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. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies, signifying adherence to the most rigorous federal standards for quality, safety, and production. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. The core mission of 503B Compounding Pharmacy is to provide practitioners with access to a reliable supply of high-quality compounded medications, thereby supporting the delivery of personalized patient care.
The operations at 2160 W State Road 434 are governed by Current Good Manufacturing Practices (cGMP), which are the strict quality standards enforced by the FDA for all drug manufacturers. This commitment to cGMP ensures that every batch of medication produced within the facility undergoes rigorous testing for potency, sterility, and purity. The environment at 2160 W State Road 434 is meticulously controlled, with sterile compounding performed in ISO-classified cleanrooms by highly trained personnel. This level of quality control provides healthcare providers with the confidence that the medications they receive from 503B Compounding Pharmacy meet consistent and reproducible standards, batch after batch.
503B Compounding Pharmacy provides healthcare professionals with essential medications that are often on shortage or are not commercially available from large pharmaceutical manufacturers. By serving as a vital link in the healthcare supply chain, the facility at 2160 W State Road 434 helps ensure that patient treatments are not interrupted. Healthcare providers can confidently order the compounded medications they need for their practice, knowing they are sourced from an outsourcing facility that prioritizes compliance and patient safety above all else. The team at 2160 W State Road 434 is dedicated to maintaining the highest level of service for the medical community.
For more information about the services and compliance standards of this FDA-registered outsourcing facility, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team is available to answer questions and provide support. You can reach them at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ to learn more about the specific medications and services available from their 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 operates under Section 503B of the FD&C Act and must comply with Current Good Manufacturing Practices (cGMP). This signifies a higher level of federal oversight compared to traditional compounding, ensuring strict standards for quality, testing, and production controls for all medications we compound.
Who can order medications from 503B Compounding Pharmacy?
As an outsourcing facility, our primary service is providing compounded medications for office use by healthcare practitioners. Orders from our location at 2160 W State Road 434 are intended for healthcare providers to administer or dispense to their patients within their practice setting.
What types of medications does 503B Compounding Pharmacy produce?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a range of sterile and non-sterile medications. This often includes medications that are currently in shortage or are not commercially available from pharmaceutical manufacturers, providing a critical supply for healthcare providers.
How does 503B Compounding Pharmacy ensure medication safety and quality?
Safety and quality are ensured through strict adherence to cGMP regulations. This includes environmental monitoring of our cleanrooms at 2160 W State Road 434, rigorous testing of components and finished batches for potency, sterility, and purity, and comprehensive standard operating procedures followed by our trained staff.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers can contact our facility at 2160 W State Road 434, Longwood, FL 32779 directly to discuss ordering compounded medications. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process and available formulations.