Pillars of Success for 503Bs

What makes for a successful 503B Outsourcing Facility?

1. cGMPs – To be successful, the facility and its owners and operators need to have a solid foundation and understating of the cGMPs that are applicable to their operation. As of 15 April 2016, 47 facilities have registered as a 503B Outsourcing Facility; each of these facilities has received at least 1 FDA inspection.  100% of these facilities received a form 483 at the conclusion of the inspection indicating a failure in one or more elements of the cGMPs.  Clearly, there is a lack of knowledge or understanding surrounding the cGMPs.
2. Pharmacy Practice – many of the foundational elements in the cGMPs are also included in USP 797, or basic pharmacy practice. Review of the deficiencies identified from the FDA cGMP inspections are not acceptable under traditional pharmacy practices or USP 797.  As stated in a recent warning letter – regardless if a pharmacy is operating as a traditional pharmacy (compounding on a individual prescription basis), or as a 503b Outsourcing Facility (compounding without individual prescriptions), section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies.
3. Leadership, Management, and Ethics. As Peter Drucker stated “Management is doing things right; Leadership is doing the right things” ref. Essential Drucker: Management the Individual and Society.  Given the inspection failure rate, and that some of the identified conditions do not meet basic pharmacy practice is there a fundamental gap in leadership?  Leadership sets the tone that the organization follows – Are we as Drucker stated doing the right things to be successful as a 503B Outsourcing Facility?

While undoubtedly there may be more elements that contribute to the overall success of the organization the three pillars described above are critical based on my experience in review of multiple Form 483s, Warning Letters, and discussions with pharmacy industry professionals.