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 in strict compliance with 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 sterile and non-sterile compounded medications. The 503B designation signifies that our pharmacy adheres to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP). This ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779, have access to a reliable source of high-quality compounded medications for their patients.
The primary function of a 503B compounding pharmacy is to produce medications in larger batches for office use by healthcare practitioners. This model is distinct from traditional compounding, as it allows physicians, surgeons, and other medical professionals to have essential medications readily available for administration during patient visits, procedures, or surgeries. By serving as a bulk manufacturer, 503B Compounding Pharmacy provides a critical component of the healthcare infrastructure for the medical community at 2160 W State Road 434, Longwood, FL 32779. Our operations are subject to rigorous FDA oversight, which includes regular inspections and strict quality control protocols for every batch produced.
For healthcare providers at our specific location, the benefits of utilizing a 503B outsourcing facility are significant. It eliminates the need for in-office compounding, which can be resource-intensive and may not meet the same stringent standards. 503B Compounding Pharmacy provides assurance that each medication is produced in a controlled environment with validated processes for sterility, potency, and purity. This allows medical professionals to focus on patient care with the confidence that the medications they use are of the highest quality. Our commitment is to support the local healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779, by delivering safe, effective, and reliable compounded preparations.
503B Compounding Pharmacy is an essential partner for hospitals, clinics, and private practices that require access to medications that may be in short supply or not commercially available. Our facility is equipped to handle complex compounding needs, ensuring a consistent supply of critical drugs. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in aseptic technique and quality assurance. We invite healthcare providers at 2160 W State Road 434, Longwood, FL 32779, to learn more about how our 503B services can enhance their practice. For more information or to inquire about our products, please contact us via our website at https://503bcompoundingpharmacy.com/ or by phone at (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 operates under Section 503B of the FD&C Act. This registration requires us to comply with current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional compounding pharmacies, ensuring a higher level of quality and safety for the medications we produce.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our primary clients are physicians, surgeons, and other qualified medical professionals who administer medications within their practice at or associated with 2160 W State Road 434, Longwood, FL 32779. We do not typically dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in producing sterile and non-sterile compounded medications in larger batches. This often includes injectable medications, ophthalmics, and other preparations that are essential for hospital, clinical, and surgical settings serving the location at 2160 W State Road 434, Longwood, FL 32779.
How does the quality control process work at your facility?
Quality control is paramount at our 503B compounding pharmacy. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779, undergoes rigorous testing for sterility, potency, and endotoxins. Our processes are validated, and our facility is subject to regular FDA inspections to ensure ongoing compliance with all federal regulations.
How can a healthcare provider at this location place an order?
Healthcare providers interested in our services can initiate the process by contacting 503B Compounding Pharmacy directly. The most efficient way to discuss your practice's specific needs is to visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381. Our team will provide detailed information on our available products and ordering procedures for 2160 W State Road 434, Longwood, FL 32779.