Legacy Ranch #2 – FDA Warning Letter, Oct 8, 2015

On September 30 and October 08, 2015, the FDA inspected Legacy Ranch #2, a dairy operation in Pixley, California. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the extralabel use of the new animal drug (b)(4) (sterile penicillin G procaine, injectable suspension).

Specifically, Legacy Ranch #2 administered (b)(4) to dairy cows without adhering to the dosage per injection site and withdrawal period specified in the veterinarian's label directions. This constituted an extralabel use of the drug, which is only permissible under the FD&C Act if it complies with sections 512(a)(4) and (5) and 21 C.F.R. Part 530, including being by or on the lawful order of a licensed veterinarian within a valid veterinarian/client/patient relationship. The FDA found that the extralabel use of (b)(4) was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a).

This non-conformance with approved labeling and 21 C.F.R. Part 530 caused the drug to be unsafe under section 512(a) of the FD&C Act and adulterated under section 501(a)(5). Legacy Ranch #2 is