Notice of Updates
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For information regarding prior changes to the STIC webpages, see https://www.govinfo.gov/content/pkg/FR-2019-05-03/pdf/2019-09007.pdf
Updates to Standards Recognition
As of April ##, 2023 the following standards are no longer recognized:
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.
As of April ##, 2023 with certain exceptions, FDA recognizes the standard published in:
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 33rd ed. CLSI document M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2023. (CLSI)
Updates by Drug:
Drug |
Route of Administration |
Action Taken |
Therapeutic Category |
Date |
---|---|---|---|---|
Amikacin |
Injection |
FDA does not recognize MI00 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa |
Antibacterial |
4/21/2023 |
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 recognizes M100 MIC standard for Enterobacteriaceae. |
Antibacterial |
10/14/21 |
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 Haemophilus 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 |
Gentamicin |
Injection |
FDA does not recognize MI00 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa |
Antibacterial |
4/21/2023 |
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 |
Lefamulin |
Oral, Injection |
FDA recognizes M100 standard (MIC and disk diffusion) for Staphylococcus aureus (methicillin-susceptible isolates), Streptococcus pneumoniae, and Haemophilus influenzae. |
Antibacterial |
2/16/23 |
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; |
Antibacterial |
10/04/22 |
Piperacillin and Tazobactam |
Injection |
FDA does not recognize MI00 standard (MIC and disk diffusion) for Pseudomonas aeruginosa |
Antibacterial |
4/21/2023 |
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 |
Plazomicin |
Injection |
FDA recognizes M100 standard for Enterobacterales |
Antibacterial |
4/21/2023 |
Polymyxin 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 STIC as the drug is no longer approved in any application under section 505 of the FD&C Act (see 84 FR 47309). |
Antibacterial |
10/14/21 |
Tobramycin |
Injection |
FDA does not recognize MI00 standard (MIC and disk diffusion) for Enterobacterales and Pseudomonas aeruginosa |
Antibacterial |
4/21/2023 |