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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of safety, quality, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving the facility meets stringent quality control benchmarks for sterility, potency, and purity, providing healthcare providers and patients with a level of confidence and reliability that is paramount for patient care.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale production of compounded sterile preparations (CSPs) for office use. This model is designed to support the specific needs of healthcare practitioners whose practices are located near 2160 W State Road 434, Longwood, FL 32779. By maintaining an inventory of commonly needed medications, 503B Compounding Pharmacy provides a vital resource for local clinics, hospitals, surgical centers, and veterinary practices. This allows these practices to obtain essential, ready-to-administer medications without the burden and expense of maintaining their own in-house compounding capabilities, streamlining their operations and enhancing patient safety through the use of FDA-inspected products.
Services provided by 503B Compounding Pharmacy are distinct and specialized. The facility focuses on the non-sterile to sterile conversion of medications, the compounding of hormone replacement therapy (HRT) injections, and the preparation of various other injectable medications. All processes are conducted within the controlled environment of the facility at 2160 W State Road 434, Longwood, FL 32779, utilizing advanced technology and following exacting aseptic techniques. The team at 503B Compounding Pharmacy comprises highly trained pharmacists and technicians who are dedicated to the science of compounding, ensuring that each preparation is consistent and accurately dosed. The business model is exclusively oriented toward supplying other healthcare entities, not the general public directly, ensuring a professional and efficient supply chain for critical medications.
For healthcare providers serving patients in the area of 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy offers significant advantages. It mitigates drug shortage challenges, provides access to a consistent supply of high-quality medications, and reduces the potential for compounding errors within a clinical setting. The pharmacy’s operational scale allows for responsiveness to the demands of the local medical community. To learn more about the specific formulations available or to discuss how 503B Compounding Pharmacy can support your practice, visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with and inspected by the U.S. Food and Drug Administration. It operates under Section 503B of the FD&C Act, adhering to strict current Good Manufacturing Practice (cGMP) regulations, which govern the facility's production, testing, and quality control processes for compounded sterile preparations.
Who can order compounded medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to healthcare practitioners and facilities. Orders are accepted from physicians, clinics, hospitals, and other healthcare entities that serve patients and are located near 2160 W State Road 434, Longwood, FL 32779. Medications are not dispensed directly to the public.
What types of compounded medications are available from this location?
The facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a range of sterile injectable medications. This includes non-sterile to sterile conversions, hormone replacement therapy (HRT) injections, and other customized preparations needed by local healthcare providers for their practice needs.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly at (407)993-1381. The team will provide information on available formulations, ordering procedures, and any necessary documentation required to establish an account for your practice.
Why should a local practice choose 503B Compounding Pharmacy for its medication needs?
Choosing 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides local practices with access to high-quality, FDA-overseen compounded medications. This partnership ensures a reliable supply, reduces the administrative and safety burdens of in-house compounding, and supports enhanced patient care through consistent, quality-assured preparations.