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 fundamental operational distinction of a 503B Compounding Pharmacy, as defined by federal law, is the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. This model allows physicians, surgeons, veterinarians, and other medical professionals to obtain vital medications without the need for patient-specific prescriptions for each vial, syringe, or bag, thereby supporting efficient clinical practice and emergency stock needs.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to the most rigorous current good manufacturing practices (cGMP). These standards, which are more stringent than those applied to traditional 503A compounding pharmacies, ensure an unparalleled level of quality control, sterility assurance, and product consistency. Every batch of medication produced at this 503B Compounding Pharmacy is subjected to extensive testing and quality verification processes. This commitment to cGMP provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they utilize meet the highest possible standards for safety and efficacy.
The services provided by this 503B Compounding Pharmacy are exclusively tailored for office use by healthcare practitioners. The facility compounds a significant volume of medications that are essential for various medical specialties, including but not limited to anesthesia, pain management, ophthalmology, and surgery. By supplying these preparations in bulk, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 plays a critical role in the local healthcare infrastructure, ensuring that clinics and surgical centers have reliable access to necessary medications. The team at this 503B Compounding Pharmacy is comprised of highly trained pharmacists, technicians, and quality assurance professionals dedicated to the precise science of compounding.
Healthcare providers seeking a dependable source for office-use medications are encouraged to connect with this 503B Compounding Pharmacy. The facility welcomes inquiries and collaboration with medical practices to support patient care. For comprehensive information on its capabilities and processes, please visit the official website at https://503bcompoundingpharmacy.com/. To speak directly with a representative regarding services or to place an order, please call (407)993-1381. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is committed to upholding the highest standards of pharmaceutical compounding as an FDA-registered outsourcing facility.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this facility is a 503B Compounding Pharmacy?
It signifies that this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility operating under Section 503B. This federal designation means we compound large volumes of sterile medications for office use by healthcare practitioners, adhering to strict current good manufacturing practices (cGMP).
2. Can I as an individual patient get a prescription filled at this 503B Compounding Pharmacy?
No. A 503B Compounding Pharmacy primarily supplies medications for office use to healthcare providers. Individual patients with a prescription from their doctor for a compounded medication should have it filled at a traditional 503A compounding pharmacy.
3. Who can order from the 503B Compounding Pharmacy at 2160 W State Road 434?
Orders are accepted from licensed healthcare practitioners, including physicians, surgeons, veterinarians, and medical facilities, for medications to be used within their practice at 2160 W State Road 434, Longwood, FL 32779. These are typically bulk orders for office stock rather than patient-specific prescriptions.
4. How does the 503B Compounding Pharmacy ensure medication safety?
As an FDA-registered 503B outsourcing facility, we operate under rigorous cGMP standards. This involves extensive testing of components and finished products, stringent environmental monitoring, and validated processes to ensure every batch of medication meets the highest standards for sterility, potency, and purity.
5. How can a healthcare provider at this location start ordering?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can initiate the process by contacting our 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on our available formulations, ordering procedures, and how we can support your practice's medication needs. You can also learn more at https://503bcompoundingpharmacy.com/.