FDA WARNING_LETTER - Marks Marine Pharmacy - August 23, 2012

On August 23, 2012, the FDA issued a Warning Letter to Mark's Marine Pharmacy in Vancouver, B.C., for illegally promoting and selling clobazam, an unapproved and misbranded new drug, to U.S. patients and healthcare professionals. The pharmacy violated sections 502(f) and 505(a) of the FD&C Act [21 U.S.C. §§ 352(f) and 355(a)], and prohibited acts under sections 301(a) and 301(d) [21 U.S.C. §§ 331(a) and 331(d)].

The FDA stated that clobazam is an unapproved new drug because no approved application under section 505 of the FD&C Act exists for any clobazam product other than Lundbeck’s ONFI Tablets, approved October 21, 2011. Mark's Marine Pharmacy sent letters to U.S. patients and physicians advertising their ability to supply Canadian clobazam for non-Lennox-Gastaut Syndrome patients, despite ONFI's specific approval for that condition.

Furthermore, the clobazam product was deemed misbranded under section 502(f)(1) [21 U.S.C. § 352(f)(