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 a commitment to the highest standards of quality, safety, and regulatory oversight, distinguishing its operations from traditional compounding.
The core function of 503B Compounding Pharmacy is the production of medications for office use by healthcare practitioners. This service is essential for physicians, surgeons, veterinarians, and other medical professionals who require ready-to-administer medications for their practice at 2160 W State Road 434, Longwood, FL 32779. By preparing batches of medications without patient-specific prescriptions, the pharmacy provides a reliable and compliant source for drugs that are often on shortage or not commercially available. This ensures that medical practitioners in the area have immediate access to the critical medications needed for patient care.
Adherence to Current Good Manufacturing Practices (cGMP) is a fundamental aspect of the operation at this location. The facility at 2160 W State Road 434, Longwood, FL 32779 is designed with state-of-the-art environmental controls, including ISO-classified cleanrooms for sterile compounding. Every process, from ingredient sourcing to final product testing, is rigorously controlled and documented to ensure every medication meets stringent purity, potency, and sterility standards. This level of quality control provides assurance to healthcare providers about the medications they utilize.
503B Compounding Pharmacy serves a vital role in the local healthcare ecosystem by addressing drug shortages. When pharmaceutical companies have supply interruptions, this facility can compound essential medications, helping to prevent delays in treatment for patients. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on this outsourcing facility as a strategic partner for obtaining necessary drugs, from injectables and ophthalmics to topical preparations, all compounded under the exacting requirements of federal law.
For more information on the specific services and products available, healthcare entities are encouraged to contact the facility directly. The dedicated team at 2160 W State Road 434, Longwood, FL 32779 is available to discuss needs and provide comprehensive support. The official website, https://503bcompoundingpharmacy.com/, offers detailed resources, and the facility can be reached by phone at (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 compounds medications in accordance with Section 503B of the FD&C Act. This requires compliance with Current Good Manufacturing Practices (cGMP) for rigorous quality control and oversight.
Who can purchase medications from 503B Compounding Pharmacy?
Medications are compounded for office use and are distributed to licensed healthcare practitioners, including physicians, hospitals, and surgical centers, for administration to their patients at 2160 W State Road 434, Longwood, FL 32779. We do not dispense medications directly to individual patients based on a prescription.
What types of medications does 503B Compounding Pharmacy produce?
As an outsourcing facility, we compound a wide range of sterile and non-sterile medications in batches. This includes injectables, ophthalmics, and topical preparations that are often on drug shortage lists or are not commercially available for healthcare providers at our location.
How does 503B Compounding Pharmacy ensure medication safety and quality?
Our facility at 2160 W State Road 434, Longwood, FL 32779 operates under cGMP standards. This involves stringent testing of ingredients, validated compounding processes, environmental monitoring in cleanrooms, and final product testing to ensure sterility, potency, and purity.
How can a healthcare provider at this location place an order or get more information?
Healthcare providers can contact our facility directly for more information or to discuss their specific needs. Please call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for comprehensive details on our services and products.