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 commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We provide these critical pharmaceutical preparations for healthcare providers to administer to their patients within clinical settings.
The core function of 503B Compounding Pharmacy is the production of medications that are not commercially available. This includes creating formulations without non-essential allergens like dyes or preservatives, adjusting dosages to meet specific patient needs as determined by a prescriber, or compounding a medication that is currently on the FDA’s drug shortage list. All processes at our 2160 W State Road 434, Longwood, FL 32779 location are conducted under a rigorous quality control system. This ensures every preparation meets precise sterility, stability, and potency specifications before it is released for distribution to area practitioners.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by highly trained pharmacists and technicians. We adhere to current Good Manufacturing Practices (cGMP), which mandates stringent environmental controls, extensive personnel training, and thorough validation of all processes and equipment. This level of operational excellence provides healthcare professionals with the assurance that the medications they receive from 503B Compounding Pharmacy are of consistent and reliable quality, supporting positive patient outcomes.
503B Compounding Pharmacy serves an essential role in the local healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779. By providing access to vital medications that are otherwise unavailable, we support physicians, clinics, and hospitals in delivering personalized and effective care. Our operations are designed for efficiency and scale, enabling us to be a dependable partner for the medical community. For more information on our services or to speak with our team, please contact us via our website at https://503bcompoundingpharmacy.com/ or 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 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 operate under Section 503B of the FD&C Act, which requires compliance with stricter current Good Manufacturing Practices (cGMP) for larger-scale production of compounded medications intended for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications exclusively to healthcare practitioners and facilities for office use. Orders must be placed by a licensed medical professional or their authorized agent. Medications are not dispensed directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding both sterile and non-sterile preparations that are not commercially available. This includes medications on the FDA drug shortage list, specific strengths or dosages, and formulations free of certain allergens.
How does the quality control process work at your facility?
At our location on 2160 W State Road 434, Longwood, FL 32779, we maintain a comprehensive quality control unit that operates under cGMP standards. Every batch of medication undergoes rigorous testing for sterility, potency, and stability before it is released, ensuring the highest level of safety and efficacy for practitioners and their patients.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. For detailed information, to discuss specific medication needs, or to begin the onboarding process, please call our team at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.