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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, the pharmacy adheres to the most rigorous current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and sterility. The 503B outsourcing facility is equipped to produce large volumes of compounded medications for office use, which are then distributed to healthcare providers for patient administration within their practice settings.
The core function of 503B Compounding Pharmacy is the production of sterile and non-sterile compounded preparations. This includes a significant focus on injectable medications, such as hormone replacement therapies, vitamins, and other sterile solutions that are essential for physician offices, hospitals, and clinics. By operating under 503B regulations, the pharmacy provides a vital service to the medical community, ensuring a reliable supply of high-quality medications that are not readily available from commercial manufacturers. The team at the 2160 W State Road 434 location comprises skilled pharmacists and technicians who are experts in aseptic technique and quality control, guaranteeing the integrity and safety of every compounded preparation.
Healthcare providers seeking a trusted source for office-use medications will find 503B Compounding Pharmacy to be an indispensable partner. The facility’s commitment to compliance and quality provides practitioners with the confidence that the medications they use in their practice are produced under the strictest regulatory oversight. For more information on services or to place an order, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local medical community with exceptional compounded pharmaceutical services.
FAQ
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 FDA and operates under Section 503B of the FD&C Act. This requires us to comply with stringent federal current good manufacturing practices (cGMP) for the production of compounded drugs, ensuring a higher level of quality control and sterility assurance compared to traditional pharmacies.
Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare practitioners. We provide compounded medications for office use to physicians, clinics, and other healthcare facilities. These medications are administered to patients within the clinical setting by the provider.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in producing large-scale batches of sterile injectable medications. This includes preparations like hormone therapy injections, vitamin complexes, and other customized sterile solutions that are not commercially available or are in shortage, all produced at our location on W State Road 434.
How does the quality control process work at your facility?
Our location at 2160 W State Road 434, Longwood, FL 32779 follows rigorous cGMP protocols. This involves extensive testing of components, in-process testing, and finished preparation testing. Our sterile products are compounded in ISO-classified cleanrooms by highly trained personnel to ensure every preparation meets strict standards for potency, purity, and sterility.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers can place orders for office-use compounded medications by contacting our facility directly. You can reach our team at 2160 W State Road 434, Longwood, FL 32779 by phone at (407)993-1381. You can also find more information and contact details on our website at https://503bcompoundingpharmacy.com/.