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 establishes a critical standard for quality and safety in pharmaceutical compounding. As a 503B outsourcing facility, this pharmacy adheres to rigorous current good manufacturing practices (cGMP), which are the same standards followed by major pharmaceutical manufacturers. This ensures that every preparation leaving the facility meets stringent specifications for potency, purity, and sterility. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to providing healthcare providers with a reliable source for high-quality compounded medications.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications for office use by healthcare practitioners. This means that physicians, surgeons, dermatologists, ophthalmologists, and other medical professionals serving patients in Longwood can source essential medications directly from this facility. The pharmacy at 2160 W State Road 434 compounds significant quantities of sterile injectables, ophthalmic drops, and other preparations that are vital for clinical settings. These medications are supplied for office administration and are not intended for individual patient dispensing. This service model supports local clinics and practices by ensuring they have access to necessary drugs that may be in short supply or not commercially available.
Operating from its location at 2160 W State Road 434, Longwood, FL 32779, the pharmacy maintains a state-of-the-art cleanroom environment. This controlled space is essential for the aseptic processing required to produce sterile preparations, such as IV bags, intramuscular injections, and ophthalmic solutions. The environmental controls, along with rigorous testing and validation protocols, are central to the 503B compliance mandate. The staff at this facility includes highly trained pharmacists and technicians who specialize in sterile compounding techniques, ensuring that every product is prepared with precision and care. The commitment to cGMP provides an additional layer of safety and quality assurance for the local medical community.
503B Compounding Pharmacy provides a vital service by addressing drug shortages. When commercially manufactured drugs become unavailable, this facility at 2160 W State Road 434, Longwood, FL 32779 can step in to compound those essential medications, helping to prevent interruptions in patient care for local practices. Furthermore, the pharmacy can compound formulations that are not otherwise available on the market, such as specific strengths or combinations tailored for clinical use. Healthcare providers can confidently order these medications knowing they are produced under the highest regulatory oversight applicable to compounding pharmacies. The focus remains on supporting the specific needs of medical professionals at 2160 W State Road 434, Longwood, FL 32779.
For healthcare providers seeking a trusted partner for office-use medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a resource built on compliance and quality. The facility welcomes inquiries from local medical practices to discuss their specific needs. You can learn more about their services or place an order by visiting their website at or by calling the pharmacy directly at (407)993-1381.
FAQ
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 medications in large volumes for office use by healthcare providers. It operates under stricter federal regulations, including current good manufacturing practices (cGMP), which ensures a higher level of quality control and testing compared to traditional compounding pharmacies.
2. Can I as an individual patient get a prescription filled at this location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications exclusively for "office use" by licensed healthcare practitioners. Individual patients should have their medications administered by their provider at the clinical practice and cannot pick up prescriptions directly from this facility.
3. What types of medications does this 503B pharmacy compound?
The pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile preparations, including injectables, IV bags, and ophthalmic solutions. These are primarily compounded in larger batches for healthcare providers to use within their practices for procedures, treatments, and injections.
4. How does ordering work for a local medical practice?
Healthcare providers and medical practices can place orders for compounded medications directly with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. You can initiate an order or discuss your practice's specific needs by contacting the pharmacy at (407)993-1381.
5. Why should a provider choose a 503B outsourcing facility?
Choosing this 503B facility at 2160 W State Road 434, Longwood, FL 32779 ensures the medications you use in your practice are produced under the most rigorous quality standards mandated by the FDA. This provides assurance of sterility, potency, and purity, which is critical for patient safety and effective treatment outcomes.