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 in strict compliance with 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. The 503B designation signifies adherence to the highest level of federal regulation, which includes current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous standards for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to medications that are not commercially available. This includes producing formulations without certain dyes or preservatives for patients with allergies, creating specific dosage strengths not offered by manufacturers, or compounding a medication that is currently on the FDA’s drug shortage list. By operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves as a critical component of the local healthcare infrastructure, supporting clinics and practitioners with reliable access to essential medications.
As an outsourcing facility, 503B Compounding Pharmacy prepares medications based on the orders received from licensed healthcare professionals. The team of skilled pharmacists and technicians utilizes state-of-the-art equipment and technology within their facility to ensure precision and quality control in every batch. The environment at 2160 W State Road 434, Longwood, FL 32779 is meticulously controlled, with sterile compounding performed in ISO-classified cleanrooms to prevent contamination and ensure patient safety.
Patients and prescribers who utilize the services of 503B Compounding Pharmacy can have confidence in the quality and consistency of their medications. The facility’s commitment to compliance and excellence provides a trusted source for compounded medications. For more information or to inquire about services, please contact 503B Compounding Pharmacy at their location: 2160 W State Road 434, Longwood, FL 32779. You can reach them by phone at (407)993-1381 or visit their website at .
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. We comply with stringent current Good Manufacturing Practices (cGMP) for compounding, which are more comprehensive than traditional pharmacy standards, ensuring a higher level of quality control and consistency in our preparations.
2. Can I walk into the facility at 2160 W State Road 434 to get a prescription filled?
No. 503B Compounding Pharmacy operates as an outsourcing facility that prepares large batches of medications based on orders from licensed healthcare providers. We do not have a public storefront for walk-in patients. Your prescriber must send the order directly to our facility for processing and dispensing.
3. How do I get a medication compounded at your Longwood location?
You must first consult with your healthcare provider. If they determine that a compounded medication is medically necessary for you, they will place an order directly with our facility at 2160 W State Road 434, Longwood, FL 32779. We will then compound the medication and ship it to your provider or directly to you, as directed.
4. What types of medications does 503B Compounding Pharmacy prepare?
Our facility specializes in compounding medications that are on the FDA drug shortage list or are not available from commercial manufacturers. This includes sterile injectables, ophthalmics, and other formulations that require a controlled environment. We produce these in larger batches for distribution to healthcare providers.
5. How can I contact 503B Compounding Pharmacy with questions?
For any questions regarding our services or a specific order, you or your healthcare provider can contact us directly. We are located at 2160 W State Road 434, Longwood, FL 32779. You can call us at (407)993-1381 or find more information on our website at .