Pew, NABP Report Finds that More State Pharmacies Comply with Compounding Best Practice Standards, Yet Continues to Advocate Against Physician Access to Drugs for Office-Use Compounding

This week, the Pew Charitable Trusts and the National Association of Boards of Pharmacy (NABP) released a report titled “State Oversight of Drug Compounding”that found that the majority of states have taken steps to make compounded drugs safer for patient use, since 2015 when Pew conducted its last survey. According to the report, states have strengthened compounding oversight by conforming to sterile compounding standards. However, the report also praises states for restricting 503A pharmacies for compounding sterile drugs for office use. Currently, 32 states require 503A traditional compounders to fully comply with sterile compounding standards issued by the United States Pharmacopeia (USP). Additionally, 39 states and the District of Columbia prohibit 503A traditional compounders from stocking sterile drugs for office-use compounding, beyond what is specified in the FDA’s prescription requirement guidance. ASCRS strongly opposes restricting 503A traditional compounders from producing sterile drugs for office-use compounding without a patient-specific prescription because 503B outsourcing facilities often do not produce drugs in the limited quantities or in ophthalmic solutions required by ophthalmologists. ASCRS will continue to advocate for regulations that ensure physician and patient access to needed medications.