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. As a 503B outsourcing facility, we adhere to the highest standards of quality control, purity, and safety, providing medications for healthcare providers to administer to their patients in-office or for use within institutional settings.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded drugs that are patient-specific yet not individually identified. This model allows us to support the medical community with essential medications that may be in shortage or are not commercially available. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by a team of highly trained pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. Every process, from ingredient sourcing to final preparation and testing, is rigorously controlled to ensure the integrity and potency of every preparation that leaves our facility.
Our services are integral to hospitals, clinics, and healthcare practitioners who rely on a consistent and reliable source of high-quality compounded medications for their patients. We provide a critical service by compounding medications that are often on the national drug shortage list, ensuring that patient care is not interrupted. The operations at 503B Compounding Pharmacy are subject to regular FDA inspections and strict current Good Manufacturing Practice (cGMP) regulations, which far exceed the standards applied to traditional compounding pharmacies. This commitment to regulatory excellence provides our clients with the utmost confidence in the medications they utilize.
For healthcare providers seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of reliability and quality. We encourage you to contact us to discuss how our services can support your practice and patient care protocols. You can reach us by phone at (407)993-1381 or visit our website to learn more about our capabilities and compliance standards 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. This registration requires us to comply with stringent current Good Manufacturing Practices (cGMP) and subjects us to routine FDA inspections to ensure the quality, safety, and sterility of our compounded medications.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare providers and institutions, such as hospitals, clinics, and physician offices, for office-use and administration to their patients. We do not provide medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in the large-scale compounding of both sterile and non-sterile medications, with a significant focus on drugs that are currently on the FDA’s drug shortage list. This includes a wide range of injectables, ophthalmics, and other preparations that are essential for medical procedures and patient treatment plans.
How does 503B Compounding Pharmacy ensure medication quality?
Quality is assured through a multi-layered approach at our 2160 W State Road 434 location. This includes sourcing APIs and components from FDA-registered and inspected suppliers, employing rigorous testing protocols, maintaining an advanced cleanroom environment, and adhering to strict cGMP standards throughout the entire compounding and quality control process.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers and institutions can initiate an order or inquire about our services by contacting our facility directly at (407)993-1381. Our team will provide information on our available formulations, ordering process, and delivery options to the 2160 W State Road 434, Longwood, FL 32779 location or directly to your practice.