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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the preparation of sterile and non-sterile compounded medications. This designation signifies our commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and their patients by providing access to vital medications that are not otherwise commercially available.
The operations at our Longwood location are built upon a foundation of rigorous quality control. As a 503B outsourcing facility, our processes are subject to current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This involves extensive testing of components, in-process materials, and finished drug products, alongside meticulous environmental monitoring to ensure the sterility and potency of every preparation that leaves our facility. Patients and prescribers at 2160 W State Road 434, Longwood, FL 32779 can have full confidence in the integrity and quality of the medications we compound.
503B Compounding Pharmacy provides essential medications for a wide range of therapeutic needs. Our capabilities include the compounding of sterile injectables, ophthalmics, and other dosage forms that are critical for patient care. We work directly with healthcare providers to support their practice and patient treatment plans. The medications prepared at our facility are vital for patients who have allergies to commercial preservatives or dyes, require specific dosages not available from manufacturers, or need a medication that has been discontinued.
Engaging with 503B Compounding Pharmacy is a streamlined process for prescribers at our location. Healthcare providers can initiate an order by contacting our facility directly. Our team of skilled pharmacists and technicians is available to discuss specific patient needs and formulation requirements. We are committed to providing responsive service and support to the medical community serving patients at 2160 W State Road 434, Longwood, FL 32779.
For more information about our services or to speak with a pharmacist, please contact 503B Compounding Pharmacy. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. This requires us to adhere to stricter current Good Manufacturing Practices (cGMP) for higher-volume compounding, which includes more rigorous testing, quality control, and reporting standards than a traditional 503A pharmacy.
Who can place an order with 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications based on the orders of licensed healthcare providers. We work directly with prescribers and their offices to compound medications for their patients. Patients should consult their healthcare provider to determine if a compounded medication from our facility is appropriate for their needs.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a range of medications, with a significant focus on sterile preparations such as injectables, infusions, and ophthalmics. We compound these medications in accordance with prescriptions from healthcare providers.
How does the quality assurance process work at your facility?
As a 503B outsourcing facility, our quality assurance process is comprehensive. It includes testing raw materials, validating our compounding processes, conducting sterility testing, performing stability studies, and continuously monitoring our cleanroom environments to ensure every batch of medication meets exacting standards for safety, potency, and purity.
How can a prescriber at this location start ordering from 503B Compounding Pharmacy?
Prescribers can initiate the process by contacting our facility directly at (407)993-1381. Our pharmacy team will provide information on our available formulations, discuss specific patient requirements, and guide them through the ordering process. We are here to support the healthcare providers at 2160 W State Road 434, Longwood, FL 32779.