Politwoops

Compounded drugs serve an important medical need for patients who can’t use an FDA-approved medication. In today’s #FDA #SUNDAYTWEETORIAL, I’m going to talk about what FDA is doing to preserve access to appropriately compounded drugs while protecting patients from serious risks. https://t.co/3wbotaDsKV

In drug compounding, ingredients are combined, mixed or altered to create a sterile or non-sterile medication tailored to a patient - such as those with an allergy who need a drug without a certain dye or a child who can’t swallow a tablet and needs medicine in a liquid form. https://t.co/ehe20yaZIx

But compounded drugs, which aren’t FDA-approved, may pose serious risks if not produced properly, potentially resulting in contamination or medications that do not possess the strength, quality or purity they are supposed to have https://t.co/UE5agszlNC https://t.co/cOXVMzFKAx

In 2012, contaminated compounded steroid drugs were injected into patients in multiple states. Hundreds of people developed fungal meningitis and other infections, and scores died. https://t.co/BOmCaTrfdZ

The outbreak illuminated the need for improved compounding practices, more robust oversight, close federal/state collaboration, and a clear legal framework with tools for FDA to address unlawful compounding practices.

Also apparent was the need to better define and regulate compounding facilities acting as large-scale drug manufacturers, outside FDA’s routine oversight. Congress responded with the Drug Quality & Security Act (DQSA). https://t.co/pvwWt95myj https://t.co/qzoTQoMuAB

The DQSA enabled FDA to fully implement & enforce existing law about traditional compounders – licensed physicians/licensed pharmacists in state-licensed/federal facilities - and created a new compounding category, outsourcing facilities. https://t.co/mgaAbTUOfP

Pharmacy compounders produce medicines for an individual patient with a valid prescription and states continue to have day-to-day oversight. https://t.co/wIr4ehsys0

Outsourcing facilities may engage in larger-scale, nationwide distribution with the potential to expose more patients to risks. They must meet FDA’s CGMP requirements, be inspected by FDA according to a risk-based schedule, report adverse events and meet other conditions.

Since 2013, we have made great strides in DQSA implementation through robust inspection and enforcement, policy development, oversight and stakeholder outreach. We have also convened advisory committee meetings to get scientific advice and collaborated with the states. https://t.co/JTioZQUSSO