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, providing a critical service for healthcare providers who require bulk, office-use medications for their patients.
The core function of 503B Compounding Pharmacy at its Longwood location is the production of compounded medications that are not available commercially or are in shortage. This includes a wide array of sterile injectables, ophthalmics, and other preparations made in a controlled environment that meets current Good Manufacturing Practices (cGMP). The medications produced are distributed to healthcare settings for office use, ensuring practitioners have access to the necessary drugs to treat their patient populations effectively and safely.
Healthcare professionals who source medications from 503B Compounding Pharmacy at 2160 W State Road 434 can be assured of a supply chain that prioritizes integrity and compliance. The facility’s registration with the FDA and its operation under Section 503B provides a layer of oversight and accountability that is essential for patient safety. By focusing on bulk compounding for office use, 503B Compounding Pharmacy supports the local medical community with reliable access to essential medications.
For more information about the services and compliance standards of 503B Compounding Pharmacy, visit their website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the highest levels of pharmaceutical compounding.
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 operates under Section 503B of the FD&C Act. This requires us to comply with stringent current Good Manufacturing Practices (cGMP) for quality, purity, and sterility, which includes rigorous testing of components and finished medications.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our location on 2160 W State Road 434 are intended for office use by healthcare practitioners. Orders are placed by licensed medical professionals and healthcare facilities, not directly by individual patients.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in the large-scale compounding of medications, particularly sterile injectables and preparations that are on drug shortage lists or are not commercially available. This is done to support the needs of healthcare providers serving their patients from our location in Longwood.
How does 503B Compounding Pharmacy ensure medication safety?
Our facility at 2160 W State Road 434 adheres to strict cGMP protocols. This involves validated processes, environmental monitoring, and extensive quality control testing to ensure every batch of medication meets defined specifications for potency, purity, and sterility before it is released.
How can a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our facility directly at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more detailed information on our available medications and ordering procedures.