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. This designation, granted under Section 503B of the Federal Food, Drug, and Cosmetic Act, signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, a 503B outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections. This ensures that every preparation leaving our facility meets stringent standards for sterility, potency, and purity, providing healthcare providers and patients at our location with an unparalleled level of confidence.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are distributed for office use by healthcare practitioners. This model is essential for medical practices, clinics, and hospitals that require immediate access to ready-made, sterile compounded preparations to administer to patients during appointments and procedures. By providing these medications in advance, 503B Compounding Pharmacy enables healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to enhance patient care through efficiency and convenience, eliminating the wait times associated with traditional patient-specific prescriptions. Our services are pivotal for treatments such as hormone replacement therapy, ophthalmologic injections, pain management solutions, and other specialized injectable medications.
Patients who receive treatments prepared by 503B Compounding Pharmacy benefit from the assurance that their medication is produced in a controlled, sterile environment that adheres to the most exacting pharmaceutical manufacturing protocols. The team at our Longwood facility comprises skilled pharmacists and technicians who utilize state-of-the-art equipment and validated processes to ensure consistency and reliability in every batch. We operate with a patient-first philosophy, understanding that the work we do directly impacts health outcomes. For healthcare providers and patients at our specific location, 503B Compounding Pharmacy is a trusted partner in delivering safe, effective, and high-quality compounded medications.
To learn more about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website for additional information at https://503bcompoundingpharmacy.com/. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to supporting the local medical community with federally compliant compounding solutions.
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 U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This subjects us to federal oversight, mandatory compliance with current Good Manufacturing Practices (cGMP), and routine FDA inspections to ensure the sterility, safety, and quality of our compounded medications.
Can I as a patient pick up a prescription directly from your location?
No, 503B Compounding Pharmacy primarily compounds medications for office use by healthcare providers. Your physician or clinic orders medications from us in bulk to have on hand for procedures and treatments. You would receive the medication directly from your healthcare provider during your appointment, not from our facility at 2160 W State Road 434.
What types of medications does 503B Compounding Pharmacy prepare?
We specialize in compounding sterile injectable medications in large batches. This includes preparations for hormone therapy, pain management, ophthalmology, and other specialized treatments needed by healthcare practitioners for administration to their patients at their practice locations.
How does using a 503B outsourcing facility benefit me as a patient in Longwood?
When your healthcare provider uses medications from our facility at 2160 W State Road 434, you benefit from receiving a medication produced under the highest federally regulated standards for sterility and quality. It also allows for immediate treatment during your office visit, as your provider will already have the necessary compounded preparation on hand.
How can my medical practice at this location start ordering from 503B Compounding Pharmacy?
Healthcare providers and practices interested in our services can initiate the process by contacting our facility directly. Please call us at (407)993-1381 to speak with a representative who can discuss your needs, explain the ordering process, and provide any necessary documentation. Our website at https://503bcompoundingpharmacy.com/ also serves as a resource for information.