Title 21

SECTION 530.5

530.5 Veterinary records.

§ 530.5 Veterinary records.

(a) As a condition of extralabel use permitted under this part, to permit FDA to ascertain any extralabel use or intended extralabel use of drugs that the agency has determined may present a risk to the public health, veterinarians shall maintain the following records of extralabel uses. Such records shall be legible, documented in an accurate and timely manner, and be readily accessible to permit prompt retrieval of information. Such records shall be adequate to substantiate the identification of the animals and shall be maintained either as individual records or, in food animal practices, on a group, herd, flock, or per-client basis. Records shall be adequate to provide the following information:

(1) The established name of the drug and its active ingredient, or if formulated from more than one ingredient, the established name of each ingredient;

(2) The condition treated;

(3) The species of the treated animal(s);

(4) The dosage administered;

(5) The duration of treatment;

(6) The numbers of animals treated; and

(7) The specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs, or any food which might be derived from any food animals treated.

(b) A veterinarian shall keep all required records for 2 years or as otherwise required by Federal or State law, whichever is greater.

(c) Any person who is in charge, control, or custody of such records shall, upon request of a person designated by FDA, permit such person designated by FDA to, at all reasonable times, have access to, permit copying, and verify such records.

---