JCB Laboratories Supports New Compounding Legislation

JCB Laboratories has long been an advocate for more stringent guidelines for high risk sterile compounding so we applaud Congress for the passage of the Drug Quality and Security Act (DQSA).  The passage of this bill is the result of a bipartisan effort between the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pension Committee.  Now  that the President has signed this piece of legislation, we will be following it closely and look forward to seeing the final regulations.

DQSA creates a new category of compounders, called Outsourcing Facilities, that will be regulated by the FDA.  JCB Labs has the expectation that the DQSA will benefit our industry by leading to a higher level of integrity in compounded sterile products and therefore increasing patient safety.  Since the tragedy in New England a little over a year ago, it was clear that Congress saw a need to address this issue.  Choosing to register with the FDA to become an Outsourcing Facility is voluntary.  It it is our expectation that providers will overwhelmingly choose sterile compounders that commit to the more stringent regulations and register with the FDA.  

We hear from providers every day that  sterile compounders fill a vital role in making sure critical medications are available when they  need them. With a higher standard in place, and regulations that allow non-patient specific ordering, quality compounded medications can be readily available to providers.  To show our support for the new legislation, JCB has started the registration process and we expect to be listed as an Outsourcing Facility very soon

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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