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
Cefiderocol	Injection	FDA recognizes M100 minimum inhibitory concentration (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 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 Enterobacteriaceae	Antibacterial	10/14/21
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 does not recognize M100 standard for Enterobacterales	Antibacterial	5/17/22
Polymixin B	Injection	FDA does not recognize M100 standard for Enterobacteriaceae and Pseudomonas aeruginosa	Antibacterial	10/14/21
Telithromycin	Oral	FDA has removed telithromycin breakpoints as the drug has been withdrawn	Antibacterial	10/14/21

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Notice of Updates

Distribution channels: Healthcare & Pharmaceuticals Industry

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