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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the mission of providing high-quality compounded medications for office use by healthcare practitioners. Located at 2160 W State Road 434, Longwood, FL 32779, the facility adheres to the most rigorous current good manufacturing practices (cGMP) set forth by the FDA, ensuring every preparation meets stringent standards for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and compounded non-sterile preparations. These medications are not manufactured for individual patient-specific prescriptions but are instead produced in larger batches for healthcare facilities to have on hand for immediate use. This service is invaluable to clinics, hospitals, surgical centers, and veterinary practices, providing them with access to essential drugs that may be in short supply or not available from conventional manufacturers. By serving the medical community from its location at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy plays a critical role in the local healthcare infrastructure.
Operating as a 503B outsourcing facility differentiates this pharmacy from traditional 503A compounding pharmacies. The key distinction lies in the regulatory oversight and scale of production. While 503A pharmacies compound patient-specific prescriptions, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is subject to federal manufacturing standards, mandatory FDA inspections, and reporting of adverse events. This elevated level of regulation provides healthcare professionals with an added layer of confidence in the medications they administer to their patients.
The team at 503B Compounding Pharmacy comprises highly skilled pharmacists, pharmacy technicians, and quality assurance professionals dedicated to precision and safety. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. This unwavering commitment to quality ensures that every vial, syringe, or bottle that leaves the facility at 2160 W State Road 434, Longwood, FL 32779 is of the highest possible standard, supporting positive patient outcomes.
For healthcare providers seeking a reliable partner for their office-use medication needs, 503B Compounding Pharmacy stands as a trusted resource. To learn more about its services or to initiate an order, healthcare entities can contact the facility directly. The website at https://503bcompoundingpharmacy.com/ offers detailed information, and the team can be reached by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates in compliance with Section 503B of the FD&C Act. We adhere to strict current good manufacturing practices (cGMP) and are subject to routine FDA inspections, ensuring the highest standards of quality and safety for our compounded medications.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not compound medications for individual patients based on a prescription. Our facility at 2160 W State Road 434, Longwood, FL 32779 produces medications exclusively for office use by healthcare practitioners. Patients should contact a traditional 503A compounding pharmacy for their personal prescription needs.
3. What types of healthcare facilities does 503B Compounding Pharmacy serve at its Longwood location?
We provide compounded medications for office use to a variety of healthcare providers located near our facility. This includes, but is not limited to, hospitals, surgery centers, clinics, and veterinary practices that require bulk, non-patient-specific compounded preparations for their practice.
4. How does ordering work for healthcare providers?
Healthcare providers and facilities can place orders for compounded medications directly with 503B Compounding Pharmacy. To begin the process, discuss your needs, or request a catalog, please contact our team at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/.
5. Why would a healthcare provider order from a 503B outsourcing facility instead of a traditional compounder?
Healthcare providers choose 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 for the added assurance of federal oversight, cGMP compliance, and large-scale, consistent production. This is particularly important for medications used in a sterile environment or for drugs that are on shortage, providing a reliable and quality-assured source.