Compounding Pharmacies: How to navigate the New Regulatory and Business Environment and Ensure High Quality, Safe Products, which are Cost Effective

Abstract

Compounding pharmacies are under new regulations and scrutiny from the FDA and state agencies. Large scale compounders, regional medical systems and small local hospitals face challenges implementing the recently amended section 503 of the Federal Food, Drug and Cosmetic Act. This law will cause significant changes to the compounding pharmacy business model and operations of hospital pharmacies. Flaws in previous compliance and regulatory regimen led to major safety issues. For example in 2012, the New England Compounding Center prepared drug that was contaminated, causing a deadly fungal meningitis outbreak in several states. This event triggered legislation that will impact the industry in the following ways: i. The compounding pharmacies will need to change their business and compliance practices. ii. Implementation and enforcement of the law will result in increased costs and consolidation of large-scale compounding pharmacies. iii. H ospitals that utilized outsourced compounding pharmacies will need to allocate more resources to ensure that drug products are sterile, potent, stable and pure. iv. Impr oved quality and consistency of drug products and processes will result from the new law. Ensuring patient safety and reducing risk should be a top priority of compounding pharmacies and hospitals. The institutions that achieve compliance will succeed.