Custom compounding provides real solutions for individuals that have a variety of needs that regular pharmacy cannot meet. It enables medications to be personalized for patients. For example, individuals with allergies to preservatives, dyes, gluten, and sugar can receive medication that can be formulated without the problematic ingredient(s). In addition, compounding pharmacists can flavor medications to make them more palatable for young children, elderly patients, and even pets. And, for patients who have difficulty swallowing pills, compounding can allow their medication to be created into a pleasant tasting liquid, or perhaps even a topical cream or gel. Compounding can also make medications that are no longer available through conventional pharmacy.
Unfortunately, legislation has been proposed that could create an environment that would restrict access to compounded medications, even when they provide the best treatment options for patients, as determined by their physicians. While the goal of the bill was to originally provide oversight of those compounding sterile products dispensed interstate for non-patient specific situations, bill S.959 allows intrusions into compounding while it excludes key areas of compounding, specifically hospitals, and does not help prevent another NECC-like tragedy.
Here are just some of the unintended consequences of the bill:
- Interrupt therapy for patients by requiring physicians and pharmacist to provide documentation to the FDA if a compounded medication is deemed “demonstrably difficult.”
- Restrict access to needed drug products by putting in place inclusive and exclusive drug product lists.
- Make it difficult to provide patients with compounded solutions for drug shortages.
- Interfere with the doctor, pharmacist, patient triad by giving the FDA authority to question the professional expertise provided by the doctor and pharmacist on behalf of the patient.
- Classify all compounds as “new drugs” which will open the door to FDA scrutiny and ultimately drive up costs for patients.
We ask that you act right now and oppose Senate Bill 959. This bill especially affects medications for hormone replacement therapy, pain, autism spectrum disorder, and pets. It’s imperative that you act today and help make sure that the millions of Americans that rely on compounded medications each year can continue to do so. Help protect your right to personalized medicine. Go to ProtectMyCompounds.com to learn more. You can send an email to your legislators from this website. Just navigate to the bottom of the page, select an issue that represents your concerns, and follow the instructions.
Thank you for your support.
Read More