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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving the facility meets stringent quality control benchmarks for potency, purity, and sterility.
The core service of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed for office use by healthcare providers at 2160 W State Road 434, Longwood, FL 32779. This model is essential for physicians, surgeons, dermatologists, veterinarians, and other medical professionals who require ready-to-use, pre-made medications to administer to patients within their practice. By providing these critical medications, 503B Compounding Pharmacy supports the local medical community, enabling efficient patient care and treatment. The facility specializes in producing sterile injectables, ophthalmic solutions, and other complex dosage forms that are often in short supply from conventional manufacturers.
Patients who receive treatments at medical practices utilizing medications from 503B Compounding Pharmacy benefit from the assurance of quality that comes with federal registration. The medications are compounded in a controlled, cleanroom environment by highly trained professionals using pharmaceutical-grade ingredients. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with an outsourcing facility streamlines inventory management, reduces the compounding burden on their own staff, and mitigates risk through the use of FDA-inspected products. This allows practitioners to focus their expertise on patient diagnosis and care.
To learn more about the services provided or to inquire about becoming a client, you can contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Detailed information about its capabilities, compliance standards, and the process for healthcare providers is available on its official website at https://503bcompoundingpharmacy.com/.
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 complies with strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet the highest standards for safety, sterility, and quality control.
Can I as an individual patient pick up my prescription directly from your location?
No. 503B Compounding Pharmacy operates as an outsourcing facility that provides medications for office use by healthcare providers. Individual patient prescriptions are typically dispensed by a traditional pharmacy. Our medications are supplied directly to licensed practitioners for administration to their patients within their practice.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile preparations, including injectables, infusions, and ophthalmic drops. These are often medications that are on shortage or are needed by physicians in a ready-to-use format for procedures and treatments in their offices.
How do healthcare providers at this location order from you?
Healthcare providers and practices located at 2160 W State Road 434, Longwood, FL 32779 can establish an account with our facility. They can place orders directly by contacting us at (407)993-1381. Our team will guide them through the onboarding and ordering process.
Why would a doctor at this address use your services instead of a regular pharmacy?
Doctors use our services because we provide FDA-regulated, high-quality compounded medications for office use. This saves their practice time and resources, ensures product consistency and reliability, and allows them to access medications that may be commercially unavailable, all from a trusted local source.