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 is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies a commitment to a higher standard of quality and safety, distinct from traditional compounding. As a 503B outsourcing facility, we produce compounded medications on a larger scale without requiring patient-specific prescriptions beforehand. These medications are intended for office use by healthcare practitioners, enabling them to have essential drugs readily available for patient care.
The operational protocols at 503B Compounding Pharmacy are governed by Current Good Manufacturing Practices (cGMP). This rigorous framework ensures that every batch of medication compounded at our Longwood location meets stringent standards for sterility, potency, and purity. Our dedicated team of pharmacists and technicians utilizes state-of-the-art equipment and processes within our controlled environment to achieve these results. The primary focus of 503B Compounding Pharmacy is on the production of sterile injectable medications, which are often in short supply or unavailable from conventional pharmaceutical manufacturers. By providing these critical drugs, we serve as a vital component of the local healthcare infrastructure, supporting clinics and practitioners in delivering timely and effective treatments to their patients.
Healthcare providers who utilize the services of 503B Compounding Pharmacy benefit from the assurance that comes with FDA oversight and cGMP compliance. The medications produced at 2160 W State Road 434, Longwood, FL 32779 are accompanied by documentation that verifies their quality. This allows practitioners to confidently administer these medications, knowing they originate from a facility that prioritizes patient safety above all else. The model of an outsourcing facility helps mitigate the risks associated with drug shortages and ensures a consistent supply of necessary compounds for office-based procedures and treatments.
Engaging with 503B Compounding Pharmacy is a streamlined process for qualified healthcare professionals. Our team is prepared to discuss specific compound needs and provide information on our available formulations. We maintain a professional relationship with the medical community, focusing on the reliable distribution of high-quality medications from our facility directly to practitioners. The services rendered by 503B Compounding Pharmacy are an integral part of the healthcare ecosystem, emphasizing safety, compliance, and reliability in every batch compounded.
For comprehensive information regarding our compliance and services, we encourage a visit to our website at https://503bcompoundingpharmacy.com/. To speak directly with a representative, please contact us by phone at (407)993-1381. 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779, and we are dedicated to serving the needs of healthcare providers from this location.
Frequently Asked Questions
What is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds large volumes of sterile medications for healthcare practitioners to keep in stock for office use. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under this federal designation, adhering to Current Good Manufacturing Practices (cGMP).
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our facility are distributed exclusively to licensed healthcare practitioners for office use. Orders are not dispensed directly to individual patients from 2160 W State Road 434, Longwood, FL 32779 without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in the compounding of sterile injectable medications. These are often drugs that are on shortage or are not commercially available, providing essential options for practitioners at our Longwood location.
How does 503B Compounding Pharmacy ensure medication safety?
Safety is ensured through strict adherence to cGMP standards at our facility on 2160 W State Road 434, Longwood, FL 32779. This includes rigorous testing for sterility, potency, and purity for every batch of medication we compound.
How can a healthcare provider place an order?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381 or through our website at https://503bcompoundingpharmacy.com/. Our team will provide ordering information and support for practitioners utilizing our Longwood facility.