rxshopmd.com

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

your website offers drug products for sale in the U.S. and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID‐19***1*** and a variety of other diseases such as HIV.

Passage 2

these products are unapproved new drugs introduced into interstate commerce in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 355(a)].

Passage 3

these products are misbranded drugs under section 502 of the FD&C Act [21 U.S.C. § 352].

Passage 4

No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.

Passage 5

In the description of “Hivus‐LR (Lopinavir + Ritonavir 200/50 mg),” your website states, “The medication known mostly as Kaletra is based on Lopinavir + Ritonavir. It is a HIV medication that is used in a combination therapy. In 2020, it have[sic] been also tested and included in the protocols of treatment of the novel coronavirus COVID‐19.”

Passage 6

under the “Generic Hivus‐LR (Lopinavir + Ritonavir 200/50 mg) guide” heading, www.rxshopmd.com states, “The medication sold under the brand name Kaletra is used as a part of a complex therapy of HIV and AIDS. Since March 2020, it is also approved for the treatment of the novel coronavirus, COVID‐19...”

Passage 7

Because the aforementioned drug is a prescription drug intended for a condition that is not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for the intended use. Consequently, the labeling for this drug fails to bear adequate directions for use, causing it to be misbranded under section 502(f)(1) of the FD&C Act.

Passage 8

By offering this drug for sale to U.S. consumers, www.rxshopmd.com is causing the introduction of a misbranded drug into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

Passage 9

By offering the aforementioned drugs without requiring a prescription, www.rxshopmd.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)].