In the wake of changing regulatory landscape, including the Federal Drug Quality and Security Act (DQSA) hospital pharmacies have been struggling with compliance issues surrounding their compounding of sterile preparations for their patients. The need to comply with the overlapping regulations including USP <795>, USP <797>, USP <800> and other OSHA & NIOSH requirements hospitals, out-reach clinics & associated physician’s practices have accelerated most health system’s plans to invest in their cleanroom operations. But no matter what the organization’s commitment to its infrastructure, the growing trend is to outsource more and more of these formulations to FDA registered 503B outsourcing compounders.

With this service model shift has come some challenges for all involved. Not the least of which is, how do your customers or prospective customers measure your program against the prevailing regulation or other providers so that the pharmacy’s administration and the hospital’s C-suite is satisfied that all these standards are being met?

Even in the best-case scenario, when you can get a prospect or customer to tour your service location, they cannot be expected to fully absorb all the data needed to assure compliance to their own requirement that you, as an extension of their compounding program, be fully in compliance with all the prevailing standards. So how can you overcome this hurdle? By providing these customers with a "standard yardstick" provided by a third party, you can open a dialogue where you can discuss the quality and safety features of your program.

LDT Health Solutions is proud to offer LDT-CV™, our Compounder Verification program. Subscribers to the LDT-CV™ annually and independently verify that all prevailing statues, rules, and regulations for their CSP program are being met. The program is designed for both national and local providers to see how they comply with the known industry standards and to communicate these quality indicators to their customers and prospects in a way that is supported by an independent third party, qualified to do so.

INDEPENDENT REVIEW ORGANIZATION (IRO) SERVICES POWERED BY LDT-CV™

LDT can also provide the service of LDT-CV™ directly to a Health System, Independent Hospital, Physician Group, or any healthcare organization interested in purchasing, partnering with, or obtaining these critical outsourced preparations from a 503B provider. Acting as an Independent Review Organization (IRO) with the expertise, experience, and knowledge to assist your organization in making an informed critical decision with respect to the provision of these compounded preparations LDT can, acting as your agent, properly survey your prospective 503B candidate or current provider to assure that all regulatory requirements are being met.

Please contact us today for further information and a demonstration of the power of LDT’s Compounder Verification Program.