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 Peter & Dawn Erlwein 3/9/15-Our investigation found that you administered (b)(4) to a bob veal calf identified with back tag (b)(4) (sale tag (b)(4)) without following the slaughter class as directed in the approved labeling. Your extralabel use of (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 an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Your extralabel use of a fluoroquinolone ((b)(4)) in an unapproved production class is prohibited by 21 C.F.R. 530.41(a)(10). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug 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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