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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed for office use by healthcare practitioners. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and reporting, which are distinct from those of a traditional 503A compounding pharmacy. This ensures that every preparation leaving the facility meets the highest levels of safety, potency, and purity for patient care.
The core service provided at the 2160 W State Road 434 location is the production of compounded medications in bulk for healthcare providers. This includes a significant focus on sterile injectables, such as IV bags, hormone therapy injections, and other preparations administered in clinical settings. The 503B Compounding Pharmacy's operations are vital for supplying physicians, hospitals, and clinics with essential medications that may be in short supply or not readily available from conventional pharmaceutical manufacturers. By operating from its facility in Longwood, it provides a critical and reliable source for these important therapeutics.
Patients receiving treatments that originate from 503B Compounding Pharmacy at 2160 W State Road 434 can have confidence in the quality of their medications. The facility's compliance with Current Good Manufacturing Practices (cGMP) mandates stringent environmental controls, validated processes, and robust quality assurance testing. This level of oversight is a fundamental aspect of the 503B designation and is central to the mission of the pharmacy. While patients do not typically visit this location directly, their healthcare providers rely on its services to administer safe and effective compounded medications.
For healthcare practitioners utilizing the services of 503B Compounding Pharmacy, the process is streamlined and professional. Orders are managed through established protocols, and the pharmacy provides the necessary documentation and support to ensure seamless integration into clinical practice. The team at the Longwood facility is committed to supporting the local medical community by providing a dependable source of high-quality compounded preparations. For more information or to inquire about services, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy at 2160 W State Road 434?
It means this specific facility is registered with the FDA as an outsourcing facility under Section 503B. This registration requires compliance with more rigorous federal manufacturing standards, including Current Good Manufacturing Practices (cGMP), for the bulk compounding of medications intended for office use by healthcare practitioners.
Can I, as a patient, pick up my prescription directly from the 2160 W State Road 434 location?
No. 503B Compounding Pharmacy primarily distributes compounded medications in bulk for office use to licensed healthcare providers. Patients receive their treatments directly from their physician or clinic, which administers the medication that was produced at this facility.
What types of medications are compounded at the Longwood facility?
The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in compounding sterile preparations, such as injectable medications, hormone therapies, and IV nutritionals. These are provided in larger quantities for healthcare providers to use within their practice for patient care.
How does the 503B Compounding Pharmacy ensure medication safety?
Operating under strict FDA oversight as an outsourcing facility, the pharmacy at 2160 W State Road 434 follows cGMP guidelines. This includes rigorous environmental monitoring, sterility testing, potency verification, and endotoxin testing on all applicable batches to ensure the highest levels of safety and quality.
How can a healthcare provider at a local clinic place an order with your pharmacy?
Healthcare providers can initiate the process by contacting 503B Compounding Pharmacy directly at (407)993-1381 or through the professional portal on the website at https://503bcompoundingpharmacy.com/. The team will provide information on ordering protocols, available formulations, and required documentation.