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 Drug Quality and Security Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to stringent federal quality standards, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies. This ensures that every batch of medication produced is of the highest quality, purity, and consistency, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for their patients' needs.
The core function of 503B Compounding Pharmacy is to provide medications for office use. This means that healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can obtain compounded medications to have on hand for immediate administration to patients during office visits, procedures, or treatments. This service is essential for clinics and practices that require ready access to specific drug formulations that are not commercially available. By sourcing from an FDA-registered 503B outsourcing facility like this one, practitioners at 2160 W State Road 434, Longwood, FL 32779 can be confident in the regulatory compliance and quality assurance of the medications they use.
503B Compounding Pharmacy serves a critical role in the healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779 by addressing drug shortages. When a commercially manufactured drug is on backorder or discontinued, this facility can often compound a necessary formulation to prevent interruptions in patient care. This capability is vital for ensuring that patient treatment plans remain uninterrupted at 2160 W State Road 434, Longwood, FL 32779. The pharmacy compounds a significant volume of medications, which are then distributed to healthcare settings to be administered under professional supervision.
For healthcare providers and practices located at 2160 W State Road 434, Longwood, FL 32779, engaging with 503B Compounding Pharmacy offers a distinct advantage. The facility provides a vital link between complex patient needs and precise medication solutions, all while operating under the highest level of federal oversight. To learn more about its services or to place an order, healthcare entities at 2160 W State Road 434, Longwood, FL 32779 can contact the pharmacy directly via its website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
1. What does it mean that this is a 503B outsourcing facility? It means this pharmacy is an FDA-registered facility that compounds large volumes of sterile and non-sterile medications in accordance with strict federal current Good Manufacturing Practices (cGMP). This is a different regulatory standard than a traditional compounding pharmacy and ensures batch-level quality and testing for medications supplied to healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
2. As a patient at 2160 W State Road 434, Longwood, FL 32779, can I order medications directly from you? No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. Your healthcare provider at 2160 W State Road 434, Longwood, FL 32779 can order and stock these medications to administer to you directly during your appointment or procedure.
3. What types of medications does 503B Compounding Pharmacy provide for practices at this location? The pharmacy compounds a wide array of medications, including sterile injectables, ophthalmics, and other formulations that are often on shortage or are not available from large commercial manufacturers. These are supplied to healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order? Healthcare providers can place orders for their practice by contacting 503B Compounding Pharmacy directly through the official website, https://503bcompoundingpharmacy.com/, or by calling the facility at (407)993-1381 to speak with a representative.
5. Why should a clinic at 2160 W State Road 434, Longwood, FL 32779 source from a 503B outsourcing facility? Sourcing from this FDA-registered 503B outsourcing facility provides assurance of compliance with the highest federal quality standards. This mitigates risk for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and ensures their patients receive medications that have undergone rigorous testing for potency, sterility, and purity.