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 that are not available commercially. As a 503B Compounding Pharmacy, we serve healthcare providers by producing medications in larger batches for office use, ensuring a reliable supply of essential drugs for patient care.
The operations at 2160 W State Road 434, Longwood, FL 32779 are distinct from traditional compounding pharmacies. Our status as a 503B outsourcing facility means we adhere to rigorous current good manufacturing practices (cGMP) as required by the FDA. This commitment to the highest standards of quality and safety is central to our mission. The medications produced at our facility are intended for administration by healthcare professionals within their practice settings, providing a critical resource for clinics and hospitals.
Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by a team of experienced compounding professionals. We specialize in creating formulations that are often in short supply or discontinued by major manufacturers. By focusing on these essential medications, 503B Compounding Pharmacy helps to mitigate drug shortages and supports the local healthcare infrastructure. Our processes are designed for efficiency and scale, ensuring that healthcare providers have access to the medications they need when they need them.
Quality control is paramount at our facility. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes stringent testing and validation to ensure potency, purity, and sterility. This unwavering dedication to quality distinguishes 503B Compounding Pharmacy and provides peace of mind to the healthcare providers we serve. We operate with transparency and a commitment to compliance with all federal regulations governing 503B outsourcing facilities.
For more information about our services or to inquire about our available medications, please contact 503B Compounding Pharmacy. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website for detailed information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
Being an outsourcing facility means 503B Compounding Pharmacy is registered with the FDA under Section 503B and complies with current good manufacturing practices (cGMP). This allows us to compound large volumes of sterile and non-sterile medications for healthcare providers to administer in their practice at 2160 W State Road 434, Longwood, FL 32779.
Who can purchase medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications primarily to healthcare facilities and practitioners for office use. Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare providers, not for direct dispensing to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding medications that are on the drug shortage list or are no longer available from commercial manufacturers. Our facility at 2160 W State Road 434, Longwood, FL 32779 produces these essential sterile and non-sterile preparations in larger batches.
How does the quality assurance process work at your facility?
At our location at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy implements a rigorous quality assurance program. This includes extensive testing and validation of every batch to ensure it meets strict standards for sterility, potency, and purity before it is released.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information. All operations are conducted from 2160 W State Road 434, Longwood, FL 32779.