Compounded medications can be an important tool in providing individualized care. The FDA 1
defines drug compounding on their website “as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient.” These compounded drugs can be lifesaving for those who need them. For example, a patient who is allergic to the coloring added in a medication can simply have a compounding pharmacy make the medication without the coloring. The medication can also be changed to a liquid form rather than a pill and flavoring added as needed. Now granted, these changed medications are not those that were studied prior to receiving FDA approval for manufacturing. That means that compounded medications do come with their own set of risks and are not FDA approved.
There are examples of when compounding pharmacies cut corners on safety and patients paid the price. This suggests a need to better regulate compounding pharmacies, which is
exactly why the FDA is going through a process right now to do just that. However, that process has come with some unfortunate side effects. Current compounding laws and regulations are worded in such a way that a physician who mixes loose herb components to make an herbal tea consisting of 3 or more herbs would be classified as a compounding pharmacy. That means that any practice that prepares teas, tinctures, glycerites, or uses IVs or injectables with more than 2 ingredients falls under compounding laws and regulations 2 . In most instances this means preparing those substances in a clean room under an ISO 5 laminar flow hood. For
many small practices this can be an undertaking they aren’t prepared to take on. They must either hope to fly under the radar or discontinue use of compounded medications. There is also considerable misunderstanding, and many continue to operate out of ignorance.
Now compounding has a new problem. The FDA review process has largely ignored herbs and
vitamins. Likewise, medications that already have an FDA approved equivalent are being removed. As a result, over 240 substances will no longer be available for compounders to use whether that is in a tincture, tea, or an IV preparation. What that translates into is a significant loss in patient options for treatment. Say goodbye to your tinctures. Say goodbye to allergen free medications.
While it is important to ensure the safety of products produced by compounding pharmacies, currently they are taking that mandate too far. Fortunately, there are many people banding together trying to preserve patient choice to use compounding pharmacies and medications. Among the initiatives to preserve compounding substances there is a citizens petition 3,4 , a go fund me 5 , and most recently legislation (HR1959) 6 .
If these issues are important to you or directly effect you and your loved ones, please consider taking an active part in protecting access to these invaluable tools.