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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. As a 503B outsourcing facility, this 503B Compounding Pharmacy adheres to rigorous current good manufacturing practices (cGMP), which are the same standards followed by conventional pharmaceutical manufacturers. This ensures a level of quality, sterility, and consistency that is paramount for patient safety.
The core mission of this 503B Compounding Pharmacy is to provide healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with access to a reliable and high-quality supply of essential medications. The 503B Compounding Pharmacy prepares these medications in advance of receiving a patient-specific prescription, allowing for immediate availability. This is a critical service for clinics, hospitals, surgical centers, and other healthcare providers who require certain medications on hand for urgent or routine procedures. The 503B Compounding Pharmacy's portfolio typically includes a wide array of sterile preparations, such as intravenous (IV) bags, injectables, ophthalmics, and other solutions that must be prepared in a controlled, sterile environment to avoid contamination.
By choosing a 503B Compounding Pharmacy, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can be confident in the integrity of the medications they administer. Every batch produced by this 503B Compounding Pharmacy undergoes stringent testing and quality control checks. The 503B Compounding Pharmacy is subject to regular FDA inspections, providing an additional layer of oversight and accountability that is not present with traditional 503A compounding pharmacies. This regulatory framework minimizes the risk of compounding errors and contamination events, offering peace of mind to both practitioners and their patients. The 503B Compounding Pharmacy serves as a vital partner in the local healthcare ecosystem, ensuring that providers have the necessary tools to deliver effective and safe care.
For healthcare entities operating at 2160 W State Road 434, Longwood, FL 32779, establishing a relationship with this 503B Compounding Pharmacy streamlines the procurement process for essential non-patient-specific medications. The 503B Compounding Pharmacy operates with a focus on reliability and compliance, making it a trusted source for compounded sterile preparations. To learn more about the services and products available from this 503B Compounding Pharmacy, or to inquire about becoming a client, please contact the facility directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. Detailed information about the 503B Compounding Pharmacy, its compliance status, and its product offerings can also be found on its official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare practitioners. This 503B Compounding Pharmacy follows strict cGMP standards and is subject to federal oversight, ensuring a higher level of quality control for medications used at 2160 W State Road 434, Longwood, FL 32779.
2. Who can order from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy provides medications exclusively to healthcare professionals and entities, such as doctors, clinics, hospitals, and surgical centers, for office use. Patients cannot order directly from a 503B Compounding Pharmacy; instead, their healthcare provider will administer medications obtained from this 503B Compounding Pharmacy.
3. What types of medications does this 503B Compounding Pharmacy provide?
This 503B Compounding Pharmacy specializes in producing compounded sterile preparations (CSPs). This typically includes sterile injectables, IV bags, ophthalmics, and other solutions required for medical procedures and treatments administered by healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality assurance of a 503B Compounding Pharmacy differ?
As a 503B Compounding Pharmacy, this facility must comply with current Good Manufacturing Practices (cGMP), which involve rigorous batch testing, environmental monitoring, and validation processes. This is a more standardized and federally enforced quality system than the USP standards applied to traditional compounding pharmacies.
5. How can a healthcare practice at this location start ordering?
Healthcare practices at 2160 W State Road 434, Longwood, FL 32779 can initiate the process by contacting the 503B Compounding Pharmacy directly. You can call (407)993-1381 to speak with a representative or visit https://503bcompoundingpharmacy.com/ to learn more about setting up an account and the ordering procedures.