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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.
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Our Bloggers
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Paula Gallagher
Paula is a highly qualified and experienced nutrition counselor on the staff at Village Green.
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Margo Gladding
Margo's impressive knowledge base is the result of a unique blend of educational and professional experience.
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Dr. Neal Barnard
Dr. Barnard leads programs advocating for preventive medicine, good nutrition, and higher ethical standards in research.
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Dr. Joseph Pizzorno
Dr. Joseph Pizzorno, ND is a pioneer of integrative medicine and a leading authority on science-based natural medicine.
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Debi Silber
Debi is a registered dietitian with a master’s degree in nutrition, a personal trainer, and whole health coach.
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