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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to our mission at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we are held to the highest standards of pharmaceutical compounding, adhering to rigorous Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility is of the utmost quality, purity, and potency. Our primary function is the large-scale compounding of medications for office use, which are then distributed to healthcare practitioners for patient administration within their clinical settings.
The services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional retail compounding. We support the local medical community by providing physicians, surgeons, veterinarians, and other healthcare providers with access to essential medications that may be commercially unavailable, in short supply, or require a specific formulation not offered by major manufacturers. Our work enables these practitioners to better serve their patients by ensuring they have the necessary pharmaceutical tools for a wide range of treatments and procedures. The medications we compound are prepared in bulk and are not intended for direct dispensing to individual patients without a prescription from their provider.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly skilled pharmacists and technicians who are experts in sterile and non-sterile compounding techniques. We maintain an unwavering commitment to quality control, with stringent testing and documentation protocols in place for every batch we produce. This level of oversight, mandated by our 503B status, provides an additional layer of safety and reliability for the healthcare professionals who depend on our products. By choosing 503B Compounding Pharmacy, local providers are partnering with a facility that prioritizes regulatory compliance and patient safety above all else.
For healthcare providers seeking a reliable source for high-quality compounded medications for office use, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands ready to assist. We encourage you to explore our capabilities and learn how our services can support your practice. You can reach us by phone at (407)993-1381 to speak with a representative, or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information about our processes and available formulations.
Frequently Asked Questions
1. 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 U.S. Food and Drug Administration and operates in compliance with Section 503B of the FD&C Act. This requires us to adhere to strict Current Good Manufacturing Practice (cGMP) regulations, which include rigorous testing, quality control, and reporting standards for all medications we compound.
2. Can I, as an individual patient, pick up my prescription directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds medications for office use by healthcare providers. Individual patients must receive their medications directly from their prescribing physician, veterinarian, or a dispensing pharmacy that has sourced the product from our facility.
3. What types of medications does 503B Compounding Pharmacy at this location provide?
We provide a wide range of sterile and non-sterile compounded medications in larger batches for healthcare providers. This includes formulations that address drug shortages, specific strengths or dosages not commercially available, and medications free of certain allergens or dyes, all prepared at our facility on W State Road 434.
4. How do healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can initiate the ordering process by contacting our facility directly at (407)993-1381. Our team will work with them to discuss their specific needs, provide information on available formulations, and guide them through our ordering and verification procedures.
5. Why should a healthcare provider choose 503B Compounding Pharmacy for their office-use medications?
Choosing our facility ensures that the medications used in your practice are produced under the highest federally mandated quality standards. Our 503B status at 2160 W State Road 434, Longwood, FL 32779 guarantees a level of oversight, consistency, and safety that is specifically designed for bulk compounding for office use.