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. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies, as it adheres to the highest current good manufacturing practices (cGMP) for sterile and non-sterile preparations. Located at 2160 W State Road 434, Longwood, FL 32779, the facility is equipped with state-of-the-art technology and employs a team of highly skilled pharmacists and technicians dedicated to the precise science of pharmaceutical compounding on a larger scale. The core mission of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, bulk compounded medications that are essential for patient care but may be unavailable or in short supply from conventional pharmaceutical manufacturers.
The services provided by 503B Compounding Pharmacy at its Longwood location are specifically tailored for office use by healthcare practitioners. This means the facility produces large batches of compounded medications that are then distributed to hospitals, clinics, surgery centers, and other healthcare providers for administration to their patients within a clinical setting. This model ensures that healthcare professionals at facilities near 2160 W State Road 434 have a reliable, local source for critical medications, including sterile injectables, hormone replacement therapies, ophthalmics, and other essential preparations. Every batch produced undergoes rigorous quality control testing, including sterility and endotoxin testing for injectables, to guarantee potency, purity, and safety, providing practitioners and their patients with the utmost confidence.
By focusing on office-use compounding from its facility at 2160 W State Road 434, 503B Compounding Pharmacy plays a vital role in supporting the local medical community. The availability of these reliably sourced medications helps prevent treatment delays, supports efficient practice operations, and contributes to positive patient outcomes. The team at 503B Compounding Pharmacy works closely with area healthcare providers to understand their specific needs and to ensure a consistent supply of the compounded medications they depend on. For more information about their services or to inquire about becoming a client, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This 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. We are subject to strict federal quality standards, including current Good Manufacturing Practices (cGMP), and undergo regular FDA inspections to ensure the safety and quality of our compounded medications.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare providers and institutions. Medications compounded at our facility on W State Road 434 are intended for "office use," meaning they are supplied to authorized practitioners—such as physicians, hospitals, and clinics—for administration to patients within their practice setting, not for individual patient prescription dispensing.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we produce a wide range of sterile and non-sterile compounded medications in larger batches. This includes, but is not limited to, sterile injectables, intravenous (IV) bags, ophthalmics, and hormone therapy preparations, all manufactured under cGMP standards at our Longwood location.
How does the quality control process work at your facility?
Quality is our highest priority. Every batch of medication produced at 2160 W State Road 434 undergoes extensive testing to verify identity, strength, quality, and purity. For sterile preparations, this includes mandatory sterility testing, endotoxin testing, and potency assays to ensure every product meets our rigorous specifications before it is released for distribution.
How can a local healthcare provider place an order?
Healthcare providers and institutions interested in our services can initiate the process by contacting our facility directly. You can reach us by phone at (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information on our product offerings and ordering procedures.