Regulating Drug Compounders: Opportunities Remain on Inspections, Report Says

Posted 26 February 2018 | By Zachary Brennan 

Regulating Drug Compounders: Opportunities Remain on Inspections, Report Says

In the five years since contaminated injections compounded at a Massachusetts pharmacy led to more than 70 deaths, sterile compounding oversight laws and rules have been strengthened, but there is more room for inspections and oversight at the state level, a new report from the Pew Charitable Trusts and the National Association of Boards of Pharmacy found.

Among the report’s key findings is that the majority of states now conform to best practices in two key areas: Prohibiting traditional pharmacies from compounding sterile “office stock” for human use and conforming to scientifically sound standards, such as those established by the US Pharmacopeial Convention (USP).

But the report also highlighted a lack of annual inspections of facilities that perform sterile compounding, with less than half of jurisdictions reporting that they conduct such inspections.

“Site inspections are the most important tool to assess pharmacy compliance with laws and regulations on compounding, and the national framework relies on states to inspect the vast majority of compounding activity,” Elizabeth Jungman, director of the Pew Charitable Trusts’ work on public health, wrote.


In the wake of the Massachusetts meningitis outbreak, the Drug Quality and Security Act (DQSA) was instituted at the federal level to clarify the distinction between traditional compounders (i.e. state-regulated pharmacies or doctors compounding patient-specific drugs) and federally regulated outsourcing facilities that compound drugs for clinicians to keep on hand as “office stock.”

Traditional compounders must meet state quality standards, while outsourcing facilities must meet standards similar to what pharmaceutical manufacturers adhere to.

But as the report notes, compounded drugs “pose a higher level of risk to patients than FDA-approved drugs because they have not been tested for safety and efficacy, have not gone through an approval process, and are typically not made under the same quality standards as approved products are.”


In terms of strengthening sterile compounding oversight since a 2015 assessment, the report found that 32 state boards of pharmacy “require traditional pharmacies that compound sterile drugs for humans to be in full compliance with the widely recognized quality standards established by the USP in its General Chapter <797>, ‘Pharmaceutical Compounding—Sterile Preparations.’”

Thirty-nine states and the District of Columbia also prohibit traditional pharmacies from compounding sterile office stock for human use, the report noted, though 11 states have office stock policies (many predating the DQSA) that are not aligned with federal statute.

As far as recommendations, the report calls on states to require compounders to comply with applicable USP standards and to align with federal law if compounders produce office stock. States should also require inspectors of sterile compounding pharmacies to be educated and trained to examine the type of facility they are reviewing, the report adds.

State Oversight of Drug Compounding

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