Ever since the meningitis outbreak associated with the products from the New England Compounding Center, the FDA and the States have been taking a closer look at this segment of the industry. So far, in 2013 alone, the FDA has issued 51 Safety Alerts for Human Medical Products (here), of which 17 (33%) related to sterile pharmacy compounded products and/or laboratories that tested those products for sterility and/or potency. In addition, FDA has taken 54 separate actions (here) against compounding pharmacies in 2013 alone, with only 24 actions taken in the previous 5 years. This is a troubling statistic, particularly given the fact that this segment of the industry has grown so substantially.
Now don’t get me wrong-as a pharmacist, I strongly believe in pharmacy compounding in the traditional sense of the practice. I also believe that this segment of the industry performs a valuable and cost-effective public health need by preparation of ad-mixtures and medications that are either in short supply, or for which a patient might not be able to use an FDA approved product (for example, when a patient may not be able to tolerate a particular inactive ingredient, such as a preservative or dye that is a component of the finished approved drug product). However, a sterile drug product manufacturer without adequate manufacturing controls, disguised as a pharmacy compounder, can create a potentially serious safety problem, as we have already seen based on FDA’s public notifications. With proper safeguards in place, and, when operations are conducted in accordance with good manufacturing and good compounding practices, with sterility assurance and in accordance with the receipt of a valid individual patient prescription, these services are invaluable to patients, physicians, hospitals, and the health care system in general.
Obviously from FDA’s findings, self-policing of the industry is not working, and now Congress is proposing various pieces of legislation to “fix” the problem. A piece of legislation typically leads to a set of regulations by the Agency charged with implementing the specific statute. Let’s hope that the legislation is clear and provides a framework for establishing a workable regulatory scheme wherein the public is protected and patients still have access to these services. The primary goal of any law or regulation should obviously be to protect patient safety, let’s see if our legislative and regulatory bodies are up to the challenge. Given the state of the industry today and the negative findings that appear to be rolling in every week, let’s hope for some action sooner rather than later to establish some certainty for the industry and the health care community. Meanwhile, while the controversy continues, take care in the marketplace and keep an eye on the FDA alerts and any Congressional action.
