CFR section

21 CFR 530.12(c): Labeling

PART 530-EXTRALABEL DRUG USE IN ANIMALS · Subpart B-Rules and Provisions for Extralabel Uses of Drugs in Animals

Key facts

Citation 21 CFR 530.12(c)
Section Labeling
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) (c) Any directions for use specified by the veterinarian, including the class/species or identification of the animal or herd, flock, pen, lot, or other group of animals being treated, in which the drug is intended to be used; the dosage, frequency, and route of administration; and the duration of therapy;

At a glance

  • 10–99 Inspections citing this section
  • 1–9 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.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data

Browse all CFR sections cited by the FDA