Jo Prang - Comment

I am a small-fry, rural town compounding pharmacist. We are one of a few in our area for several states around us. Most of our compounds are hormones, and we strictly follow USP 795 and 797 guidelines on all our compounding. The largest batch of anything we've ever made in our sterile room is a batch of 25 vials of Sod Bicarbonate 8.4% because there was such a shortage and desperation surrounding the shortage. We dutifully waited for our test results to return for both potency and sterility from Eagle Labs before releasing even a single vial. We do not have a sales force calling on doctors, nor do we mail out promotional information. We have a website, but we are simply a compounding pharmacy. I cannot imagine that the FDA in its current form could possibly regulate every compounding pharmacy in the nation. There are some that do not even have a clean room. For those of us who do, it's more of an expense to have one than it is of making a profit. We use it primarily to make emergency eye antibiotics for patients who without immediate treatment would lose their eyesight. There is no window for testing for potency or sterility, but the items are refrigerated and a short expiriation date is applied according to USP 797 guidelines. They are patient specific and ordered by a physician. If I had to wait for FDA approval, that could be tragic. The categories shou;d be 1) Hospitals 2) traditional compounding pharmacies and 3) non-traditional, big lot pharmacies. I believe the FDA should be in charge of "non-traditional, or mulit-batching" pharmacies along with state supervision for all. My proposal would be to have each board of pharmacy assemble a panel of experts in compounding in their state, and have them advise the inspectors and help write state board of pharmacy rules pertaining to compounding in each state. I am a member of PCCA, IACP, APhA and NCPA, so I have been following this issue carefully, as I believe compounding is necessary for good health practices.