Knowledge Center

FDA News

by William Stuart

Increased Regulations And Inspections Of Sterile Compounding Pharmacies

In light of recent events from the New England Compounding Center Pharmacy tragedy, both state and federal agencies have increased regulations and inspections of sterile compounding pharmacies. Specifically, the FDA has initiated a significant program of inspecting sterile compounding pharmacies nationwide. For reference, pharmacies are regulated by their respective State Boards of Pharmacy.

Notwithstanding this, the FDA has begun its own program of inspecting facilities. I have been aware of and paid significant attention to the FDA’s inspections and observations of other sterile compounding pharmacies. Within my industry, a common topic of discussion among the more astute compounding pharmacies is not if the FDA will inspect you, but when.

In June of this year, the FDA inspected Hartley Medical. Although I cannot say this was a particularly enjoyable visit, it was paradoxically both a stressful and enlightening event – and exceptionally comprehensive. The inspection occurred over four days and covered a wide range of questions that the FDA is asking compounding pharmacies.

I felt that due to our advance preparation, we were already aware of many of their concerns and observations, so we were already actively engaged in the process of making changes at Hartley Medical. During the visit, we received several key suggestions and even a few compliments – all of which made our first visit from the FDA a positive experience.

At the conclusion of the inspection, the FDA will issue a Form 483. This form discusses the FDA’s observations. I want to reiterate that these are observations only. The process is they have made observations and they would like you to address them. Addressing their observations is voluntary to some extent, but some observations for some pharmacies may be so egregious that the pharmacy will have to make some difficult decisions due to the scope of their practice and procedures.

If you become aware that your compounding pharmacy has received an FDA inspection and subsequent Form 483, I strongly encourage you to engage with your compounding pharmacist to discuss the 483 and their next steps. If you have further interest, I recommend you Google: “FDA inspections compounding pharmacies 2015.”