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 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for patient-specific medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the preparation of compounded medications in bulk for office use by healthcare practitioners. This means physicians and clinicians at 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications for their practice without the need to maintain a large inventory. The pharmacy compounds a significant volume of medications, ensuring consistent supply and sterility for injectables, ophthalmics, and other formulations required for immediate patient care within the medical community at 2160 W State Road 434, Longwood, FL 32779.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy is subject to current Good Manufacturing Practice (cGMP) regulations and undergoes regular FDA inspections. This regulatory framework ensures that every product leaving the facility meets the highest standards for potency, purity, and stability. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this translates to confidence and trust in the medications they administer to their patients, knowing they are sourced from a fully compliant and transparent operation.
503B Compounding Pharmacy provides a critical service to the local medical community by addressing drug shortages and discontinuations. When a commercially manufactured drug is unavailable, the team at 2160 W State Road 434, Longwood, FL 32779 can compound a safe and effective alternative, preventing interruptions in patient treatment plans. This capability is vital for ensuring continuous care and is a cornerstone of the service provided by this FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779.
The team of pharmacists and technicians at 503B Compounding Pharmacy is highly trained in advanced compounding techniques within a controlled environment. Their expertise ensures that all preparations, especially sterile injectables, are free from contaminants. For healthcare professionals at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B outsourcing facility means accessing a team dedicated to precision, quality, and supporting the specific needs of their practice and patients.
To learn more about the services provided or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. The facility is ready to assist the medical community at 2160 W State Road 434, Longwood, FL 32779 with their compounding needs.
Website: | Phone: (407)993-1381
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 is registered with the U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the FD&C Act. We comply with current Good Manufacturing Practices (cGMP) and are subject to regular FDA inspections to ensure the highest quality and safety standards for the medications we provide to healthcare providers.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for healthcare providers and practitioners. We supply compounded medications for office use to medical professionals who require bulk, consistent formulations for their practice at 2160 W State Road 434, Longwood, FL 32779. We do not compound medications for individual patients based on direct consumer requests.
What types of medications does 503B Compounding Pharmacy typically prepare?
As a 503B outsourcing facility, we specialize in the large-scale compounding of both sterile and non-sterile medications. This includes a wide range of preparations such as sterile injectables, ophthalmic solutions, and topical formulations that are often used by healthcare providers in clinical settings at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure the sterility of its injectable products?
Our facility at 2160 W State Road 434, Longwood, FL 32779 maintains strict environmental controls, including ISO-classified cleanrooms. Our processes for sterile compounding follow rigorous cGMP protocols, and we perform extensive testing, including sterility testing and endotoxin testing, on each batch to ensure every product meets its required specifications before being released.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact our facility directly to discuss their specific needs and place an order. Our team is available to provide information and support. You can reach us by phone at (407)993-1381 or visit our website at .