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 at its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction in the pharmacy sector, setting this facility apart from traditional compounding pharmacies. The 503B Compounding Pharmacy is subject to rigorous current good manufacturing practice (CGMP) standards and undergoes regular FDA inspections. This ensures that every preparation leaving the facility meets the highest possible standards for sterility, purity, and potency. The core mission of this Longwood facility is to provide healthcare practitioners with access to high-quality, compounded medications that are not commercially available, thereby enabling more personalized patient care.
The operations at 2160 W State Road 434 are fundamentally different from a standard pharmacy. As a 503B outsourcing facility, the pharmacy compounds medications in advance of receiving a patient-specific prescription. This allows for the preparation of larger batches of medications based on historical need, which are then distributed to hospitals, clinics, and physician offices for office use. This model is essential for providing healthcare providers in Longwood with immediate access to vital medications used in procedures, emergency kits, and general patient treatment. The ability to supply these medications without delay directly supports the local medical community's efficiency and effectiveness.
Patients and practitioners visiting or utilizing the services of the 503B Compounding Pharmacy at 2160 W State Road 434 can be assured of an uncompromising commitment to quality. The environment within the facility is meticulously controlled, with stringent protocols governing every aspect of production, from ingredient sourcing to final packaging. All components are sourced from FDA-registered suppliers, and every finished product undergoes rigorous analytical testing to verify its identity, strength, quality, and purity. This level of oversight is a mandatory requirement of the 503B designation and provides a layer of safety and reliability that is paramount for the medications they produce.
The team at the Longwood location comprises highly skilled pharmacists, pharmacy technicians, and quality assurance professionals who are experts in the science of sterile and non-sterile compounding. Their expertise ensures that every formulation is prepared with precision and accuracy. The facility is equipped with state-of-the-art technology, including advanced laminar airflow hoods and isolators, to maintain sterility during the compounding process. For healthcare providers at 2160 W State Road 434 and the immediate vicinity, partnering with this 503B Compounding Pharmacy means integrating a resource of consistently reliable, high-quality medications into their practice.
Engaging with the 503B Compounding Pharmacy is designed to be seamless for medical professionals. The facility provides a dependable supply of essential medications, helping to mitigate drug shortages and ensure that practitioners have the necessary tools for patient care. To learn more about the specific formulations available or to discuss how this outsourcing facility can support a medical practice, healthcare providers are encouraged to initiate a direct conversation. The dedicated team can be reached at (407)993-1381 for inquiries. Comprehensive information about the facility's capabilities and compliance is also available on their official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy at 2160 W State Road 434?
It means this specific facility is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This location adheres to strict federal manufacturing standards, including current good manufacturing practices (CGMP), and is subject to periodic FDA inspections.
2. Can I as an individual patient get a prescription filled at this Longwood location?
No. The 503B Compounding Pharmacy at 2160 W State Road 434 operates as an outsourcing facility for healthcare providers. It provides compounded medications for office use to hospitals, clinics, and physician practices. Individual patients must have their prescriptions filled by a traditional pharmacy that dispenses based on a patient-specific prescription.
3. What types of medications does this 503B facility in Longwood typically compound?
The 503B Compounding Pharmacy compounds a range of medications that are often used in clinical settings, such as sterile injectables, ophthalmics, and other preparations that may be experiencing a drug shortage or are not available from commercial manufacturers. All preparations are made in accordance with the facility's registered capabilities.
4. How does a medical practice at 2160 W State Road 434 order from the 503B Compounding Pharmacy?
Healthcare practices and facilities can establish an account by contacting the 503B Compounding Pharmacy directly. The business development or sales team will guide you through the onboarding process, which includes setting up ordering protocols. You can initiate this process by calling (407)993-1381.
5. How can I verify the regulatory status of this specific 503B facility?
The FDA maintains a public list of registered 503B outsourcing facilities. You can verify the registration and inspection history of the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 through the official FDA website. Additionally, information regarding their compliance and quality standards is available on their website at https://503bcompoundingpharmacy.com/.