WARNING LETTER
ivsupplyclinic.com
MARCS-CMS 672780 —
February 09, 2024
Product:
Drugs
Recipient:
ivsupplyclinic.com
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
Secondary Issuing Offices
United States
FROM: The United States Food and Drug Administration
RE: Notice of Unlawful Sale of Misbranded Drugs to United States Consumers Over the Internet
DATE: February 9, 2024
WARNING LETTER
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your website at the Internet address www.ivsupplyclinic.com and has observed that your website introduces into interstate commerce misbranded drugs in violation of sections 301(a), 301(k), and 503(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(k), and 353(b)].
As discussed below, FDA has observed that www.ivsupplyclinic.com introduces into interstate commerce misbranded intravenous (IV) fluid drug products. There are inherent risks to consumers who purchase misbranded drugs. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. In addition, the IV fluid products marketed by www.ivsupplyclinic.com are intended for injection, which heightens the public health concern associated with these products and may further contribute to the potential for patient harm. Injectable drug products can pose a serious risk of harm to users because they are delivered directly into the bloodstream and bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis. Accordingly, FDA requests that www.ivsupplyclinic.com cease offering any misbranded drugs for sale to U.S. consumers. This is critical to protect the public from harm.
Misbranded Drugs:
Certain products offered for sale by www.ivsupplyclinic.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body.
For example, www.ivsupplyclinic.com offers IV fluids marketed as “Lactated Ringer’s and 5% Dextrose Injection USP” 1000mL manufactured by Baxter Healthcare Corporation. Lactated Ringer’s and 5% Dextrose Injection, USP manufactured by Baxter Healthcare Corporation is an FDA-approved drug indicated for use as a source of water, electrolytes and calories or as an alkalinizing agent. Using images of FDA-approved Lactated Ringer’s and 5% Dextrose Injection, USP manufactured by Baxter Healthcare Corporation indicates that the product sold on your website is intended for the same use as the FDA-approved product -- as a source of water, electrolytes and calories or as an alkalinizing agent.
Your website also offers IV fluids marketed as “0.9% Sodium Chloride Injection USP” 50mL manufactured by Baxter Healthcare Corporation. 0.9% Sodium Chloride Injection, USP manufactured by Baxter Healthcare Corporation is an FDA-approved drug indicated for use as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures. Using images of FDA-approved 0.9% Sodium Chloride Injection, USP manufactured by Baxter Healthcare Corporation indicates that the product sold on your website is intended for the same use as the FDA-approved product -- as a source of water and electrolytes and for use as a priming solution in hemodialysis procedures.
In addition, www.ivsupplyclinic.com offers IV fluids marketed as “5% Dextrose Injection USP” 1000mL manufactured by Baxter Healthcare Corporation. 5% Dextrose Injection manufactured by Baxter Healthcare Corporation is an FDA-approved drug indicated for use as a source of water and calories. Using images of FDA-approved 5% Dextrose Injection manufactured by Baxter Healthcare Corporation indicates that the product sold on your website is intended for the same use as the FDA-approved product -- as a source of water and calories.
FDA-approved Lactated Ringer’s and 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and 5% Dextrose Injection products manufactured by Baxter Healthcare Corporation are limited by their approved applications to use under the supervision of a practitioner licensed by law to administer such drugs. Therefore, these products are prescription drugs as defined in section 503(b)(1)(A) of the FD&C Act [21 U.S.C. § 353(b)(1)(A)], because, in light of their toxicity or potential for harmful effects, the method of their use, or the collateral measures necessary for their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them. By 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. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
FDA 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.” By removing the “Rx only” symbol from the labels of the aforementioned prescription drugs, www.ivsupplyclinic.com misbrands the drugs under section 503(b)(4) of the FD&C Act [21 U.S.C. § 353(b)(4)]. The alteration, mutilation, destruction, obliteration or removal of the whole or any part of the labeling of a drug is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act.
By 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)].
FDA is sending this warning letter to www.ivsupplyclinic.com because of the inherent risks to consumers who purchase misbranded drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including, without limitation, seizure and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
If you are not located in the U.S., please note that products that appear to be misbranded drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov.
Sincerely,
/S/
S. Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
Content current as of:
03/05/2024
Regulated Product(s)
Drugs