FDA WARNING_LETTER - Med Shop Total Care Inc. - November 01, 2018

The FDA issued a Warning Letter to Med Shop Total Care, Inc. following an inspection from October 15 to November 1, 2018, which identified significant violations related to the production of animal drugs for food-producing animals. The firm compounds drugs like Estradiol and Progesterone-Estradiol from bulk drug substances for use in breeding heifers, which FDA considers food-producing animals. The FDA determined these compounded products are unapproved new animal drugs under section 201(v) of the FD&C Act, as they lack general recognition of safety and effectiveness. Consequently, they are unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act. The introduction of these adulterated drugs into interstate commerce and any act resulting in their misbranding are prohibited acts under sections 301(a) and 301(k), respectively. The firm's compounding from bulk drug substances does not qualify for the extralabel use exception (AMDUCA), which is limited to approved finished drugs. This practice poses public health risks due to potential drug residues in edible tissues without established tolerances or withdrawal times. Med Shop Total Care, Inc. must respond in writing within 15 working days, outlining corrective actions to address these violations and prevent recurrence. Failure to promptly correct these deficiencies may result in legal action, including seizure and injunction.