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 that are distributed for office use by healthcare practitioners. This model ensures that medical professionals at our local Longwood location have immediate access to a consistent and reliable supply of high-quality compounded preparations, which are essential for patient treatment plans.
The 503B outsourcing facility designation signifies that our pharmacy on State Road 434 adheres to the FDA's Current Good Manufacturing Practices (cGMP). This represents the highest possible standard for drug manufacturing, far exceeding the standards applied to traditional compounding. For medical practices in Longwood, this means every batch of medication produced within our facility undergoes rigorous testing for potency, sterility, and purity. This unwavering commitment to quality and safety provides practitioners and their patients with unparalleled confidence in the medications they depend on.
Our core service at the Longwood facility is the production of medications for office-use. We support healthcare providers by compounding preparations that are often in short supply or unavailable from conventional manufacturers. This includes a wide array of sterile injectables, hormone replacement therapies, ophthalmics, and other essential drugs. By partnering with 503B Compounding Pharmacy at 2160 W State Road 434, local clinics and hospitals can enhance their patient care protocols with medications that are prepared under a level of scrutiny that ensures efficacy and safety.
Choosing 503B Compounding Pharmacy means selecting a partner dedicated to the highest levels of pharmaceutical excellence. Our team of skilled pharmacists and technicians utilizes state-of-the-art technology and follows meticulous procedures within our controlled environment. We understand the critical role we play in the local healthcare ecosystem at our Longwood address, and we are committed to being a dependable source for the medical community. For more information or to initiate an order, please contact us directly.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Location: 2160 W State Road 434, Longwood, FL 32779
FAQ
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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires us to comply with Current Good Manufacturing Practices (cGMP), which are the strictest quality standards for drug production, ensuring every batch is consistently high quality, pure, and potent.
Who can order medications from 503B Compounding Pharmacy in Longwood?
Our services are designed for healthcare practitioners for office-use. Medications compounded at our 2160 W State Road 434 location are distributed to licensed healthcare professionals for administration to patients within their practice settings. We do not dispense medications directly to individual patients at this facility.
What types of medications does the Longwood 503B facility compound?
503B Compounding Pharmacy specializes in compounding a broad range of sterile and non-sterile preparations. This includes, but is not limited to, sterile injectables, hormone therapy formulations, ophthalmic solutions, and other medications that may be on shortage from large-scale manufacturers, all produced at our location on State Road 434.
How does the quality assurance at a 503B facility differ from a traditional pharmacy?
Unlike traditional compounding pharmacies, our operations at 2160 W State Road 434 are governed by cGMP regulations. This mandates extensive testing of raw materials, in-process testing, and final product testing for sterility, potency, and endotoxins. This rigorous quality control framework provides an additional layer of safety and reliability for healthcare providers in Longwood.
How can a medical practice at our Longwood location place an order?
Healthcare practices can contact 503B Compounding Pharmacy directly to establish an account and discuss their specific medication needs. You can reach our facility at 2160 W State Road 434 by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information.