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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction in the pharmacy sector, signifying a facility that adheres to the most rigorous federal standards for quality, safety, and production volume. Unlike traditional compounding, the operations at 503B Compounding Pharmacy are conducted on a larger scale, producing batches of medications for office use by healthcare practitioners without patient-specific prescriptions. The facility at 2160 W State Road 434 is a vital local resource for the medical community, providing sterile and non-sterile compounded preparations that are essential for various clinical applications.
The core mission of 503B Compounding Pharmacy is to supply healthcare providers with access to high-quality, reliable compounded medications that are often unavailable from standard commercial manufacturers. The services provided from the Longwood facility are defined by a commitment to cGMP (current Good Manufacturing Practices), which are enforced by the FDA. This ensures every preparation leaving 2160 W State Road 434 meets stringent criteria for potency, purity, and sterility. The team of highly trained pharmacists and technicians utilizes state-of-the-art equipment and validated processes to compound a range of formulations, including hormone replacement therapy (HRT), office-use injectables, ophthalmics, and other specialized solutions required for specific medical treatments.
For healthcare practices in need of consistent and trustworthy pharmaceutical products, 503B Compounding Pharmacy at 2160 W State Road 434 serves as an indispensable partner. The outsourcing facility model allows for the efficient and safe production of medications that practitioners can keep in stock for immediate administration to patients, enhancing the level of care they can provide. The focus remains exclusively on serving the professional medical community from this specific operational base, ensuring all products are handled with the utmost precision and care. The facility’s compliance with federal oversight provides an additional layer of confidence for every healthcare provider it serves.
Engaging with 503B Compounding Pharmacy is a streamlined process designed for medical professionals. Orders and inquiries are managed directly through the facility’s dedicated channels. To learn more about the specific preparations available or to initiate service, healthcare providers can contact the facility at (407)993-1381 or visit the official website for comprehensive information at https://503bcompoundingpharmacy.com/. The team at 2160 W State Road 434 is prepared to address the specific compounding needs of the local medical community with professionalism and expertise.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our operations at 2160 W State Road 434, Longwood, FL 32779 are registered with and inspected by the U.S. Food and Drug Administration. We operate under Section 503B of the FD&C Act and must comply with strict current Good Manufacturing Practices (cGMP), which are federally mandated standards for drug quality and safety.
2. As a healthcare provider, how do I order medications from your facility?
Healthcare providers can place orders for office-use compounded medications by contacting our facility directly at (407)993-1381. Our team at 2160 W State Road 434 will guide you through the ordering process and provide all necessary information regarding available preparations.
3. Can patients directly receive medications from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide medications for office use by healthcare practitioners. We do not compound patient-specific prescriptions that would be dispensed directly to an individual. All our preparations are supplied to licensed healthcare providers for administration within their practice.
4. What types of compounded preparations are available from your Longwood location?
From our facility at 2160 W State Road 434, we compound a range of sterile and non-sterile preparations, including but not limited to hormone therapy formulations, injectables, and ophthalmics. These are produced in batches for healthcare providers to utilize in their practice.
5. How can I verify the quality standards of your compounded products?
Our status as a 503B outsourcing facility requires us to adhere to rigorous cGMP standards, which include extensive testing and quality control protocols. Healthcare providers can learn more about our specific quality assurance processes by visiting our website at https://503bcompoundingpharmacy.com/ or by speaking with our team directly.