FDA WARNING_LETTER - Rebecca W. Allen, DVM, PLLC - December 17, 2014

On November 24, December 3, and December 17, 2014, the FDA investigated Rebecca W. Allen, DVM, PLLC, regarding drug use in veterinary practice. The investigation found that Dr. Allen caused animal drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively, due to extralabel drug use not conforming to approved uses or 21 CFR Part 530.

Specifically, Dr. Allen prescribed human drug Meloxicam Tablets, USP, and new animal drug (b)(4) (Ampicillin) for extralabel uses without meeting the requirements of 21 CFR 530.20(a)(2)(ii), (iii), and (iv). These sections require establishing extended withdrawal periods, maintaining treated animal identity, and assuring withdrawal timeframes are met to prevent illegal drug residues.

Furthermore, the extralabel prescriptions for Meloxicam and (b)(4) lacked required labeling information under 21 CFR 530.12(c) and (e). This includes specific directions for use (class/species, dosage, frequency, route, duration) and the veterinarian's specified withdrawal/discard time for food products.

The FDA acknowledged a December 30, 2014, response from Dr. Allen but deemed it inadequate, lacking specific documentation