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 our operation at 2160 W State Road 434, Longwood, FL 32779 apart from traditional compounding pharmacies. As a 503B outsourcing facility, we adhere to the FDA's stringent current good manufacturing practices (cGMP), ensuring the highest possible standards of quality, purity, and consistency in every preparation we compound. Our primary mission is to provide healthcare providers with access to high-quality, sterile and non-sterile compounded medications that are essential for patient care but may be unavailable or in short supply from conventional pharmaceutical manufacturers.
The services provided by 503B Compounding Pharmacy at our facility on W State Road 434 are fundamentally oriented toward bulk compounding. This means we compound medications without receiving a patient-specific prescription in advance. These preparations are then distributed to hospitals, clinics, surgery centers, and physician offices for office use, allowing healthcare professionals to have vital medications on hand for immediate administration to patients. This model is essential for emergency kits, surgical packs, and commonly used formulations that require the assurance of quality that only an FDA-registered 503B outsourcing facility can provide. Our work supports the local medical community by ensuring a reliable and compliant source for these critical medications.
Our state-of-the-art facility at 2160 W State Road 434 is designed and maintained to meet rigorous regulatory standards. This includes advanced environmental controls, comprehensive testing of components and finished preparations, and a meticulous quality assurance process. Every batch of medication is compounded by our highly trained staff of pharmacists and technicians, who utilize precision equipment and validated processes. The result is a product that healthcare providers at local practices can trust implicitly for their patients. We are committed to upholding the integrity of the 503B designation through unwavering compliance and a dedication to excellence in every aspect of our operation in Longwood.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders directly with our facility for the compounded medications they require. Our team is dedicated to providing reliable service and support, ensuring that orders are fulfilled accurately and efficiently. We understand the critical nature of the medications we prepare and the importance of timely delivery to support patient treatment plans. For more detailed information about our capabilities or to initiate an order, we encourage you to contact us directly or visit our website.
For inquiries and orders, please contact 503B Compounding Pharmacy at (407)993-1381. Comprehensive information about our services and regulatory status can be found on our website at https://503bcompoundingpharmacy.com/. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist the healthcare community.
Frequently Asked Questions
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 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 federal current good manufacturing practices (cGMP) for drug manufacturing, which governs everything from ingredient sourcing to testing and sterility assurance.
Who can order medications from 503B Compounding Pharmacy at this location?
Our services are available to healthcare providers and institutions. This includes physicians, hospitals, clinics, and surgery centers that require bulk compounded medications for office use. We do not compound medications based on individual patient prescriptions for the public from this facility.
What types of medications does 503B Compounding Pharmacy compound?
As a 503B outsourcing facility, we focus on compounding preparations that are often used in clinical settings. This includes sterile injectables, hormone replacement therapy (HRT) formulations, ophthalmics, and other medications that may be on drug shortage lists or are not commercially available for healthcare providers to keep in stock.
How does the quality assurance process work at your Longwood facility?
Our quality assurance process is comprehensive and mandated by cGMP regulations. It involves rigorous testing of raw materials, in-process testing during compounding, and finished preparation potency, sterility, and endotoxin testing. Every batch is meticulously documented and reviewed before release to ensure it meets all specifications.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers and their authorized staff can place orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the ordering process, discuss availability, and arrange for delivery from our location at 2160 W State Road 434.