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. We serve healthcare providers and their patients by producing medications that are not commercially available, ensuring specific patient needs are met with precision and care.
The operations at 503B Compounding Pharmacy are distinct from traditional compounding. As a 503B outsourcing facility, we adhere to Current Good Manufacturing Practices (cGMP), which are the stringent regulations enforced by the FDA for drug manufacturers. This means every batch of medication prepared at our Longwood location undergoes rigorous testing, quality control checks, and is produced in a controlled, sterile environment. This level of oversight provides an additional layer of safety and reliability for the medications we compound.
Our services at 2160 W State Road 434 are essential for healthcare providers who require patient-specific medications. We compound a significant volume of medications for office use, allowing physicians and clinicians in our community to have vital preparations on hand for immediate administration to patients. This includes sterile injectables, hormone replacement therapies, and other complex formulations that are critical for various treatment plans. The ability to access these high-quality, ready-made compounds from a trusted local source is a significant advantage for medical practices.
Patients who receive medications from 503B Compounding Pharmacy can be assured of their origin and quality. Every product that leaves our facility is traceable and produced under the highest pharmaceutical standards. We are dedicated to supporting the health and wellness of the community by providing healthcare professionals with the reliable compounded medications they need to deliver exceptional care. Our team of experienced pharmacists and technicians is committed to excellence in every step of the compounding process.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and capabilities at https://503bcompoundingpharmacy.com/. We are proud to serve the medical community from our location at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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), which are the strict quality standards required for drug manufacturers, ensuring the highest level of safety, potency, and purity in our compounded medications.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by licensed healthcare providers. Our services are designed for physicians, clinics, and other healthcare practitioners who need compounded medications readily available to administer to their patients at their practice location.
3. Can I as a patient pick up my prescription directly from your facility?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications to healthcare providers for office use. Patients receive their medications directly from their prescribing physician or clinic, not from our location at 2160 W State Road 434.
4. What types of medications does 503B Compounding Pharmacy prepare?
We compound a wide range of sterile preparations, including injectables and other medications that are essential for healthcare providers. These are typically medications that are not available commercially or are in shortage, requiring the specialized compounding services of an FDA-registered 503B outsourcing facility.
5. How do I contact 503B Compounding Pharmacy for more information?
You can contact us by calling (407)993-1381. For more detailed information about our facility and services, please visit our website at https://503bcompoundingpharmacy.com/.