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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to stringent current Good Manufacturing Practices (cGMP), ensuring the highest standards of quality, purity, and potency for all compounded preparations. This distinguishes its operations from traditional compounding pharmacies and provides healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for patient-specific medications that may not be commercially available.
The core service of 503B Compounding Pharmacy is the provision of compounded medications for office use. This means healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications for immediate administration to patients within their practice. This is crucial for treatments such as hormone replacement therapy, pain management, ophthalmic solutions, and other injectable medications. By supplying medications in bulk to medical professionals, 503B Compounding Pharmacy supports the efficient operation of local clinics and practices, ensuring they have the necessary pharmaceutical tools on hand.
Patients and providers at 2160 W State Road 434, Longwood, FL 32779 benefit from the rigorous quality control measures inherent to an FDA-registered 503B outsourcing facility. Every batch of medication undergoes extensive testing and quality assurance protocols. This includes sterility testing, endotoxin testing, and potency verification to guarantee that every preparation meets exact specifications. This level of oversight provides an added layer of safety and confidence for medical professionals when selecting a supplier for their compounded pharmaceutical needs.
Accessing the services of 503B Compounding Pharmacy is designed for healthcare providers. Medical practices located at 2160 W State Road 434, Longwood, FL 32779 can establish an account to order compounded medications for office use. The facility works directly with physicians and their authorized staff, not directly with patients. For more information on becoming a client or to place an order, providers can contact 503B Compounding Pharmacy directly. The team is available to answer questions and discuss specific compounding capabilities.
To connect with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, please use the following contact information. Website: | Phone: (407)993-1381. The facility welcomes inquiries from healthcare professionals seeking a trusted partner for their compounding requirements.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile and non-sterile medications for office use by healthcare providers. It operates under stricter federal regulations (cGMP) than a traditional compounding pharmacy, focusing on batch-level quality control and testing.
2. Can I, as a patient, walk into 2160 W State Road 434 to get a prescription filled?
No. 503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners and their practices. Patients must receive their compounded medications directly from their doctor during a clinic visit or procedure at the provider's location.
3. What types of medications does this 503B facility compound?
The 503B Compounding Pharmacy at 2160 W State Road 434 compounds a wide range of preparations, including sterile injectables, hormone therapies, pain management solutions, and other medications that are often administered in a clinical setting. All compounding is done for healthcare providers to use within their practice.
4. How do I, as a healthcare provider, order from this location?
Healthcare providers with practices can contact the facility directly by phone at (407)993-1381 to establish an account and discuss their specific compounding needs. Orders are placed by the provider or their authorized staff for pickup or delivery.
5. Why should a provider at 2160 W State Road 434 choose this 503B facility?
Choosing this 503B Compounding Pharmacy ensures your practice receives medications produced under the highest federally mandated quality standards. The rigorous testing for sterility, potency, and purity provides confidence in the medications you administer to your patients.