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 is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. Unlike traditional compounding pharmacies, our 503B status means we are subject to rigorous federal oversight, including current Good Manufacturing Practices (cGMP), which ensures every preparation leaving our facility meets stringent purity, potency, and sterility testing requirements.
At our Longwood location, we specialize in the large-scale production of compounded sterile preparations (CSPs) for office use. Our primary clientele consists of healthcare providers and medical facilities who require bulk, non-patient-specific medications. This model allows physicians, surgeons, and clinics in the area to obtain essential medications, such as injectables, infusions, and ophthalmics, without the burden and expense of in-house compounding. By relying on our 503B Compounding Pharmacy, healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 can be assured they are administering medications produced under the most exacting quality controls.
The core of our service is providing a reliable, safe, and compliant source for medications that are often in short supply or unavailable from conventional manufacturers. Our state-of-the-art facility at 2160 W State Road 434 is designed to maintain a controlled environment, utilizing advanced technology and processes to mitigate the risk of contamination. Every batch is meticulously crafted and tested by our team of highly skilled pharmacists and technicians, ensuring the integrity of every product we supply to the local medical community.
We understand the critical role we play in the local healthcare ecosystem. By delivering high-quality compounded medications, we support the efforts of medical professionals dedicated to patient care. Our operations are tailored to meet the specific needs of practitioners who require these vital preparations for their practice at our location. For more information about our services or to discuss your needs, please contact us directly. We are committed to upholding the trust placed in us as a pivotal resource for compounded medications.
For inquiries, reach out to us via our website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is ready to assist you.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility. We operate under Section 503B of the FD&C Act, which subjects us to federal oversight and mandatory compliance with current Good Manufacturing Practices (cGMP) for heightened quality and safety standards.
Who can receive medications from your pharmacy at this location?
Our 503B Compounding Pharmacy provides medications for office use by healthcare providers. We supply compounded sterile preparations in bulk to physicians, hospitals, and clinics. These are not patient-specific prescriptions for individual pickup but are intended for administration by medical professionals within their practice.
What types of medications do you compound at your Longwood facility?
At our location on 2160 W State Road 434, we specialize in compounding sterile preparations. This includes a range of injectables, intravenous (IV) bags, ophthalmics, and other medications that require sterility, often for use in surgical, clinical, or therapeutic settings.
How does the quality control process work at your facility?
As a 503B outsourcing facility, we adhere to strict cGMP protocols. Every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing for sterility, potency, and purity before it is released, ensuring the highest level of safety and quality for healthcare providers.
How can a healthcare provider at this location place an order?
Healthcare providers and facilities can place orders by contacting our pharmacy directly. You can reach our team at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/ to discuss your specific needs and our available preparations.