NOVARX: FDA Warning Letter (June 8, 2026)

Summary

Company

Nova Vascular LLC (dba NOVARX)

Letter number

#728290

Issue date

June 8, 2026

Subject

False & Misleading Claims/Misbranded (Telehealth)

The FDA objected to how this firm described compounded tirzepatide. For what actually differs from the brand drug: Compounded tirzepatide vs Zepbound: same molecule, different product.

FDA’s letter of June 8, 2026 to OrderlyMeds also cites its recipient for false or misleading claims about the drugs it sells.

Word for word, from the letter of June 8, 2026

This letter notifies you of our concerns and provides you an opportunity to address them. If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration. If you cannot completely address this matter within fifteen (15) business days, state the reason for the delay and the time within which you will do so.

If you are not located in the U.S., please note that drug products that appear to be misbranded may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your drug products referenced above appear to be misbranded drug products that cannot be legally sold to consumers in the U.S.

1 The semaglutide and tirzepatide products offered on your website 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 diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

2 See 21 C.F.R. § 201.1(h)(2) (“The appearance on a drug product label of a person’s name without qualification is a representation that the named person is the sole manufacturer of the product. That representation is false and misleading, and the drug product is misbranded under section 502(a) of the act, if the person is not the manufacturer of the product in accordance with this section.”); see also FD&C Act § 503(b) [21 U.S.C. § 353(b)], FD&C Act § 503B(a)(10)(A)(ii) [21 U.S.C. § 353b(a)(10)(A)(ii)]. We note that 21 C.F.R. § 201.1(a) does not apply to drug products dispensed in accordance with section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)]. However, see 45 Fed. Reg. 25760, 25765 (Apr. 15, 1980) (“…if the label of a prescription drug product dispensed by a pharmacist does contain a representation as to the manufacturer, packer, or distributor, it must comply with all the provisions of § 201.1….”). In addition, the labels of your drug products as depicted on the website do not indicate that they are dispensed under section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)], nor do they appear to comply with the requirements of section 503(b)(2) [21 U.S.C. § 353(b)(2)].

3 While an entity may elect to register with FDA as an outsourcing facility under section 503B of the FD&C Act [21 U.S.C. § 353b], this registration does not constitute FDA approval or licensure of the facility or its compounded drug products. Neither compounders operating under section 503A nor outsourcing facilities operating under section 503B undergo FDA premarket review or approval of their compounded drug products. Compounded drug products are not FDA-approved drugs; they have not been evaluated by FDA for safety, effectiveness, or quality before marketing as is required for new drug applications (NDAs) or abbreviated new drug applications (ANDAs).

Quoted word for word from the U.S. Food and Drug Administration. We assert nothing beyond what the agency published, and the full letter is at https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nova-vascular-llc-dba-novarx-728290-06082026

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Other warning letters in our database

• Peak Performance Peptides — August 24, 2026
• Zappy — February 20, 2026
• Hcg Institute — September 9, 2025
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• Usapeptidecom — February 26, 2025