Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1By offering the aforementioned drugs without requiring a prescription, www.ivsupplyclinic.com jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act.
Passage 2FDA has also observed that www.ivsupplyclinic.com has altered the pictures of the labels of the Lactated Ringer’s and 5% Dextrose Injection 50mL, 0.9% Sodium Chloride Injection 1000mL, and 5% Dextrose Injection 1000mL products manufactured by Baxter Healthcare Corporation and marketed on your website to remove the “RX ONLY” symbol and references to dosing as directed “BY A PHYSICIAN.”
Passage 3By offering these misbranded drugs for sale to U.S. consumers, www.ivsupplyclinic.com is also causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].