Access to Compounded, Repackaged and Low-Volume Treatments
Access to sight-saving treatments remains paramount to ophthalmology’s patients. The Food and Drug Administration in January released new draft guidance on repackaged biologics. It proposes a pathway for outsourcing facilities to set longer beyond-use dates, which should preserve access for our profession. However, while larger facilities would most likely be able to meet stringent, proposed testing requirements, smaller compounders could find these requirements difficult to meet.
What the Academy is doing
Based on conversations with outsourcing facilities and other stakeholders, the Academy endorsed the FDA’s plan for expanding biologic beyond-use dates. We are urging the FDA to adopt this revised proposal, which we’ve impacted through years of education and advocacy to agency leaders.
While we support the FDA’s proposed pathway to longer beyond-use dates, we still want clarifications on access. We’ll continue to support the needs of compounding facilities because they are an important partner as we deliver best-quality care to our patients.