# 21 CFR § 211.34: Consultants

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-211.34

## Section

- **Citation:** 21 CFR § 211.34
- **Heading:** Consultants
- **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 C—DRUGS: GENERAL > PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS > Subpart B—Organization and Personnel

## Text

Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide.

## Nearby sections

- [21 CFR § 211.1 § 211.1 Scope.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.1.md)
- [21 CFR § 211.3 § 211.3 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.3.md)
- [21 CFR § 211.22 § 211.22 Responsibilities of quality control unit.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.22.md)
- [21 CFR § 211.25 § 211.25 Personnel qualifications.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.25.md)
- [21 CFR § 211.28 § 211.28 Personnel responsibilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.28.md)
- [21 CFR § 211.34 § 211.34 Consultants.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.34.md)
- [21 CFR § 211.42 § 211.42 Design and construction features.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.42.md)
- [21 CFR § 211.44 § 211.44 Lighting.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.44.md)
- [21 CFR § 211.46 § 211.46 Ventilation, air filtration, air heating and cooling.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.46.md)
- [21 CFR § 211.48 § 211.48 Plumbing.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.48.md)
- [21 CFR § 211.50 § 211.50 Sewage and refuse.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.50.md)
- [21 CFR § 211.52 § 211.52 Washing and toilet facilities.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.52.md)
- [21 CFR § 211.56 § 211.56 Sanitation.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.56.md)
- [21 CFR § 211.58 § 211.58 Maintenance.](https://www.frixlaw.com/law-library/statutes/ecfr-21-211.58.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-211.34. Check the current official text before relying on it. Not legal advice.