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 operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and facilities by providing bulk quantities of medications that are often in short supply or unavailable from conventional manufacturers.
The core function of 503B Compounding Pharmacy is the production of medications for office use. This means healthcare professionals at our local medical facilities can utilize our products for their patients without the need for individual patient-specific prescriptions for each vial or preparation. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 employs rigorous testing protocols, advanced environmental monitoring, and validated processes to ensure every preparation meets stringent potency, sterility, and purity standards. This level of quality control is a fundamental aspect of operating as a 503B outsourcing facility.
By focusing on the specific needs of the healthcare community at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy helps mitigate drug shortages and provides access to critical medications. Our operations are designed to support local clinics, hospitals, and surgical centers with a reliable source of high-quality compounded preparations. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in the science of compounding within a federally regulated environment.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and processes 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 strict federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of regulatory oversight for the medications we produce compared to a traditional pharmacy.
2. Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use by healthcare providers. Our services are designed for licensed medical professionals and healthcare facilities at 2160 W State Road 434, Longwood, FL 32779 who need bulk quantities of medications for administration to patients within their practice.
3. Do you compound medications for individual patients with a prescription?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for healthcare facilities. We do not accept individual patient prescriptions. Our focus is on producing large-scale batches for office use by medical professionals at our location.
4. How does 503B Compounding Pharmacy ensure medication safety?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous cGMP standards. This includes extensive testing of ingredients (APIs), validated sterility assurance processes, environmental monitoring of our cleanrooms, and thorough quality control checks on finished preparations before they are released.
5. How can a healthcare facility at your location place an order?
Healthcare providers and facilities at 2160 W State Road 434, Longwood, FL 32779 can initiate an order or inquire about our available preparations by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide all necessary information and support.