize M100 standard for Enterobacterales, Pseudomonas aeruginosa, or Acinetobacter spp. Rationale.	Antibacterial	1/17/23
Telithromycin	Oral	FDA has removed telithromycin breakpoints as the drug has been withdrawn.	Antibacterial	10/14/21