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: Your FDA-Registered Outsourcing Facility in Longwood
503B Compounding Pharmacy operates from its facility at 2160 W State Road 434, Longwood, FL 32779 as an FDA-registered outsourcing facility. This designation, achieved under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility in Longwood meets stringent quality control benchmarks for the healthcare providers and patients we serve.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. This process is conducted in our state-of-the-art cleanroom environment at 2160 W State Road 434, which is meticulously controlled to prevent contamination. By operating on a larger scale, we provide healthcare practitioners with access to medications that may be experiencing a shortage, have been discontinued by major manufacturers, or require a specific formulation not otherwise commercially available. This vital service supports local clinics, hospitals, and practices by ensuring they have the necessary medications for their patients.
Patients and providers who utilize the services of 503B Compounding Pharmacy at 2160 W State Road 434 can have confidence in the integrity of their medications. Our processes are designed for reliability and consistency, providing a critical link in the healthcare chain. We encourage local healthcare providers to consider 503B Compounding Pharmacy as a trusted partner for their compounding needs. For more detailed information about our practices and capabilities, please visit our website or contact us directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
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 complies with federal standards for compounding medications on a larger scale. We follow current Good Manufacturing Practices (cGMP) and undergo regular FDA inspections, which provides an additional layer of quality and safety assurance beyond traditional pharmacy compounding.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at our Longwood facility are typically distributed to healthcare providers and institutions. Patients receive these medications through their prescribing physicians, clinics, or hospitals. We work directly with the healthcare community serving the area around 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile injectables, ophthalmics, and other formulations that are often used in clinical settings. This includes medications that are on shortage or are not available from conventional pharmaceutical manufacturers, providing a vital service to local medical practices.
How does 503B Compounding Pharmacy ensure sterility and quality?
Our facility at 2160 W State Road 434 in Longwood maintains a controlled cleanroom environment with strict protocols for air quality, personnel attire, and equipment sterilization. All processes are governed by cGMP standards, and our quality control department conducts rigorous testing to ensure the potency, purity, and sterility of every preparation.
How can a healthcare provider at a local practice place an order?
Healthcare providers can initiate the process by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on ordering, available formulations, and how we can support the medication needs of their practice located near 2160 W State Road 434.