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 large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest standards of pharmaceutical quality, undergoing rigorous FDA inspections to ensure every preparation meets exacting specifications for strength, purity, and stability. We serve healthcare providers by providing them with essential medications that are not commercially available, enabling them to better treat their patients' unique needs.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals in Longwood can rely on our facility for a consistent, high-quality supply of compounded preparations. This allows clinicians to have critical medications on hand for immediate administration during patient visits, procedures, or treatments, enhancing both the efficiency of their practice and the level of care they can provide directly from their offices.
Our state-of-the-art facility at 2160 W State Road 434 is designed to uphold a environment of uncompromising quality control. Our sterile compounding suites are equipped with advanced technology and environmental monitoring systems to ensure the integrity of every injectable, ophthalmic, and inhalation drug we produce. The team at 503B Compounding Pharmacy consists of highly trained pharmacists and technicians who are experts in the science of compounding, working meticulously to follow current Good Manufacturing Practices (cGMP). This commitment to quality at our Longwood location is the foundation of everything we do.
503B Compounding Pharmacy provides a vital service to the local medical community by compounding drugs that are on the FDA drug shortage list. When commercially manufactured medications become unavailable, our facility can step in to help prevent interruptions in patient care. Healthcare providers at practices near 2160 W State Road 434 can depend on us to compound these essential medications, ensuring their patients continue to receive the therapies they need without delay. We monitor drug shortages closely to proactively address the needs of the practitioners we serve.
For healthcare providers seeking a trusted 503B outsourcing facility, we invite you to connect with us. You can learn more about our services and processes by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our pharmacy directly at (407)993-1381. The team at 503B Compounding Pharmacy is ready to support your practice with reliable, high-quality compounded medications from our location at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. 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 requires us to comply with stringent current Good Manufacturing Practices (cGMP), undergo regular FDA inspections, and report adverse events, ensuring a higher level of quality and oversight for the medications we compound.
2. Can I as an individual patient pick up my compounded medication directly from your location?
No. 503B Compounding Pharmacy provides medications primarily for office use by healthcare practitioners. Your prescribing provider will administer or dispense the medication to you from their office. Patients do not typically pick up medications directly from our facility at 2160 W State Road 434.
3. How do I, as a healthcare provider, order compounded medications from your pharmacy?
Healthcare providers can place orders for their practice by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process and provide any necessary documentation for the medications you require from our location at 2160 W State Road 434.
4. What types of medications does 503B Compounding Pharmacy typically prepare?
We compound a wide range of sterile and non-sterile medications, including injectables, ophthalmics, topicals, and oral dosages. These are often preparations that are on FDA shortage lists or are not available from traditional commercial manufacturers, providing essential options for healthcare providers.
5. How does your pharmacy ensure the quality and sterility of its compounded preparations?
Our facility at 2160 W State Road 434 utilizes isolator technology, rigorous environmental monitoring, and validated processes to ensure sterility. Every batch undergoes thorough testing and quality control checks by our trained staff in compliance with cGMP standards to guarantee the safety, potency, and purity of all medications we produce.