Committed supply of high-quality controlled substances from a trusted 503B outsourcing facility
From pre-filled, ready-to-use, operating room syringes to intravenous (IV) bags, Fagron Sterile Services US (FSS) state-of-the-art facilities are prepared to handle the production of sophisticated sterile medications.
Safety. Quality. Control. No Compromise.
Compliance-oriented healthcare facilities trust FSS to deliver high-quality sterile medications that support patient safety at every step of the production process. Quality control is at the heart of the Fagron icon and is an integral component of all cGMP compliant operations, controlled substances are no exception.
Quality you can rely on
FSS employs decades of sterile pharmaceutical manufacturing and quality expertise.
Customers appreciate our trusted supplier management, product development, process validation, environmental monitoring, state-of-the-art production, advanced product testing, and safeguarded customer ordering and shipping from secure facilities.
Experience top-tier 503B outsourcing firsthand . Request a free consultation at the bottom of this page and set up a virtual or in-person site audit (COVID restriction may apply).
FDA / DEA Registered & Inspected
ISO 5 environments
Advanced labeling with drug schedule indication
Thoughtful OR syringe and IV bag labeling supports patient safety on every controlled substance product from FSS. Advanced labeling allows clinicians to quickly identify the most critical presentation information, including the drug schedule and safety warnings.
Controlled substance labels clearly display:
- Presentation specification
- Route of administration
- Storage requirements
- Expiration dating
- TALLman lettering
- Drug schedule
The United States Drug Enforcement Agency (DEA) classifies drugs and chemicals used to manufacture drugs into five unique categories or schedules based upon a drug’s medical use and potential for abuse or dependency.
Fagron Sterile Services US currently provides customers with a reliable supply of Schedule II, III, and IV controlled substances.
With controlled substances, security is critically important. In our 503B outsourcing facility, controlls are protected by a state-of-the-art security system with 24-hour monitoring.
Drugs are stored in a massive concrete and steel vault under detailed activity tracking by dozens of security devices throughout the facility. This helps support the safety of our employees and your patients.
Employee interactions with controlled drugs are limited to a select group who have received advanced training and undergone specific background screenings.
Convenient CSOS electronic ordering provides FSS customers with the ease of digitally signing for Schedule II medications and placing full orders without ever having to leave the FSS web shop.
Why CSOS electronic ordering?
About Fagron Sterile Services US
FSS, a top-tier DEA and FDA-registered 503B Outsourcing Provider, produces reliable supply of high-quality sterile medications with cGMP compliant operations, for patient-focused healthcare facilities across North America.
FSS’ team employs expertise in legal and regulatory compliance, pharmaceutical manufacturing, and repackaging, leveraging industry leading automation, advanced environmental monitoring, and sophisticated in-house quality testing labs.