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 at 2160 W State Road 434, Longwood, FL 32779
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 specifically designed and regulated to produce large volumes of compounded sterile preparations (CSPs) for healthcare providers. Unlike traditional compounding, our 503B status signifies that we adhere to rigorous federal standards for current good manufacturing practices (cGMP), ensuring a higher level of sterility assurance, purity, and consistency in every preparation we compound. Our primary mission is to provide healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, reliable medications that are essential for patient care.
The operations at our 503B outsourcing facility are distinct. We compound medications based on the orders we receive from healthcare professionals; we do not provide medications directly to individual patients without a prescription from their provider. This model allows us to support the medical community at 2160 W State Road 434, Longwood, FL 32779 by acting as a bulk manufacturer of essential drugs that may be in shortage or are not commercially available. Our state-of-the-art cleanrooms, advanced environmental monitoring systems, and validated processes are all dedicated to producing sterile preparations like injectables, ophthalmics, and inhalants that meet precise specifications for strength, purity, and stability.
Our commitment to quality at our Longwood facility is paramount. Every batch of medication is compounded under the supervision of our expert pharmacists and quality control professionals. We employ robust testing protocols, including sterility testing, endotoxin testing, and potency assays, to verify the safety and efficacy of our preparations before they are released for distribution. This unwavering dedication to cGMP standards provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with the confidence that the medications they administer are of the highest possible quality. We are a critical partner for hospitals, clinics, and surgical centers, helping to ensure patient safety and positive therapeutic outcomes.
For healthcare entities operating at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves as a vital resource for obtaining medications that are often on the FDA drug shortage list. Our ability to compound these essential drugs helps to prevent delays in treatment and ensures continuity of care. We work closely with practitioners to understand their specific needs and to provide solutions that support their practice and their patients. Our location at 2160 W State Road 434, Longwood, FL 32779 is a center for quality, reliability, and partnership within the local medical community.
To learn more about our services or to place an order, healthcare providers can contact us directly. We are here to support the medical needs of practitioners serving patients at 2160 W State Road 434, Longwood, FL 32779.
Website: | Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
1. What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal current good manufacturing practices (cGMP). This ensures the compounded sterile preparations we produce for healthcare providers meet the highest standards for sterility, purity, and quality.
2. Can I, as an individual patient, order medication directly from this 503B pharmacy?
No. As an FDA-registered 503B outsourcing facility, we compound medications exclusively for healthcare practitioners and entities. Individual patients must receive our preparations through their doctor, hospital, or clinic at 2160 W State Road 434, Longwood, FL 32779 who will order on their behalf.
3. What types of medications does this 503B facility typically compound?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding large batches of sterile preparations, including injectables, intravenous (IV) bags, ophthalmics, and inhalation solutions. These are often medications that are on national shortage or are not available from commercial manufacturers.
4. How does the quality control process work at this location?
Quality control is integral to our 503B operations. At our facility on W State Road 434, every batch undergoes rigorous testing, including sterility, endotoxin, and potency testing, by our quality control team before being released to healthcare providers, ensuring patient safety.
5. How can a healthcare provider at this address place an order with your 503B pharmacy?
Healthcare providers and institutions at 2160 W State Road 434, Longwood, FL 32779 can place orders by contacting our pharmacy directly via phone. Our team will work with you to process your order and coordinate delivery. Phone: (407)993-1381.