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 our location at 2160 W State Road 434, Longwood, FL 32779. We function under the rigorous standards set forth by Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that defines our operational protocols, quality control measures, and commitment to patient safety. Unlike traditional compounding, our 503B status means we produce medications on a larger scale without patient-specific prescriptions, adhering to current Good Manufacturing Practices (cGMP) that are synonymous with major pharmaceutical manufacturers. Our mission is to provide healthcare providers serving the local community with access to high-quality, sterile and non-sterile compounded medications they can trust implicitly.
The core of our service at 2160 W State Road 434 is the large-scale production of compounded pharmaceutical preparations. This includes the compounding of sterile injectables, ophthalmics, and other dosage forms that are essential for hospitals, surgery centers, clinics, and other healthcare entities. Our work ensures that these local facilities have a reliable and compliant source for critical medications, including those that may be in short supply. By operating as a 503B outsourcing facility, we provide an additional layer of safety and assurance, as our processes and testing are subject to strict FDA oversight and regular inspection. This commitment to excellence directly benefits patient care throughout our local healthcare ecosystem.
Our facility at 2160 W State Road 434 is equipped with state-of-the-art technology and maintained under stringent environmental controls to ensure the integrity of every preparation. Our team of skilled pharmacists and technicians are highly trained in advanced compounding techniques and cGMP compliance. Every batch we compound undergoes rigorous testing and quality assurance checks before it is released, documenting its potency, sterility, and stability. This meticulous approach guarantees that the healthcare providers we serve receive medications that meet the highest possible standards, allowing them to focus on patient outcomes with confidence.
503B Compounding Pharmacy is dedicated to being a vital partner to the medical community. We understand the critical needs of healthcare providers and work diligently to support them with a consistent supply of essential medications. For more information about our services or to discuss how we can assist your practice, we invite you to contact us directly. You can reach our team at (407)993-1381 or visit our website to learn more about our compliance and offerings: https://503bcompoundingpharmacy.com/. We are proud to serve the healthcare community from our facility at 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 in compliance with Section 503B of the FD&C Act. This requires us to adhere to strict current Good Manufacturing Practices (cGMP) for the production of compounded medications, which includes rigorous testing, quality control, and reporting.
Who can receive medications from 503B Compounding Pharmacy?
As a 503B outsourcing facility, we provide compounded medications to healthcare providers and facilities, such as hospitals, clinics, and surgery centers. We do not compound medications based on individual patient prescriptions for the public; instead, we supply medications in larger batches for office use by licensed practitioners.
What types of medications does 503B Compounding Pharmacy produce?
From our location at 2160 W State Road 434, we specialize in compounding sterile injectables, ophthalmics, and other preparations that are often used in clinical settings. This includes medications that may be on shortage or are necessary for specific procedural needs of local healthcare providers.
How does the quality assurance process work at your facility?
Every batch of medication compounded at our Longwood facility undergoes extensive quality testing before release. This includes testing for sterility, potency, endotoxins, and stability to ensure it meets all specifications and cGMP standards, providing a high level of safety for patients.
How can a healthcare facility at 2160 W State Road 434 place an order?
Healthcare providers and facilities can contact 503B Compounding Pharmacy directly to discuss their needs and place orders. You can reach our dedicated team by phone at (407)993-1381. Our website, https://503bcompoundingpharmacy.com/, also provides information for potential partners.