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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies adherence to the highest current good manufacturing practice (cGMP) standards, ensuring that healthcare providers at this location have access to a reliable source of high-quality compounded pharmaceutical products.
The core function of 503B Compounding Pharmacy is to provide bulk compounded medications for office use by healthcare practitioners. This service is essential for physicians, surgeons, veterinarians, and other medical professionals who require ready-to-use medications for procedures, treatments, and immediate patient needs at their practices. By operating under Section 503B, the pharmacy can compound drugs without patient-specific prescriptions for these purposes, which are then distributed to healthcare providers for administration within their professional practice. The facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by highly trained compounding pharmacists and technicians who are experts in aseptic processing and quality control.
Quality and safety are the foremost priorities at 503B Compounding Pharmacy. Every batch of medication produced undergoes rigorous testing and quality assurance protocols as mandated by the FDA for 503B outsourcing facilities. This includes stringent environmental monitoring, sterility testing, endotoxin testing, and potency verification. For healthcare providers at this location, this translates to an unparalleled level of confidence in the medications they use to treat their patients. The pharmacy's commitment to cGMP standards provides a critical layer of safety and reliability that distinguishes it from traditional compounding pharmacies.
Healthcare professionals seeking a trusted partner for their pharmaceutical needs can rely on the services provided at 2160 W State Road 434, Longwood, FL 32779. The team at 503B Compounding Pharmacy works closely with providers to understand their specific requirements and to ensure a consistent supply of essential medications. For more information on available formulations or to discuss your office use needs, please contact 503B Compounding Pharmacy directly. Website: https://503bcompoundingpharmacy.com/ | Phone: (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 complies with strict federal standards for compounding, known as current good manufacturing practices (cGMP). This ensures the highest level of quality, purity, and safety for the medications we compound.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for healthcare professionals, including physicians, surgeons, dentists, and veterinarians, who require compounded medications for office use to administer to their patients within their practice at this location.
Do you provide medications directly to individual patients at your Longwood location?
No. As a 503B outsourcing facility, our primary function is to supply compounded medications in bulk for office use by healthcare practitioners. Patients should receive their medications directly from their healthcare provider who has ordered from us.
What types of medications does 503B Compounding Pharmacy compound?
We compound a wide range of sterile and non-sterile medications, including but not limited to hormone replacement therapies, ophthalmics, injectables, and other formulations needed by healthcare providers for their practice at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider at this location place an order?
Healthcare providers can initiate an order or inquire about our available products by contacting our facility directly. Please call us at (407)993-1381 or visit our website for more information: https://503bcompoundingpharmacy.com/.