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503B HUMAN DRUG OUTSOURCING

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JCB Labs Blog

FDA and State Registration for Outsourcing Facilities

Posted By Brian Williamson on Fri, May 16, 2014 @ 11:05 AM

The passing of the Drug Quality and Security Act (DQSA) in November of 2013 was one of the most significant events in the compounding industry in decades.  The DQSA came to fruition after many months of debate and controversy over who had authority and jurisdiction over sterile compounding pharmacies. The result was that a sterile compounding pharmacy could voluntarily register with the FDA as a 503B Outsourcing Facility.  According to the DQSA, this type of registration allows a sterile compounding pharmacy to ship products via interstate commerce without the need for specific patient prescriptions.  However, it does place the pharmacy squarely under the jurisdiction of the FDA and subjects the facility to current Good Manufacturing Practices (cGMP).  cGMP are the regulations that large pharmaceutical manufacturing firms must adhere to in their daily practices.  Complying with cGMP can be a daunting task and not every sterile compounder will elect to register as an Outsourcing Facility.  

In reality, after 6 months under the DQSA, very little has changed. There are still many things evolving regarding federal and state enforcement of the Act.  It will likely take several more months to determine how the FDA and State Boards of Pharmacy will work together to enforce compliance.  It is clear that many State Boards of Pharmacy will require registered Outsourcing Facilities to register in their state as either drug distributors, wholesalers, manufacturers or, in some cases, all three!  In addition, some states are requiring that Outsourcing Facilities have a pharmacy license in their state, while the DQSA stated that an Outsourcing Facility didn’t even have to be a pharmacy?!  

What is not clear is whether the FDA registration will override State Boards of Pharmacy requirements.  JCB is actively pursuing all appropriate registration in each state to ensure that we stay in compliance and are able to continue shipping product to health care providers. This process will take some time but we have made significant progress. We started with states that require prescriptions for products being administered to patients within a healthcare facility in an effort to help them become more efficient as soon as possible.  JCB is contacting current clients in those states where the appropriate registration has been obtained and approved.  Clients have been very excited and relieved.  We will continue to keep you updated on any changes that occur related to individual state boards or with the FDA.    

Tag: 503B, outsourcing facility, FDA, DQSA, State Boards of Pharmacy,