Knowledge Center

Category: USP 797

Sterile Compounding: New Laws and Regulations: A Review

  I recently attended a symposium conducted by Western University of Health Sciences, College of Pharmacy entitled, Sterile Compounding New Laws And Regulations. This took place at the Newport Beach Hyatt on January 18 of this year, and it was truly rewarding. There were great speakers who had up-to-date information on the new laws – […]

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20th Annual Napa Pain Conference, William Stuart, RPh

At the 20th Annual Napa Pain Conference, I was fortunate to conduct a presentation at a pre-conference meeting entitled, “Drugs for Intrathecal Administration: Access and Safety.” I began with a discussion of pharmacy provider considerations in order to provide basic relevant criteria for determining a qualified compounding pharmacy provider. Among my topics for consideration was […]

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ASHP’s Outsourcing Sterile Products Assessment

The process of outsourcing to compounding pharmacies plays a vital role in the medical community because compounding pharmacies: Can help alleviate drug shortages, which have increased in number and duration; Can provide specialized, tailored medications for individual patients; Can resolve operational inefficiencies for health systems in areas such as batch compounding, and ease consolidation of […]

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Did You Know? USP <797> Sterility and Endotoxin Testing

Did You Know? that USP <797> mandates that all high-risk level compounded sterile pharmaceuticals prepared in groups of more than 25 identical individual, single-dose packages or in multiple-dose vials for administration to multiple patients shall meet a sterility test before they are dispensed or administered and that they shall be tested to ensure that they […]

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Quality is Paramount: Performing Due Diligence with Compounding Pharmacies

In light of the recent meningitis outbreak, and due to the overwhelming number of requests made by physicians and medical professionals, Hartley Medical will be hosting a Webinar entitled, “Quality is Paramount: Performing Due Diligence with Compounding Pharmacies.” This Webinar will be held Friday, October 12, 2012 at 8:00 AM PDT (11:00 AM EDT) and […]

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Are You Getting the Greatest Value With Your Compounding Pharmacy?

When researching service providers, do you take into account the not-so-subtle difference between price and value? Well, when considering pharmaceutical providers, this evaluation is a must—after all, you are making decisions on behalf of your patients, not just your practice. Price represents the monetary costs for goods and services provided; whereas value takes into account […]

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Practice What You Preach! Perform Due Diligence

Due diligence: the act of researching, investigating, and/or auditing to prepare for a potential investment. Many companies encourage their clients and prospective clients to perform due diligence to ensure that they are meeting or, in Hartley Medical’s case, exceeding expectations. However, how many companies actually practice what they preach? Hartley Medical strongly encourages those who […]

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Surface Testing: Setting the Standard for Environmental Monitoring

Here at Hartley Medical, quality is paramount. We go above and beyond the mandates of USP to ensure that our products are compounded at the highest level – a level that guarantees patient safety. One of the many ways we do this is through an environmental monitoring method called microbial surface testing. Surface testing is […]

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A USP 797 Compliant Clean Room

As we have stated in the past, not all compounding pharmacies are the same. This applies to clean rooms as well. The first thing to know is that there are different levels of clean rooms. The International Standards Organization (ISO) classifies clean rooms based on the number of contaminants per-cubic-meter. The lower the ISO rating, […]

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Pharmacies Can No Longer Meet Standards … They Must Exceed Them

Compounding pharmacies ARE regulated by state boards, but whether or not compounding pharmacies have to be in compliance with USP 797 guidelines is completely up to those individual states. This creates a quality assurance disparity from state-to-state. Therefore, the question of, “Is simply meeting requirements good enough?” must be asked. In the wake of the […]

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