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 preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, we adhere to the highest standards of quality and safety, producing medications in large batches for office use by healthcare practitioners or for distribution to other pharmacies within a hospital system. The 503B Compounding Pharmacy model is distinct, focusing on a higher level of regulatory oversight to ensure patient safety and medication integrity.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are not otherwise commercially available. The medications prepared at our Longwood facility are essential for many medical treatments and procedures. Physicians, surgeons, hospitals, and clinics rely on our 503B outsourcing facility for a consistent and reliable supply of critical drugs. Our work supports the local medical community by ensuring that practitioners have the necessary pharmaceutical tools to provide optimal patient care, all sourced from our specific location on W State Road 434.
Quality control is the foundation of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility at 2160 W State Road 434 is designed to meet rigorous FDA standards. Every batch of medication is subjected to extensive testing and validation processes to guarantee potency, purity, and sterility. This unwavering commitment to quality ensures that every product leaving our facility is safe and effective for its intended use. The 503B designation signifies our pledge to operate with transparency and accountability, providing peace of mind to the healthcare professionals we serve in Longwood.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare providers. Orders for compounded medications are placed directly by medical practices and institutions. Our team at the Longwood location works diligently to fulfill these orders with efficiency and precision, ensuring timely delivery to support patient treatment schedules. For more information about our services or to initiate an order, healthcare providers can contact 503B Compounding Pharmacy directly. We are available to answer questions and provide detailed information about our available formulations and compliance protocols.
Contact 503B Compounding Pharmacy:
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 2160 W State Road 434, Longwood, FL 32779
Frequently Asked Questions
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 under Section 503B of the FD&C Act. This designation requires compliance with Current Good Manufacturing Practices (cGMP), which includes rigorous testing, quality control, and reporting standards for the medications we compound.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners, such as physicians, surgeons, and dentists, as well as for healthcare institutions like hospitals and clinics. Orders are placed by the practice or institution directly with our facility at 2160 W State Road 434.
Can individual patients pick up prescriptions directly from your Longwood location?
No. As a 503B outsourcing facility, our primary function is to supply medications in bulk for office use by healthcare providers. Individual patient prescriptions are typically dispensed by a traditional compounding pharmacy or a clinic that has sourced medication from our facility.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares a range of sterile and non-sterile compounded medications in batches. This includes, but is not limited to, hormonal preparations, pain management solutions, dermatological creams, and other formulations that are prescribed by healthcare providers for their patients.
How does a healthcare provider place an order with your facility?
Healthcare providers and institutions can place orders by contacting 503B Compounding Pharmacy directly via phone at (407)993-1381. Our team will provide information on available medications, ordering procedures, and delivery options from our location at 2160 W State Road 434, Longwood, FL 32779.