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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers by providing them with essential medications that are not commercially available, enabling them to better treat their patients' unique needs.
The core function of 503B Compounding Pharmacy is the production of medications in bulk for office use by healthcare practitioners. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is designed to maintain stringent environmental controls and utilizes advanced analytical testing to ensure every preparation meets precise specifications. By operating as a 503B outsourcing facility, we provide physicians, surgeons, dermatologists, and other medical professionals with a reliable source for high-quality compounded preparations, which they can then administer or dispense to their patients directly from their practice locations.
Our services are pivotal for patient care when standard, FDA-approved manufactured drugs are not suitable. This includes creating medications free of specific allergens like dyes or preservatives, altering the dosage form for easier administration, or compounding a medication that is currently on shortage or discontinued. The team of highly skilled pharmacists and technicians at our Longwood location leverages specialized equipment and rigorous protocols to compound a wide array of preparations, including sterile injectables, hormonal therapies, topical creams and gels, and other customized dosage forms.
Quality assurance is the foundation of everything we do at 503B Compounding Pharmacy. Every batch of medication produced at our facility on W State Road 434 undergoes thorough testing, including sterility testing, endotoxin testing, and potency analysis. This rigorous process, mandated by our FDA registration, provides an additional layer of safety and confidence for the medical community we serve. Healthcare providers can trust that the medications they receive from our facility are prepared with the utmost precision and care, supporting positive patient outcomes.
For healthcare providers seeking a dependable partner for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands ready to assist. We encourage you to explore our capabilities and learn how our 503B services can support your practice. You can reach us by phone at (407)993-1381 or visit our website for more detailed information at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and batch testing compared to a traditional pharmacy.
2. As a patient, can I walk into the Longwood facility to pick up a prescription?
No. 503B Compounding Pharmacy primarily compounds medications in bulk for office use by healthcare providers. Your prescribing physician or clinic would order the medication from us and then administer or dispense it to you directly from their practice location.
3. What types of medications does the 503B Compounding Pharmacy in Longwood prepare?
Our facility on W State Road 434 specializes in compounding a wide range of sterile and non-sterile medications, including injectables, IV preparations, ophthalmics, topical creams, and other formulations that are not commercially available or are in shortage.
4. How does a healthcare provider at a local clinic order from your pharmacy?
Healthcare providers can establish an account with our facility by contacting us directly. Our team at (407)993-1381 can provide information on our ordering process, current product offerings, and how we can meet the specific needs of their practice located near our Longwood facility.
5. Why would a doctor choose a 503B outsourcing facility over other options?
Doctors choose our services for the assurance of quality and compliance that comes with our FDA-registered status. It provides a reliable source for essential medications, especially during drug shortages, and ensures the products they use meet rigorous safety and potency standards.