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 specific designation is a critical component of the pharmaceutical services provided at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility status signifies adherence to rigorous federal standards for sterile and non-sterile compounding, ensuring a level of quality control and patient safety that goes beyond traditional pharmacy practice. The operations conducted at this location are dedicated to the large-scale compounding of medications that are not commercially available, serving specific patient needs that can only be met through this specialized practice.
The core function of 503B Compounding Pharmacy at its Longwood facility is the production of medications in bulk for office use by healthcare practitioners. This model allows physicians, surgeons, veterinarians, and other medical professionals to obtain necessary medications directly for administration within their practice settings at 2160 W State Road 434, Longwood, FL 32779. By functioning as an outsourcing facility, 503B Compounding Pharmacy provides a reliable source for compounded preparations that are essential for various medical procedures and treatments, all produced under the strict cGMP (current Good Manufacturing Practice) regulations mandated by the FDA for such entities.
Patients and healthcare providers utilizing the services of 503B Compounding Pharmacy benefit from the assurance that all preparations are made in an environment that meets the highest standards for sterility and stability. The processes employed at 2160 W State Road 434, Longwood, FL 32779 are designed to mitigate risks associated with compounding, focusing on consistency and reliability in every batch produced. The 503B outsourcing facility is integral to the healthcare infrastructure, providing essential medications that are critical for patient care and are not otherwise obtainable from standard commercial manufacturers.
Engaging with 503B Compounding Pharmacy requires coordination through healthcare providers. The facility at 2160 W State Road 434, Longwood, FL 32779 works directly with medical practices to supply the compounded medications needed for their patients. For detailed information on the specific preparations available and to understand the scope of services, healthcare providers are encouraged to initiate contact. The official channel for information is the website: https://503bcompoundingpharmacy.com/ or by telephone at (407)993-1381.
Frequently Asked Questions:
Q: What does it mean that this is a 503B outsourcing facility? A: It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal standards for compounding medications on a larger scale for office use by healthcare practitioners.
Q: Can I walk into the Longwood location to get a prescription filled for myself? A: No. 503B Compounding Pharmacy provides medications in bulk for healthcare providers. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies, not an outsourcing facility at 2160 W State Road 434, Longwood, FL 32779.
Q: Who can order from this 503B facility? A: Orders are placed by licensed healthcare practitioners, such as doctors, surgeons, or veterinarians, whose practices require compounded medications for office-use procedures at their own facilities.
Q: How does the 503B process ensure medication safety? A: The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under current Good Manufacturing Practices (cGMP), which enforce rigorous testing, environmental controls, and quality assurance protocols for all compounded preparations.
Q: How can a healthcare provider start ordering? A: Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs. Initiate the process by calling (407)993-1381 or visiting the website at https://503bcompoundingpharmacy.com/ for more information.