Drug Safety Project

Pharmaceutical compounding is the creation of medications for patients whose clinical needs cannot be met by commercially available products approved by the Food and Drug Administration. Pharmacists have always tailored medications to specific clinical situations; that practice remains an important part of health care. Over time, however, compounding has expanded and evolved. Today, some compounders do not dispense drugs to individual patients but instead produce large quantities for hospitals and other health care providers that need supplies of medications not made by pharmaceutical manufacturers or not made in the specific form, combination, or strength that patients may require. Examples of these products include epidural analgesics used during childbirth, intravenous nutrition for patients who cannot eat and digest normally, and preservative-free versions of sterile products for patient populations such as newborns who may be harmed by certain ingredients that extend a product’s shelf life.

The way compounding is regulated has also changed, though sometimes not quickly enough. This was tragically evident when compounded drugs produced at a single Massachusetts facility caused a nationwide outbreak of fungal meningitis in 2012 and 2013 that sickened more than 750 people and killed more than 70. In response, lawmakers and regulators enacted federal- and state-level reforms to protect patient safety. The federal Drug Quality and Security Act (DQSA) passed on a bipartisan basis in 2013, clarifying FDA authority over compounders that produce bulk supplies of non-patient-specific drugs and requiring those facilities to apply certain protocols to prevent contamination and other potentially dangerous problems.

At the national level, Pew’s drug safety project supports enforcing and implementing the DQSA in a way that preserves access to safe compounded medications for patients who need them while helping to protect those patients from the risks of drugs produced under dangerous and illegal conditions. At the state level, Pew supports efforts to improve inspections of compounding facilities and coordination across state lines.

Previously, the project’s work to ensure the safety of the pharmaceutical manufacturing and distribution system focused on drug serialization and tracking.