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 precisely 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, our 503B status means we adhere to rigorous current good manufacturing practices (cGMP), ensuring every preparation is produced in a controlled, sterile environment with extensive quality control testing.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale production of compounded sterile preparations (CSPs) for healthcare providers. We provide these essential medications for office use, allowing physicians and clinicians in Longwood to have critical drugs readily available for patient care without the need for in-office compounding. Our services are integral to supporting the local medical community by supplying high-quality, reliable medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers.
Our operations at the Longwood facility are dedicated to consistency and reliability. By focusing on batch compounding, we ensure that each preparation is identical in strength, purity, and quality. This process involves stringent environmental monitoring, validated sterilization techniques, and thorough analytical testing. The medications produced at 503B Compounding Pharmacy are intended for administration by healthcare professionals within their practice settings, facilitating immediate treatment and enhancing patient outcomes for the community we serve directly from our location on W State Road 434.
Patients and healthcare providers at 2160 W State Road 434 can have full confidence in the medications prepared by 503B Compounding Pharmacy. Our FDA-registered outsourcing facility status provides an additional layer of oversight and assurance. We are a vital resource for physicians, hospitals, and clinics, providing them with access to essential medications that are compounded under the most stringent regulations. For more information or to discuss your needs, please contact us directly at (407)993-1381 or visit our website 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 operates under Section 503B of the FD&C Act. This requires us to comply with current good manufacturing practices (cGMP), which include rigorous testing, sterile production standards, and federal oversight, ensuring the highest quality and safety of our compounded medications.
2. As a patient in Longwood, can I order medications directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides compounded medications for office use by healthcare providers. Your physician or clinic orders the medications they need from our facility on W State Road 434 and then administers them to you during your appointment.
3. How does 503B Compounding Pharmacy support local healthcare providers?
We supply physicians and clinics with sterile, ready-to-use compounded medications produced in batches. This allows healthcare providers at 2160 W State Road 434 to have essential drugs on hand for immediate patient treatment without the burden and liability of compounding them in their own offices.
4. Why would a healthcare provider at this location use a 503B outsourcing facility?
Healthcare providers use our services at 2160 W State Road 434 for access to high-quality, reliable medications that may be on shortage or not commercially available. Our cGMP compliance and batch testing provide a level of quality and consistency that is critical for patient safety and effective treatment.
5. How can a healthcare provider at this address place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. We can be reached by phone at (407)993-1381. More information about our processes and capabilities is also available on our website at https://503bcompoundingpharmacy.com/.