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. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures that every preparation leaving our facility meets stringent, reproducible quality standards.
At our location on W State Road 434, we specialize in the large-scale compounding of medications that are essential for healthcare providers and patients. Our primary focus is on producing non-patient-specific, sterile injectable medications in bulk for office use by physicians, clinics, and hospitals. This allows healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 to have critical medications readily available for immediate administration to patients, enhancing both convenience and patient care outcomes. Our operations are designed to support the local medical community with a reliable, high-quality source for these essential drugs.
The core of our service at 503B Compounding Pharmacy is the provision of sterile compounded preparations. This includes a wide array of injectable medications, such as hormone replacements, vitamins, electrolytes, and other therapeutic agents. By operating under cGMP, we implement extensive testing on ingredients (APIs), utilize state-of-the-art environmental monitoring in our cleanrooms, and enforce strict sterility assurance protocols. For our clients at 2160 W State Road 434, Longwood, FL 32779, this translates to an unparalleled level of confidence in the medications they use in their practice.
Engaging with 503B Compounding Pharmacy is a straightforward process for medical practices. Healthcare providers can place bulk orders for office-use medications directly with our facility. Our team is dedicated to ensuring a seamless experience, from order placement through to delivery. We encourage all local providers to explore how our services can integrate into and enhance their practice. For more detailed information about our available preparations and to initiate an order, please contact us directly or visit our website.
To learn more about 503B Compounding Pharmacy or to discuss your specific needs, we are readily available. You can reach us by phone at (407)993-1381. For a comprehensive overview of our services and capabilities, please visit our website at https://503bcompoundingpharmacy.com/.
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 FDA and operates under Section 503B of the FD&C Act. This subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP), ensuring the highest level of quality, sterility, and safety for the bulk compounded medications we produce.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for healthcare providers and institutions. Licensed physicians, surgeons, clinics, and hospitals can order non-patient-specific, office-use compounded medications in bulk from our location to have on hand for patient treatment.
3. Can I as an individual patient pick up a prescription at your facility?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Individual patients should work with their prescribing doctor or a traditional 503A compounding pharmacy that handles patient-specific prescriptions.
4. What types of medications does 503B Compounding Pharmacy prepare?
We specialize in the large-scale compounding of sterile injectable medications, including but not limited to hormone therapies, vitamin cocktails, and electrolyte solutions. These are prepared in bulk for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
5. How do I place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders by contacting our facility directly at (407)993-1381. Our team will guide you through the ordering process and provide information on product availability and delivery to your practice at 2160 W State Road 434, Longwood, FL 32779.