COMPOUNDED AND COMMERCIAL PRODUCTS

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Compounded Products and FDA-Approved Products (commercial) are two distinct categories of medications, each with different characteristics and regulatory requirements. 

• Compounded Products are medications prepared by licensed pharmacists or healthcare professionals who mix or modify ingredients to create customized formulations tailored to an individual patient’s needs. These products are regulated primarily by state boards of pharmacy, and specific requirements may vary by state. 

• Commercial Products are manufactured by pharmaceutical companies under strict guidelines established by the U.S. Food and Drug Administration (FDA). Before reaching the market, these medications undergo extensive testing to ensure their safety, effectiveness, and quality.  

Both types of medications serve specific purposes. Compounded products are often used when commercially available alternatives are not available or suitable, such as when a patient requires a specific dosage strength or has unique medication needs. 

Patients should consult with their healthcare providers to determine the most appropriate treatment option based on their individual circumstances.

To access the latest FDA information on Drug Shortages and Discontinuations, click here: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm