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 unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. We serve healthcare providers and patients by providing access to essential medications that are not commercially available or are experiencing a shortage.
The core function of 503B Compounding Pharmacy is the production of medications in anticipation of receiving a prescription, or in limited quantities ahead of receipt of a prescription, for use by practitioners in their office or for dispensing to patients. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with advanced environmental controls and utilizes rigorous testing protocols to ensure every preparation meets stringent sterility and potency specifications. This process provides a critical link in the healthcare chain, ensuring that practitioners at 2160 W State Road 434, Longwood, FL 32779 have reliable access to high-quality compounded preparations.
Our services are integral to supporting the local medical community. We provide healthcare professionals with a trusted source for medications that are essential for patient care but may be unavailable from conventional manufacturers. The operations at our 2160 W State Road 434, Longwood, FL 32779 location are fundamental to this mission. Patients who receive medications compounded at our facility can have confidence in the quality and integrity of their prescribed treatments, knowing they are produced under the most rigorous federal oversight applicable to compounding.
For more information about the specific preparations available from our facility, healthcare providers are encouraged to contact us directly. You can reach 503B Compounding Pharmacy by visiting our website at https://503bcompoundingpharmacy.com/ or by calling our dedicated phone line at (407)993-1381. Our team is prepared to provide detailed information and support for the medications we compound at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 quality control and consistency for the medications we produce.
Who can order medications from 503B Compounding Pharmacy?
Our medications are produced for healthcare practitioners. Patients receive our compounded preparations through their prescribing doctor or a dispensing pharmacy that sources from our facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications, often focusing on those that are on drug shortage lists or are not commercially available. Specific available preparations can be confirmed by contacting us at (407)993-1381.
How does the quality assurance process work at your facility?
Our compounding processes at 2160 W State Road 434, Longwood, FL 32779 adhere to rigorous cGMP standards. This includes extensive testing of ingredients, environmental monitoring of our cleanrooms, and validated sterility testing on finished products to ensure patient safety.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can initiate orders and obtain more information by calling 503B Compounding Pharmacy directly at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to learn more about our services.