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 from its location at 2160 W State Road 434, Longwood, FL 32779. Functioning under the stringent regulations of Section 503B of the Federal Food, Drug, and Cosmetic Act, this 503B compounding pharmacy provides a critical service by producing large quantities of compounded sterile preparations for healthcare providers. The 503B designation signifies a commitment to the highest standards of quality, safety, and compliance, distinguishing it from traditional compounding pharmacies.
The core mission of this 503B compounding pharmacy is to supply healthcare practitioners with essential medications that are not readily available from commercial manufacturers. This includes producing formulations that are on the FDA drug shortage list, allowing for continuity of patient care when standard options are unavailable. By operating as a 503B outsourcing facility, the pharmacy adheres to Current Good Manufacturing Practices (cGMP), ensuring every preparation meets rigorous testing and quality control standards for sterility, potency, and purity before it is released for distribution.
Located at 2160 W State Road 434, Longwood, FL 32779, this 503B compounding pharmacy serves a vital role for the local medical community. The services provided by this 503B compounding pharmacy are integral to hospitals, clinics, and surgical centers, ensuring they have access to the necessary sterile compounded medications for their patients. The facility is equipped with state-of-the-art cleanrooms and utilizes advanced technology to compound a wide array of injectable medications, including IV bags, epidurals, and other sterile preparations required in various clinical settings.
Patients and healthcare providers who partner with this 503B compounding pharmacy benefit from the assurance that comes with FDA oversight and cGMP compliance. The 503B model is designed for scalability and reliability, providing a consistent and trusted source for medications that are critical for patient treatment plans. For more information on the specific sterile preparations available from this 503B compounding pharmacy, or to inquire about services, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B compounding pharmacy?
Being a 503B compounding pharmacy means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility. This requires us to comply with stricter federal standards, including Current Good Manufacturing Practices (cGMP), for the production of sterile compounded medications.
Who can order from this 503B compounding pharmacy?
This 503B compounding pharmacy provides its compounded sterile preparations to healthcare practitioners and entities. Orders are typically placed by hospitals, clinics, surgical centers, and other healthcare providers for administration to their patients under their care.
What types of medications does this 503B compounding pharmacy prepare?
This 503B compounding pharmacy specializes in producing large-scale batches of sterile injectable medications. This includes preparations like IV solutions, pain management injections, and other medications that are often on shortage or require specific, sterile compounding not offered by large manufacturers.
How does the 503B compounding pharmacy ensure medication safety?
Safety is paramount at this 503B compounding pharmacy. Our processes at 2160 W State Road 434, Longwood, FL 32779 are governed by cGMP, which includes rigorous environmental monitoring, extensive testing for sterility and potency, and comprehensive quality control procedures before any product is released.
How can a healthcare provider get started with this 503B compounding pharmacy?
Healthcare providers interested in the services of this 503B compounding pharmacy can initiate the process by contacting us directly. You can visit our website at https://503bcompoundingpharmacy.com/ for more information or call us at (407)993-1381 to speak with a representative about your specific needs.