Compounding pharmacies must adhere to regulatory standards to protect the health and safety of patients. Whether you’re a 503A or 503B pharmacy, staying compliant can be challenging.
Compliance applies to all areas of compounding, including:
Standard operating procedures (SOPs)
Cleaning and garbing
Employee and environmental monitoring
Packing and shipping material
The FDA frequently introduces new regulations to ensure safe compounding practices. In 2020, USP released new operational considerations in response to PPE, garb and disinfecting supply shortages caused by the pandemic. Since compliance guidelines are always evolving, it’s good to monitor announcements and updates from the different regulatory bodies.
We compiled resources from trusted industry sources to help your compounding pharmacy stay compliant with USP, FDA and State Board regulations.
The American Society for Healthcare Engineering (ASHE) published a monograph for hospitals to comply with USP <800> hazardous drugs regulations. Their pharmacy compliance advice guide provides useful information about setting up a new cleanroom.
Each compounding pharmacy is responsible for staying compliant and DiNovo can help. We supply everything a compounding pharmacy needs, including PPE, sterile medical devices, environmental monitoring products, disinfectants, sporicides, and validated shipping containers.
The resources listed here are an overview; please contact your local state/FDA inspector for detailed compliance information.
Since 2013, DiNovo Pharmacy & Packaging Provisions has been a leader in delivering cleanroom consumables, disinfectants, medical devices, and cold chain shipping solutions to the compounding and specialty pharmacy marketplace. As an educational resource, coupled with top global manufacturer partnerships, DiNovo helps pharmacies drive efficiency, manage costs, and enhance compliance to help guide you through a constantly changing pharmacy marketplace.