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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, providing healthcare providers and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. This means we supply physician offices, hospitals, and clinics with essential medications that are not readily available from commercial manufacturers. By operating under Section 503B, our facility adheres to Current Good Manufacturing Practices (cGMP), which are the strict quality standards required of traditional pharmaceutical manufacturers. This ensures every batch of medication produced at our Longwood location undergoes rigorous testing, environmental monitoring, and quality control procedures.
Our services are pivotal for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 who require reliable access to medications that may be in short supply, discontinued, or not commercially available. The 503B Compounding Pharmacy provides a critical link in the healthcare chain, ensuring that practitioners have the necessary tools to treat their patients effectively without compromising on safety or quality. The medications compounded at our facility are prepared in advance and are available for healthcare providers to keep on hand for immediate patient needs.
Patients benefit indirectly from the services of the 503B Compounding Pharmacy through their trusted healthcare providers. When a physician utilizes medications from our outsourcing facility, patients can be assured they are receiving a product made under the most stringent regulatory conditions. The operations at 2160 W State Road 434, Longwood, FL 32779 are focused on supporting the local medical community with a consistent and dependable supply of high-quality compounded pharmaceuticals, reinforcing the overall standard of care in the area.
For more information about the specific services and products available from our outsourcing facility, healthcare providers are encouraged to contact us directly. You can reach 503B Compounding Pharmacy at our website, https://503bcompoundingpharmacy.com/, or by phone at (407)993-1381. Our team is ready to assist with inquiries and provide detailed information relevant to the needs of medical practices.
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 FDA and complies with stringent federal standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy?
Our medications are supplied to healthcare providers, such as physicians, clinics, and hospitals. Patients receive these medications through their prescribing healthcare professional who has obtained them from our facility for office use.
What types of medications does 503B Compounding Pharmacy provide?
As a 503B outsourcing facility, we compound a wide range of sterile and non-sterile medications that are often used in clinical settings, including those that may be on drug shortage lists or are not commercially available from standard manufacturers.
How does the quality assurance process work at your facility?
Every batch of medication produced at our location on W State Road 434 undergoes comprehensive testing and quality control procedures as mandated by cGMP regulations. This includes sterility testing, potency verification, and environmental monitoring to ensure patient safety.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or learn more about our available formulations by contacting 503B Compounding Pharmacy directly via our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381.