FOIA was updated today with 12 new actions, but I’m not able to summarize those today due to time constraints. I will do that as soon as I can, but I wanted to rush this out because I just learned that Paul Elmer, the founder of Indiana’s only Outsourcing Facility to date was found guilty last night in federal court on 10 counts. nine for adulterating compounded drugs and one for conspiracy. He was acquitted on the Obstruction of Justice charge. Sentencing date is not yet set.
I’ve included a hyperlink to the article that appears in today’s Indianapolis Business Journal and I urge you all to click it and read the entire story.
I’ve covered the circumstances surrounding this event several times over the years, including the following bold/italic copy-and-paste of the recap I wrote in a newsletter from June 2016:
There is only one 503B Registered Outsourcing Facility in the state of Indiana so far, which is Pharmakon Pharmaceuticals of Noblesville. This company shares ownership with a large and successful LTC pharmacy called, Pharmakon Long Term Care Pharmacy Inc, also of Noblesville.
You may remember the sequence of events surrounding Pharmakon Pharmaceuticals recently which occurred as follows:
- Pharmakon Pharmaceuticals was issued 483s on 3/13/2014 and on 4/8/2014, which were followed by a Warning Letter on 5/21/2015;
- On 2/11/16, Pharmakon initiated a voluntary recall of a lot of super-potent morphine sulfate which had been labeled as 0.5 mg/ml;
- On 2/16/16, FDA was alerted of serious adverse events in three infants in two hospitals – one in Indiana and one in Illinois – that were associated with the super-potent compound;
- On 2/18/16, a team of four investigators from FDA began an inspection of Pharmakon Pharmaceutical, which ended on 3/16/16 with the issuance of a 483;
- On 3/21/16, an Amended 483 was issued;
- On 4/11/16, FDA recommended a recall of all unexpired products intended to be sterile and a cessation of sterile operations until appropriate corrective actions had been taken;
- On 4/12/16 the company informed FDA that it would neither cease sterile operations, nor perform a recall of all sterile products within expiry;
- On 4/15/16, FDA alerted health care practitioners not to use sterile drug products from Pharmakon Pharmaceuticals, Inc.;
- On 4/18/16, FDA began an inspection of Pharmakon Long Term Care Pharmacy, Inc.;
- On 4/19/16, Pharmakon Pharmaceuticals issued a voluntary nationwide recall of all sterile compounded products and ceased compounding operations temporarily;
- On 5/11/16, Pharmakon Long Term Care Pharmacy was issued a 483 at the end of its inspection that began on 4/18/16; and
- On 5/20/16, Pharmakon Pharmaceuticals resumed production of sterile compounds
- Today, 6/16/16, a pdf of the Pharmakon Long Term Care Pharmacy 483 was posted to the website