In 2012, many of the people who received contaminated steroid injections produced at the New England Compounding Center had already been suffering from chronic pain. The compounded drugs were supposed to provide relief. Instead, they infected these patients with fungal meningitis, killing 64 and sickening 753.  

The tragedy was a wakeup call for regulators, who saw the weaknesses it exposed. The pharmacy where the tainted drugs originated had evaded federal and state oversight for years, producing compounded drugs in filthy conditions and at volumes far greater than what was typical for compounding pharmacies.

Since then, FDA and the boards of pharmacy have worked diligently to ensure that something like this never happens again. NABP has assisted both through various programs, such as through our Verified Pharmacy Program, an inspection service created in collaboration with our member boards.

Now we are partnering with FDA in its efforts to improve the oversight of compounding pharmacies through the implementation of the Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (MOU), which was developed in consultation with NABP as described in Section 503A of the Federal Food, Drug, and Cosmetic Act. Our efforts aim to help boards of pharmacy comply with the reporting requirements of the MOU, which obligates states to track pharmacies that are compounding human drug products and flag the ones that distribute inordinate amounts interstate. The MOU also requires states to report complaints about compounded human drug products.

One way that the boards can share this information with FDA is through NABP’s newly expanded Information Sharing Network, which is available through NABP e-Profile Connect. The online network automates the reporting process, notifying boards about pharmacies whose submitted data show that they are distributing inordinate amounts of compounded human drugs interstate. Boards can then submit this data to FDA with a click of a button, reducing the boards’ administrative burden and making it easy to comply with the MOU. In addition, the Information Sharing Network provides boards with an easy way to report complaints to FDA.

The MOU and the Information Sharing Network put federal and state authorities in a better position to ensure compounding pharmacies are complying with important practice regulations and safety standards. We hope that boards will take the time to review this new data sharing program and consider signing the MOU. You can email NABP to learn more. Because no patient should ever be harmed by medications that are supposed to heal.