Compounding Pharmacists & NECC 
Posted by Carlos on Oct 11, 2012

When we studied pharmacy, compounding was in integral part of our education.

English: A small and simple white mortar and p...

Back in the day…

On a weekly basis, we compounded just about everything: creams, lotions, elixirs, suspensions, parenterals, capsules (by hand), etc., etc. Balances, graduates, mortars and pestles, spatulas…these were all part of the trade that we used pretty regularly.

Of course, those days are largely gone. Pharmacists rarely receive prescriptions to compound something. There are a few reasons for this. First, physicians find that the need for something customized is not as great as is once was (with some exceptions, like dermatology). Second, insurance companies are not as willing to cover compounded prescriptions. And third, pharmacists rarely have enough time to devote to the craft of compounding an elegant lotion.

So it is with some sense of nostalgia and trepidation that we read this story about the New England Compounding Center and their release of contaminated preparations of methylprednisolone.

To catch up on this story, see:

> Fred Silverman’s discussion, including the KV angle

> Video asking if pharmacies should be held to FDA standards

> Reuters coverage of the story

This entire situation is disturbing. First, we question whether NECC was operating as a pharmacy or as a manufacturer. As a pharmacy, the laws are pretty clear. Pharmacies are not allowed to compound anything unless it’s in response to a written order from a physician. There are nuances as you go from state to state, but in reality it’s very simple: No Rx, no compounding.

Hospitals have a bit more leeway in that they can prepare customized dosages of parenterals, for example, in anticipation of orders being placed during the day. They have the flexibility to use historical trends and prepare small batches with short expiration dates (usually hours), knowing that the orders will come later. Large nursing homes which have an internal pharmacy also have similar leeway.

These two scenarios are quite different from NECC, which sounds like it was acting as a manufacturer. The Reuters story suggests that Massachussets authorities share this concern:

Officials have expressed concern that NECC and other compounding pharmacies may have violated laws that allow them to alter drugs based on the needs of individual patients rather than produce large batches of medication for sale. NECC shipped more than 17,000 vials of the steroid methylprednisolone acetate, used mainly for back pain.

Clearly there is more to this story. For example, it’s unclear if the 17,000 vials shipped is one batch?
But this really doesn’t matter. Unless NECC has 17,000 prescriptions sitting there waiting to be filled with compounded, parenteral methylprednisolone, then they are a manufacturer, and hence subject to FDA oversight. So they were manufacturing without a license.
If they were operating as a “pharmacy” under Massachusetts law, then they have possibly violated State laws regarding compounding in advance without a prescription.
There may also be Federal Laws regarding the shipment of these products if they were “manufactured” without a license to manufacture parenterals.
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