§317.2. List of qualifying pathogens that have the potential to pose a serious threat to public health.
21 C.F.R. § 317.2
The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:
Acinetobacter— species.
Aspergillus— species.
Burkholderia cepacia— complex.
Campylobacter— species.
Candida— species.
Clostridium difficile.
Coccidioides— species.
Cryptococcus— species.
Enterobacteriaceae.
Enterococcus— species.
Helicobacter pylori.
Mycobacterium tuberculosis— complex.
Neisseria gonorrhoeae.
Neisseria meningitidis.
Non-tuberculous mycobacteria species.
Pseudomonas— species.
Staphylococcus aureus.
Streptococcus agalactiae.
Streptococcus pneumoniae.
Streptococcus pyogenes.
Vibrio cholerae.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 355f, 371.
Source
Source: 79 FR 32480, June 5, 2014, unless otherwise noted.