Understanding the FDA’s Role in Compounded Medications

February 6, 2024

By: Belmar Pharmacy

There is a misconception in healthcare that only FDA-approved medications deserve a place in trusted patient care. While commercially available drugs are considered standard practice, compounded medications hold considerable value as well. Compounding pharmacies and the pharmaceutical ingredients they use are highly regulated. 

Commercial medications are limited to the exact formulation approved by the FDA. The strength, dosage form, and fillers of an FDA-approved drug cannot be changed to accommodate a specific patient’s needs. If a person requires a different dose, form, or is sensitive to the inactive ingredients in a commercial product, that patient may benefit from using a compounding pharmacy. Compounding pharmacies can personalize the medication to meet a patient’s exact needs.  

Due to the wide range of doses, dosage forms, and formulations, compounded medications are not subjected to the same FDA approval process as commercial drugs. The FDA may not approve finished compounded prescriptions, but they certainly play an important role in what goes into them.  

Belmar Pharmacy purchases the ingredients for our customized compounds from FDA registered drug facilities. Our supplier qualification program ensures all manufacturers and wholesalers providing our pharmaceutical ingredients are registered and certified by the appropriate regulating bodies. We go above and beyond by confirming that each of our supplier’s sources are also compliant. You can feel confident in Belmar Pharmacy’s products because the FDA has oversight over all active pharmaceutical ingredients used in our compounding. 

Each compounding pharmacy is regulated and licensed by its State Board of Pharmacy. Compounding pharmacies are required to hold licensure in all states where they ship medications. Additionally, the entire compounding industry is subjected to regulatory scrutiny at the state and federal levels. Belmar Pharmacy prepares extensively for these evaluations. We perform regular inspections of our own facilities to ensure our products are stable, safely stored, and free of contamination. While many compounders meet these expectations, we exceed them, holding our facilities to the highest criteria.    

To learn more about Belmar Pharmacy’s quality and safe practices, including our National Association of Boards of Pharmacy (NABP) Accreditation, of our Golden, Colorado location, click here: https://www.belmarpharmasolutions.com/about-us/quality-and-service/