CFR section
21 CFR 530.13(b)(5): 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)(5) |
|---|---|
| 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 | Veterinary |
| Regulation text (excerpt) | (5) The scale of the compounding operation is commensurate with the established need for compounded products (e.g., similar to that of comparable practices); and |
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