Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
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.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility operating in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is dedicated to the large-scale compounding of sterile and non-sterile medications, which are then distributed for patient-specific use. As a 503B outsourcing facility, we adhere to the highest standards of current Good Manufacturing Practices (cGMP), providing an elevated level of safety, quality, and consistency that goes beyond traditional compounding.
The core function of 503B Compounding Pharmacy is to provide healthcare providers serving the community at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable supply of compounded medications. We work directly with physicians, hospitals, and clinics, enabling them to obtain necessary medications that are not commercially available or are experiencing a shortage. Our operations are designed to support the local medical community by ensuring that practitioners have the specific medications they need to treat their patients effectively, without the need for them to engage in in-office compounding.
Operating from our location at 2160 W State Road 434, Longwood, FL 32779, our 503B outsourcing facility is subject to rigorous FDA oversight, including routine inspections. This regulatory framework ensures that every batch of medication we produce meets stringent quality control standards for potency, purity, and sterility. Our commitment to cGMP means that our processes, from ingredient sourcing to final product testing, are meticulously documented and validated, offering unparalleled traceability and reliability for the healthcare professionals we serve.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy means mitigating risk and enhancing patient care. We compound a significant volume of medications, which allows us to provide products that are essential for a wide range of medical treatments. Our team of experienced pharmacists and technicians utilizes state-of-the-art technology and cleanroom environments to ensure the integrity of every preparation. We are a pivotal resource for medications that have been identified by the FDA as being in drug shortage, helping to prevent interruptions in patient treatment plans.
To learn more about our services or to speak with our team, we encourage you to visit our website at https://503bcompoundingpharmacy.com/ or contact us directly by phone at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779, and we are committed to supporting the local medical community with high-quality, compounded pharmaceutical solutions.
Frequently Asked Questions for 503B Compounding Pharmacy
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 are held to current Good Manufacturing Practice (cGMP) standards, which are the same rigorous quality regulations followed by major pharmaceutical manufacturers, ensuring a higher level of safety and quality control for our compounded medications.
2. Can I, as a patient, order medications directly from 503B Compounding Pharmacy?
No, 503B Compounding Pharmacy does not dispense medications directly to patients. We are an outsourcing facility that compounds medications in large batches for healthcare providers. Your physician or hospital at 2160 W State Road 434, Longwood, FL 32779 can order from us, and then they will dispense the medication to you as part of your treatment plan.
3. How does using a 503B outsourcing facility benefit my local doctor's office?
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, using our 503B outsourcing facility provides access to high-quality, pre-made compounded medications. This saves their office the time, resources, and liability associated with in-house compounding, allowing them to focus on patient care while being confident in the quality and consistency of the medications they administer.
4. What kinds of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 produces a wide range of sterile and non-sterile compounded medications, including many that are on the FDA drug shortage list. This includes essential preparations used in offices and clinics for injections, infusions, topical applications, and other routes of administration, as prescribed by local healthcare providers.
5. How can a healthcare professional at my local clinic place an order?
Healthcare professionals serving 2160 W State Road 434, Longwood, FL 32779 can initiate an order or inquire about our services by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide all necessary information regarding our product list, ordering process, and compliance requirements. More information is also available on our website at https://503bcompoundingpharmacy.com/.