This is a very common question that we receive at Collier Compounding from patients, doctors, nurses, and even other pharmacies.
I believe that the people asking this question recognize the value of compounding and believe we offer a beneficial service that can meet patients’ needs. Undoubtedly, I agree with them. Compounding does offer unique solutions and cost effective options that meet unique needs that are simply not available with many commercial products.
However, there are a couple of primary rules that we MUST follow when determining if we can compound a medication:
Rule #1: We cannot make a copy of a commercially available product.
Recently, I received a call from a nurse at a local doctor’s office. The medication that the doctor had prescribed for the patient was not covered by the patient’s insurance. That meant the cost of the medication for the patient was going to be over $200! The nurse called me and asked if we could compound the drug instead. Looking at the medication, I knew the ingredients to make the medication were available to order, but because the drug was still available commercially (although expensive) we were not allowed to make it.
The reason for this is because the company that has brought the commercial medication to market has spent a lot of money to do so, and making a copy of it would be infringing on their patent…a big no-no.
What we can do in certain situations is to make an alternative to the commercial product that is significantly different from the commercial product. Significantly is the key word here and creates the primary question of what does “significantly” entail. Unfortunately, there isn’t a clear cut answer, as the answer could differ depending on if you are speaking to a compounding pharmacist, a manufacturer, or a regulator.
Here’s a well-accepted example of a compound being significantly different. A patient is prescribed a very common medication for an infection that is readily available commercially. However, the patient has an allergy to lactose (which is a common filler used in commercial products). The only commercial products available all contain lactose as a filler. In this instance, we would be allowed to compound the medication without using lactose for the patient, because due to the allergy, the commercial product is not an option for them. We would document the allergy on the prescription as the reason for needing to compound the medication.
Rule #2: We can make a copy of a commercially available product IF…it’s not currently available.
If a commercial medication is not available to order, meaning it is back-ordered from available suppliers, compounding can step in to fill the gap until the commercial product is available again so patients don’t have to go without their medication. As always, we must document that the medication is unavailable to order prior to filling the medication.
In the not too distant past, there was a very common vitamin injection that became unavailable for a period of time. Although common, only a couple of companies produced it for sale. When one of the companies had manufacturing issues, the other company was not able to keep up with the demand on the market. At this point, compounding pharmacies were able to supply this medication to patients to avoid patients being left untreated.
As you may have gathered, there are a lot of rules and regulations that compounding pharmacies and pharmacies in general must abide by in order to stay on the right side of the law. As pharmacists, we are charged with making the best decisions we can for our patient’s health while maintaining an ethical and lawful stance with regards to regulations. It’s a responsibility we take very seriously.
If you ever have a question about whether or not a medication can be compounded, don’t hesitate to contact our Collier Compounding location. Our knowledgeable staff will discuss options and help you find the best option that is also the most cost-effective for the patient. Sometimes there is an alternative medication that we compound that will meet your need, sometimes there is a better option that is not a compound. Regardless, our staff will help you find the best product for you, even if it’s not a product we carry.