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. Located at 2160 W State Road 434, Longwood, FL 32779, our facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of compounded pharmaceutical products that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare providers. This model is distinct from traditional compounding, as our 503B status signifies rigorous compliance with Current Good Manufacturing Practices (cGMP). This ensures every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 undergoes stringent quality control testing for sterility, potency, and purity. For medical professionals at this location, this means unparalleled confidence in the medications they administer to their patients.
Our services at 2160 W State Road 434, Longwood, FL 32779 are specifically designed to support the local medical community. We compound a wide array of preparations, including sterile injectables, ophthalmics, and other dosage forms that are essential for various medical treatments. By providing these vital medications, 503B Compounding Pharmacy acts as a critical partner to physicians, surgeons, and other healthcare providers at 2160 W State Road 434, Longwood, FL 32779, enabling them to offer enhanced patient care with medications tailored to specific clinical needs.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare practices at 2160 W State Road 434, Longwood, FL 32779. Orders are placed directly through our secure channels, and our team is dedicated to ensuring timely and accurate fulfillment. We encourage all medical professionals at this location to connect with us to discuss their specific compounding requirements and to learn how our FDA-registered facility can serve their practice. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information.
Frequently Asked Questions for 2160 W State Road 434, Longwood, FL 32779
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 in compliance with Section 503B of the FD&C Act. This requires us to follow Current Good Manufacturing Practices (cGMP), which include rigorous testing for sterility, potency, and endotoxins to ensure the highest quality and safety of our compounded preparations for healthcare providers at this location.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are exclusively for healthcare practitioners, including physicians, surgeons, and other qualified medical professionals, for office use within their practices at 2160 W State Road 434, Longwood, FL 32779. We do not compound patient-specific medications for direct distribution to individual consumers from this facility.
3. What types of medications does 503B Compounding Pharmacy provide to practices at this address?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a broad range of sterile injectable medications, ophthalmics, and other preparations that are often on shortage or are not available from commercial manufacturers. This provides a critical supply chain solution for local medical offices.
4. How does a medical practice at 2160 W State Road 434 place an order?
Healthcare practices at this location can initiate orders by contacting 503B Compounding Pharmacy directly. The process is designed for medical office staff and practitioners. Please call us at (407)993-1381 or visit https://503bcompoundingpharmacy.com/ to begin the ordering process and establish an account.
5. Why should a practice at this specific location choose a 503B outsourcing facility?
Choosing an FDA-registered 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 ensures that the medications you use in your practice are produced under the most stringent quality and safety standards mandated by federal law. This mitigates risk and provides assurance regarding the quality of compounded preparations used in patient care at your facility.