01 / Capabilities
Sterile compounding.
Aseptic preparation in our ISO 5 cleanroom. Single-dose and multi-dose configurations. Full environmental monitoring and traceability on every batch.
503B Outsourcing Facility · Deerfield Beach, FL
Sterile injectables,
documented end to end.
Hybrid Pharma is an FDA-registered 503B outsourcing facility. We compound sterile and non-sterile medications under USP <797>. cGMP documentation on every batch.
USP
Cleanroom
USP <797> . ISO 5 hood
503B
FDA outsourcing facility
USP <797>
Cleanroom standard
cGMP
Every batch
ISO 5
Hood classification
From prescription to release.
Four steps, with documentation at each stage. No skipped QC. No exceptions.
01
Intake
Prescription or shortage list. Customer specifies dosage form, strength, and quantity. Verified against current cGMP scope before compounding.
02
Compound
Aseptic preparation in our ISO 5 hood. Single-dose and multi-dose configurations. Each technician certified under USP <797>.
03
Test
Potency, sterility, and endotoxin on every batch. HPLC stability testing. Analytical results filed against release criteria.
04
Release
Batch record issued at release. cGMP traceable. Cold-chain shipping or scheduled courier to your loading dock.
What we compound.
Five core capabilities under cGMP. Each batch documented. Each test archived.
503B Operations
Hospital and health systems.
Shortage medications, cGMP-documented, distributed nationwide to hospitals, clinics, and outpatient centers.
Quality control.
Potency, sterility, endotoxin. HPLC stability testing. Every batch tested before release.
R&D / Formulation
Custom formulation development.
Stability work. Bioavailability improvements. New dosage forms. R&D support from concept through clinical supply.
Veterinary compounding.
Sterile and non-sterile preparations for animal patients. Flavoring and dosage adjustments for easier administration.
Quality is not a department.
USP <797> . cGMP . Every batch
We operate as the FDA regulates a 503B outsourcing facility. Current Good Manufacturing Practices apply. The same guidelines that govern commercial pharmaceutical manufacturers apply to our compounding work.
Every batch is tested for potency, sterility, and endotoxins. Documentation accompanies every release.
Our cleanroom exceeds USP <797> requirements. ISO 5 hood certification. Environmental monitoring on a documented schedule. Our quality control laboratory runs HPLC, stability testing, and full analytical release.
When you receive a Hybrid Pharma batch, the documentation chain runs from intake to your loading dock. No gaps. No exceptions.
The facility.
Where the work happens. Real rooms, real equipment, real batch records.
ISO 5 hood certification
Cleanroom suite
HPLC, endotoxin, stability
Quality control
Custom formulation work
R&D laboratory
Temperature-monitored dispatch
Cold-chain shipping
Frequently asked.
Procurement questions, QA questions, account questions. Honest answers.
About 503B
What is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds sterile and non-sterile medications in larger batches under cGMP. 503Bs can supply hospitals and clinics across state lines, helping address drug shortages.
How is 503B different from 503A?
503A pharmacies compound patient-specific prescriptions under USP <795> and <797>. 503B facilities operate under cGMP, supply in batches, and are subject to FDA inspection. Hospitals and health systems typically partner with 503Bs.
Quality and compliance
What standards do you follow?
We compound under current Good Manufacturing Practice guidelines. Our cleanroom exceeds USP <797> requirements. Environmental monitoring runs on a documented schedule. Every batch is tested for potency, sterility, and endotoxins before release.
What documentation comes with a release?
Every shipment includes a complete batch record: formulation, compounding log, environmental readings, QC results, and chain of custody. Documentation is cGMP traceable and audit-ready.
How do you handle out-of-spec results?
Out-of-spec results trigger a documented investigation. The batch is held. If the result is confirmed, the batch is rejected and recorded. Our QA team reviews the investigation before any further compounding in the affected scope.
Operations and partnership
How does a hospital account start?
Contact us to set up a new account. We provide your procurement team with our quality agreement, audit pack, and account forms. Once the agreement is in place, your team can submit shortage or custom-formulation requests.
What is the typical lead time?
Standard compounded batches ship within the lead time specified in your account agreement. Custom formulations and shortage work have longer lead times depending on R&D scope.
Do you compound for individual patients?
Patient-specific prescriptions are routed through our community pharmacy license. Hospital and health system partners use our 503B scope. If you are an individual patient, contact us for a referral.
Next step
Request an audit pack.
Send your procurement team the documentation: cGMP procedures, environmental monitoring records, batch records, USP <797> certification, and sterility validation.
Direct line
Phone
954-708-2771Email
info@hybridpharma.comFacility
1015 W. Newport Center Dr, Suite 106A
Deerfield Beach, FL 33442