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 specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially. As a 503B outsourcing facility, it adheres to rigorous current good manufacturing practices (cGMP), providing an additional layer of safety and quality assurance for healthcare providers and their patients at 2160 W State Road 434, Longwood, FL 32779.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for office use by healthcare practitioners. This service is essential for medical practices, hospitals, and clinics that require immediate access to specific, high-quality compounded preparations to administer to patients during visits. By operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy ensures a reliable and compliant source for these critical medications, supporting the local medical community with consistent and trustworthy products.
Patients and practitioners visiting or utilizing the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from its strict adherence to federal standards. The medications compounded at this location undergo stringent quality control testing, including sterility testing, endotoxin testing, and potency verification. This commitment to quality differentiates an FDA-registered 503B outsourcing facility from a traditional 503A compounding pharmacy, offering peace of mind regarding the safety and integrity of the medications provided from this specific location.
The team at 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals dedicated to the precise science of compounding. Their expertise ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets exact specifications and is free from contaminants. This dedication to excellence makes 503B Compounding Pharmacy a vital partner for healthcare providers who prioritize patient safety and effective treatment outcomes.
For healthcare providers seeking a dependable source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pillar of quality and compliance. To learn more about its services or to place an order, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
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 in compliance with Section 503B of the FD&C Act. This requires us to follow current good manufacturing practices (cGMP) for the compounding of medications, which includes rigorous testing and quality control standards that exceed those of a traditional pharmacy.
2. Can I as an individual patient pick up a prescription directly from your location?
503B Compounding Pharmacy primarily compounds medications for office use by healthcare practitioners. Individual patient prescriptions are typically handled through traditional 503A compounding pharmacies. Healthcare providers can order from our facility at 2160 W State Road 434, Longwood, FL 32779 to administer medications directly to their patients within their practice.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 prepare?
Our facility specializes in compounding a wide range of sterile and non-sterile medications that are not commercially available. This includes injectables, ophthalmics, and other preparations needed in bulk quantities by healthcare providers for use in their practices located near 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality assurance process work at your facility?
Every batch of medication compounded at our location undergoes a comprehensive quality assurance process. This includes testing for sterility, potency, and endotoxins by our in-house quality control laboratory to ensure every product meets strict cGMP standards before it is released for use by healthcare providers.
5. How can a healthcare provider place an order with your pharmacy?
Healthcare providers can place orders for compounded medications by contacting 503B Compounding Pharmacy directly. You can reach our team at our facility located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. Additional information and resources are also available on our website at https://503bcompoundingpharmacy.com/.