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 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 rigorous federal standards for quality control, testing, and production, ensuring that healthcare providers and patients at this location receive medications that are consistently produced to the highest levels of safety and efficacy.
The core function of 503B Compounding Pharmacy is to provide bulk compounded pharmaceutical products for office use by licensed medical practitioners. This means that healthcare professionals practicing in and around the 2160 W State Road 434, Longwood, FL 32779 area can source essential medications directly for administration to patients within their practice settings. The services provided by 503B Compounding Pharmacy are distinct from traditional retail pharmacy compounding, focusing on supplying physicians' offices, hospitals, and clinics with medications that are often in short supply or not commercially available.
By operating as a 503B outsourcing facility, this pharmacy is subject to Current Good Manufacturing Practice (cGMP) regulations. This involves stringent environmental monitoring, validated processes, and end-product testing for sterility and potency. For medical professionals at 2160 W State Road 434, Longwood, FL 32779, this regulatory framework provides a critical layer of assurance regarding the quality and safety of the compounded medications they utilize in patient care. The facility's commitment to compliance and excellence makes it a reliable partner for the local medical community.
Patients and providers seeking the services of 503B Compounding Pharmacy can be confident in the integrity of every product that leaves the facility. The team at 2160 W State Road 434, Longwood, FL 32779 is comprised of skilled pharmacists and technicians who are experts in the art and science of pharmaceutical compounding. They utilize state-of-the-art technology and equipment to compound a range of preparations, ensuring that each batch meets precise specifications. For more information or to inquire about services, please contact 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
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 complies with Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to adhere to strict Current Good Manufacturing Practice (cGMP) regulations, which include rigorous testing, quality control, and reporting standards for all compounded medications we produce.
2. Can I, as a patient, pick up a prescription directly from the 2160 W State Road 434 location?
No. 503B Compounding Pharmacy primarily supplies compounded medications in bulk for "office use" by healthcare practitioners. Patients should receive their medications directly from their doctor's office or clinic. Our facility at 2160 W State Road 434, Longwood, FL 32779 is not a retail pharmacy for direct patient pickup.
3. How do healthcare providers at 2160 W State Road 434, Longwood, FL 32779 order from your facility?
Licensed medical practitioners can establish an account with our facility to order compounded medications for office use. We recommend contacting our team directly at (407)993-1381 to discuss your specific needs, our product availability, and the onboarding process for providers serving this location.
4. What kinds of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we compound a wide array of sterile and non-sterile preparations, including medications that are on the FDA drug shortage list or are not otherwise available from commercial manufacturers. The specific products available can be discussed by contacting our facility at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a local healthcare provider choose your 503B facility over other compounders?
Choosing our 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 ensures you are sourcing medications from a facility that meets the highest federal manufacturing standards. Our commitment to cGMPs, batch testing, and quality assurance provides an elevated level of safety and reliability for your practice and patients.