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 preparation of compounded medications in an environment that adheres to rigorous federal standards. As a 503B outsourcing facility, we produce medications on a larger scale than a traditional pharmacy, supplying sterile and non-sterile preparations to healthcare providers for office use. This model ensures that practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to critical medications without the need to anticipate specific patient needs in advance.
The operations at 503B Compounding Pharmacy are defined by a commitment to quality and compliance. Our facility at 2160 W State Road 434, Longwood, FL 32779 is subject to current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This regulatory framework mandates stringent controls over all aspects of production, from component sourcing and facility cleanliness to sterility testing and final product release. For healthcare professionals relying on our services at 2160 W State Road 434, Longwood, FL 32779, this translates to a higher level of assurance in the safety, potency, and purity of the medications they administer.
503B Compounding Pharmacy provides essential medications that may be in short supply or unavailable from conventional manufacturers. By producing these necessary drugs, our facility at 2160 W State Road 434, Longwood, FL 32779 helps to mitigate drug shortages, ensuring continuity of care. The services provided by 503B Compounding Pharmacy are integral to the healthcare infrastructure supporting the medical community at 2160 W State Road 434, Longwood, FL 32779. We serve as a reliable partner for physicians, clinics, and hospitals by providing bulk compounded preparations for office use, which are essential for various treatments and procedures.
Healthcare providers utilizing the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be confident in the regulatory oversight and quality systems in place. Our status as an FDA-registered 503B outsourcing facility differentiates us from 503A pharmacies, as we operate under a distinct set of federal regulations designed for larger-scale production. The focus of 503B Compounding Pharmacy is on supplying medications in bulk to practitioners, enabling them to have necessary treatments on hand for immediate use during patient visits at their practices near 2160 W State Road 434, Longwood, FL 32779.
For more information about the services provided by 503B Compounding Pharmacy, please contact us. Our facility at 2160 W State Road 434, Longwood, FL 32779 is ready to assist healthcare providers. You can reach 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
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 FDA and complies with current Good Manufacturing Practices (cGMP). This ensures the medications we produce for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 meet stringent federal standards for safety and quality.
Who can receive medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy supplies compounded medications exclusively to healthcare practitioners for office use. We provide these medications to physicians and healthcare facilities that serve patients at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy produces both sterile and non-sterile compounded preparations in larger batches. These are often medications that are on shortage or are not commercially available, supplied to medical practices at 2160 W State Road 434, Longwood, FL 32779 for use in their procedures and treatments.
How does the quality control process work at 503B Compounding Pharmacy?
As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we operate under a robust quality system mandated by cGMP. This includes rigorous testing of components, environmental monitoring, and sterility testing to ensure every product leaving our facility meets predefined specifications.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate an order or request more information by contacting us directly. Please visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381 to speak with a representative.