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, granted 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 compounding pharmacies, this facility adheres to rigorous current good manufacturing practices (cGMP) and is subject to regular FDA inspections. The core function of this location is the large-scale production of compounded sterile preparations (CSPs) for office use, which are then distributed to healthcare practitioners for patient administration within their clinical settings.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are specifically designed to support the local medical community. Healthcare providers in the area can access a reliable supply of high-quality, sterile medications that are often in short supply or unavailable from conventional manufacturers. The 503B outsourcing facility model ensures that these medications are produced in a controlled environment with extensive testing and quality assurance protocols. This provides practitioners with confidence in the medications they administer, allowing them to focus on patient care without concerns about drug sourcing or sterility. The facility's operations are a critical component of the local healthcare infrastructure, ensuring essential medications are available for patients in need.
By focusing on non-patient-specific, office-use compounding, the pharmacy at 2160 W State Road 434, Longwood, FL 32779 streamlines the process for medical practices. Physicians, surgeons, dermatologists, and other healthcare professionals can order the necessary preparations without the need for individual patient prescriptions for each vial or syringe. This bulk manufacturing approach is efficient and cost-effective, reducing the administrative burden on local clinics and hospitals. The available preparations often include injectables, ophthalmics, and other sterile products that are essential for procedures, treatments, and ongoing patient therapy protocols within the medical community.
The team at 503B Compounding Pharmacy is dedicated to upholding the strict standards required of an FDA-registered outsourcing facility. Every process, from ingredient sourcing to final product testing, is meticulously controlled and documented. This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets precise specifications for potency, purity, and sterility. For healthcare providers seeking a trusted partner for their office-use medication needs, this location represents a source of quality and reliability. To learn more or to discuss your practice's requirements, you can contact the facility via their website at or by phone 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 operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration signifies adherence to stricter production standards, including current good manufacturing practices (cGMP), and subjects the facility to routine FDA inspections to ensure the quality and safety of its compounded sterile preparations.
2. Can I, as a patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications exclusively for office use by healthcare practitioners. Patients do not receive prescriptions directly from this facility. Instead, your healthcare provider will administer the medication to you during your appointment at their clinic or office.
3. What types of medications does this facility compound?
This location specializes in compounding sterile preparations, which are typically injectable, ophthalmic, or other medications requiring a sterile environment. These are often drugs that are on shortage or not commercially available. The specific formulations are designed for use by healthcare professionals in a clinical setting at their practice locations.
4. Who is authorized to place an order with your pharmacy?
Orders are accepted from licensed healthcare providers and medical facilities. This includes physicians, surgeons, dermatologists, and other qualified medical professionals who require bulk, non-patient-specific compounded medications for office use. Orders are not placed by individual patients.
5. How can a local healthcare provider start ordering from your facility?
Healthcare providers interested in utilizing our services can initiate the process by contacting our facility directly. We will provide information on our available preparations, ordering procedures, and compliance requirements. You can reach us for more details at our website, , or by calling (407)993-1381.