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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical quality and safety. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular inspections. This ensures that every preparation leaving the 503B Compounding Pharmacy meets stringent standards for potency, purity, and sterility.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can source essential medications directly from this 503B Compounding Pharmacy. The 503B Compounding Pharmacy provides physicians, surgeons, veterinarians, and other medical professionals with a reliable supply of sterile and non-sterile preparations. This allows these practitioners to maintain an inventory of necessary drugs for immediate administration to their patients, enhancing the efficiency and scope of care available directly within their practices at 2160 W State Road 434, Longwood, FL 32779.
The services of this 503B Compounding Pharmacy are distinct from traditional compounding. The 503B Compounding Pharmacy focuses on producing batches of medications without patient-specific prescriptions, which are then distributed to healthcare providers for office stock. This model is crucial for medications that are in short supply or have been discontinued by major manufacturers. By mitigating drug shortages, the 503B Compounding Pharmacy plays a vital role in the local healthcare ecosystem, ensuring that practitioners have consistent access to critical drugs. The team at this 503B Compounding Pharmacy comprises skilled pharmacists and technicians dedicated to the precise science of large-scale compounding.
Quality assurance is the foundation of every operation at this 503B Compounding Pharmacy. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented. The 503B Compounding Pharmacy utilizes state-of-the-art equipment and facilities to ensure the integrity of its preparations. Patients and practitioners who utilize medications from this 503B Compounding Pharmacy can have absolute confidence in their quality, safety, and efficacy. For more detailed information about the specific preparations available, healthcare providers are encouraged to contact the 503B Compounding Pharmacy directly or visit the official website.
To learn more about the services provided by this 503B Compounding Pharmacy or to inquire about becoming a client, please use the following contact information. The 503B Compounding Pharmacy can be reached at (407)993-1381. Comprehensive information is also available on the official website for this 503B Compounding Pharmacy: https://503bcompoundingpharmacy.com/. The team at the 503B Compounding Pharmacy is ready to assist healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with their medication needs.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy? This 503B Compounding Pharmacy is an FDA-registered outsourcing facility that operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation means the 503B Compounding Pharmacy adheres to heightened production standards, including current Good Manufacturing Practices (cGMP), and is subject to regular FDA inspections to ensure medication quality and safety.
2. Who can order from this 503B Compounding Pharmacy? This 503B Compounding Pharmacy provides medications for office use to healthcare practitioners. Physicians, surgeons, veterinarians, and other qualified medical professionals with practices at 2160 W State Road 434, Longwood, FL 32779 can order compounded preparations to maintain their office supply for immediate patient care.
3. Can I as a patient get a prescription filled directly at this 503B Compounding Pharmacy? No. The 503B Compounding Pharmacy model is designed for bulk compounding for healthcare provider office stock, not for filling individual patient prescriptions. You would receive a medication compounded by this 503B Compounding Pharmacy directly from your healthcare provider during an office visit or procedure.
4. How does the 503B Compounding Pharmacy help with drug shortages? This 503B Compounding Pharmacy can compound large batches of medications that are on the FDA drug shortage list or have been discontinued. This provides a critical alternative supply chain for healthcare providers at 2160 W State Road 434, Longwood, FL 32779, ensuring they have access to essential medications for their patients.
5. How can a healthcare provider at this location start ordering from the 503B Compounding Pharmacy? Healthcare providers interested in the services of this 503B Compounding Pharmacy should contact the facility directly to establish an account. You can reach the 503B Compounding Pharmacy by phone at (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/ for more information on the ordering process and available preparations.