America’s approach to drug compounding changed dramatically in 2013 with the enactment of the Drug Quality and Security Act (DQSA) and the creation of Section 503B outsourcing facilities. Even as the DQSA continues to be implemented by the U.S. Food and Drug Administration (FDA) seven years later, the landscape for drug compounders, hospitals, and patients is shifting again – this time as a major national outsourcing pharmacy exits the marketplace.
This sudden exit has left many hospital pharmacy directors looking for ways to ensure they have on hand the life-saving and life-sustaining therapies their patients need. Access to medicines is also being complicated by the spread of the coronavirus, forcing hospital pharmacists to prepare for potential shortages. However, the solutions for filling these supply chain gaps should never come at the expense of quality and patient safety.
Despite the changing landscape, CAPS® (Central Admixture Pharmacy Services, Inc.) has established a legacy of safety by providing hospitals and their patients with the highest quality compounded therapies for nearly 30 years. This commitment to quality and safety is why CAPS endorsed the DQSA in 2013, and why we work closely with the FDA as it fully implements the law.
CAPS’ focus on quality and safety is also why we support the FDA’s policy for 503B outsourcing facilities to only compound from FDA-approved, commercially available products, rather than bulk drug substances. This policy allows outsourcers to compound from bulk drug substances only if a drug is listed on FDA’s shortage list or if there is an FDA-recognized clinical need. We believe the policy is essential to ensuring the safe supply of compounded drugs.
It’s also essential because bulk drug substances – many of which originate overseas – are not subject to the same oversight as FDA-approved drug products, which undergo a pre-market review for safety, effectiveness, and quality. Compounding from bulk drug substances is a higher risk process which undermines the drug approval process and may increase future drug shortages.
The FDA’s policy on bulk drugs compounding is a critical step forward to protecting patients. But regulators must do more – especially at a time when marketplace uncertainties could put patients at risk. That’s why we have requested that FDA accelerate its process for reviewing bulk drug substances nominated to be included on the agency’s clinical need list. This would more quickly close the loophole some outsourcers use to compound from bulk drugs. Further, we believe the FDA must clearly communicate its policy on bulk drug compounding to strongly emphasize that hospitals and pharmacists should not purchase and dispense products compounded from bulk drugs when a drug compounded from an FDA-approved alternative exists.
In the face of marketplace changes, CAPS will continue our work to prepare safe and effective therapies for the patients we serve. Patient safety and well-being has always been our highest priority – one that is shared by the hospitals we partner with. We will also continue supporting policies and practices to ensure that compounded therapies are prepared to the highest standards of patient safety, and we encourage others to join in this effort. Learn more at www.CAPSPharmacy.com.