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 consistency, exceeding the requirements of a traditional compounding pharmacy. We serve an important role in the healthcare supply chain by providing bulk medications for office use by healthcare practitioners.
The core function of 503B Compounding Pharmacy is the production of medications that are not readily available from commercial manufacturers, whether due to drug shortages, discontinuations, or the need for a specific formulation not offered on the market. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and rigorous testing protocols to ensure every preparation meets stringent quality control standards. This process includes thorough environmental monitoring, validation of sterility, and precise analytical testing to guarantee potency and purity.
Healthcare providers in need of reliable, high-quality compounded medications for their practice can rely on 503B Compounding Pharmacy. Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped to handle a significant volume of orders, ensuring that practitioners have access to the necessary medications for their patient care protocols. By operating as a 503B outsourcing facility, we provide a critical service that helps mitigate drug shortages and supports the local medical community with essential pharmaceutical preparations.
For more information about the specific preparations available or to discuss your facility's needs, we encourage you to contact our team directly. You can reach 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381. Our dedicated professionals are available to answer questions and provide detailed information about our processes and product offerings from our location at 2160 W State Road 434, Longwood, FL 32779.
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 complies with Current Good Manufacturing Practices (cGMP). This ensures a higher level of regulatory oversight for sterility, safety, and quality compared to a traditional pharmacy.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our 503B outsourcing facility primarily provides medications for office use by healthcare practitioners and institutions. Orders are typically placed by physicians, hospitals, and clinics for administration to patients within their practice setting.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a wide range of sterile and non-sterile medications in larger batches. This often includes preparations that are on drug shortage lists or have been discontinued by major manufacturers.
How does the quality control process work at your facility?
Our location at 2160 W State Road 434, Longwood, FL 32779 adheres to strict cGMP standards. This involves rigorous testing of raw materials, validated sterility assurance processes, environmental monitoring of cleanrooms, and finished preparation potency testing to ensure every product meets its specified quality attributes.
How can I place an order or get more information?
To place an order or inquire about our available preparations, please contact 503B Compounding Pharmacy directly. You can call us at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/ for more details on our services from our location at 2160 W State Road 434, Longwood, FL 32779.