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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. We specialize in the non-sterile and sterile compounding of medications, adhering to the highest standards of quality and safety as mandated by federal law. As a 503B outsourcing facility, our primary focus is on producing large batches of compounded medications for office use by healthcare practitioners, ensuring a reliable supply of critical drugs for their patients.
The operations at our Longwood location are distinct from a traditional compounding pharmacy. We serve healthcare providers by supplying them with medications that are often in short supply or unavailable from conventional manufacturers. The medications produced at 2160 W State Road 434 are prepared for office use, meaning a healthcare professional can administer them to a patient within their practice setting without the need for an individual patient-specific prescription. This model provides physicians, surgeons, and other practitioners with immediate access to essential medications, enhancing patient care and procedural efficiency.
Our facility at 2160 W State Road 434 is designed to meet rigorous FDA compliance standards. This includes robust quality control protocols, stringent environmental monitoring, and validated processes for both sterile and non-sterile production. By operating under the 503B regulations, we provide an added layer of safety and assurance for healthcare providers, as our operations are subject to regular FDA inspections. The team at our Longwood location is comprised of skilled pharmacists and technicians who are dedicated to the precise and accurate preparation of every formulation that leaves our facility.
We encourage healthcare providers and their staff to contact us directly to discuss their specific medication needs. Our team is ready to provide detailed information about our current product offerings and processes. You can reach us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information about the services provided from our location at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 subjects us to federal quality standards and routine FDA inspections, which differ from the state-level regulation of traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare practitioners. Medications produced at our facility on W State Road 434 are supplied for office use to physicians, clinics, hospitals, and other healthcare providers for administration to patients within their practice.
Can individual patients pick up prescriptions at 2160 W State Road 434?
No. As a 503B outsourcing facility, we do not typically dispense medications directly to individual patients based on a personal prescription. Our business model is focused on supplying healthcare providers for office use. Patients should contact their healthcare provider for information on obtaining their medications.
What types of medications does 503B Compounding Pharmacy produce?
Our facility in Longwood specializes in compounding both sterile and non-sterile medications that are often on drug shortage lists or are not commercially available. This includes various injectables, ophthalmics, and other preparations needed by healthcare providers for their practices.
How can a healthcare provider place an order with your facility?
Healthcare providers can contact our facility directly to establish an account and discuss their needs. Please call us at (407)993-1381 to speak with a representative. All ordering and fulfillment is managed from our location at 2160 W State Road 434, Longwood, FL 32779.