APR 25, 2019
Academy Amplifying Positive Developments for Federal Compounding Policy
The Academy is taking new steps in the next few weeks to ensure continued access to important compounded, office-use treatments. We’re mustering support for legislation that would address existing issues obtaining these drugs. The Academy also is preparing to represent our profession during a Food and Drug Administration workshop in which stakeholders will discuss revised policies aimed at facilities’ access to office stock from outsourcers.
Congressional legislation would improve timely access
The Academy is again endorsing a recently reintroduced bipartisan proposal in the U.S. House of Representatives to let traditional compounding pharmacies distribute these drugs without a patient-specific prescription in states that allow office-use compounding.
The bill is sponsored by Reps. Morgan Griffith, R-Va., and Henry Cuellar, D-Texas. It would help to ensure ophthalmology patients have timely access to treatment, especially when urgent care is required.
Aid our efforts: Ask your congressional lawmaker to cosponsor legislation on office-use compounding.
FDA brings stakeholders together to discuss office-stock issues
At a public workshop next month, the FDA will discuss policies aimed at expanding access to office stock from outsourcing facilities in the context of revised federal guidelines. During the May 21 meeting, which will be webcast live, stakeholders will explore how the revised draft guidance would affect outsourcing facilities producing drugs requested for office stock, filling smaller orders of these products and providing products with beyond-use-dating that meets prescribers’ requests.
A second event slated for June will allow stakeholders to present before the FDA’s senior officials.
The Academy and its physician leaders will participate in both to ensure that our profession’s needs are met. We’ll cite our ongoing difficulties obtaining compounded treatments, including antiviral drugs, such as ganclycovir and foscarnet, that are used to treat retinal or anterior segment infections.