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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous FDA inspections and adheres to Current Good Manufacturing Practices (cGMP), ensuring that every preparation meets stringent federal guidelines for strength, quality, and purity.
The services provided at our Longwood location are dedicated to supplying compounded medications for office use by healthcare practitioners. We work directly with physicians, clinics, hospitals, and other healthcare providers located at 2160 W State Road 434, Longwood, FL 32779, ensuring they have access to the specific medications their patients need. Our role is to support the local medical community by producing large batches of sterile and non-sterile preparations that are readily available for administration within professional practice settings. This allows healthcare providers to focus on patient care with the confidence that their medications are sourced from a trusted, federally regulated facility.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with advanced technology and staffed by a team of highly skilled pharmacists and technicians. We specialize in the compounding of a wide array of preparations, including sterile injectables, ophthalmics, and other essential formulations that are often in short supply. By operating as a 503B outsourcing facility, we help mitigate drug shortages and provide a reliable source of high-quality medications for the healthcare practitioners we serve at our specific location. Our process is built on a foundation of precision, accountability, and unwavering quality control from raw material sourcing to the final product release.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy means accessing a dependable and compliant source for critical medications. We encourage local practitioners to learn more about our services and how we can support their practice. You can reach us directly at (407)993-1381 to speak with our team or visit our website at https://503bcompoundingpharmacy.com/ for comprehensive information about our capabilities and compliance standards. 503B Compounding Pharmacy is your local partner in advancing patient health through quality compounding.
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 under Section 503B of the FD&C Act. This requires us to comply with Current Good Manufacturing Practices (cGMP) and undergo regular FDA inspections, ensuring the medications we compound meet the highest federal standards for quality, strength, and purity.
2. Who can order medications from 503B Compounding Pharmacy at this location?
Our services are designed for healthcare practitioners for office use. Physicians, surgeons, clinics, and other healthcare providers with a practice at 2160 W State Road 434, Longwood, FL 32779 can order compounded medications from our facility to administer to their patients within their practice setting.
3. Can I as a patient directly pick up a prescription from your facility?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications to licensed healthcare providers for office use. Patients should receive their medications directly from their healthcare provider at the location of their treatment, such as a clinic or doctor's office at 2160 W State Road 434, Longwood, FL 32779.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in compounding both sterile and non-sterile preparations in larger batches. This includes, but is not limited to, sterile injectables, ophthalmics, and other formulations that are essential for healthcare providers practicing at our location.
5. How do I contact 503B Compounding Pharmacy to discuss services for my practice?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can contact us directly by phone at (407)993-1381 to speak with a representative. You can also visit our website at https://503bcompoundingpharmacy.com/ for more detailed information about our specific services and compliance.