It was more than 4 decades ago that I considered starting my own compounding pharmacy. It was an idea hatched during a meeting among Drs. Joseph Letteri, Lawrence Brennan (both were nephrologists practicing at the Nassau County Medical Center), Shelly Fialkoff, and me. Both Drs. Letteri and Brennan were gracious in offering their time and input to a young tyke like me.

We were considering a means to fund the marketing of a new dialyzer. No, the dialyzer was not going to be part of the pharmacy operations. But, the pharmacy would supply dialysate (the salt water solution used in the therapy) to hospitals. The profits from that company would fund the dialyzer business. Back then, there wasn’t a complete dialysis industry like there is now. And, dialysate was sold primarily by small pharmaceutical houses around the US. We were going to offer our product in just one state, at the outset.

While we never consummated (applications filed, designs completed) that concept (the dialyzer was licensed to another firm), I still followed the industry. (I also used that knowledge and expertise for the pharmaceutical/medical device manufacturing entity that we did develop later on.) And, I was very interested in reading how the pharmacy in Massachusetts created such havoc with patients.

You see, each of the compounding pharmacies are registered with their respective state boards, and are subject to their regulations. A compounding pharmacy is supposed to produce drugformulations that are not available on the marketplace, hence the term compounding. They may add various drugs together, provide a drug in a different manner (dissolving a compound into an IV bag or converting it into an injectable formulation). A licensed pharmacist is required, and s/he combines, mixes, or alters ingredients in response to a prescription from a physician to meet the needs of a patient. And, since the pharmacy is licensed in only certain states, those are the ones where the drugs can be sold (since the prescription must be valid in the state).

It was clear that the Massachusetts firm, the New England Compounding Center, was pushing the envelope at best- but more probably breaking the law by shipping products all over the US. It did get the attention of the US Food and Drug Administration, though- which began (finally) inspecting the various larger compounding facilities, those that operate across state lines. But, it should also clear to the public that the FDA tends to look at process and not product.

To the FDA, a sterile product is one that is made in a “clean facility”, one that is maintained to be free of contamination. But, sterile products can be made in less stringent environments, by processing the product though filters that remove microbes, by subjecting the product to sterilization and de-pyrogenation. So, when the FDA cites some of these compounding facilities as not meeting the FDA standards, I tend to examine the facts a little closer. Like- is the pharmacy producing products that have demonstrable contamination, or it is that the clean room is just not so clean?

As for me, I would much prefer getting my drugs and devices from a facility that insures that the final product is sterile- and not that the room where they make it is. Because it’s the former that keeps me protected, and the latter only makes it easier for an agency to inspect.

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