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 large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and consistency, surpassing the requirements of a traditional compounding pharmacy. We serve healthcare providers by providing them with essential medications that are not commercially available, thereby playing a critical role in the local patient care ecosystem.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals in the vicinity of our Longwood facility can rely on us for a consistent supply of high-quality, pre-made medications. This allows these practitioners to have the necessary drugs on hand for immediate administration to patients during procedures, treatments, or office visits, enhancing the efficiency and effectiveness of care delivered at their practices located near 2160 W State Road 434.
Our status as a 503B outsourcing facility mandates rigorous testing, robust quality control protocols, and adherence to Current Good Manufacturing Practices (cGMP). Every batch of medication produced within our facility undergoes stringent testing for potency, sterility, and endotoxins. This ensures that every vial, syringe, or container dispensed from our location meets exacting specifications for purity and strength. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, this translates to unparalleled confidence in the medications they use to treat their patients.
503B Compounding Pharmacy provides a vital service by compounding medications that are currently on the FDA’s drug shortage list or are otherwise unavailable from standard pharmaceutical manufacturers. This capability is essential for preventing interruptions in treatment protocols and ensuring that patient care continues without compromise. By addressing these critical shortages from our facility, we support the continuity of medical services for the community surrounding our location.
Engagement with 503B Compounding Pharmacy is conducted through healthcare providers. Patients who require medications compounded at our FDA-registered outsourcing facility will receive them directly from their doctor’s office. We maintain a professional and collaborative relationship with the medical community, ensuring that our compounded preparations meet their specific clinical needs. For more information about our services or to inquire about becoming a client, please contact us directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
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 FDA and operates under Section 503B of the FD&C Act. We comply with Current Good Manufacturing Practices (cGMP), which include rigorous testing for sterility, potency, and purity on all batches of medication we compound, ensuring a higher level of quality control than traditional compounding pharmacies.
Can I, as a patient, pick up my medication directly from your location?
No. 503B Compounding Pharmacy provides medications exclusively for office use by healthcare providers. Your physician, surgeon, or other medical practitioner will order and stock our compounded medications at their practice. You will receive any medication compounded at our facility directly from your healthcare provider during your appointment or treatment.
What types of medications does 503B Compounding Pharmacy produce?
Our FDA-registered outsourcing facility specializes in compounding sterile injectables, ophthalmics, and other preparations that are on FDA shortage lists or are not commercially available. We produce these medications in larger batches for healthcare providers to have on hand for patient care at their practices located near our facility.
How do healthcare providers at 2160 W State Road 434 order from you?
Healthcare providers and their authorized staff can initiate orders by contacting our facility directly via phone at (407)993-1381 or through our professional website at https://503bcompoundingpharmacy.com/. We will guide them through our onboarding process to establish an account and discuss their specific compounding needs.
Why would a healthcare provider choose a 503B outsourcing facility over other sources?
Healthcare providers choose 503B Compounding Pharmacy because of our commitment to cGMP standards and batch-level testing. This provides assurance of consistency, safety, and quality in every preparation they use from our facility. It allows them to mitigate risks associated with drug shortages and offer treatments with medications that are not available from conventional manufacturers.