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.
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
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 healthcare providers with access to essential medications that are not commercially available. Our operations are strictly regulated and subject to current Good Manufacturing Practice (cGMP) regulations, ensuring every preparation meets rigorous standards for potency, purity, and sterility.
The primary function of 503B Compounding Pharmacy is to supply compounded medications in bulk for office use by healthcare practitioners. We serve the medical community located near 2160 W State Road 434, Longwood, FL 32779, enabling physicians, surgeons, dermatologists, and other healthcare professionals to have the specific medications they need on hand for patient procedures and treatments. By operating as a 503B outsourcing facility, we provide a critical link in the healthcare supply chain, offering a reliable source for high-quality compounded preparations that are essential for patient care in various clinical settings.
Our services at the Longwood location are defined by our compliance with federal oversight. This includes regular FDA inspections, stringent environmental monitoring, and validated processes for sterilization and analytical testing. The medications produced at our 2160 W State Road 434 facility are prepared for office use and are not intended for direct dispensing to individual patients without a prescription. We work directly with healthcare providers to ensure they have the necessary pharmaceutical tools to serve their patients effectively and safely.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with our 503B outsourcing facility means accessing a dependable resource for compounded medications. Our commitment is to uphold the integrity of the pharmaceutical compounding process as defined by Section 503B, providing assurance to the local medical community that the products they use are manufactured under the most exacting quality controls.
For more information, please contact 503B Compounding Pharmacy. Website: | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. We compound large volumes of sterile and non-sterile medications for office use by healthcare practitioners and must comply with current Good Manufacturing Practice (cGMP) regulations.
2. Can I, as a patient, pick up my prescription directly from your location?
No. 503B Compounding Pharmacy supplies medications for office use to healthcare providers. Individual patients do not pick up prescriptions directly from our facility at 2160 W State Road 434, Longwood, FL 32779. Your healthcare provider will administer or dispense the medication to you from their office stock, which they sourced from our 503B outsourcing facility.
3. What types of medications does this 503B outsourcing facility compound?
Our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of preparations, including sterile injectables, ophthalmics, and other medications that are often in short supply or unavailable from traditional manufacturers. All compounds are prepared for office use by local healthcare providers.
4. How does a healthcare provider at 2160 W State Road 434 order from you?
Healthcare providers can establish an account with our 503B outsourcing facility by contacting us directly. Orders from providers at 2160 W State Road 434, Longwood, FL 32779 can be placed through our dedicated channels. Please contact us for more details at or (407)993-1381.
5. Why should a healthcare provider choose a 503B outsourcing facility?
Choosing an FDA-registered 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779 ensures the medications you use in your practice are produced under the strict cGMP standards required by federal law. This provides a higher level of quality assurance, sterility testing, and potency validation compared to traditional pharmacy compounding.