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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the mission of providing high-quality compounded medications for office use by healthcare practitioners. Located at 2160 W State Road 434, Longwood, FL 32779, this facility adheres to the most rigorous standards of pharmaceutical compounding, ensuring that every preparation meets strict quality and safety protocols. The 503B outsourcing facility model is distinct, focusing on producing large batches of medications without patient-specific prescriptions, which are then distributed to hospitals, clinics, and physician offices for administration to their patients.
The operations at 2160 W State Road 434 are built upon a foundation of compliance and precision. As a 503B Compounding Pharmacy, the facility is subject to current Good Manufacturing Practice (cGMP) regulations, which are enforced by the FDA. This involves stringent controls over the facility's environment, equipment, personnel qualifications, component sourcing, production processes, and finished product testing. For medical professionals seeking a reliable source for compounded sterile preparations (CSPs) and other office-use medications, the Longwood location represents a trusted partner committed to patient safety and therapeutic efficacy.
Services provided by 503B Compounding Pharmacy at its 2160 W State Road 434 facility are specifically tailored for healthcare providers. The pharmacy compounds a range of medications, including hormone replacement therapy (HRT) formulations, ophthalmologic solutions, injectable pain management treatments, and other sterile preparations essential for modern medical practice. By supplying these medications in bulk, the pharmacy supports the operational needs of local clinics and practices, allowing them to efficiently stock necessary drugs for in-office procedures and treatments. This model ensures that practitioners have immediate access to critical medications that are compounded under the highest standards of pharmaceutical science.
Engaging with 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, means partnering with a facility dedicated to transparency and quality. The team of licensed pharmacists and trained technicians utilizes state-of-the-art technology within a controlled environment to consistently produce medications that healthcare providers can use with confidence. For more information on available formulations or to discuss your practice's specific needs, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our pharmacy at 2160 W State Road 434 is registered with the FDA and operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires us to comply with current Good Manufacturing Practices (cGMP) for the bulk compounding of medications intended for office use by healthcare practitioners.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our 2160 W State Road 434 location are available for order by licensed healthcare practitioners and healthcare facilities for office use. These medications are not dispensed directly to individual patients without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434 specializes in compounding a variety of sterile preparations, including but not limited to hormone replacement therapies, ophthalmologic solutions, and injectable pain management medications, all produced for office use under strict cGMP standards.
How does the quality assurance process work at your facility?
At our Longwood location, every batch of medication undergoes a rigorous quality assurance process. This includes testing for sterility, potency, and endotoxins to ensure each preparation meets the stringent safety and quality standards required of an FDA-registered 503B outsourcing facility.
How can a healthcare practice place an order with your pharmacy?
Healthcare practices interested in our services can initiate an order by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide you through the process. You can also find more information on our website at https://503bcompoundingpharmacy.com/.