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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the operations at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality, safety, and production, which distinguishes its services within the pharmaceutical sector. The facility is dedicated to the large-scale compounding of medications that are not available commercially, ensuring a reliable supply for specific patient needs.
The core function of 503B Compounding Pharmacy is the preparation of sterile and non-sterile compounded medications in bulk. This process is conducted under strict environmental controls and quality assurance protocols mandated for all 503B facilities. The medications produced are intended for office use by healthcare practitioners, rather than being dispensed directly to individual patients under a prescription. This model supports local medical practices and clinics by providing them with essential medications that are ready for administration.
Located at 2160 W State Road 434, Longwood, FL 32779, the pharmacy serves the specific needs of the medical community with a focus on compliance and precision. The operations are designed to meet the demands of healthcare providers who require compounded pharmaceutical products that are prepared under the highest standards of pharmaceutical compounding. The facility's commitment is to provide products that support the treatment protocols established by local medical professionals.
For further information regarding the services provided by 503B Compounding Pharmacy, you can visit their website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381. The team is available to discuss the scope of their compounding services and how they can assist local healthcare providers.
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the 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 Federal Food, Drug, and Cosmetic Act. This registration signifies adherence to current Good Manufacturing Practices (cGMP) for the compounding of medications.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy prepares compounded medications in bulk for office use by healthcare practitioners. This includes both sterile and non-sterile preparations that are not readily available from commercial manufacturers, produced under strict quality controls at their Longwood facility.
Who can order medications from 503B Compounding Pharmacy?
Medications are supplied to healthcare practitioners for office use. The facility at 2160 W State Road 434, Longwood, FL 32779 provides its products to licensed medical professionals and clinics that require compounded pharmaceutical products for their practice.
How does the quality assurance process work at this facility?
The quality assurance process at 503B Compounding Pharmacy is governed by the standards required for 503B outsourcing facilities. This includes rigorous testing, environmental monitoring, and adherence to cGMP to ensure the safety, potency, and purity of all medications compounded at the Longwood location.
How can a healthcare provider get more information or place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can obtain more information or place an order by contacting the facility directly at (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/.