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ASHP Urges FDA to Make Changes to Compounding Guidances Released in April 2016


On July 18, ASHP submitted comments strongly urging FDA to make revisions to the three draft compounding guidances published in April 2016. Compounding regulation has long been a priority issue for ASHP. “ASHP and our members have been leaders in ensuring that compounded preparations are safe for the patients we serve,” said ASHP Chief Operating Officer and Senior Vice President of the Office of Policy, Planning and Communications Kasey K. Thompson, Pharm.D., M.S., M.B.A. “In a highly regulated environment overseen by CMS, state Boards of Pharmacy, state health departments, various accrediting bodies, and others, we need guidance that is tailored to ensure that hospital and health systems can continue to provide high-quality, effective, and efficient care to the patients they serve.”
ASHP’s comments touch on all three guidance documents but focus most heavily on the draft guidance for hospitals and health systems (the “Hospital and Health System Guidance”). Specifically, ASHP strongly recommends that FDA remove the Hospital and Health System’s arbitrary 1-mile radius limitation on distribution of compounded medications due to its potential negative impact on access and quality. “We applaud FDA’s efforts to create a sound regulatory framework for large-scale compounding manufacturers,” added Thompson. “However, it is important that FDA not create situations where patient care is negatively impacted.”
ASHP suggests replacing the 1-mile limitation, which would prevent hospitals and health systems from supplying non-patient-specific compounded medications to related healthcare facilities more than 1 mile away, with time-based standards derived from USP chapters <797> and <800>. Such an approach would protect patient health and safety, while limiting the amount of product created and ensuring that product is used in a timely fashion.
ASHP’s comments also request that FDA reconsider its broad proposed definition of “facility” under 503B, which could hinder the development of 503B outsourcing facility programs. Finally, ASHP notes that some of FDA’s proposed compounding documentation requirements may create compliance difficulties in hospital and health-system settings.
Thompson noted that ASHP will continue to engage fully on compounding issues, stating “ASHP will be working closely with FDA officials and other stakeholders to help ensure that Congress’s intent with the Drug Quality and Security Act is preserved without causing unintentional disruptions in patient care.”
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