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 from its location at 2160 W State Road 434, Longwood, FL 32779. Functioning under the stringent regulations of Section 503B of the Federal Food, Drug, and Cosmetic Act, this 503B Compounding Pharmacy distinguishes itself through a commitment to producing high-quality, large-scale compounded medications. The 503B Compounding Pharmacy model is designed to provide healthcare providers with a reliable source for compounded sterile preparations (CSPs) that are essential for patient care. The operations at 2160 W State Road 434 are central to this mission, housing the advanced technology and controlled environments necessary for this specialized level of pharmaceutical manufacturing.
The core service of this 503B Compounding Pharmacy is the bulk production of medications that are often in shortage or are not commercially available. By operating as a 503B outsourcing facility, the pharmacy adheres to Current Good Manufacturing Practices (cGMP), which are the highest standards for quality control. This ensures that every preparation leaving the facility at 2160 W State Road 434 meets rigorous testing and safety protocols. Healthcare professionals can confidently source vital medications from this 503B Compounding Pharmacy, knowing they are receiving products that have been created under the most scrupulous conditions to ensure purity, sterility, and potency for their patients.
For healthcare providers seeking a trusted partner for compounded medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, offers a critical service. The facility’s compliance with federal oversight provides an added layer of assurance beyond traditional compounding. The team at this 503B Compounding Pharmacy specializes in creating sterile injectables, ophthalmics, and other preparations that are vital in hospital, clinic, and surgical settings. The focus remains on fulfilling the specific needs of practitioners by providing consistent, high-volume access to essential drugs, thereby supporting the local healthcare infrastructure directly from its base on W State Road 434.
Engaging with the 503B Compounding Pharmacy is a streamlined process for medical practices. Orders and inquiries are managed through the pharmacy’s dedicated channels. To learn more about the services or to initiate an order, healthcare providers are directed to contact the 503B Compounding Pharmacy directly via their website at https://503bcompoundingpharmacy.com/ or by telephone at (407)993-1381. The professional staff at the 503B Compounding Pharmacy is available to discuss specific formulation needs and the ordering process, ensuring a seamless integration into a practice’s patient care protocols.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that this is a 503B Compounding Pharmacy?
It signifies that our facility at 2160 W State Road 434 is an FDA-registered outsourcing facility operating under Section 503B. This federal designation means we adhere to Current Good Manufacturing Practices (cGMP) for the large-scale compounding of sterile medications, providing a higher level of regulatory oversight and quality assurance compared to traditional compounding.
Who can order from the 503B Compounding Pharmacy?
Our 503B Compounding Pharmacy provides medications exclusively to licensed healthcare practitioners for office use and administration to patients within their practice. We do not dispense medications directly to individual patients at our location on W State Road 434.
What types of medications does the 503B Compounding Pharmacy prepare?
This 503B Compounding Pharmacy specializes in producing sterile compounded preparations, such as injectables, ophthalmics, and other solutions that are often on drug shortage lists or are not commercially available. All preparations are compounded in bulk quantities at our facility on W State Road 434.
How does the 503B Compounding Pharmacy ensure medication safety?
As a 503B Compounding Pharmacy, we operate under strict cGMP standards. This involves rigorous environmental monitoring, validated processes, and extensive testing for sterility and potency on all batches of medication produced at our Longwood facility to ensure the highest levels of patient safety.
How can a practice place an order with the 503B Compounding Pharmacy?
Healthcare practices can place orders by contacting our 503B Compounding Pharmacy directly. Please reach out to our team via our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381 to discuss your practice's specific needs and our ordering procedures.