CFR section
21 CFR 58.83: Reagents and solutions
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart E-Testing Facilities Operation
Key facts
| Citation | 21 CFR 58.83 |
|---|---|
| Section | Reagents and solutions |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart E-Testing Facilities Operation |
| Subchapter | 21 CFR A General |
| Product types cited | General |
| Regulation text (excerpt) | All reagents and solutions in the laboratory areas shall be labeled to indicate identity, titer or concentration, storage requirements, and expiration date. Deteriorated or outdated reagents and solutions shall not be used. |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.