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 federal standards for quality control, testing, and production, providing healthcare providers and patients with medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals located at and serving 2160 W State Road 434, Longwood, FL 32779 can utilize our services to obtain essential medications for their practice needs. This allows for immediate patient treatment during procedures, in-office administration, or for dispensing directly to the patient from the practitioner's supply. Our operations are distinct from traditional retail compounding, focusing on supplying other medical professionals rather than individual consumer walk-in service.
As a 503B outsourcing facility, our processes are governed by Current Good Manufacturing Practices (cGMP). This ensures every batch of medication produced at our Longwood facility undergoes rigorous quality assurance testing for potency, sterility, and stability. This level of oversight provides an additional layer of safety and reliability for the medical community at 2160 W State Road 434, Longwood, FL 32779. Healthcare providers can confidently utilize our products, knowing they meet the most stringent quality benchmarks in the compounding industry.
The medications compounded at 503B Compounding Pharmacy are critical for a wide range of treatments. We provide essential solutions that are often on national shortage lists or are needed in specific strengths and formulations not offered by large commercial manufacturers. This service is vital for ensuring continuity of care and enabling advanced treatment protocols for medical practitioners operating at 2160 W State Road 434, Longwood, FL 32779.
To learn more about our specific formulations and how 503B Compounding Pharmacy can serve your practice, we encourage you to contact us directly. Our team is ready to provide detailed information and support. You can reach us at (407)993-1381 or visit our website for comprehensive details at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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. We comply with Current Good Manufacturing Practices (cGMP) for rigorous quality control, testing, and reporting, which exceeds the standards applied to traditional compounding pharmacies.
2. Can I walk into the facility at 2160 W State Road 434 to pick up a prescription?
No. 503B Compounding Pharmacy does not typically serve individual patients directly. Our primary function is the large-scale production of compounded medications for office use by licensed healthcare practitioners. Patients should receive their medications directly from their prescribing provider.
3. How do healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare practitioners can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. We work with physicians, clinics, and hospitals to supply them with the medications they need for their practice. Please call (407)993-1381 to speak with our team about your specific requirements.
4. What types of medications does 503B Compounding Pharmacy produce?
We compound a broad range of sterile and non-sterile medications that are often on drug shortage lists or are not available from commercial manufacturers. This includes, but is not limited to, injectables, ophthalmics, topicals, and hormone preparations, all produced under strict cGMP standards at our facility.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours provides assurance of quality, safety, and compliance. Our adherence to cGMP standards means every batch is tested for potency, sterility, and purity, mitigating risk for practitioners and providing the highest quality medications for patients at 2160 W State Road 434, Longwood, FL 32779.