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)
- Validation protocols
- Cleaning and garbing
- Employee and environmental monitoring
- Compounding products
- 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.
- USP regularly publishes compounding standards updates and notifications on their website. Here you can find the full USP Compounding Compendium and general chapters <795>, <797>, and <800>.
- Compounding Today, a website published by the International Journal of Pharmaceutical Compounding (IJPC), can help your pharmacy stay in the know. In the compliance section of Compounding Today, links from organization like USP, DEA, FDA and CDC are conveniently located in one place. Additionally, Compounding Today and IJPC have downloadable documents related to USP, FDA, and State Boards of Pharmacy standards.
- The FDA human drug compounding website has links to laws and policies surrounding compounding pharmacies; information about compounding oversight and compliance actions; and an FAQ about FDA inspections.
- Learn more about accreditation and USP standards from the Pharmacy Compounding Accreditation Board (PCAB). This website also includes information on how to become accredited.
- 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.
- The American Society of Health-Systems Professionals (ASHP) has educational compounding resources for pharmacists and pharmacy technicians at all skill levels.
- The Compounding Pharmacy Compliance 2021 conference will be held virtually June 16-17. Discussion topics include a keynote from the FDA, compounding best practices, automation, and the future of facility design and workflow.
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.