Analysis Says State Guidelines for Compounding Vary Widely

A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations.

The survey of state boards of pharmacy by the Pew Charitable Trusts is intended to see how states have adapted to the changing regulatory landscape for sterile compounding facilities following the 2014 passage of the Drug Quality and Security Act that imposed a slew of federal controls on compounders, many of which are overseen by the states.

The analysis — based on responses from 43 of the 51 pharmacy boards contacted (50 states and D.C.) — found that 34 of the states relied heavily on standards set by the U.S. Pharmacopeial Convention, either referencing them or incorporating them into their sterile compounding laws and regulations. However, 13 of these USP-focused states indicated that they only follow the USP standard partially.

The good news is that of the eight states that do not draw their sterility laws from the USP, seven indicated that pending policy changes will more closely align their approach with USP standards.

The survey also found “notable differences” in how state boards define “compounding” for regulatory purposes, with criteria ranging from the number of ingredients used to their dilution or reconstitution. These varied definitions have practical implications for the quality of compounded products shipped between states.

In that same vein, the analysis found that 28 of the 43 participating state boards do not exceed the USP standards for specialized training in sterile compounding. Ten states impose their own training requirements for licensure beyond the USP standard, while the remainder have no requirements.

Lastly, the survey showed that state regulatory bodies tend to be “uneven” in their monitoring and enforcement activity. According to the group, only 24 of the 43 participating states reported that they track the number of pharmacies performing sterile compounding.

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