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 is an FDA-registered outsourcing facility operating under 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. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, providing healthcare providers with access to essential medications that are not commercially available.
The core function of 503B Compounding Pharmacy is to support the medical community by producing medications in larger batches for office use. This means physicians and practitioners at clinics and hospitals can have critical medications on hand without the need to engage in their own compounding processes. Our operations at 2160 W State Road 434, Longwood, FL 32779 are strictly regulated and routinely inspected by the FDA, ensuring every preparation meets rigorous testing standards for potency, sterility, and purity.
Our facility specializes in producing a range of compounded medications, including sterile injectables, ophthalmics, and other formulations that are essential for patient care. The 503B Compounding Pharmacy model is distinct from traditional compounding, focusing on supplying healthcare settings rather than fulfilling individual patient prescriptions directly. This allows us to maintain a consistent and reliable supply of vital drugs for the medical professionals we serve from our location at 2160 W State Road 434, Longwood, FL 32779.
Healthcare providers who utilize the services of 503B Compounding Pharmacy can be confident in the integrity of the medications they administer. Our commitment to compliance, quality control, and patient safety is paramount. We operate with transparency and professionalism, ensuring that every product that leaves our facility at 2160 W State Road 434, Longwood, FL 32779 is of the highest possible quality. For more information on our services or to inquire about becoming a client, please contact us directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
1. 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 operates in compliance with strict federal regulations under Section 503B of the FD&C Act. This includes adhering to Current Good Manufacturing Practices (cGMP) for higher standards of quality and safety compared to traditional compounding.
2. Can I, as an individual patient, pick up a prescription directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications for office use by healthcare providers. We supply our compounded preparations to physicians, hospitals, and clinics. Individual patients should obtain their medications through their healthcare provider or a traditional compounding pharmacy that serves the public directly.
3. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers and institutions can establish an account with 503B Compounding Pharmacy by contacting us directly via phone at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/. Our team will guide you through the onboarding process to facilitate orders for your practice.
4. What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectables, ophthalmics, and other non-sterile preparations that are often in short supply or not available from large commercial manufacturers. All products are made for office use by medical professionals.
5. Why should a healthcare provider choose 503B Compounding Pharmacy?
Choosing 503B Compounding Pharmacy ensures you are receiving medications from a facility that is subject to FDA oversight and rigorous quality control testing. This provides an added layer of safety and reliability for the medications you use in your practice, all sourced from our specific location at 2160 W State Road 434, Longwood, FL 32779.