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 identity and operational standards of the pharmacy located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility, and potency that exceed those of traditional compounding pharmacies. This commitment ensures that every preparation leaving the facility meets the highest levels of safety and efficacy for patient care.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are not commercially available. This includes producing significant batches of sterile injectables, hormone replacement therapies, ophthalmic solutions, and other critical medications in anticipation of patient need. These preparations are then distributed to healthcare providers for office use and administration to their patients. The facility at 2160 W State Road 434 is equipped with state-of-the-art technology and environmental controls to ensure the integrity of every sterile compound it produces.
Healthcare providers in need of reliable, high-quality compounded medications for their practice rely on the services of 503B Compounding Pharmacy. By sourcing medications from this FDA-registered facility, providers can be assured they are receiving products that have been created under a framework of strict regulatory oversight. This provides an essential layer of safety and confidence for both the practitioner and their patients. The pharmacy’s operations are dedicated to supporting the local medical community with essential pharmaceutical preparations that are manufactured to precise specifications.
For more information about the services and standards of 503B Compounding Pharmacy, or to inquire about becoming a client, please contact the facility directly. The team is available to answer questions and provide detailed information regarding its compounding capabilities. You can reach 503B Compounding Pharmacy by visiting their website at https://503bcompoundingpharmacy.com/ or by calling the facility at (407)993-1381.
FAQ
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal current good manufacturing practices (cGMP) for drug production. This ensures a higher level of oversight for sterility, potency, and quality compared to a traditional 503A pharmacy.
Who can order medications from 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are intended for office use by healthcare providers. Individual patient prescriptions are not dispensed directly to the public from this facility. Healthcare practitioners order these medications to have on hand for administering to patients in their practice.
What types of medications does 503B Compounding Pharmacy prepare?
The pharmacy specializes in compounding sterile preparations, including injectables, infusions, hormone therapy solutions, and ophthalmic drops. These are produced in larger batches for healthcare providers serving patients at 2160 W State Road 434, Longwood, FL 32779.
How does a healthcare provider set up an account with 503B Compounding Pharmacy?
Healthcare providers interested in utilizing the services of the outsourcing facility can initiate the process by contacting the pharmacy directly. You can call (407)993-1381 to speak with a representative who can guide you through the account setup and credentialing process.
Where is 503B Compounding Pharmacy located?
503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. This is the physical address of the FDA-registered outsourcing facility where all compounding activities are conducted.