CFR section
21 CFR 610.10: Potency
PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS · Subpart B-General Provisions
Key facts
| Citation | 21 CFR 610.10 |
|---|---|
| Section | Potency |
| Part | PART 610-GENERAL BIOLOGICAL PRODUCTS STANDARDS |
| Subpart | Subpart B-General Provisions |
| Subchapter | 21 CFR F Biologics |
| Product types cited | Biologics, Drugs, Other_Regulations |
| Regulation text (excerpt) | Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in § 600.3(s) of this chapter. |
At a glance
- 1–9 Inspections citing this section
- None Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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.