EXPERTS IN STERILE PHARMACEUTICAL SOLUTIONS
503B HUMAN DRUG OUTSOURCING
|Providing high-quality sterile preparations that are produced with industry-leading automation and quality control systems.|
Posted By Brian Williamson on Wed, Mar 12, 2014 @ 16:03 PM
There have been a lot of questions surrounding the Drug Quality and Security Act (DQSA) that created the 503B Outsourcing Facility category. Now it looks like CMS may not authorize payment for compounded drugs covered by Medicare unless those drugs were supplied by an Outsourcing Facility that is compliant with FDCA Section 503B.
JCB Labs was one of the first sterile compounding pharmacies to register with the FDA as a 503B Outsourcing Facility. That means that there should be no question whether or not drugs you buy from us will be covered. For more information on this very important topic, please go to this link for an interesting article and food for thought.
Posted By Brian Williamson on Wed, Mar 12, 2014 @ 16:03 PM
The definition of high-risk sterile compounding is “Starting with a non-sterile Active Pharmaceutical Ingredient (API) and creating a sterile product.” We have written many articles about how important quality is in high-risk sterile compounding. JCB Labs has gone to great lengths and considerable expense to develop a facility and processes that satisfy cGMP practices and are capable of producing a sterile product every time. This is what the FDA expects from pharmacies that, like JCB Labs, are registered as 503B Outsourcing Facilities.
Please go to this link to see a very well written article concerning the importance of vetting your high-risk compounding pharmacy. The information might be invaluable to you and your facility as you decide where to get your compounded products.
Posted By Brian Williamson on Wed, Apr 24, 2013 @ 15:04 PM
The sterile compounding industry has been under a microscope for the last six months. Since the New England Compounding Center tragedy, a few other compounding pharmacies have issued voluntary and mandatory product recalls. The recalls have been primarily related to “lack of assurance of sterility” and have been brought about by either patient infections, floating material in products, or both. Additionally, the FDA has completed the inspection of 30 compounding pharmacies and the information gathered is being summarized and processed to determine how to regulate compounders going forward.
It is important to note that all the FDA inspections were done using current Good Manufacturing Practices (cGMP) standards instead of USP 797. Sterile compounding pharmacies are regulated by state boards of pharmacy and most boards require sterile compounding pharmacies to be compliant with USP 797. So, it is not surprising that all of the pharmacies received inspectional observations form FDA 483 when inspected against cGMP standards. USP 797 has been the “gold standard” for sterile compounding pharmacies for years. Products prepared and the testing of those products using USP 797 procedures results in sterile products that are safe. It is when sterile compounding pharmacies cut corners or do not follow USP 797 to the letter that problems can occur.
The cGMP standards are more stringent than USP 797 in some areas, most notably in air sampling requirements and validation of compounding and testing methods. Going forward, we expect there to be requirements put in place that incorporate parts of USP 797 and cGMP. The greatest predictor of things to come can be summarized by a statement made on March 23, 2013 by FDA Commissioner, Margaret A. Hamburg, M.D. Her statements indicate that the FDA, in cooperation with state boards of pharmacy, will continue inspections of compounding pharmacies. Commissioner Hamburg asked Congress to draft legislation establishing minimum federal standards for firms that compound sterile drug products, and wants Congress to enhance the FDA’s authority to inspect pharmacies, asking for the “FDA [to] have clear authority to proactively inspect pharmacies to determine the scope and nature of their operations.” Two areas that the FDA seems to be set on changing or adding oversight is compounding of sterile products in anticipation of an order or prescription and large-scale interstate shipping of products. We have already seen many states either starting to enforce their regulations regarding “office-use vs. prescription” compounding, or implement emergency regulations to prohibit office-use compounding, or both.
So, what does this mean for you, for JCB, and for the patients you serve? As many of you know, the changes made by many states requiring prescriptions for compounds is a logistical nightmare. It is time consuming, costly, and likely not the best approach to ultimately protecting patient safety. There are better ways to track lot numbers of products to individual patients and many of you are already doing this. Nevertheless, JCB Labs will comply with the rules and regs put in place by each state board of pharmacy and will help you remain compliant as well. If you are in a state that requires prescriptions for office use compounds, we will continue to ask you for prescriptions unless or until the regulations are changed.
It appears that the FDA will likely have more oversight in the compounding industry. Whether or not this happens, JCB will continue to provide sterile products of the highest quality and help ensure the safety of your patients. JCB’s facility is always open for you to visit or audit. If you do come to visit JCB, we are confident that you will leave completely satisfied that you are working with a sterile compounding partner you can trust.
Posted By Brian Williamson on Thu, Feb 21, 2013 @ 14:02 PM
While the aforementioned article was referring to commercial manufacturers, I think some people have the same opinions regarding compounded products. I have two concerns with this focus on the lowest price and the belief that all products are equivalent. First, do you really want to use the compounding pharmacy that competes solely by offering the lowest price? The customers I speak with want a sterile compounder that is accredited by the Pharmacy Compounding Accreditation Board (PCAB) and one that meets or exceeds the United States Pharmacopeia (USP) 797 requirements. They want a compounding pharmacy they can trust to make sure their patients receive the best care possible. Secondly, it appears that not all products undergo the same sterility, endotoxin and potency testing. Ask your compounder for their policy and procedure on testing sterile products. Does your compounding pharmacy test per USP 797 guidelines? They should, but the recent dramatic increase in the number of test samples sent in to analytical labs appears to indicate that not every pharmacy follows USP 797. I recently spoke with one of our independent testing laboratories and they said their business tripled in the two months following the deadly meningitis outbreak caused by contaminated compounded steroids. That seems to indicate that not everyone was testing properly prior to the tragedy.
Now is the time for you to take critical look into your compounding pharmacy. Ask the tough questions of your high risk sterile compounding pharmacy. Make sure you have all the documentation you need not only to give you peace of mind but also to satisfy your regulatory auditors.