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.