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 a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, the 503B Compounding Pharmacy adheres to the most rigorous federal standards for quality, safety, and sterility. This means that all medications produced within this facility are subject to current Good Manufacturing Practices (cGMP), ensuring a level of consistency and reliability that is paramount for patient care.
The core function of the 503B Compounding Pharmacy is the large-scale production of compounded medications. These are medications that are prepared when a commercially available drug is not suitable for a patient's specific needs. The facility at 2160 W State Road 434, Longwood, FL 32779 specializes in producing sterile injectable medications, which are often used in hospital, clinic, and office settings. By operating under Section 503B, this pharmacy can provide bulk quantities of these essential medications without requiring patient-specific prescriptions, thereby serving the needs of healthcare providers efficiently and reliably.
Patients and healthcare professionals who utilize the services of the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the assurance that comes with FDA oversight. Every batch of medication is rigorously tested for potency, sterility, and purity. This process significantly reduces the risk of contamination and medication errors, providing a safer alternative for medications that are in short supply or not available from conventional manufacturers. The facility's commitment to cGMP standards ensures that each product meets precise specifications every time.
The 503B Compounding Pharmacy provides a vital service to the local medical community by addressing critical drug shortages. When a commercially manufactured drug becomes unavailable, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on this outsourcing facility to provide a high-quality, compounded alternative. This helps to ensure continuity of care and prevents interruptions in essential treatment plans for patients. The pharmacy's role is integral to the healthcare infrastructure, supporting physicians and hospitals with a dependable source of necessary medications.
For more information about the specific services and products available, or to understand how the 503B Compounding Pharmacy can meet your needs, please contact the facility directly. The dedicated team is available to answer questions and provide support. You can reach them by visiting their website at https://503bcompoundingpharmacy.com/ or by calling the pharmacy at (407)993-1381. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is committed to upholding the highest standards of pharmaceutical compounding.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and follows strict current Good Manufacturing Practices (cGMP). This ensures the highest level of quality, sterility, and safety for the compounded medications we produce.
2. Who can receive medications from the 503B Compounding Pharmacy?
Our medications are typically distributed to healthcare providers and facilities. Patients receive our medications through their doctors, clinics, or hospitals located at 2160 W State Road 434, Longwood, FL 32779, not directly from our facility.
3. What types of medications does the 503B Compounding Pharmacy specialize in?
We specialize in the large-scale compounding of sterile injectable medications. These are often medications that are on shortage or are not commercially available, providing a critical supply for medical practices at 2160 W State Road 434, Longwood, FL 32779.
4. How is a 503B outsourcing facility different from a regular compounding pharmacy?
A traditional compounding pharmacy operates under state law, while our facility at 2160 W State Road 434, Longwood, FL 32779 is federally regulated under Section 503B. We are subject to FDA inspections and mandatory compliance with cGMP for higher-volume, batch production.
5. How can a healthcare provider at this location place an order?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can initiate orders by contacting our facility directly. For more details on our ordering process and available formulations, please call us at (407)993-1381 or visit https://503bcompoundingpharmacy.com/.