The American Society of Health-System Pharmacists (ASHP) is encouraged by the provisions included in draft legislation released by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to address regulatory gaps in the oversight of compounding outsourcers.
“Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, PharmD, FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a “compounding manufacturer” that would be overseen by the Food and Drug Administration (FDA).”
The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers.
The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies.
ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline.
Source: ASHP
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