CFR section
21 CFR 530.13(b)(4): Extralabel use from compounding of approved new animal and approved human drugs
PART 530-EXTRALABEL DRUG USE IN ANIMALS · Subpart B-Rules and Provisions for Extralabel Uses of Drugs in Animals
Key facts
| Citation | 21 CFR 530.13(b)(4) |
|---|---|
| Section | Extralabel use from compounding of approved new animal and approved human drugs |
| Part | PART 530-EXTRALABEL DRUG USE IN ANIMALS |
| Subpart | Subpart B-Rules and Provisions for Extralabel Uses of Drugs in Animals |
| Subchapter | 21 CFR E Drugs Animal |
| Product types cited | Drugs, Veterinary |
| Regulation text (excerpt) | (4) Adequate procedures and processes are followed that ensure the safety and effectiveness of the compounded product; |
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- 1–9 Warning letters citing this section
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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.