503B Outsourcing

What 503B outsourcing means for health systems

Hospital pharmacies are under constant pressure to ensure medications are available, safe, and ready for use, especially during periods of drug shortages or operational strain. FDA-registered 503B outsourcing facilities exist to support that responsibility.

Outsourcing facilities can compound sterile medications in advance, without patient-specific prescriptions, while operating under current Good Manufacturing Practice (cGMP) requirements. For health systems, this model reduces the need for in-house sterile compounding while increasing consistency, scalability, and regulatory confidence. At Quva, 503B outsourcing is a part of a broader medication risk strategy - not a transactional supply decision - so health systems can make informed, confident decisions in the face of uncertainty.

Additional resources that expand your pharmacy operation

Quva’s provides your hospital pharmacy with additional qualified resources so that you can focus more time on improving health care delivery, patient safety, and clinical outcomes.

503B outsourcing can assist hospital pharmacy by freeing up time and capital that may otherwise be spent compounding products in the hospital pharmacy. It can also reduce the regulatory and compliance risk associated with increasing requirements for hospitals doing their own sterile product compounding.

Outsourcing enables your Pharmacy to easily obtain ready-to-administer syringes, bags, CADDs and more so you can focus more on important tasks of patient care and other operational activities.

Quva Pharma Sterile Product Portfolio

Quva uses only FDA-approved, commercially available sterile starting material when producing sterile-to-sterile compounded sterile products (CSPs).

We provide essential CSPs to support labor & delivery, anesthesia & OR, general medicine, cardiovascular, anti-infective, and pain management. Some of our most requested medications are Morphine, Fentanyl, Oxytocin, Epinephrine, Ephedrine, Rocuronium, Norepinephrine, Phenylephrine, Succinylcholine, Vancomycin, Cefazolin, and Fentanyl/Bupivacaine epidurals.

Quva offers specialty admixtures in IV bags, syringes and CADD cassettes.

Product presentations

Syringes

3 mL . 5 mL . 10 mL . 20 mL . 50 mL . 60 mL

IV Bags

1 L . 500 mL . 250 mL . 125 mL . 100 mL 50 mL

CADD

50 mL . 100 mL . 200 mL . 250 mL

Monoject Syringe Barrels

35 mL

Pharmacy Bulk Package

L.E.T. Syringes

3 mL . 5 mL

Reduced compounding burden without sacrificing control

Quva helps health systems decrease reliance on in-house sterile compounding while maintaining the oversight, transparency, and accountability required in highly regulated environments.

More consistent access to critical medications

By compounding medications in advance under cGMP requirements, Quva supports greater predictability and reliability of supply, particularly for products impacted by drug shortages or sourcing instability.

Regulatory confidence is built into every step

As an FDA-registered 503B outsourcing facility, Quva operates with regulatory rigor embedded into manufacturing, quality systems, and documentation, helping health systems navigate compliance with greater confidence.

What types of health systems benefit most from 503B outsourcing?

503B outsourcing is most valuable for health systems managing drug shortages, limited sterile compounding capacity, or the need for greater consistency and regulatory confidence across sites of care.

How does Quva support regulatory and compliance requirements?

Quva operates FDA-registered 503B outsourcing facilities and compounds sterile medications under current Good Manufacturing Practice (cGMP) requirements, with quality systems designed to support transparency, documentation, and oversight.

Can 503B outsourcing reduce the operational burden on hospital pharmacies?

Yes. By providing ready-to-use and ready-to-administer sterile medications, 503B outsourcing can reduce in-house compounding workload and allow pharmacy teams to focus on clinical and operational priorities.

How does Quva help during drug shortages or supply disruptions?

Quva combines pharmacy manufacturing with healthcare intelligence to help health systems anticipate shortages, secure access to critical medications, and respond with greater clarity when supply conditions change.

What 503B outsourcing means for health systems

Additional resources that expand your pharmacy operation

Quva Pharma Sterile Product Portfolio

Quva uses only FDA-approved, commercially available sterile starting material when producing sterile-to-sterile compounded sterile products (CSPs).

More than 90% of Quva's Portfolio has a 90-Day BUD

Therapeutic Classes

Product Types