For over 25 years, PharMEDium Services has served as a preeminent provider of choice for outsourced, ready-to-use compounded sterile preparations (CSPs). PharMEDium was among the first to voluntarily register our centers as FDA Registered 503B Outsourcing Facilities after Congress enacted the Drug Quality and Security Act (DQSA) in November 2013. Since our inception and through the years as laws, regulations, and FDA guidance standards for entities engaged in anticipatory compounding of sterile preparations have evolved, PharMEDium has been anchored by the enduring values of patient safety, flawless quality, and outstanding customer service. The company is committed to undisputed compliance with FDA’s 503B requirements, upholding the highest ethical standards in the industry. As part of AmerisourceBergen, PharMEDium supports the healthcare industry by enabling increased product access and delivering powerful services like consultative support in medication management process improvements that result in enhanced patient safety, operational efficiencies, decreased medication waste, and simplified compliance. Together, we are united in our responsibility to create healthier futures.
Purposely, PharMEDium does not compound sterile medications from bulk drug substances. Only FDA-approved* sterile drug vials, FDAapproved sterile diluents, and FDA-cleared sterile containers are used in PharMEDium’s 503B Outsourcing Facilities to provide for the highest levels of quality assurance and patient safety. 100% of our CSP batches are tested for pH, sterility, bacterial endotoxin, and potency. PharMEDium also includes stringent environmental and personnel monitoring as part of our batch release criteria. Our real-time stability verification is done both in-house and by independent FDAregistered laboratories. PharMEDium’s long-standing commitment to advancing patient safety and our daily goals to produce the highest-quality CSPs and business solutions makes all the difference to our health system partners and the patients they serve. Hospitals and ambulatory surgery centers rely on PharMEDium Compounded Sterile Preparations (CSPs) for operating room anesthesia; pain management; labor and delivery services, emergency, and critical care medications.
Features & Options
PharMEDium has long been the industry leader in labeling and packaging of ready-to-use compounded sterile preparations. Our labels are designed to help eliminate the potential for errors in the process of dispensing and administering medications. PharMEDium’s proprietary labeling includes additional design enhancements, including the use of color coding and Tall Man lettering. On PharMEDium prefilled syringe labeling, the drug name appears up to eight times, making it viewable from any clinical orientation. Our packaging is designed to ensure the integrity of chemical composition and sterility of the preparation through the shipping and storage process. PharMEDium CSPs are available in containers to fit all major infusion devices available today. Our ready-to-use syringes are compatible with the most commonly used anesthesia carts and automated dispensing cabinets, including mini-drawers for controlled substances.
“PharMEDium is focused on enhancing the quality assurance and quality control programs we employ to meet the highest standard for the cGMP compliance required of 503B compounders. We know we are on the right path for our business partners which will enable us to continue to expand our relationships through mutual trust and confidence in the quality and reliability of the services we deliver.” — Scott Aladeen, President, PharMEDium Services
PharMEDium has a team of national account managers who serve as liaisons between PharMEDium, group purchasing organizations (GPOs), and integrated delivery networks (IDNs) so customers can take advantage of volume discounts and the ease of ordering direct from PharMEDium. PharMEDium currently has GPO contracts with: Vizient, HPG, Premier, The Resource Group (TRG), ROI, Intalere, Kaiser, and Cardinal.
This post is related to:Admixture Compounding Services (503B Outsourcing Facilities) Drug Distributors / Wholesalers