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 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 that are distributed for office use by healthcare practitioners. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, including current Good Manufacturing Practices (cGMP), providing a critical component of the pharmaceutical supply chain for local medical practices.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available or are in shortage. This includes a wide array of compounded formulations that meet the specific needs of prescribers at 2160 W State Road 434, Longwood, FL 32779. Our operations are strictly regulated and routinely inspected by the FDA, ensuring that every preparation meets stringent quality assurance protocols. We serve as a reliable source for physicians, surgeons, veterinarians, and other healthcare providers who require bulk compounded medications for their practice.
Our services at the 2160 W State Road 434 location are exclusively for office-use dispensing. This means that medications are prepared in larger quantities for healthcare professionals to have on hand for immediate administration to their patients within their practice. Patients seeking individual prescriptions should consult with their healthcare provider. The team at 503B Compounding Pharmacy works directly with medical practices to ensure they have the necessary pharmaceutical preparations to support their treatment protocols and patient care standards.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy means accessing a consistent supply of high-quality, compounded medications. Our facility is equipped with state-of-the-art technology and staffed by experienced compounding professionals, including pharmacists and technicians, who are dedicated to precision and excellence. We are committed to supporting the local medical community with dependable service and products that comply with all federal regulations governing 503B outsourcing facilities.
To learn more about our services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. Our team is ready to assist with your compounding needs from our facility at 2160 W State Road 434, Longwood, FL 32779. Visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381 for more information.
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. We compound large volumes of sterile and non-sterile medications for office use and are subject to federal oversight, including compliance with current Good Manufacturing Practices (cGMP) and routine FDA inspections.
Can I, as a patient, pick up my personal prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy provides medications exclusively for office-use by healthcare practitioners. We do not dispense medications directly to individual patients. Patients should receive their compounded medications directly from their healthcare provider's office after it has been administered or dispensed by them.
What types of medications does 503B Compounding Pharmacy at this location prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 compounds a broad spectrum of medications that are often on shortage or not available from traditional manufacturers. This includes sterile injectables, ophthalmics, and other formulations required in bulk quantities by local healthcare practices for use within their facilities.
How can a healthcare provider at this address place an order with 503B Compounding Pharmacy?
Healthcare providers can place orders for compounded medications by contacting our facility directly. We serve providers at 2160 W State Road 434, Longwood, FL 32779 and can be reached by phone at (407)993-1381. Our team will work with you to process your order for office-use medications.
Why should a practice at 2160 W State Road 434 choose 503B Compounding Pharmacy?
Practices choose us because we are a local, FDA-registered 503B outsourcing facility that guarantees a supply of high-quality, cGMP-compliant compounded medications. Our location at 2160 W State Road 434, Longwood, FL 32779 provides a reliable and convenient source for essential medications that may be in shortage, supporting uninterrupted patient care.