In recent weeks, new “Paks” have begun to hit the market among compounding pharmacies. These Paks are being marketed as almost a hybrid to kits and patches, but with the large difference that they claim to have FDA approval. The Paks are designed to treat a variety of different conditions, including dermatological conditions. The big question of course is how they will be treated by the FDA and/or the PBMs. Before embarking on new lines of products, pharmacies should fully vet out any new product from a regulatory compliance standpoint, as well as from a PBM standpoint. In addition, there may be steps pharmacies can take to proactively and prospectively lower their risk and exposure. Frier Levitt is well-versed in reviewing various types of products, both from a FDA compliance standpoint, and also in terms of risk vis-a-vis the PBMs. If you have questions about FDA and PMB compliance, contact Frier Levitt today.
New “Paks” are Hitting the Market Among Compounding Pharmacies, but are They FDA and PBM Compliant?
