{"data":{"id":"us/21-cfr-317.2","jurisdiction":"us","citation":"21 CFR 317.2","heading":"List of qualifying pathogens that have the potential to pose a serious threat to public health.","body":"The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:\n(a) Acinetobacter species.\n(b) Aspergillus species.\n(c) Burkholderia cepacia complex.\n(d) Campylobacter species.\n(e) Candida species.\n(f) Clostridium difficile.\n(g) Coccidioides species.\n(h) Cryptococcus species.\n(i) Enterobacteriaceae.\n(j) Enterococcus species.\n(k) Helicobacter pylori.\n(l) Mycobacterium tuberculosis complex.\n(m) Neisseria gonorrhoeae.\n(n) Neisseria meningitidis.\n(o) Non-tuberculous mycobacteria species.\n(p) Pseudomonas species.\n(q) Staphylococcus aureus.\n(r) Streptococcus agalactiae.\n(s) Streptococcus pneumoniae.\n(t) Streptococcus pyogenes.\n(u) Vibrio cholerae.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER D—DRUGS FOR HUMAN USE","PART 317—QUALIFYING PATHOGENS"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"934f0792c08503b8a205270f1145139edb39f6e6fda0f76460cf9ada0369d906","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-317.1","next":"us/21-cfr-320.1"},"notice":"GroundRules: Original legal text. Not legal advice."}