Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies adherence to the highest standards of pharmaceutical compounding, including Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous standards for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications to healthcare providers for office use. This service is essential for physicians, surgeons, hospitals, and clinics that require ready-to-administer medications for their patients. By operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves as a critical partner to the local medical community, helping to ensure patient access to vital medications that may be commercially unavailable or in short supply.
The services provided by 503B Compounding Pharmacy are distinct from traditional retail pharmacy compounding. As an outsourcing facility, the focus is on producing medications without patient-specific prescriptions for healthcare facilities to have on hand. This includes a wide range of preparations such as sterile injectables, ophthalmics, and other dosage forms that are essential for various medical procedures and treatments conducted by practitioners in the area.
Patients and healthcare professionals visiting 2160 W State Road 434, Longwood, FL 32779 can be assured of the quality and safety of all compounded preparations. The facility's commitment to compliance with federal regulations provides an additional layer of safety and reliability. For more information on services or to discuss specific needs, contact 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. We comply with stricter Current Good Manufacturing Practice (cGMP) regulations and are subject to regular FDA inspections, ensuring the highest quality and safety standards for our compounded medications.
Can I, as a patient, walk into 2160 W State Road 434, Longwood, FL 32779 to get a prescription filled?
No. 503B Compounding Pharmacy primarily supplies compounded medications in bulk to healthcare facilities and practitioners for office use. Patients should contact their healthcare provider, who can then source medications from our facility for administration in a clinical setting.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, ophthalmics, and other non-sterile preparations in larger quantities. These are provided to healthcare providers to support a wide array of treatments and procedures.
How does a healthcare provider at a local clinic order from your facility?
Healthcare providers and facilities can place orders directly with 503B Compounding Pharmacy by contacting us at (407)993-1381. Our team will work with you to understand your specific needs and provide the necessary compounded medications for your practice.
Why would a healthcare provider choose 503B Compounding Pharmacy?
Healthcare providers choose our facility at 2160 W State Road 434, Longwood, FL 32779 because of our commitment to quality, safety, and reliability. Our FDA-registered 503B status and adherence to cGMP standards provide assurance that the medications they use in their practice are compounded to the highest possible specifications.