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 is an FDA-registered outsourcing facility operating under 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 large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, we adhere to the highest standards of pharmaceutical quality, producing medications in bulk for healthcare providers to administer in-office or dispense to their patients. Our mission is to provide healthcare practitioners with access to a reliable supply of high-quality compounded medications, supporting them in delivering superior patient care.
The operations at our Longwood facility are defined by a rigorous commitment to compliance and quality assurance. We operate under current Good Manufacturing Practices (cGMP), which are the strict quality standards set forth by the FDA. This ensures that every batch of medication we produce undergoes extensive testing for potency, sterility, and purity. The medications prepared at 503B Compounding Pharmacy are not intended for individual patient-specific prescriptions but are instead made for office use by physicians, surgeons, veterinarians, and other healthcare professionals who require bulk quantities of specific formulations for their practice.
Our location at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and cleanroom environments that meet or exceed regulatory requirements. This advanced infrastructure allows us to compound a wide array of preparations, including sterile injectables, ophthalmics, and other dosage forms that are essential for various medical treatments. By serving the local medical community from this specific facility, we provide a critical resource for practitioners seeking dependable, quality-compounded pharmaceuticals for their patients.
Healthcare providers who utilize the services of 503B Compounding Pharmacy can be confident in the integrity and safety of the medications they receive. Our dedicated team of pharmacists, technicians, and quality control professionals works meticulously to ensure that every product meets our exacting specifications. For more information about our services or to discuss your facility's needs, we invite you to contact us directly. Visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381.
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 the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This registration requires us to comply with stringent current Good Manufacturing Practices (cGMP) for the production of compounded medications intended for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our medications are produced for office use and are available for order by licensed healthcare professionals, including physicians, surgeons, dentists, and veterinarians. These medications are for administration or dispensing within their professional practice and are not dispensed directly to individual patients from our facility.
What types of medications are compounded at your Longwood facility?
At our location on W State Road 434, we specialize in compounding a range of sterile and non-sterile medications in larger batches. This includes but is not limited to sterile injectables, ophthalmics, and other formulations required by healthcare providers in bulk quantities for their practice needs.
How does the quality control process work at your facility?
Quality control is paramount at our Longwood facility. Every batch of medication undergoes rigorous testing in our quality control laboratory to verify sterility, potency, and purity. Our processes are designed to meet the exacting standards of cGMP to ensure the safety and efficacy of every product we ship.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or inquire about our available formulations by contacting 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more information on our services and ordering process.