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 is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies a commitment to the highest standards of quality, safety, and sterility in the preparation of compounded medications. As a 503B outsourcing facility, we produce medications on a larger scale than traditional compounding pharmacies, but without the commercial manufacturing volumes of pharmaceutical companies. This unique position allows 503B Compounding Pharmacy to provide healthcare providers serving the community at 2160 W State Road 434, Longwood, FL 32779 with access to essential drugs that may be in shortage or not readily available from standard manufacturers.
The operational protocols at 503B Compounding Pharmacy are governed by Current Good Manufacturing Practices (cGMP). This rigorous framework ensures that every preparation leaving our facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent criteria for identity, strength, quality, and purity. Our processes involve extensive environmental monitoring, validated sterilization techniques, and thorough quality control testing. The medications produced by 503B Compounding Pharmacy are intended for office use by healthcare practitioners, enabling them to have critical drugs on hand for immediate administration to patients during clinical visits, surgical procedures, or other treatments in the local area.
503B Compounding Pharmacy provides a vital service to the healthcare ecosystem surrounding 2160 W State Road 434, Longwood, FL 32779 by addressing drug shortages. When a widely used injectable medication becomes unavailable from primary manufacturers, it can disrupt patient care. Our facility can step in to compound that medication, helping to ensure continuity of treatment for patients. The scope of services at 503B Compounding Pharmacy is defined by our status as an outsourcing facility, focusing on the production of sterile injectables, including IV bags, syringes, and other parenteral medications that are essential for hospitals, clinics, and surgical centers.
Engagement with 503B Compounding Pharmacy is conducted through healthcare providers. Physicians, surgeons, and other medical professionals can rely on the consistent and reliable supply of high-quality compounded medications from our location at 2160 W State Road 434, Longwood, FL 32779. By choosing an FDA-registered 503B outsourcing facility, providers gain the assurance that the medications they use in their practice are produced under the most exacting standards. This partnership is fundamental to advancing patient safety and positive health outcomes within the local community.
For comprehensive information about the regulatory framework and services of 503B Compounding Pharmacy, healthcare providers are encouraged to visit our website at https://503bcompoundingpharmacy.com/. To discuss specific needs or to place an order, please contact our facility directly at (407)993-1381. 503B Compounding Pharmacy is dedicated to supporting the medical community at 2160 W State Road 434, Longwood, FL 32779 with uncompromising quality and reliability.
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 U.S. Food and Drug Administration and complies with strict federal standards, including Current Good Manufacturing Practices (cGMP), for producing sterile compounded medications primarily for office use by healthcare providers.
Who can order medications from 503B Compounding Pharmacy?
Medications produced at 503B Compounding Pharmacy are supplied to licensed healthcare providers, such as physicians, hospitals, and clinics, for administration to their patients. We do not dispense medications directly to individual patients at our location on 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy specialize in?
As a 503B outsourcing facility, we specialize in producing large-scale batches of sterile injectable medications, including solutions for intravenous (IV) therapy, which are essential for addressing drug shortages and meeting the needs of healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication safety?
Safety is ensured through rigorous adherence to cGMP standards at our facility on 2160 W State Road 434, Longwood, FL 32779. This includes validated sterilization processes, stringent environmental controls, and comprehensive quality assurance testing on every batch of medication we produce.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team is available to discuss product availability, specifications, and ordering procedures tailored to the needs of local medical practices.