CFR section
21 CFR 530.13(b)(2): 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)(2) |
|---|---|
| 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) | (2) There is no approved new animal or approved new human drug that, when used as labeled or in conformity with criteria established in this part, will, in the available dosage form and concentration, appropriately treat the condition diagnosed. Compounding from a human drug for use in food-producing animals will not be permitted if an approved animal drug can be used for the compounding; |
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