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. 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. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing a critical service for healthcare providers and patients who require medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals serving the community from 2160 W State Road 434, Longwood, FL 32779 can obtain reliable, high-quality medications for their practice needs. The pharmacy compounds a significant volume of medications without receiving patient-specific prescriptions in advance, which are then kept in stock for immediate use during procedures or treatments in clinical settings.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy maintains strict compliance with Current Good Manufacturing Practices (cGMP). This ensures that every batch of medication produced meets exacting standards for potency, purity, and sterility. The medications are prepared in a controlled environment with stringent quality assurance protocols, including stability testing and endotoxin testing for sterile preparations. This level of quality control is a fundamental requirement for an FDA-registered 503B outsourcing facility and provides assurance to the medical community.
The services provided by 503B Compounding Pharmacy are distinct from traditional retail compounding. This location focuses on supplying other healthcare entities rather than dispensing directly to individual patients based on a prescription. The pharmacy serves as a vital partner to hospitals, clinics, and surgical centers by providing them with essential medications, such as sterile injectables, ophthalmics, and other formulations that may be in short supply or unavailable from conventional pharmaceutical manufacturers.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, accessing these services is straightforward. Orders can be placed directly with the facility. The professional staff is available to discuss specific compounding needs and provide detailed information about available formulations. To learn more about the services or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this is a 503B compounding pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, it compounds medications in large volumes for office use by healthcare practitioners under strict federal quality standards.
Who can order medications from this 503B compounding pharmacy?
Medications are supplied to healthcare practitioners and entities for office use. This includes physicians, surgeons, veterinarians, hospitals, and clinics that utilize the medications within their practice at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to the public.
What types of medications does this facility compound?
As a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we compound a wide range of sterile and non-sterile medications in bulk. This includes injectables, ophthalmics, and other formulations that are often used in clinical and surgical settings.
How does the quality assurance process work?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under Current Good Manufacturing Practices (cGMP). Every batch of medication undergoes rigorous testing for potency, sterility, and endotoxins to ensure it meets the highest quality and safety standards required for an FDA-registered 503B outsourcing facility.
How can a healthcare provider place an order?
Healthcare providers can place orders by contacting our facility directly. For more information or to discuss your compounding needs, please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.