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 a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy adheres to the most rigorous federal standards for quality, safety, and production. The operations at this specific location are dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed to healthcare providers for office use, ensuring a reliable and compliant source of essential drugs.
The core function of 503B Compounding Pharmacy is the production of medications that are often in short supply or unavailable from conventional pharmaceutical manufacturers. By operating under strict FDA oversight, the facility at 2160 W State Road 434, Longwood, FL 32779 provides physicians and clinics with access to vital preparations they need for patient care. The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists and technicians who utilize state-of-the-art technology and processes to ensure every preparation meets exacting standards for potency, purity, and sterility.
Patients and healthcare professionals who engage with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a commitment to uncompromising quality. The facility's compliance with current Good Manufacturing Practices (cGMP) is a cornerstone of its operation, providing assurance that all products are consistently produced and controlled according to the highest quality standards. For more information on the services and compliance standards of this facility, please visit the official website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this specific facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with stringent federal regulations, including current Good Manufacturing Practices (cGMP), for the large-scale production of compounded medications for office use by healthcare providers.
Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at the 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 are typically distributed to healthcare facilities and practitioner offices for administration to patients within a clinical setting, rather than being dispensed directly to individual patients.
How does the 503B Compounding Pharmacy ensure medication safety?
The 503B Compounding Pharmacy adheres to rigorous cGMP standards, which include extensive testing of components, stringent environmental monitoring, validation of sterilization processes, and thorough quality control checks on finished preparations at our facility on 2160 W State Road 434, Longwood, FL 32779.
Can I pick up a prescription directly from the 503B Compounding Pharmacy?
As an outsourcing facility, the primary operation at 2160 W State Road 434, Longwood, FL 32779 is focused on supplying healthcare providers. For specific questions regarding prescription dispensing, it is best to contact the pharmacy directly at (407)993-1381.
Where can I find more information about the services offered?
For detailed information about the specific services and capabilities of the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779, please visit the official website at https://503bcompoundingpharmacy.com/.