Report: Majority of States Have Adopted Policies to Make Compounded Drugs Safer

WASHINGTON—Some five years after contaminated injections compounded at a Massachusetts pharmacy caused 76 deaths and 778 illnesses in a nationwide outbreak of fungal meningitis, a substantial majority of states now require state-regulated traditional pharmacies to follow robust quality standards and obtain patient-specific prescriptions. According to “State Oversight of Drug Compounding,” a report released today by The Pew Charitable Trusts and the National Association of Boards of Pharmacy (NABP), states have taken important steps to protect patient safety since Pew research first assessed their compounding policies in 2015.

Compounded drugs—made by or under the supervision of pharmacists or physicians, rather than conventional drug manufacturers—are tailored to patients whose clinical needs cannot be met by U.S. Food and Drug Administration-approved products. These compounded medications pose a higher level of risk to patients than FDA-approved drugs because they have not been tested for safety and efficacy, and are typically not made under the same quality standards. Meaningful quality standards are important for all forms of compounded drugs, including tablets, capsules, syrups, and topical creams, but rigorous standards are most critical for drugs that are injected or infused into the body and therefore must be sterile to minimize the risk of infection.

Most compounding is done by traditional compounders—pharmacists or physicians who can dispense drugs only after receiving a prescription for a specific patient. Traditional compounders are principally overseen by states. (Other compounders make bulk supplies of non-patient-specific sterile drugs for clinicians to keep on hand as “office stock.” These drugs are regulated by FDA.)

Both compounding pharmacies and physicians who compound drugs in their offices can be considered traditional compounders, but this study focused on oversight of pharmacies. The research found that a substantial majority of states have adopted policies for traditional pharmacies that are critical to ensuring patient safety:

• 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 United States Pharmacopeial Convention (USP) in its General Chapter <797>, “Pharmaceutical Compounding—Sterile Preparations."

  An additional 11 states have strong requirements on sterile compounding practice—which 10 states characterize as “equivalent to or stricter than” Chapter <797>, even if some elements are less specific. An additional four states have pending policy changes that, if passed, would require full compliance with Chapter <797> or other strong state requirements. In 2015, 26 states reported mandating Chapter <797> or equivalent quality standards for sterile compounding.

• 39 states and the District of Columbia now prohibit—through their laws or regulations, guidance, or by advising compounders to follow the federal law prohibiting the practice—traditional pharmacies from compounding sterile office stock for humans. In 2015, representatives from nearly two-thirds of state boards of pharmacy that responded to a Pew assessment allowed traditional compounding pharmacies to produce drugs without prescriptions to at least some extent.

“It’s encouraging that so many states have taken decisive steps to strengthen oversight of sterile compounding, because states play a critical role in protecting patients who rely on compounded products,” said Elizabeth Jungman, Pew’s director of public health. “This is the time for jurisdictions that have not yet adopted appropriate quality standards and office stock restrictions to join the majority that have.

“Regardless of where sterile compounding occurs,” Jungman added, “quality assurance is critical to keeping patients safe.”

In a third key area, however, the new report’s findings are less promising: Only 22 states and the District of Columbia reported routine inspections at least annually of in-state pharmacies that perform sterile compounding, down from 27 jurisdictions in 2015.

“Facility inspection is the most important tool that regulators have to ensure that facilities maintain safe compounding and storage practices,” said Jeanne Waggener, RPh, DPh, NABP president.. “Even states with limited resources can make their inspection system more effective by using a risk-based approach, in which compounding activities that pose greater potential risks to patients are subject to more frequent and rigorous inspections.”

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The Pew Charitable Trusts is driven by the power of knowledge to solve today’s most challenging problems. Learn more at pewtrusts.org.

The National Association of Boards of Pharmacy is the independent, international, and impartial Association that assists its state member boards and jurisdictions for the purpose of protecting the public health.