• Hormonal
    Medicines

    We have more than 16 years of experience compounding Hormonal Medicines

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  • Reproductive
    Medicines

    We have more than 16 years of experience compounding Reproductive Medicines

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  • Dental
    Medicines

    We have more than 16 years of experience compounding Dental Medicines

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  • Sports
    Medicines

    We have more than 16 years of experience compounding Sports Medicines

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  • Veterinary
    Medicines

    We have more than 16 years of experience compounding Veterinary Medicines

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Compounded Sterile Products-Higher Standards and Increased Patient Safety

In the world of sterile compounding, much has changed over the last two years.  Prior to the passage of the Drug Quality and Security Act (DQSA) in November 2013, USP 797 was the quality standard for compounded sterile products (CSPs).  Now that the DQSA has passed, providers have the option of getting their CSPs from 503B Outsourcing Facilities (OF) that must follow current Good Manufacturing Processes (cGMP).   This significantly higher cGMP standard is preferred among physicians, pharmacists and nurses who want to make sure they give their patients CSPs of the highest possible quality.  In fact, both the FDA and CMS have stated their preference that providers purchase CSPs only from FDA registered 503B Outsourcing Facilities. 

 One significant change that is a result of becoming a 503B Outsourcing Facility is the CSP testing requirements. The requirements are so much more than simply sterility, endotoxin and potency testing. The level of rigor, suitability and specificity is significantly higher. The sterility test must comply with United States Pharmacopeia (USP) 71, the endotoxin test must comply with USP 85 and the potency tests must be based on the compendial method described in the products’ USP monograph.   Make sure your CSP provider is performing these tests at the required level and make sure you ask your Outsourcing Facility for these test results!

 As a consequence of the cost and lengthy time requirements of this level of testing, the days of compounding sterile products one, two or even fifty at a time are over.  To maximize efficiency, control costs and ensure consistent, high-quality products, Outsourcing Facilities must produce their products in larger batches.  JCB Laboratories’ has decreased its’ formulary of products and invested considerable time and resources into manufacturing processes to make sure all products meet the highest standard.  That is the JCB commitment to your patients and that is what I call value!

 While, in rare cases, this may mean the product you used to get from JCB is no longer available, it certainly does not mean we are not innovating, researching and compounding new products. We have been and always will be a dependable, reliable source for innovative new compounds and for drug shortage products.  As you go to conferences and learn about new CSP options or when a drug shortage has an adverse effect on your ability to take care of patients, let us know. We welcome the opportunity to compound CSPs that you need the most.

Your Partner,

 

Greg Rockers. R.Ph.

VP-Business Development

Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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