Pharmacists and Healthcare Professionals Working Together to Protect Patient Access to Compounded Medications
Greetings Healthcare Professionals!
I recently had the good fortune to serve on a congressional briefing healthcare panel, which included practicing pharmacists and physicians who educated congressional staff on the importance of pharmacy compounding for patients. Specifically, we focused on the recent Drug Quality and Security Act (DQSA) of 2013, which was partly designed to ensure that compounding pharmacies adhere to certain standards to provide high-quality medicines. In order to enforce these standards, Congress instructed the FDA to conduct regular inspections at compounding pharmacies.
However, Congress DID NOT intend for the FDA to inspect pharmacies using manufacturing standards, as is currently the case. The USP, which has been around for almost two hundred years, already has standards in place that allow compounding pharmacies to operate using the best practices. In addition, state boards of pharmacy have even implemented some of their own enforceable standards. We reminded Congress that the true intent of the DQSA was not to force pharmacies to adhere to GMP standards, but that pharmacies should adhere to their respective state regulations.
We also focused on the important role that “office-use” plays in healthcare. Many of you have reached out to my pharmacy team asking for products to be housed in your practice without patient names. While we would be happy to do that, FDA regulations are preventing us from doing so. These regulations make it extremely difficult to provide emergency medications when your patients need it most, resulting in increased risk of patient harm or worse.
Finally, we emphasized the need to permit pharmacies to ship products across state lines. There is currently a Memorandum of Understanding (MOU) in place that would force each state to follow the FDA’s lead on interstate shipment of compounded medications. Essentially, the proposed MOU states that pharmacies are permitted to ship no more than 30% of products across state lines. This can be troublesome for healthcare professionals and patients who need unique products that are only available from a few pharmacies in neighboring states.
I’m sending you this information to let you know that our arguments to Congress are not pharmacy issues, but PATIENT ACCESS issues! I will continue to fight for this cause so that our patients have every option at their disposal!
Please see the communication below from my trade organization, the International Academy of Compounding Pharmacists (IACP), for additional details on the congressional briefing.
Thank you for relying on us as your compounding pharmacy provider!