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 facility is located at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility designation signifies a commitment to the highest standards of pharmaceutical compounding, providing medications for office use by healthcare practitioners and for specific patient prescriptions.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are defined by the rigorous regulatory framework of a 503B Compounding Pharmacy. This includes the large-scale production of compounded sterile preparations (CSPs) that are distributed to healthcare facilities and practitioners for office stock. The operations at this location are subject to current good manufacturing practices (cGMP), ensuring consistent quality and sterility in every batch prepared. The 503B Compounding Pharmacy model allows for the provision of essential medications, particularly during times of drug shortages, directly from the facility at 2160 W State Road 434, Longwood, FL 32779.
As an FDA-registered outsourcing facility, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 undergoes regular FDA inspections. This oversight provides an additional layer of safety and quality assurance for the medications compounded and distributed from this specific location. The focus of the 503B Compounding Pharmacy is on serving the needs of healthcare providers by supplying them with high-quality, compounded medications for their practice needs.
The core function of the 503B Compounding Pharmacy is the compounding of medications in an environment that adheres to the strictest sterility and quality controls. This process is conducted by trained professionals within the facility at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy provides a critical service by compounding medications that may be commercially unavailable or in short supply, ensuring patient care is not interrupted.
Healthcare practitioners can engage with the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 for their compounding needs. The facility's operations are dedicated to supporting the medical community with reliable access to compounded pharmaceutical products. For more information or to discuss specific needs, the 503B Compounding Pharmacy can be contacted directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds medications in large volumes for office use by healthcare practitioners, operating under specific federal regulations and current good manufacturing practices (cGMP).
Who can receive medications from the 503B Compounding Pharmacy?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are primarily distributed to healthcare practitioners and facilities for use within their practice; patients receive these medications through their healthcare provider.
What kind of quality controls are in place at this location?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 follows current good manufacturing practices (cGMP) and is subject to periodic inspections by the FDA to ensure the sterility, potency, and quality of all compounded preparations.
Can I pick up a prescription directly from 2160 W State Road 434?
As a 503B outsourcing facility, the primary distribution is to healthcare practitioners. You should consult with your healthcare provider regarding obtaining any medications compounded at this location.
How do I contact the 503B Compounding Pharmacy?
You can contact the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/.