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 standard in pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations for office use by healthcare practitioners. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to the most current Good Manufacturing Practices (cGMP), ensuring a level of quality, sterility, and safety that meets rigorous federal oversight.
The core function of this 503B Compounding Pharmacy is to provide physicians, surgeons, hospitals, and clinics with access to a consistent and reliable supply of high-quality compounded medications. By operating as a 503B outsourcing facility, this 503B Compounding Pharmacy can compound medications in advance of receiving a patient-specific prescription, which is essential for healthcare providers who require certain medications to be immediately available for procedures and treatments. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced technology and staffed by highly trained professionals dedicated to the precise science of compounding within the 503B framework.
Patients benefit indirectly from the services of this 503B Compounding Pharmacy through the care provided by their local healthcare professionals. When a medical provider at a practice or clinic near 2160 W State Road 434, Longwood, FL 32779 utilizes medications from this 503B Compounding Pharmacy, they are administering preparations that have been produced under the highest standards of pharmaceutical compounding. The 503B Compounding Pharmacy provides an essential service to the local medical community by compounding preparations that may be on shortage from large-scale manufacturers or that require a specific formulation not available commercially.
The team at the 503B Compounding Pharmacy is committed to the principles of quality and safety inherent in the 503B designation. Every process, from ingredient sourcing to final packaging, is conducted with meticulous attention to detail and in accordance with the enforceable quality standards set forth for a 503B outsourcing facility. For healthcare providers seeking a trusted partner for their compounded medication needs, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a local resource of paramount integrity and reliability.
To learn more about the 503B Compounding Pharmacy or to inquire about services, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381. The 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy follows current Good Manufacturing Practices (cGMP) for a higher level of federal oversight and quality control.
2. Who can order from the 503B Compounding Pharmacy at 2160 W State Road 434?
The 503B Compounding Pharmacy primarily provides medications for office use by healthcare practitioners. Physicians, surgeons, clinics, and hospitals can order from this 503B Compounding Pharmacy to have essential compounded medications on hand for procedures and patient treatments.
3. Can I as a patient walk into the 503B Compounding Pharmacy to get a prescription filled?
The 503B Compounding Pharmacy operates as an outsourcing facility for healthcare providers. Patients should contact their healthcare provider directly, as that provider may source medications from this 503B Compounding Pharmacy for administration in their practice.
4. What kind of medications does this 503B Compounding Pharmacy prepare?
This 503B Compounding Pharmacy specializes in compounded sterile preparations (CSPs). These are typically injectable medications, IV bags, ophthalmics, and other preparations that must be sterile, often used in surgical, clinical, and therapeutic settings by medical professionals.
5. How does the 503B Compounding Pharmacy ensure medication safety?
As a 503B outsourcing facility, this 503B Compounding Pharmacy adheres to strict cGMP standards. This involves rigorous testing of components, validated sterility testing processes, environmental monitoring, and extensive documentation for every batch produced, ensuring the highest level of safety and quality.