Special PP&P Buyer's Guide: Outsourced Compounding

June 2017 - Vol.14 No. 6 - Page #20
Category: Outsourced Compounding Services (503B)

Avella, a national specialty pharmacy, offers SourceB, a 503B compounding product suite that provides high-quality, safe, and effective sterile preparations designed to meet the outsourcing needs of hospitals and physician practices at a competitive price. SourceB products include sterile IV drugs, such as PCAs, epidurals, admixtures, nerve blocks, and OR syringes. In addition, many difficult-to-source products are available, including ophthalmology preparations. These therapies are produced in one of two cGMP-compliant cleanrooms, located in Texas and Arizona; together, these facilities comprise over 80,000 square feet. This operational redundancy ensures availability and on-time delivery. Rigorous potency and sterility testing for every batch is performed, along with endotoxin testing for epidural products, which exceeds USP <797> requirements. More information is available at www.avella.com/sourceb.

From Avella Specialty Pharmacy

Central Admixture Pharmacy Services, Inc’s (CAPS) network of outsourcing admixture pharmacies delivers high-quality, same-day services and solutions to hospitals and outpatient facilities across the country. Founded in 1992, CAPS’ trained, licensed pharmacy personnel compound a broad range of patient-specific and non-patient specific CSPs, embracing the latest compounding technology, including proprietary software for ordering prescriptions and bar code safety checks for automated and manual compounding processes. CAPS operates 22 state-licensed 503A regional pharmacies that dispense labeled, patient-specific prescriptions, including parenteral nutrition; CAPS also has two 503B outsourcing facilities registered with the FDA to provide batch non-patient specific compounding services.

The 503B outsourcing facilities offer a broad line of pre-filled, ready-to-use CSPs, including anesthesia syringes, controlled substances, oxytocin, vancomycin, and more, with up to 65 days’ beyond-use dating. Standardized, bar coded labels with TALLman lettering and ASTM color differentiation by drug class help identify drug groups and draw attention to look-alike/sound-alike medications. CAPS’ Test, Hold, and Release (THR) quality program meets standards for 503B cGMP release testing for sterility, potency, and endotoxin testing prior to release and shipment. To learn more, go to www.CAPSpharmacy.com.

From Central Admixture Pharmacy Services, Inc (CAPS)

JCB Laboratories and Fagron Sterile Services’ (FSS) FDA-registered 503B outsourcing facilities, located in Wichita, Kansas, fulfill institutional sterile compounding needs nationwide. The cleanroom suites are designed to ensure unilateral movement of preparations and personnel, with each suite controlled by an independent HVAC system and fitted with advanced automation and monitoring technologies. JCB and FSS offer ophthalmic preparations, preservative-free corticosteroids, mitomycin bladder instillation solutions, a line of IV admixture preparations, OR anesthesia solutions, and contract manufacturing capabilities. Stringent testing processes ensure the safety of every batch.

From JCB Laboratories/Fagron Sterile Services

QuVa Pharma, a 503B outsourcing facility, is dedicated to improving quality standards of compounded products, reducing risks for hospitals, and enabling the delivery of excellent patient care. Each product has its own Certificate of Analysis attesting to sterility, potency and endotoxin levels. With 40,000 square feet of manufacturing capacity, and expansion plans for an additional 90,000 square feet coming in the second half of 2017, QuVa Pharma has the capability and capacity to service hospitals by providing safe CSPs across all major therapeutic categories.

From QuVa Pharma

SCA Pharmaceuticals, an FDA 503B outsourcing facility, provides high-quality sterile admixtures and prefilled syringes to hospitals in all 50 states, offering quick turnaround time and outstanding quality and customer service. Its portfolio includes PCAs, epidurals, OR/anesthesia syringes, oral-dose syringes, and IV admixtures. SCA performs 100% final product sterility testing with lot-specific laboratory reports for every sterile product produced. In addition, full endotoxin testing on every batch of sterile products is performed prior to release, fulfilling requirements for endotoxin (pyrogen) testing per USP <85> guidelines and cGMP guidance.

In August 2017, SCA will open a 90,000 square-foot facility in Windsor, Connecticut, featuring cGMP cleanrooms and GLP micro and chemistry laboratories to meet the standards of stringent FDA quality regulations. Located 1 mile from the Bradley-Hartford International Airport, the new facility will increase shipping efficiency, improve turnaround time, and increase production capacity.

From SCA Pharmaceuticals

PharMEDium, an FDA-registered 503B outsourcing facility, provides an extensive portfolio of CSPs and ready-to-use prefilled syringes, compounding exclusively from FDA-approved sterile drugs in their finished dosage form and using only FDA-cleared drug delivery devices. A wide variety of drug concentrations, fill volume options, and delivery systems are offered. PharMEDium provides high-quality OR/anesthesia, pain management (epidural, nerve block, and PCA), critical care (cardiac, sedation, antibiotic, and electrolyte), and labor and delivery services, in an efficient manner. The portfolio comprises over 2,800 CSP SKUs, serving over 3,200 hospitals, outpatient departments, and ambulatory surgery centers. Hospitals and ambulatory surgery centers considering PharMEDium are invited to visit and learn about our processes.

From PharMEDium Services LLC

US Compounding Pharmacy, an FDA-registered 503B outsourcing facility licensed with state boards of pharmacy nationwide, provides compounded medications to patients, physician clinics, hospitals, and surgery centers throughout the United States. Customized compounds range from sterile injectables to bio-identical hormone replacement therapies and transdermal pain creams. Each lot of sterile injectable is tested by an independent, FDA-registered laboratory for sterility, potency, and endotoxin prior to QA release. As a DEA-licensed manufacturer, controlled substances can be distributed across state lines without patient-specific prescriptions. In addition, US Compounding Pharmacy’s PCAB accreditation ensures it meets or exceeds USP’s quality standards.

From US Compounding Pharmacy


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