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. Our facility at 2160 W State Road 434, Longwood, FL 32779 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 medications for healthcare providers to administer to their patients in-office or within other clinical settings.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available or are in shortage. Our operations at our Longwood location are strictly regulated and routinely inspected by the FDA, ensuring a level of oversight that goes beyond traditional compounding. We utilize state-of-the-art equipment and rigorous testing protocols to guarantee the potency, purity, and sterility of every preparation that leaves our facility. This commitment to excellence makes 503B Compounding Pharmacy a trusted partner for hospitals, clinics, and healthcare practitioners who require reliable access to critical medications.
Our services are distinct from a traditional retail pharmacy. 503B Compounding Pharmacy does not typically serve individual walk-in patients filling prescriptions. Instead, we work directly with healthcare providers and institutions, supplying them with the necessary medications to support their patient care protocols. The medications compounded at our facility on W State Road 434 are essential for a wide range of treatments, including hormone replacement therapy, ophthalmics, and other injectable preparations that are vital for patient health and well-being.
Choosing 503B Compounding Pharmacy means choosing a partner committed to uncompromising quality. Our team of highly skilled pharmacists and technicians operates within a controlled environment, following current Good Manufacturing Practices (cGMP). Every batch is meticulously documented and tested, providing a chain of custody and assurance that is paramount for patient safety. For healthcare providers at our local address, this translates to confidence and reliability in the medications they use to treat their patients.
To learn more about how 503B Compounding Pharmacy can serve your practice or to inquire about our available formulations, we encourage you to contact us directly. You can reach our team at our facility located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. For comprehensive information about our compliance, services, and the importance of 503B outsourcing facilities, please 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 specific 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. This subjects us to federal oversight, routine FDA inspections, and strict compliance with Current Good Manufacturing Practices (cGMP), ensuring a higher level of quality control for compounded medications.
2. Can I, as an individual patient, come to your location to have a prescription filled?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications in bulk to healthcare providers and institutions. Individual patients should have their prescriptions filled at a traditional retail or 503A compounding pharmacy. Our services are directed at medical professionals.
3. What types of medications does 503B Compounding Pharmacy produce at its Longwood facility?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a significant volume of sterile injectables, including hormone therapies, ophthalmics, and other solutions that are often on drug shortage lists or are not available from large pharmaceutical manufacturers.
4. How do I, as a healthcare provider, order from 503B Compounding Pharmacy?
Healthcare providers and institutions can initiate orders by contacting our facility directly at (407)993-1381. Our team will guide you through the process, which includes establishing an account and providing necessary documentation to ensure a compliant and efficient supply chain for your practice.
5. Why should a clinic at this location choose 503B Compounding Pharmacy as a supplier?
Choosing our facility ensures you receive medications produced under the most rigorous quality standards mandated by the FDA. This provides certainty regarding the sterility, potency, and purity of the medications you administer to your patients, mitigating risk and enhancing patient care standards at your practice.