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 at 2160 W State Road 434, Longwood, FL 32779. This designation, defined under Section 503B of the Federal Food, Drug, and Cosmetic Act, establishes a critical standard for quality and safety in pharmaceutical compounding. As a 503B outsourcing facility, this location adheres to rigorous current good manufacturing practices (cGMP) set forth by the FDA. This ensures that every preparation leaving the facility meets the highest standards for sterility, potency, and purity. The core function of 503B Compounding Pharmacy is the large-scale production of compounded medications for office use, which are then distributed to healthcare providers and facilities for patient administration.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding. This 503B Compounding Pharmacy specializes in the non-patient-specific, anticipatory compounding of medications. This model allows healthcare practitioners at local clinics, hospitals, and surgical centers to have immediate access to a reliable supply of essential sterile preparations. By maintaining an inventory of high-quality, ready-to-use medications, this 503B outsourcing facility supports the local medical community in enhancing patient care, improving operational efficiency, and ensuring preparedness for a wide range of clinical scenarios. The operations are strictly confined to this registered address, focusing on serving the specific needs of the professional medical community from this central location.
Quality assurance is the foundation of all operations at this 503B Compounding Pharmacy. The facility employs robust environmental monitoring, stringent testing protocols, and comprehensive validation processes for all equipment and methods. Every batch of medication is compounded under strict sterile conditions and is subject to thorough analytical testing to verify identity, strength, quality, and purity before it is released. This unwavering commitment to cGMP standards provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they use are safe, effective, and reliable. The dedicated team of pharmacists and technicians at this location are highly trained specialists in sterile compounding, ensuring expert execution of every process.
For healthcare providers and facilities seeking a trusted source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a partner in patient care. The facility offers a vital service to the local medical ecosystem by providing access to medications that may be in shortage or are not commercially available in the required form or strength. To learn more about the specific formulations available or to discuss your facility's needs, you can contact this 503B outsourcing facility directly. The team is available to provide information and support to the professional community from this location.
Contact 503B Compounding Pharmacy: Website: Phone: (407)993-1381 Address: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility? It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. This registration requires compliance with strict current good manufacturing practices (cGMP) for the large-scale compounding of sterile medications intended for office use by healthcare practitioners.
2. Can I, as an individual patient, get a prescription filled at this location? No. 503B Compounding Pharmacy at this address provides medications exclusively for "office use" by healthcare providers. Individual patients should work with their prescribing doctor, who may utilize medications from this facility for administration within their practice at 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does this 503B facility compound? This FDA-registered outsourcing facility specializes in sterile preparations, which can include injectables, infusions, ophthalmics, and other medications that require compounding in an ISO-classified cleanroom environment to ensure sterility. These are produced for healthcare providers practicing at this location.
4. How does a healthcare provider at this location order from the 503B Compounding Pharmacy? Healthcare providers and facilities can place orders for office-use compounded medications by contacting the facility directly at (407)993-1381. The team will provide information on available formulations, ordering procedures, and delivery options specific to 2160 W State Road 434, Longwood, FL 32779.
5. Why should a provider use a 503B outsourcing facility instead of a traditional compounding pharmacy? Utilizing a 503B outsourcing facility like this one ensures the medications are produced under federally mandated cGMP standards, which include rigorous testing for sterility, potency, and endotoxins. This provides a higher level of quality assurance for medications used in a clinical setting at 2160 W State Road 434, Longwood, FL 32779.