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
Thursday, April 16, 2020
FDA Warns Two Firms Marketing Unapproved Chloroquine Phosphate Animal Drug Products
Today, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) issued warning letters to Fishman Chemical of North Carolina, LLC, and Dr. G’s Marine Aquaculture, which distribute chloroquine phosphate products intended to treat disease in aquarium fish.
To be legally marketed, animal drug products must have an approved new animal drug application, conditionally approved new animal drug application, or listing on the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species. Chloroquine phosphate intended to treat disease in aquarium fish has not been approved, conditionally approved, or indexed. Therefore, it is an adulterated drug under the Federal Food, Drug & Cosmetic (FD&C) Act. Animal feed containing chloroquine phosphate to treat aquarium fish is also an adulterated drug under the FD&C Act, while food containing chloroquine phosphate to treat aquarium fish is an adulterated food. Introduction of an adulterated drug or food into interstate commerce is a violation of the FD&C Act.