Policy Issues in Drug Compounding Debate

The Congressional Research Service (CRS) says stakeholders have mixed views on FDA guidance and communications in implementing the Drug Quality and Security Act on drug compounding, raising issues that Congress may wish to consider. In a report, “Drug Compounding: FDA Authority and Issues for Congress,” CRS says some in Congress have responded to stakeholder complaints by writing to FDA and introducing legislation that would amend certain compounding provisions in the Federal Food, Drug, and Cosmetic Act.

“In working to address the issues raised by stakeholders and maintain public health protections,” the report says, “policymakers may consider issues such as patient access, drug quality, and the necessity of compounded drugs. For patients with a legitimate medical need, preserving timely access to compounded medications has been identified as a concern by supporters of office-use compounding. However, in the context of patient safety, drug quality is also a consideration.”

The report says a third consideration should be whether pharmacies really need to compound for office-use since hospitals, clinics, and healthcare practitioners who want to keep compounded drugs in stock for office use can generally obtain non-patient specific compounded products from outsourcing facilities that are registered with FDA and subject to more stringent regulatory requirements.

CRS notes that FDA has said that allowing pharmacies to compound without a patient-specific prescription may provide less incentive for such entities to register as outsourcing facilities. And to help healthcare providers determine which outsourcing facilities compound the drugs they need for office use, FDA has published a list of the drugs that registered outsourcing facilities have produced.

The CRS report follows recent statements by CDER director Janet Woodcock that the agency’s experience under the Drug Quality and Security Act “has demonstrated a need for further improvement in compounding practices.” She said FDA investigators have found problematic conditions in the vast majority of the 425 inspections of compounding pharmacies conducted since 2012. She also said the agency has received reports of serious adverse events, including deaths, associated with improperly compounded drugs as recently as 2017.