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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal quality standards, including current Good Manufacturing Practices (cGMP), which are more stringent than the standards applied to traditional 503A compounding pharmacies. This ensures that every preparation leaving the facility meets the highest possible benchmarks for purity, sterility, and potency.
The core mission of 503B Compounding Pharmacy at its Longwood location is to provide healthcare providers with access to high-quality, compounded medications that are essential for patient care. The facility serves an important role in the healthcare ecosystem by producing medications that are often on shortage or are not commercially available from large pharmaceutical manufacturers. By preparing these medications in bulk, 503B Compounding Pharmacy provides a reliable and consistent supply of critical drugs, helping to mitigate drug shortages and support the local medical community at 2160 W State Road 434, Longwood, FL 32779.
Services at this specific facility are tailored for healthcare providers, including hospitals, clinics, surgery centers, and physician practices. The pharmacy compounds a wide array of preparations, such as sterile injectables, ophthalmics, and other dosage forms that require an aseptic environment. The team at 503B Compounding Pharmacy comprises highly skilled pharmacists and technicians who utilize state-of-the-art technology and equipment within their modern facility to ensure every product is compounded with precision and accuracy. For more information or to inquire about services, please contact 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. 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 U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. We are subject to federal oversight and must comply with Current Good Manufacturing Practices (cGMP), which are the same strict quality standards required of major pharmaceutical manufacturers.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications primarily to healthcare providers and institutions. This includes hospitals, clinics, ambulatory surgery centers, and other healthcare practices that serve patients. We work directly with medical professionals at our location on 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we specialize in compounding sterile preparations, including injectables, IV bags, ophthalmics, and other medications that require an aseptic processing environment. Our focus is on producing these medications in larger batches for healthcare providers.
4. How does 503B Compounding Pharmacy ensure the quality and safety of its compounded medications?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous cGMP standards. This involves extensive testing of components, in-process testing, finished product testing, environmental monitoring, and comprehensive quality control procedures to ensure every preparation is pure, potent, and sterile.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 get started with your services?
Healthcare providers interested in our services can initiate the process by contacting our facility directly. We encourage you to call our dedicated line at (407)993-1381 to speak with a representative or visit https://503bcompoundingpharmacy.com/ for more detailed information about our capabilities and how we can support your practice.