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 large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and consistency, providing healthcare providers and patients with medications that are not otherwise commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals located at and serving 2160 W State Road 434, Longwood, FL 32779 can source high-quality, ready-to-administer medications directly from our facility. This allows for efficient patient care, as practitioners can have essential medications on hand for immediate use during procedures, treatments, and office visits without the need for individual patient-specific prescriptions for their stock.
As a 503B outsourcing facility, our operations are subject to rigorous FDA oversight, which includes current Good Manufacturing Practice (cGMP) regulations. This ensures that every batch of medication produced at our Longwood location meets stringent standards for potency, purity, and sterility. Our processes involve extensive testing, environmental monitoring, and quality control checks that far exceed the requirements of a traditional compounding pharmacy. Patients and providers at 2160 W State Road 434, Longwood, FL 32779 can have absolute confidence in the integrity and safety of the medications we supply.
Our portfolio includes a wide array of compounded preparations essential for various medical specialties. This includes sterile injectables, ophthalmics, hormone replacement therapies, and topical formulations. By working directly with the medical community at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy plays a vital role in the local healthcare ecosystem, ensuring that practitioners have access to the specific medications they need to provide optimal care to their patients.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 seeking a reliable source for office-use compounded medications, 503B Compounding Pharmacy is your trusted partner. We encourage you to explore our capabilities and discuss your specific needs. You can reach us by phone at (407)993-1381 or visit our website for more detailed information 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 standards, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound for office use meet the highest levels of quality, sterility, and safety.
Who can order medications from 503B Compounding Pharmacy?
Our primary clients are healthcare practitioners, including physicians, clinics, and surgical centers, who require bulk, office-use medications for their practice at 2160 W State Road 434, Longwood, FL 32779. We supply medications for administration to patients within a clinical setting.
Can individual patients pick up their prescriptions directly from your facility?
No. 503B Compounding Pharmacy operates as a wholesale outsourcing facility supplying healthcare providers. Individual patients should receive their compounded medications directly from their prescribing physician or clinic at 2160 W State Road 434, Longwood, FL 32779, not from our facility.
What types of medications does 503B Compounding Pharmacy produce?
We compound a broad range of sterile and non-sterile medications for office use, including but not limited to injectables, ophthalmics, dermatological creams, and hormone therapies. These are supplied to medical practices at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider at this location place an order?
Healthcare providers practicing at 2160 W State Road 434, Longwood, FL 32779 can initiate an order or inquire about our services by contacting us directly at (407)993-1381. Our website, https://503bcompoundingpharmacy.com/, also provides information for potential clients.