EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS

503B HUMAN DRUG OUTSOURCING

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JCB Labs Blog

Compounded Sterile Products-Higher Standards and Increased Patient Safety

Posted By Greg Rockers on Tue, Feb 24, 2015 @ 09:02 AM

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

Tag: Sterile Compounding, USP 797, Quality, Partnership, 503B, compounding, outsourcing facility, FDA, cGMP, CMS, DQSA, innovating,

Podcast 2 of 2: Drug Shortages and Gray Market

Posted By Brian Williamson on Thu, Jan 31, 2013 @ 08:01 AM

JCB was asked to take part in a podcast recording regarding drug shortages and the gray market.  You can listen to the podcast here.

In summary, the podcast covers the following topics:

  • Drug shortages and why they are more common now than ever before
  • Drugs that are the most problematic to obtain
  • Why chemotherapy drugs are hard to find and the resulting consequences of not having them available
  • What is the gray market and how has it evolved
  • What is “pedigree” in the context of drugs
  • Recommendations for handling drug shortages and evaluating alternative sources of drugs

The drug shortage issues may be somewhat relieved in 2013. However, there will still be significant shortages of life-saving and critical medications.  Stay in contact with JCB and keep calling us for information on drug shortages you are facing in your facilities.  

Tag: Sterile Compounding, Shortage, USP 797,

Podcast 1 of 2: Oversight of sterile compounding

Posted By Brian Williamson on Thu, Jan 31, 2013 @ 08:01 AM

JCB was asked to provide a podcast recording regarding sterile compounding and oversight.  You can listen to the podcast here

In summary, the podcast covers the following topics:

  • The process of sterile compounding, including facility design, training, and USP 797 requirements
  • The role of the FDA and boards of pharmacy
  • Specific training and education requirements for sterile compounding
  • Number of compounded adverse events as reported by the Institute of Safe Medication Practices (ISMP)
  • Questions to ask when considering using a compounding pharmacy

As 2013 is fully underway, we expect to see some significant changes in sterile compounding from a legislative perspective.  JCB is committed to staying in front of the changes and helping guide the process.  

Tag: Sterile Compounding, USP 797,

Determining Drug Product Shelf Life

Posted By Greg Rockers on Wed, Jun 13, 2012 @ 13:06 PM

Occasionally I get asked why a compounded product does not have an expiration date as long as that of a manufactured product. Expiration dates are required by the FDA for commercially manufactured products and are determined after years and years of extensive study of the product’s stability. Most expiration dates are expressed in years for commercial products.

Since compounded products do not undergo years of extensive study to determine the product’s stability, a much more conservative methodology, dictated by USP 797 guidelines, must be used for sterile compounded products. Under USP 797, sterile compounded products are not assigned an expiration date, instead they are assigned a “beyond use date” (BUD).  BUDs are generally days or month long and are determined after careful interpretation of appropriate information sources for the same or similar formulations. The BUDs, for products produced by those pharmacies that do not test drug strength or stability, are strictly limited to USP 797 guidelines resulting in BUDs of as little as 24 hours to a maximum of 45 days. When pharmacies send their products to a lab for strength and stability testing, like JCB does, BUDs as long as 6 months can be assigned. So, while a compounded product will have a BUD based on sound clinical information and testing, it will not have a BUD equal to that of a manufactured product.

Compounded products fill a vital need in today’s healthcare arena whether by customizing a medication for a physician or by solving a critical drug shortage.  Ensure confidence with your staff and patients by performing the necessary due diligence to make sure that your sterile compounding pharmacy uses sound procedures to determine Beyond Use Dates.  

Tag: Sterile Compounding, Risk, USP 797, Injectables, Shelf Life,