503B – Pre-registration Consulting

The Challenge

A pharmacist seeking to build a new 503B Outsourcing Facility requested assistance in the understanding and implementation of current good manufacturing practices (cGMPs) and the FDA risk based inspection processes.

Background:  In 2012, the CDC and USFDA investigated a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free MPA steroid injections from the New England Compounding Center.  The contaminated medicines resulted in a total case count of 753 infections resulting in 64 deaths.  As a result of this event, the Compounding Quality Act was passed into law Nov 2013.  This Act created the 503A Compounding Facility and 503B Outsourcing Facility Designations.  The 503A facility is a traditional pharmacy that is overseen by the individual State Board of Pharmacy and 503B Facility is a facility that compounds sterile drugs, has no shipping restrictions, and the facility may or may not obtain a prescription for identified individual patients.

The Solution

Performance Validation provided a Principal Validation Specialist with over 20 years of GMP experience to assist the pharmacy.  As part of the solution, Performance Validation provided the following deliverables:

  • Training was conducted on FDA Risk Based Inspection Techniques
  • A review was conducted on the applicable Compliance Policy Guides for both Drug Inspection and Sterile Drug Inspection.
  • A review of the cGMPs specifically called out in the FDA Draft Interim GMP Guidance document was provided.
  • The top 10 findings listed by Code of Federal Regulation and frequency of occurrence were provided to the pharmacy. This provided a better understanding of the types of issues USFDA was identifying from previous inspections.
  • A walkthrough of the facility was conducted to assist the pharmacist in identifying potential problem areas to address prior to registration and during construction of the facility.

The Results and Benefits
The designation of the 503B Outsourcing Facility is a new category that has no prior history or experience within the traditional knowledge base of pharmacy.  Approximately 119 form 483s have been issued to compounding pharmacies as a result of inspections conducted in 2014 alone.   Prior to 2013 all compounding was conducted within the guidelines of USP and under the licensing/inspection of the State Boards of Pharmacy.

As a 503B facility, the pharmacist must still perform compounding within these guidelines.  However, the pharmacist must also comply with many new regulations such as sections of cGMPs and Adverse Event Reporting.  By providing the pharmacist with a broader understanding of what to expect in a cGMP-regulated facility, and during a FDA inspection, the pharmacist can make informed decisions and be better prepared to meet the quality and compliance expectations of an FDA licensed and regulated facility.

For more information, please contact:
Rick Van Doel
President, Performance Validation LLC
5420 W Southern Ave Suite 100
Indianapolis, IN 46241
317-248-8848 Office
317-507-0351 Cell