Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, March 17, 2015
FDA Warning Letters Leroy B. Horst Jr. 3/9/15-Our investigation found that you administered the new animal drug (b)(4) to a dairy cow identified with NY State Metal Tag #(b)(4), without following the indication for use as set forth in the approved product labeling. Also, our investigation found that you administer (b)(4) to your cows without following the route of administration and indication for use as stated in the approved labeling. Your extralabel use of (b)(4) and (b)(4) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of (b)(4) resulted in illegal residues, in violation of 21 C.F.R. 530.11(d). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).
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