Just when you thought it was safe to go back into the water, a school of hungry sharks is seen circling just off shore.  I am sure most of you have seen clips of the investigation on the TV show “20/20” into counterfeit drugs entering the US and some of the claimed suppliers of “cheaper” Canadian drugs (here).  Well, the FDA posted its activity associated with the some unregistered wholesalers that target doctors’ offices and clinics offering discount drugs.  In addition, FDA has sent letters to doctors and clinics that may have purchased counterfeit or unapproved drugs.

FDA notes that:

Under the Drug Supply Chain Security Act, as of January 1, 2015, all health care providers who dispense or administer prescription drugs to patients are required to purchase their prescription drug products only from authorized trading partners licensed by or registered with the state or federal government, as applicable. This will help ensure that these prescription drugs are purchased from legitimate sources who are subject to oversight by the state or federal government.  To verify a wholesale drug distributor is licensed in the state(s) where it is conducting business, see Verify Wholesale Drug Distribution Licenses (here)

The FDA notice on their Drug Supply Chain integrity site (here) outlines actions they have recently taken on distributors that have introduced counterfeit drugs and unapproved drugs, and described the criminal cases against some of the offenders.

The FDA posting also gives tips about how to spot counterfeit products (including drugs, biologics, and medical devices.  Every purchaser of pharmaceutical products and devices should take note of this activity, because, what has been proven time and time again is, if a deal looks too good to be true, it usually is.  Manufacturers should also be vigilant and take special note of certain complaints about products that may indicate that they might not be legitimate.  After all, it is your good name and the safety of the American public you are protecting.