# 21 CFR § 317.2: List of qualifying pathogens that have the potential to pose a serious threat to public health

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-317.2

## Section

- **Citation:** 21 CFR § 317.2
- **Heading:** List of qualifying pathogens that have the potential to pose a serious threat to public health
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** 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

## Text

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.

## Nearby sections

- [21 CFR § 315.1 § 315.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.1.md)
- [21 CFR § 315.2 § 315.2 Definition.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.2.md)
- [21 CFR § 315.3 § 315.3 General factors relevant to safety and effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.3.md)
- [21 CFR § 315.4 § 315.4 Indications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.4.md)
- [21 CFR § 315.5 § 315.5 Evaluation of effectiveness.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.5.md)
- [21 CFR § 315.6 § 315.6 Evaluation of safety.](https://www.frixlaw.com/law-library/statutes/ecfr-21-315.6.md)
- [21 CFR § 317.2 § 317.2 List of qualifying pathogens that have the potential to pose a serious threat to public health.](https://www.frixlaw.com/law-library/statutes/ecfr-21-317.2.md)
- [21 CFR § 329.100 § 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.](https://www.frixlaw.com/law-library/statutes/ecfr-21-329.100.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-317.2. Check the current official text before relying on it. Not legal advice.