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The problem of compounding pharmacies.

Posted by ed_uk2010 on October 5, 2014, at 6:42:19

In reply to Re: Being affected by Klonopin shortage!, posted by Fred23 on October 3, 2014, at 14:09:42

>One poster in one of these threads says the raw material for Klonopin is available, so maybe a compounding pharmacy could make a custom batch?

True. There must be some raw material around (clonazepam) given that a variety of manufacturers are still selling generic clonazepam tabs. There are so many reasons for a shortage of the final product though.

The issue with compounding pharmacies is that few are likely to have the quality and variety of equipment and analytic techniques that even the smaller generics manufacturers possess. In addition, none would have any bioavailability data for their specially manufactured products. In contrast, all generics companies possess such data and on the basis of a dossier submitted to the FDA have been granted a license to market their product. They also receive inspections from the FDA. I do not know how the quality of manufacturing at small compounding pharmacies is controlled but it will, almost inevitably, be less consistent than at pharmaceutical companies.

The outcome could be that a compounded product would be far more expensive, less consistent and something of an unknown quantity compared with an established generic. If one generic didn't suit, trying a generic from a different manufacturer would be the first step. Most common drugs are sold by a few different suppliers at least, so there are usually some options available.

My opinion of compounding is that it's an essential pharmacy service.... but only for cases where no licensed alternative exists, or for some clear reason none of the licensed versions are suitable. A good example is that for some meds, all licensed versions contain the same dye, and for someone with a proven allergy to that substance, a compounded med might be needed. Fortunately, even in this situation it's still often possible to find a suitable alternative drug which doesn't contain the offending substance - usually a drug with a very similar mechanism of action. This can then avoid the need for compounding.

Another use for compounding is to make liquid medicines for those with swallowing difficulties, when no approved medicine is available in liquid form.

 

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URL: http://www.dr-bob.org/babble/20140914/msgs/1071862.html