CFR section
21 CFR 226.58(d): Laboratory controls
PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES · Subpart C-Product Quality Control
Key facts
| Citation | 21 CFR 226.58(d) |
|---|---|
| Section | Laboratory controls |
| Part | PART 226-CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES |
| Subpart | Subpart C-Product Quality Control |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Drugs |
| Regulation text (excerpt) | (d) A determination establishing that the drug components remain uniformly dispersed and stable in the Type A medicated article(s) under ordinary conditions of shipment, storage, and use. This may consist of a determination on a Type A medicated article(s) of substantially the same formula and characteristics. Suitable expiration dates shall appear on the labels of the Type A medicated article(s) to assure that the articles meet the appropriate standards of identity, strength, quality, and… |
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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.