Compounding Pharmacies and USP Standards: What You Need Know
What is a Compounding Pharmacy?
A compounding pharmacy, as described by the FDA, is a facility that creates medicine for distribution by manipulating raw chemicals and substances in a clean, safe environment. In today’s healthcare climate custom medicines are in high demand. These custom medicines are created and distributed from pharmacies, specifically compounding pharmacies, which can be freestanding facilities or are more commonly located within a healthcare facility. There are strict regulations for all pharmacy designs. Healthcare facility owners, facility managers, architects, engineers, and contractors should all be aware of what is required to design and maintain a safe and effective compounding pharmacy. With the correct design implemented, owners can be assured that utilizing an in-house pharmacy will provide a long-term return on their investment.
Compounding Pharmacies and USP Standards:
Healthcare organizations building a new compounding pharmacy or adding to their existing infrastructure, need the assistance of architects and engineers to provide a design to make these facilities safe, energy efficient, and profitable. The United States Pharmacopeia (USP) is an organization dedicated to protecting and improving public health through standards to ensure quality, safety, and benefit of medicines. The USP provides architects and engineers with standard design practices that protect the integrity of the production as well as the safety and comfort of all staff members working within the compounding pharmacy.
Existing pharmacies must keep current with USP’s changing standards and new pharmacies need to uphold the highest standards of design. All compounding pharmacies consist of rooms that have specific purposes. Each room has to work together to provide the correct working conditions — both determined by code and by comfort — for the staff. The four major space types within a typical pharmacy are: the working area, ante room, non-hazardous compounding, and hazardous compounding. USP provides strict design conditions and standards for all four areas that must be met by the entire design team. USP provides the tools to design pharmacies but, the engineers and architects need to be the experts in their respective fields to make the design seamless. A healthy balance of cost-effective design, energy efficiency, and maintenance cost should be met to provide the owner with the most practical and advanced design.
Keeping Pharmacies Up to Date and Impact:
Keeping pharmacies up to date with the latest technology and best design practices is important in many regards. The goals of USP standards are to provide clean and pure drugs to patients and to keep the pharmacists within the general and compounding areas safe while the compounding process is occurring. With specific architectural layouts and intricate MEP designs, the owner, architect, and MEP design team need to all work together to meet applicable codes.
Working pharmacies are crucial to doctors and, more importantly, patients. Due to the 24/7/365 operation of pharmacy compounding spaces, these areas can’t afford to be shut down for any length of time. Like any MEP system, there is potential for equipment to experience issues and require repairs. To avoid shutting down the compounding suite due to these repairs, redundant pieces of equipment and emergency backup power (such as a generator in case of grid power loss) can be provided to eliminate any system downtime. Furthermore, an important aspect of designing a pharmacy is to consider the future. Leaving spare capacity in both electrical and HVAC systems allows for more flexibility when USP upgrades pharmacy engineering and operational guidelines to keep pace with its advancing studies. When done correctly, existing pharmacies can have the capability of maintaining production when renovations and upgrades need to be performed.
Return on Investment:
With USP making updates regularly, and new technology being developed for best design practices, pharmacy projects are now being completed in record time. Quick turnaround in the design and construction fields come at quite a high price tag. Fitzemeyer & Tocci’s upcoming guide will examine potential design considerations to meet a client’s ROI when upgrading their pharmacy spaces to meet current guidelines and requirements. The USP guidelines and standards will be discussed in detail and integration of pharmacy systems and options will be explored.
Matthew Fitzemeyer Project Manager & Mechanical