kubapharm.com

Selected passages from the FDA letter

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

Passage 1

DEA has determined that you are not in possession of a modified DEA registration authorizing you to engage in such activity. Accordingly, your actions constitute a violation of U.S. law, which are subject to criminal penalties and civil enforcement.

Passage 2

you knowingly or intentionally use the Internet to advertise the sale of controlled substances by directing prospective buyers to Internet sellers of controlled substances who do not possess a valid modified DEA registration. You do not possess a valid modified DEA registration authorizing such activity, and your actions do not fall into the exceptions of 21 U.S.C. § 843(c)(2)(C). Therefore, your website(s) is operating in violation of U.S. law, which may be enforced through criminal penalties and civil enforcement.

Passage 3

By offering the aforementioned drug without requiring a prescription, www.kubapharm.com jeopardizes patient safety and misbrands the drug 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)]. By offering this drug for sale to U.S. consumers, www.kubapharm.com is also 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)].