Recent FDA 503 Actions

Last month the The FDA (U.S. Food and Drug Administration) was extremely busy taking actions in regards to 503B outsourcing facilities and 503A compounding pharmacies. A review of many of these FDA 503 actions indicates an increased and aggressive program aimed at both outsourcing facilities and compounding pharmacies that included numerous onsite inspections, warning letters, recalls, and other actions such as the issuing of Compounding Risk alerts. However, one case in particular may be worth taking a closer look at and discussing further. This is the conviction of pharmacy owner Paul Elmer, the founder of Indiana's only Outsourcing Facility, who was found guilty on April 11th of 2019 in federal court on ten (10) counts that he was charged with: nine (9) for adulterating compounded drugs and one (1) for conspiracy. Note that Mr. Elmer was acquitted on an Obstruction of Justice charge, plus his sentencing date has not yet been set.

The Events Leading To The Conviction

Mr. Elmer was the founder of Pharmakon Pharmaceuticals in 2003, which was initially located in Indianapolis, but was moved to Carmel, Indiana in 2008 and then finally to Noblesville in 2014. As we noted above, Pharmakon Pharmaceuticals (based out of Noblesville) was the only 503B Registered Outsourcing Facility in the State of Indiana. Many have pointed out, however, that the company shared ownership of the facility with a larger and successful LTC pharmacy named Pharmakon Long Term Care Pharmacy, Inc. (which is also based out of Noblesville, Indiana).Basically the charges centered around the pharmacy's history of manufacturing and selling medications and drugs that were both either more potent and/or less potent than what they should have been. Pharmakon compounded medications such as morphine and fentanyl at its Noblesville facility and then shipped them to hospitals throughout the USA. Examples of major hospitals that Pharmakon Pharmaceuticals supplied included the Walter Reed National Military Medical Center in Washington, D.C. and the Community Health Network in Indiana.Prosecutors presented voluminous documentation and third-party evidence that showed that over a four (4) period (between July 2013 through February of 2016), the company had received seventy (70) potency-test failure notices, proving that the drugs they shipped out (such as morphine sulfate and fentanyl) were either compounded "under dosed" or "overly potent". In one third party potency test the medications were as documented as being as much as twenty-five (25) times more potent than what they should have been. Many concerned citizens feel that the fact that the drugs were dispensed at the hospitals for use in the treatments of infants, children, geriatric and elderly patients (plus many military veterans) in affect made the case against Pharmakon take on an "elevated profile and urgency" by the FDA. Another point that was frequently discussed was the fact that Pharmakon had previously received greater than half a million dollars ($500,000) in tax breaks and other incentives from both state and local governments. The prosecutors in this case actually cross examined over 10 witnesses that primarily included former Pharmakon employees, some who testified that Mr. Elmer was always aware that his company was actually shipping dangerous drugs to many hospitals.

A Closer Look At the FDA's 503 Processes

To help everyone have a better understanding of the steps undertaken by the FDA in this process, let's take a chronological review of what took place between the FDA and the outsourcing facility before Pharmakon Pharmaceuticals was finally shut down in 2016 (and owner Paul Elmer finally being found guilty in April of this year).

1. The FDA issued 483 Forms to Pharmakon on 3/13/2014 and again on 4/8/2014.
2. These were followed up with an FDA Warning Letter on 5/21/2015.
3. Pharmakon initiated a voluntary recall of batches of "super-potent" morphine sulfate on 2/11/2016 that they had already previously shipped to hospitals across the nation. In one instance occurring in 2016, Pharmakon had shipped and distributed morphine sulfate compounded at their facility that had a potency level of over 2,400% to several hospitals in both Indiana and Illinois. One infant who received the medication actually had to be taken by an emergency helicopter to the Riley Hospital for Children in Indianapolis for care.
4. A team of four FDA investigators initiated an onsite inspection of Pharmakon Pharmaceuticals on 2/18/16, which ended on 3/16/2016 with the issuance of an FDA 483 Form to the facility as the result.
5. The FDA then issued an Amended 483 again to the facility on 3/21/2016.
6. On 4/11/2016, the FDA recommended a recall of all unexpired products and a cessation of Pharmakon's sterile compounding operations until appropriate corrective actions had been undertaken and demonstrated. The very next day (4/12/2016) Pharmakon informed the FDA that it would neither perform the recall, nor cease their sterile operations.
7. On 4/15/2016, the FDA alerted health care practitioners throughout the US to NOT utilize any sterile drug products distributed from Pharmakon Pharmaceuticals, Inc. to any patients under any circumstances.
8. On 4/18/2016, the FDA additionally began an inspection of the Pharmakon Long Term Care Pharmacy, Inc.
9. Finally, on 4/19/2016, Pharmakon issued a voluntary nationwide recall of all sterile compounded products and totally ceased compounding operations temporarily.
10. On 5/11/2016, Pharmakon Long Term Care Pharmacy was issued a 483 Form pursuant to the FDA inspection.
11. On 5/20/16, Pharmakon Pharmaceuticals resumed production of sterile compounds and medications once again.
12. On 6/16/16, a PDF of the Pharmakon Long Term Care Pharmacy 483 Form was posted to the FDA website.

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HCC is known as a national leader in pharmacy consulting. Since 1989, our network of seasoned advisers and in-house specialists have provided expert guidance across all sectors of the pharmacy industry. We work with businesses of every size – from the corner drug store to national corporations and organizations – with only one goal in mind: to improve your pharmacy’s business operations.One of the services that HCC specializes in is the development and customization of both 503A and 503B Policies and Procedures. We have nationally renowned in-house experts and consultants with proven "track records" and successful results in responding to both FDA 483 Forms and Warning Letters.We urge you to contact us today to see how our Pharmacy Consulting services can fit your needs and help you improve your business now, plus be ready for the future. With a full-time staff of experienced in-house Pharmacy Consulting specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online now or call us today at 800-642-1652 for a free consultation.