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 consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B outsourcing facility undergoes rigorous federal oversight, including routine FDA inspections, to ensure every preparation meets exacting standards for the healthcare providers and patients we serve at our Longwood location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. Our operations at 2160 W State Road 434 are designed to support the local medical community by providing bulk quantities of high-quality compounded preparations. This allows physicians, surgeons, dermatologists, and other healthcare professionals in our area to have essential medications readily available for their patients without the need for in-office compounding. By centralizing this process in our FDA-registered facility, we enhance patient safety through stringent quality control protocols, advanced analytical testing, and a controlled environment.
Our state-of-the-art facility at 2160 W State Road 434 is equipped with modern technology and staffed by a team of experienced pharmacists and technicians dedicated to the science of compounding. Every batch is meticulously prepared and tested to ensure potency, purity, and sterility. For healthcare providers at our location, this means access to a reliable and trusted source for critical medications, including sterile injectables, ophthalmics, and topical formulations. Patients benefit indirectly through the assurance that the medications administered in their local practitioner’s office are produced under the most rigorous quality assurance program available.
503B Compounding Pharmacy is an integral partner to the healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779. We provide a vital service that enables medical practices to operate more efficiently and safely. By choosing an FDA-registered 503B outsourcing facility, healthcare professionals demonstrate a profound commitment to patient care and safety. We invite local practitioners to learn more about how our services can support their practice. For detailed information on our available preparations and protocols, please contact us directly or visit our website.
To learn more about the services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
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 and inspected by the U.S. Food and Drug Administration (FDA) under Section 503B of the FD&C Act. This federal oversight requires us to adhere to Current Good Manufacturing Practices (cGMP), which are more rigorous than traditional pharmacy standards, ensuring a higher level of quality, testing, and consistency for the medications we compound.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy operates as an outsourcing facility that provides medications for office use by healthcare practitioners. We do not compound patient-specific prescriptions for direct pickup. Your healthcare provider at their office will administer or dispense the medication we compound to you.
3. How do I access medications compounded at your facility?
Medications are accessed through your local healthcare provider. Practitioners in the area can order compounded preparations from our facility at 2160 W State Road 434 for use within their practice. You should discuss your treatment options, including the use of compounded medications from a 503B outsourcing facility, directly with your doctor.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in compounding sterile injectables, ophthalmics, and other formulations in larger batch quantities for office use. This includes medications used in pain management, hormone therapy, dermatology, and other specialized treatments that are ordered by healthcare providers for their patients.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in utilizing our services can initiate the process by contacting 503B Compounding Pharmacy directly. They can call us at (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering procedures and available preparations.