What is required for a pharmacy to perform compounding?

For a pharmacy to engage in compounding, it must adhere to compliance with specific regulations and maintain quality standards. This requirement stems from both federal and state laws that govern the compounding of medications, ensuring that compounded products are prepared in a way that meets safety and efficacy criteria.

Regulations often include following the United States Pharmacopeia (USP) standards, which outline the criteria for compounding practices, including guidelines for ingredients, equipment, and environmental conditions necessary to uphold product integrity. Additionally, pharmacists must be knowledgeable about good compounding practices to minimize risks associated with compounded medications such as contamination, stability, and appropriate dosage forms.

While a pharmacy license is essential for operation, compounding requires more than just holding a basic pharmacy license; it demands a commitment to these comprehensive regulations and standards that safeguard patient health and safety. The involvement of regulatory agencies like the FDA is generally more about oversight and compliance rather than requiring prior approval for each compounded medication, and membership in a pharmacy association, while potentially beneficial, is not mandated for the act of compounding itself.