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 compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent standards for sterility, potency, and purity.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are centered on the large-scale production of compounded sterile preparations (CSPs) for healthcare facilities. We provide physicians, hospitals, clinics, and other healthcare providers with access to critical medications that are often in short supply or unavailable from conventional manufacturers. By operating from our specific location, we are able to support the local medical community with a reliable source of high-quality, patient-specific medications. Our work is dedicated to enabling healthcare professionals to deliver superior patient care through dependable access to essential drugs.
Our core mission is to alleviate drug shortages and enhance patient safety. The team at 2160 W State Road 434, Longwood, FL 32779 consists of highly skilled pharmacists, pharmacy technicians, and quality assurance professionals who utilize state-of-the-art technology and equipment. Every process, from ingredient sourcing to final packaging, is meticulously controlled and documented. This unwavering focus on quality control and regulatory adherence is the foundation of our operation, providing peace of mind to the healthcare providers we serve.
For more information about the services available from our facility, please visit our website at https://503bcompoundingpharmacy.com/ or contact us directly at (407)993-1381. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest principles of pharmaceutical compounding.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B. We adhere to current Good Manufacturing Practices (cGMP) and undergo regular federal inspections, which allows us to compound large volumes of sterile medications for healthcare providers without patient-specific prescriptions.
Who can receive medications from 503B Compounding Pharmacy?
Our services are provided to healthcare professionals and facilities. Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are distributed to hospitals, clinics, and physician offices for administration to their patients under their care.
How does 503B Compounding Pharmacy help with drug shortages?
Our facility at 2160 W State Road 434, Longwood, FL 32779 can compound preparations that are on the FDA drug shortage list. This provides a critical alternative source of essential medications for local healthcare providers when conventional manufacturers cannot supply them.
What quality controls are in place at your facility?
At our location on W State Road 434, we employ rigorous quality control measures mandated by cGMP. This includes stringent environmental monitoring, validated sterilization processes, and thorough testing of components and finished preparations to ensure sterility, potency, and stability.
How can a healthcare facility place an order?
Healthcare facilities interested in our services can initiate the process by contacting our team directly at (407)993-1381. We will provide information on our ordering procedures and how we can support your medication needs from our location at 2160 W State Road 434, Longwood, FL 32779.