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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. We serve the specific needs of healthcare providers and their patients by providing bulk quantities of medications that are often in short supply or not available from conventional manufacturers.
The core function of 503B Compounding Pharmacy is the production of medications for office use by healthcare practitioners. This enables physicians, dermatologists, veterinarians, and other medical professionals at 2160 W State Road 434, Longwood, FL 32779 to have immediate access to essential, high-quality medications for their patients without the delays and uncertainties of the traditional pharmaceutical supply chain. Our operations are pivotal in mitigating drug shortages and ensuring that practitioners have the necessary tools to provide continuous, effective patient care.
Quality assurance is the foundation of everything we do at our Longwood facility. Our state-of-the-art cleanrooms are designed to meet or exceed all USP <797> and USP <800> standards for sterile and non-sterile compounding. Every batch of medication undergoes rigorous testing and quality control checks to ensure potency, purity, and sterility. Our processes are meticulously documented and audited, providing complete transparency and traceability from raw materials to the finished product dispensed to practitioners at 2160 W State Road 434, Longwood, FL 32779.
By operating under Section 503B, our pharmacy is subject to ongoing FDA oversight, including routine inspections. This level of federal regulation provides an additional layer of safety and assurance for the healthcare community we serve. We are proud to be a reliable partner to the medical professionals at 2160 W State Road 434, Longwood, FL 32779, providing them with the confidence that the medications they use in their practice meet the most stringent regulatory and quality benchmarks available.
For healthcare providers seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a leader in quality and reliability. We invite you to learn more about our services and how we can support your practice. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with and inspected by the U.S. Food and Drug Administration. We compound medications in large batches for office use by healthcare practitioners under Section 503B of the FD&C Act, adhering to stricter federal standards than those required for traditional compounding pharmacies.
Can I, as a patient, order medication directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, our primary function is to supply medications in bulk for "office use" to licensed healthcare practitioners. Patients must receive their compounded medications through their prescribing doctor or clinic, who can source from our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered facility at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile medications, including injectables, infusions, ophthalmics, topicals, and hormonals. We often produce medications that are currently on drug shortage lists or are not commercially available from large manufacturers.
How does a healthcare provider at 2160 W State Road 434 order from your pharmacy?
Healthcare providers can establish an account with 503B Compounding Pharmacy by contacting us directly. We will work with you or your office staff to set up ordering protocols. You can initiate this process by calling our facility at (407)993-1381 to speak with a representative.
Why should a practitioner at 2160 W State Road 434 choose a 503B outsourcing facility?
Choosing a 503B outsourcing facility like ours provides assurance of receiving medications produced under the highest level of quality control and federal oversight. This minimizes risk, ensures consistency and potency, and provides a reliable solution for managing drug shortages for your practice at this location.