FDA WARNING_LETTER - American Pharmacy Group

The FDA issued a Warning Letter to American Pharmacy Group for offering unapproved new drugs and misbranded drugs for sale on multiple websites, including rxgreenovernight247.net and discreetdelivery.net. The products violate sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act.

Specifically, the websites sell hydrocodone and acetaminophen 10/500 mg, which is an unapproved new drug under section 201(p) and 505(a) of the FD&C Act. There are no FDA-approved applications for hydrocodone products containing 500 mg of acetaminophen, as the FDA requested manufacturers limit acetaminophen to 325 mg per tablet due to liver injury risks and withdrew approvals for higher strengths in 2014. Additionally, FDA-approved hydrocodone and acetaminophen products carry a boxed warning for serious risks like addiction, respiratory depression, and liver failure.

The product is also misbranded under section 502(f)(1) because it lacks adequate directions for use by a layperson, as it is a prescription drug requiring professional supervision. Its sale violates section 301(a) of the FD&C Act. The FDA expressed concern about the sale of hydrocodone products given the opioid abuse epidemic.

The FDA requires immediate cessation of marketing these violative drug products