dea & FDA-Registered and Inspected State-of-the-art facilities

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.

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Collage of controlled substances products

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

Compliance with FDA, DEA, cGMP, GDP and cGLP regulations and guidance ensure our process is sound and supports patient safety

cGMP Compliant

Three decades of experience employing subject matter expertise with 21 CFR Parts 210 and 211 produces quality you can trust

ISO 5 environments

16 independent aseptic processing environments with dedicated HVAC systems, automation and depyrogenation technology

Committed Supply

The medication you want, when you need it — period. Committed Supply Program customers enjoy greater than 97% same-day fill rate on orders placed before cut-off times

100% Tested

All batches must successfully pass tests for sterility, particulate matter and potency prior to being released

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
Barcode

Drug Scheduling

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.

Schedule II

Schedule II drugs, substances, or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous.

Schedule III

Schedule III drugs, substances, or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than Schedule I and Schedule II drugs but more than Schedule IV.

Schedule IV

Schedule IV drugs, substances, or chemicals are defined as drugs with a low potential for abuse and low risk of dependence.

Secure Storage

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.
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Employee interactions with controlled drugs are limited to a select group who have received advanced training and undergone specific background screenings.

Streamlined Ordering

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?

Secure Purchases

The only DEA approved electronic ordering system for Schedule II medications

Efficient Transactions

No need to visit a different portal, submit separate orders, or complete paper 222 order forms.

Accurate Orders

Customers may create, review, and submit orders, ultimately reducing ordering errors

Independent Ordering

FSS customers may place orders at their leisure to ensure products arrive when needed.

Cost Savings

Reduced paperwork and faster, more accurate, transactions can reduce inventory costs

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.