About 15 years ago, Big Pharma and the FDA pushed legislation through Congress designed to control and restrict what a compounding pharmacy could do. In addition, the legislation contained a clause restricting the ability of a compounding pharmacy to advertise its products. Essentially the legislation said that it could advertise that it compounds but could not advertise what it compounds. Imagine Congress telling General Motors it can advertise that it is a manufacturer but not advertise that it makes cars and trucks.
After multiple lawsuits the matter of advertising went to the Supreme Court and the Court found that the restriction of advertising violated the first amendment and was therefore unconstitutional. That should have ended it, but Congress chose to do nothing. The “advertising ban” remained in the legislation leaving compounding pharmacies in limbo.
As a result of the tragic events surrounding the New England Compounding Center debacle, Congress amended the law to create a special category of manufacturer / compounder, designed to increase oversight by the FDA and hopefully stop such tragic events from occurring again. In addition, Congress finally got around to striking the advertising ban from the bill.
President Obama recently signed the legislation. So now a compounding pharmacy can advertise not only that it compounds medicines but exactly what medicines it compounds. This is a great step forward for compounding and for patients and medical practitioners.
You must also understand that manufacturers (Big Pharma) and compounding pharmacies function at two different levels of patient care. Manufacturers make large volumes of medication intended for the general population and thus are required by the FDA to demonstrate that their products are safe and effective all across the general population. Whereas compounding pharmacies make a specific medication for one specific patient at a time, working closely with that patient and the patient’s medical practitioner to create a medication designed to help only that patient. Thus, a compounder can make no claims of safety and efficacy because of the very nature of the product. But rest assured it is the compounder’s responsibility as well as the medical practitioner’s to do no harm. Both do everything possible to assure that the medication is safe. Both also use their years of experience to come up with a compound that is effective in each specific patient. It is also the case that virtually 100% of the chemicals used to create a particular medication and dosage form are approved for pharmaceutical use in humans by the FDA.
You will begin to see compounders advertise what they compound as well as what treatment category the active ingredient(s) fall under. For example you might see that a compounder makes “ibuprofen topical cream” and that this compound’s active ingredient, ibuprofen, is an antiinflammatory and pain reliever. What you should not see is that this topical medication is used to treat tennis elbow or other joint pain. That would be making an unsubstantiated claim of efficacy.
We at Key Compounding Pharmacy are here Just for You! Hopefully you will never need our services but if you do you can rest assured that we will compound the safest and most efficacious medication possible for you!