FDA’s 2018 Priorities for Drug Compounding

After the fungal meningitis outbreak of 2012 that killed 76 patients and injured hundreds more, Congress passed the Drug Quality and Security Act (DQSA), which, in part, tried to bring more compounding pharmacies, traditionally overseen by state boards of pharmacy, under FDA oversight.

The DQSA created a new entity, called ‘outsourcing facilities,’ that could register with the FDA and then be allowed to sell compounded products in bulk without obtaining individual, patient-specific prescriptions.

However, of the estimated 7,500 pharmacies that specialize in compounding medications, only 60-70 of the compounding pharmacies have registered with the FDA as outsourcing facilities. To ensure patient safety, the FDA and state boards of pharmacy continue to crack down on compounding pharmacies that have not registered with the FDA as outsourcing facilities and ship compounded products in bulk.

In response to this issue and others, FDA Commissioner Scott Gottlieb announced the FDA’s priority for drug compounding in 2018.

According to Gottlieb, the FDA is preparing a new policy targeting what drugs compounding pharmacies can produce that do not go through the agency’s approval process. Additionally, the FDA plans to issue draft guidance with new criteria for determining what substances can be used to produce drugs in bulk for hospitals and doctors’ offices without individual patient prescriptions. Gottlieb also noted that the FDA is preparing a new policy that will allow state boards of pharmacy more flexibility to oversee compounding pharmacies that ship compounded drugs interstate.

If you have any questions regarding pharmacy compounding, outsourcing facilities, current good manufacturing practices or state and federal pharmacy regulations, do not hesitate to contact Baer Law.