Medscape News: Who Regulates Compounding Pharmacies?
Posted Dec 31 2012 12:01am
Since the fungal meningitis health scandal that rocked the compounding pharmacy industry in 2012, there have been rumblings among legislatures and lawmakers to increase federal regulatory oversight of compounding pharmacies.
I have been following this issue because compounding pharmacies provide bioidentical hormones for hundreds of thousands of women going through perimenopause. It is an issue that I believe we need to be paying close attention. Medcape News Today has published this article and several others on this topic that I think might be of great interest to The Perimenopause Blog readers.
I do not have permission to reprint the articles in their entirety (simply because I did not request it) and so, instead, I thought I would link to the Medscape site and let you read them for yourself there. You have to open an account to have access to the articles, but it is free. It is something I highly recommend if you are interested in keeping up with medical news.
It is easy to differentiate between your local community pharmacy and a large pharmaceutical manufacturer. The pharmacy is viewed as dispensing medications to particular patients with prescriptions from a licensed provider. In contrast, the pharmaceutical manufacturer makes large batches of drug products to be distributed to pharmacy hospitals and other resellers and users of these products.
But there is another entity that falls between these: the compounding pharmacy. To be more precise, the distinctions may best be understood as different types of activities dispensing drugs, manufacturing drugs, and compounding drugs rather than merely different types of businesses. A pharmacy, which is considered a terminal distributor of dangerous drugs, may be actively dispensing, manufacturing, and compounding.
To understand why we have compounding by pharmacies, we should first understand some of the problems that patients encounter when getting prescription medications. Consider that a patient may need, for example, 15 mg of a particular medication to treat a condition. The pharmaceutical manufacturer of the medication may make only 10-mg and 20-mg tablets. To obtain a 15-mg dose, the patient may buy 10-mg tablets, cut them in half, and take 3 of the halved (5 mg) tablets. Although the math works out just fine, many patients resist this approach; they may not want to cut tablets in half or may not be able to cut tablets in half. Furthermore, splitting tablets can lead to imprecise dosing.
So, why doesn’t the pharmaceutical manufacturer make a 15-mg tablet? One reason may be money. Although a few patients may require a 15-mg dose, most patients may be treated just fine with a 10-mg or 20-mg dose; there may simply not be enough demand to justify mass production of a 15-mg tablet. At some point, the manufacturer has to draw the proverbial line and produce those products and doses that make economic sense to them.