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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to producing high-quality compounded medications in large batches for healthcare providers. As a 503B outsourcing facility, we adhere to stringent current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every medication leaving our facility in Longwood meets the highest levels of safety, identity, strength, quality, and purity.
The primary distinction of 503B Compounding Pharmacy is our focus on supplying healthcare facilities, such as hospitals, clinics, and physician offices, with medications that are often in short supply or not commercially available. By preparing these medications in advance, we provide a critical service that helps ensure patient care is not interrupted. The medications produced at our location on W State Road 434 are created in a controlled environment with extensive quality control testing, providing healthcare professionals with a reliable and trusted source for essential drugs.
Our operations at 2160 W State Road 434, Longwood, FL 32779 are built on a foundation of compliance and quality. We undergo regular FDA inspections and maintain a transparent record of our processes. For healthcare providers seeking a dependable partner for their medication needs, 503B Compounding Pharmacy offers a vital resource. We are committed to supporting the local medical community by providing sterile and non-sterile compounded preparations that are essential for patient treatment plans.
To learn more about our services or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381. Our facility is dedicated to upholding the highest standards as an FDA-registered 503B outsourcing facility serving the needs of healthcare providers from our location in Longwood.
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 complies with stricter production standards known as current Good Manufacturing Practices (cGMP). This registration differentiates us from traditional compounding pharmacies and ensures a higher level of quality control for the medications we produce.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy primarily supplies compounded medications to healthcare facilities and practitioners, such as hospitals, clinics, and surgery centers, for office use. We do not typically dispense medications directly to individual patients at our Longwood location without a prescription from their healthcare provider.
What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434 specializes in compounding medications that are often on drug shortage lists or are not available from commercial manufacturers. This includes a range of sterile injectables, ophthalmics, and other preparations essential for healthcare settings in Longwood.
How does the quality control process work at your Longwood facility?
As a 503B outsourcing facility, we implement rigorous quality control testing for every batch of medication produced. This includes testing for sterility, potency, and endotoxins to ensure each preparation meets exact specifications before it is distributed to healthcare providers.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly to discuss their needs. Please visit our website at https://503bcompoundingpharmacy.com/ for more information or call us at (407)993-1381 to speak with a representative at our Longwood location.