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 21, 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 21, 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 |
Cefepime |
Injection |
FDA recognizes M100 susceptible-dose dependent standard (MIC and disk diffusion) for Enterobacterales |
Antibacterial |
6/21/2023 |
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 |
Fluconazole |
Injection, Oral |
FDA recognizes M27M44S susceptible-dose dependent standard (MIC and disk diffusion) for Candida species. |
Antifungal |
8/10/2023 |
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 |
Rezafungin |
Injection |
FDA identified STIC (MIC and disk diffusion) for C. albicans, C. glabrata, and C. tropicalis. FDA has reviewed STIC (MIC) for C. parapsilosis, and the M27M44S standard is recognized. FDA identified STIC (disk diffusion) for C. parapsilosis. |
Antifungal |
4/18/2023 |
Sulbactam and Durlobactam |
Injection |
FDA identified STIC for Acinetobacter baumannii-calcoaceticus complex. |
Antibacterial |
05/25/2023 |
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 |