# 21 C.F.R. § 211.28 (2026): Personnel responsibilities

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P211_S211_28

## Section

- **Citation:** 21 C.F.R. § 211.28 (2026)
- **Heading:** Personnel responsibilities
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 211 / Subpart B / § 211.28: § 211.28   Personnel responsibilities.

## Text

(a) Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination. (b) Personnel shall practice good sanitation and health habits. (c) Only personnel authorized by supervisory personnel shall enter those areas of the buildings and facilities designated as limited-access areas. (d) Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

## Nearby sections

- [21 C.F.R. § 211.22 (2026) § 211.22   Responsibilities of quality control unit.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P211_S211_22.md)
- [21 C.F.R. § 211.25 (2026) § 211.25   Personnel qualifications.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P211_S211_25.md)
- [21 C.F.R. § 211.28 (2026) § 211.28   Personnel responsibilities.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P211_S211_28.md)
- [21 C.F.R. § 211.34 (2026) § 211.34   Consultants.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P211_S211_34.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P211_S211_28. Check the current official text before relying on it. Not legal advice.