New Pew Report Urges States to Decide on Compounding Standards
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow.
The report from the Pew Charitable Trusts makes these recommendations to state agencies overseeing compounding operations in hopes of better aligning individual state policies with federal ones and the U.S. Pharmacopeial Convention standards.
The report — “Best Practices for State Oversight of Drug Compounding” — recommends that states “require traditional compounding pharmacies to comply, at a minimum, with all applicable USP standards.” This USP-centric outlook for governance also extends to out-of-state compounders that ship to their state.
Additionally, the report recommends that states inspect nonsterile compounding facilities every two years and sterile ones annually, although the report’s authors acknowledge that staffing and funding constraints may make this unfeasible. In such cases, the report suggests that state authorities adopt a risk-based approach to prioritizing inspections.
The FDA has worked closely with state pharmacy boards in recent years as it has stepped up enforcement activities against drug compounders that don’t meet sterility requirements.
The agency issued guidance in August 2015 on when to register as a compounder. In general, compounded drugs are exempt from GMP requirements if the products are for a specific patient with a prescription, or are produced in limited quantities by a pharmacist. Compounders are allowed to distribute 5 percent of their prescription orders to other states, but must enter into agreements with the FDA to distribute larger quantities.
The Pew report also suggests that compounding pharmacists be required to undergo special training through either continuing education courses or certification programs.
Additionally, the report presses states to develop specific licensure requirements for sterile compounding operations, including pre-licensure inspection and set quality standards for sterile compounders.
Other recommendations include:
- State inspections be unannounced;
- A mechanism for identifying facilities that engage in sterile compounding;
- Holding physicians who compound to the same quality and reporting standards as other compounding facilities;
- A means of requesting reports from traditional compounders on the number and volume of products sold or dispensed in the state; and
- Tools to ensure that serious adverse events are reported by compounders within 24 hours.
Most of these recommendations were limited to traditional compounding facilities, rather than larger facilities that are classified as outsourcing compounders. For those facilities, states can rely on FDA oversight.
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