eCFR Reference Browser

---

title: "21 CFR §317.2"

source: "https://www.ecfr.gov/current/title-21/section-317.2"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "317"

part_subject: "QUALIFYING PATHOGENS"

subpart_code: "B"

subpart_subject: "Combination Drugs"

section_number: "317.2"

section_subject: "List of qualifying pathogens that have the potential to pose a serious threat to public health."

cfr_reference: "21 CFR 317.2"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

The term “qualifying pathogen” in section 505E(f) of the Federal Food, Drug, and Cosmetic Act is defined to mean any of the following:

(a)Acinetobacter species.

(b)Aspergillus species.

(c)Burkholderia cepacia complex.

(d)Campylobacter species.

(e)Candida species.

(f)Clostridium difficile.

(g)Coccidioides species.

(h)Cryptococcus species.

(i)Enterobacteriaceae.

(j)Enterococcus species.

(k)Helicobacter pylori.

(l)Mycobacterium tuberculosis complex.

(m)Neisseria gonorrhoeae.

(n)Neisseria meningitidis.

(o)Non-tuberculous mycobacteria species.

(p)Pseudomonas species.

(q)Staphylococcus aureus.

(r)Streptococcus agalactiae.

(s)Streptococcus pneumoniae.

(t)Streptococcus pyogenes.

(u)Vibrio cholerae.

§317.2 - List of qualifying pathogens that have the potential to pose a serious threat to public health.