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.
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 and safety, producing medications in larger batches for office use by healthcare practitioners or for distribution to hospitals and clinics, without patient-specific prescriptions.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under a framework of rigorous quality control. This includes comprehensive testing of components, in-process materials, and finished drug products to ensure they meet all specified standards of identity, strength, quality, and purity. The environment at our Longwood facility is meticulously controlled to prevent contamination, ensuring every preparation meets the exacting requirements for safety and efficacy that healthcare providers and their patients deserve.
503B Compounding Pharmacy provides healthcare practitioners with a reliable source for high-quality compounded medications. By serving the medical community from our location at 2160 W State Road 434, Longwood, FL 32779, we support local healthcare delivery with essential medications that are often on shortage or unavailable from conventional manufacturers. Our role is to be a trusted partner to practitioners, ensuring they have the necessary pharmaceutical tools for patient care.
The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in the art and science of compounding. Their dedication is focused on the precise and accurate preparation of medications within our facility. We are committed to upholding the integrity of the pharmaceutical compounding process at our Longwood location, providing a critical service to the healthcare infrastructure.
For more information about the services provided by 503B Compounding Pharmacy, please visit our website at or contact us directly at (407)993-1381. Our facility at 2160 W State Road 434, Longwood, FL 32779 is focused on supporting the local medical community with quality compounded pharmaceutical preparations.
Frequently Asked Questions
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 regulated under Section 503B of the FD&C Act. This requires us to comply with Current Good Manufacturing Practices (cGMP) for higher-volume production of compounded drugs for office use by practitioners.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications produced at our Longwood facility are intended for healthcare practitioners, hospitals, and clinics. These are office-use medications and are not dispensed directly to the public from this location without a specific patient prescription from a licensed practitioner.
What types of medications are prepared at the Longwood facility?
As a 503B outsourcing facility, we prepare a range of sterile and non-sterile compounded medications in batches. This includes medications that are on the FDA drug shortage list or are not otherwise available from traditional manufacturers, all produced within our facility at 2160 W State Road 434.
How does the 503B Compounding Pharmacy ensure the quality of its products?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under strict cGMP standards. This involves rigorous environmental monitoring, validated processes, and extensive testing of ingredients and finished products to ensure potency, sterility, and overall quality.
How can a healthcare provider place an order with your facility?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381 to discuss their needs. Our team at the Longwood location will provide information on ordering procedures and product availability.