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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale, non-patient-specific compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous current good manufacturing practices (cGMP) to ensure the highest standards of quality, purity, and strength for all compounded preparations.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding pharmacies. This 503B Compounding Pharmacy primarily serves healthcare providers and facilities by producing medications in bulk for office use. This enables physicians, surgeons, hospitals, and clinics in the local area to have immediate access to critical medications without the delay of patient-specific compounding. The facility's operations are strictly regulated and monitored by the FDA, providing an added layer of safety and compliance assurance for medical professionals.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, the 503B Compounding Pharmacy offers a reliable source for high-quality compounded medications. The facility is equipped to handle complex compounding needs, including sterile injectables, ophthalmics, and other formulations that require an aseptic environment. By operating under Section 503B, the pharmacy is subject to federal oversight and must meet stringent production and testing standards, which helps mitigate risk for the medical community it serves.
Patients who receive medications compounded at this location benefit from the facility's commitment to cGMP standards. While the 503B Compounding Pharmacy does not engage in direct patient-specific compounding, the medications it produces for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 are held to a level of quality that is essential for patient safety and positive therapeutic outcomes. The facility plays a crucial role in the local healthcare ecosystem by ensuring a consistent and compliant supply of essential medications.
Contact the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for more information. You can reach them via their website at or by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean to be a 503B Compounding Pharmacy at 2160 W State Road 434?
Being a 503B Compounding Pharmacy means this facility is an FDA-registered outsourcing facility that compounds medications in large batches for office use by healthcare providers. It operates under stricter federal regulations (cGMP) than traditional compounding pharmacies, focusing on non-patient-specific production for the medical community at this location.
2. Can I, as a patient, walk into 2160 W State Road 434 to get a prescription compounded?
No. The 503B Compounding Pharmacy at this address does not typically handle patient-specific prescriptions. It supplies compounded medications in bulk to licensed healthcare providers and facilities. Patients should contact their healthcare provider to inquire about medications that may have been sourced from this facility.
3. What types of medications does the 503B Compounding Pharmacy in Longwood produce?
The facility at 2160 W State Road 434 specializes in compounding sterile preparations, such as injectables, IV bags, and ophthalmics, as well as non-sterile medications. All products are compounded for office use by healthcare professionals under the regulations of Section 503B.
4. How does the 503B designation at this location benefit my local doctor?
It provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to bulk, high-quality compounded medications that are produced under federally mandated cGMP standards. This ensures reliability, consistency, and a reduced risk of contamination for the medications they use in their practice.
5. Who should I contact at 2160 W State Road 434 for more information?
Healthcare providers and facilities can contact the 503B Compounding Pharmacy directly for information on services and ordering. Please use the contact details provided: visit or call (407)993-1381.