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.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Unlike traditional pharmacies, this 503B outsourcing facility prepares large volumes of sterile and non-sterile compounded medications in advance of receiving a prescription, based on historical patient need, for distribution to healthcare providers. The facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous current good manufacturing practices (cGMP), ensuring every preparation meets stringent quality control specifications for potency, sterility, and purity.
The core service of 503B Compounding Pharmacy is the provision of high-quality, batch-compounded medications to support the local medical community and their patients. The operations conducted at the 2160 W State Road 434, Longwood, FL 32779 location are integral to the healthcare infrastructure, providing practitioners with access to medications that may be in shortage or not commercially available. The facility's processes are designed to ensure reliability and consistency in the drug supply for prescribers utilizing its services. All preparations are executed in a state-of-the-art environment at the Longwood facility, which is subject to regular FDA inspections to maintain its registered outsourcing facility status.
Engaging with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 means accessing a resource dedicated to pharmaceutical excellence. The team of qualified professionals utilizes advanced technology and validated processes to compound preparations. This focus on cGMP standards differentiates the services provided from those of a traditional 503A pharmacy, offering an additional layer of safety and quality assurance for compounded drugs. The location serves as a pivotal component in the local medication supply chain, operating with precision and a patient-focused ethos from its facility in Longwood, FL 32779.
For more information on the services provided from this location, you can visit the website at or contact the facility directly at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large batches of medications in accordance with strict current good manufacturing practices (cGMP). This ensures a high level of quality, sterility, and consistency in the preparations provided from this location.
2. Who can receive medications from your Longwood facility?
Medications compounded at our 2160 W State Road 434 location are distributed to healthcare practitioners for their patients. Patients should consult with their prescriber to determine if a medication from our 503B outsourcing facility is appropriate for their treatment.
3. How does the quality control at a 503B outsourcing facility differ?
As an FDA-registered 503B outsourcing facility in Longwood, we operate under cGMP standards. This involves rigorous environmental monitoring, extensive testing of components and finished preparations, and validated processes that exceed the standards of a traditional compounding pharmacy, ensuring the highest quality from our location.
4. Can I pick up a prescription directly from your facility at 2160 W State Road 434?
No, 503B Compounding Pharmacy operates as an outsourcing facility that provides medications to healthcare providers and their offices. Patients do not typically pick up medications directly from this location. Your healthcare provider will manage the distribution of any medications compounded here.
5. How can a healthcare provider at your location order compounded medications?
Healthcare providers interested in the services of our 503B outsourcing facility can initiate the process by contacting us directly at (407)993-1381. Our team at the Longwood location will provide information on ordering, available formulations, and compliance requirements.