By Ashley A. Noble and Richard Cauchi
In the wake of a 2012-2013 national outbreak of meningitis linked to contaminated compounded medicine, state lawmakers are taking a close look at the systems and standards needed to protect patients.
The vast majority of drugs sold in the United States are manufactured by companies in factories far from where consumers have their prescriptions filled. Each drug is produced uniformly on a mass-scale. Pharmaceutical manufacturers are regulated by the Food and Drug Administration (FDA).
However, some pharmaceutical products are not made by manufacturers, but by compounding pharmacies. Compounding pharmacies compound, or mix, drugs for consumer use, often on-site.
Compounding pharmacies can create customized doses and mixes of drugs, which may be necessary or desirable for a number of reasons. For example, if a patient had an allergy to a component of a manufactured pharmaceutical, or required a dose that is not manufactured for sale, a compounding pharmacy would make customized pharmaceuticals to meet the patient’s needs. In fact, until the mid-20th century, most, if not all, prescription drugs were mixed by a pharmacist. Today, drugs mixed by compounding pharmacies account for an estimated 1 percent to 3 percent of all drugs sold in the United States.
The compounding landscape is complex, and over time has grown to include plants operating at high volumes. While new federal legislation brings some compounders under FDA oversight and stricter standards—the same that apply to drug manufacturers—states are still the primary regulator of compounding, a traditional pharmacy practice.
The Pew Charitable Trusts has commissioned a report, "Quality Standards for Large Scale Sterile Compounding Facilities." The report, by Clinical IQ, provides an updated road map, it chronicles the dramatic changes in drug compounding over recent decades and describes quality measures needed to ensure safety when compounding occurs on a commercial scale.
As detailed in the report, although traditional compounding is primarily regulated by the states, not all compounders under state oversight are operating in a traditional manner—preparing custom medicines for individual patients.
Some businesses produce large volumes of identical compounded products, either to supply doctors’ offices and clinics or because they prepare products in batches and dispense them as prescriptions are received. When a contaminated batch of drugs has the potential to affect hundreds of patients, robust quality standards help protect the public’s health.
Today, many states reference quality standards set by the United States Pharmacopeia for safe sterile drug compounding (widely cited as “USP Chapter <797>”). But the report points out that this standard was created for traditional compounding activities, and maintains it is not sufficient for high-volume operations. The report encourages the USP to update <797>—currently under revision—to reflect compounding at different scales. In the meantime, states continue to face decisions about oversight.
Since 2013, NCSL has tracked more than 30 pieces of legislation in 14 states on this issue. NCSL also maintains the webpage State Regulation of Compounding Pharmacies. The web page contains information on laws and legislation that reflect state actions to regulate compounding pharmacies.
NCSL will continue to monitor this issue.
Ashley Noble, research analyst II with NCSL’s Health program and Dick Cauchi, program director with NCSL’s Health program work on a variety of issues in healthcare, including finance, pharmaceuticals, and diabetes.