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 commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring practitioners at 2160 W State Road 434, Longwood, FL 32779 have access to reliable pharmaceutical compounds.
The core function of 503B Compounding Pharmacy is the preparation of medications that are not commercially available. This includes creating formulations without certain allergens like dyes or preservatives, altering the strength or dosage form of a medication to meet specific patient needs, or compounding a medication that is currently on drug shortage lists. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and rigorous testing protocols, including sterility testing and endotoxin testing, to ensure every preparation meets its specified identity, strength, quality, and purity. This process provides an additional layer of safety and assurance for the patients who will receive these medications.
Healthcare professionals relying on the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a dependable source for essential medications. Our operations are pivotal for clinics, hospitals, and surgical centers that require ready-to-use, high-quality compounded preparations. By adhering to Current Good Manufacturing Practices (cGMP), we provide a level of quality control that is critical for patient safety and effective treatment outcomes. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in the art and science of pharmaceutical compounding.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can initiate orders and discuss specific compounding needs directly with our pharmacy team. We encourage all medical professionals at 2160 W State Road 434, Longwood, FL 32779 to connect with us to learn how our compounding services can support their practice and enhance patient care. For more detailed information about our capabilities or to place an order, please contact us directly. We are here to serve the specific pharmaceutical compounding needs of the healthcare community at our location.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with stricter federal standards outlined in Section 503B of the FD&C Act. This includes adhering to Current Good Manufacturing Practices (cGMP) and undergoing regular FDA inspections, which provides a higher level of quality and safety assurance for the compounded medications we produce.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779?
Our services are designed for healthcare providers and institutions. Licensed medical practitioners, including physicians, surgeons, and veterinarians, can order compounded medications from our facility for their patients or for office use. We work directly with prescribers and their authorized agents.
3. Can patients pick up medications directly from your facility?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications to healthcare providers and their practices. Patients should receive their compounded medications directly from their prescribing healthcare provider or the clinic at 2160 W State Road 434, Longwood, FL 32779 that ordered them on their behalf.
4. What types of medications does 503B Compounding Pharmacy typically compound?
We compound a wide range of sterile and non-sterile preparations, including hormone replacement therapies, ophthalmics, injectables, and topical formulations. A significant focus is also on producing medications that are currently in short supply, helping to ensure continuity of care for patients at 2160 W State Road 434, Longwood, FL 32779.
5. How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can place orders by contacting our pharmacy directly by phone at (407)993-1381. Our team will guide you through the process, which includes verifying the prescription order and discussing any specific compounding requirements for your patients.