Ensuring the Highest Standards in Compounding Pharmacies

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The regulation of compounding pharmacies by state boards varies, with compliance to USP 797 guidelines being optional depending on the state. This leads to disparities in quality assurance. The critical question, "Is simply meeting requirements good enough?" must be addressed, especially in light of recent tragic events.

Quality Assurance Disparities

Compounding pharmacies are regulated by state boards, but adherence to USP 797 guidelines is left to individual states. This results in a quality assurance disparity from state to state. The deaths in Alabama seven months ago, linked to contaminated admixtures, highlight the serious consequences of inadequate regulation. Thus, the answer to whether meeting just the minimum requirements is sufficient is unequivocally "no."

Importance of Exceeding Standards

If a compounding pharmacy meets all state requirements but still produces contaminated admixtures, it indicates a significant problem, especially for patient safety. Administering contaminated "sterile" medications to patients is a risk no healthcare provider can afford. Therefore, it is essential to find pharmacies that exceed standards, perform at a higher level than required, and adhere to USP 797 guidelines regardless of state mandates.

Recommendations for Selecting a Compounding Pharmacy

In our blog entry, "4 Steps to Choosing the Right Compounding Pharmacy," I outlined key steps for researching and selecting a suitable compounding pharmacy for your practice. One crucial recommendation is conducting a site visit to observe operations firsthand—a transparent pharmacy should welcome this. Additionally, in Hartley Medical's November-December 2011 newsletter, the article "Would You Eat From This Kitchen?" emphasized the importance of utilizing a "clean room" with advanced sterile preparation and cleaning protocols. These resources can help you verify whether your current or potential compounding pharmacy provides the highest quality sterile medications.

Hartley Medical's Commitment to Quality

At Hartley Medical, we pride ourselves on providing the highest quality sterile preparations, compounded in a state-of-the-art facility with rigorous quality assurance and environmental monitoring programs. We consistently exceed USP 797 guidelines daily, ensuring the utmost safety and efficacy for our patients.


Ensuring that your compounding pharmacy exceeds standard regulations is crucial for patient safety. I encourage you to reach out if you have any questions about Hartley Medical's preparation processes or compounding pharmacy guidelines in general. Transparency is key, and I am here to provide you with the information you need.

The question remains: "Do you know what your sterile compounding pharmacy is doing?"

For further reading, refer to the source article by Terri D'Arrigo, "A Call to Action on Sterile Compounding Gains Traction," published in Pharmacy Practice News, July 2011.

For more insights and resources, visit Hartley Medical's Knowledge Center.