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 October 14, 2021, the following standards are no longer recognized:

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing. 29th ed. CLSI supplement M100. Wayne, PA: Clinical and Laboratory Standards Institute; 2019.

Clinical and Laboratory Standards Institute (CLSI). Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard. 2nd ed. CLSI guideline M24-A2. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.

As of October 14, 2021, with certain exceptions, 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.

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.

Updates by Drug:

Drug	Route of Administration	Action Taken	Therapeutic Category	Date
Azithromycin	Oral, Injection	For Neisseria gonorrhoeae, FDA has reviewed STIC and concludes no changes are needed at this time. Rationale	Antibacterial	10/14/21
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
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
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
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
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