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, this outsourcing facility adheres to the most rigorous federal standards for quality, safety, and production. The operations at this specific location are dedicated to the large-scale compounding of sterile and non-sterile medications that are distributed to healthcare providers for office use, ensuring practitioners have the necessary preparations on hand for patient care.
The core function of 503B Compounding Pharmacy is the production of medications in bulk by an outsourcing facility. This means that the pharmacy at 2160 W State Road 434, Longwood, FL 32779 does not typically fulfill individual patient-specific prescriptions directly for the public. Instead, it provides healthcare professionals with access to a consistent and reliable supply of high-quality compounded preparations. These medications are produced without specific patient prescriptions and are essential for clinics, hospitals, surgical centers, and other healthcare providers who require medications for immediate administration or dispensing within their practice.
As an FDA-registered outsourcing facility, 503B Compounding Pharmacy is subject to ongoing FDA oversight and must comply with Current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets stringent standards for potency, purity, and sterility. The commitment to cGMP provides an additional layer of safety and quality assurance for the healthcare providers and, ultimately, the patients who rely on these vital medications.
The services provided by this outsourcing facility are integral to the local healthcare ecosystem. By supplying healthcare practices from its location at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy supports the ability of local clinicians to offer specialized treatments, manage drug shortages, and utilize medications that are not otherwise commercially available. The facility’s work ensures that medical professionals have access to the necessary tools to provide optimal patient care.
For more information about the operations of this FDA-registered outsourcing facility, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team at 2160 W State Road 434, Longwood, FL 32779 is available to answer questions and provide details about its compounded preparations. You can reach them by phone at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. It compounds medications in bulk for healthcare providers to have for office use, adhering to strict federal manufacturing standards.
2. Can I, as an individual patient, get a prescription filled at this location?
No. 503B Compounding Pharmacy primarily supplies medications to healthcare providers and practices. Individual patients should contact a traditional compounding pharmacy or their healthcare provider for prescriptions.
3. How does a healthcare provider order from this outsourcing facility?
Healthcare providers can initiate orders and inquire about available preparations by contacting the facility at 2160 W State Road 434, Longwood, FL 32779 directly via phone at (407)993-1381 or through their website at https://503bcompoundingpharmacy.com/.
4. What are the benefits of using an FDA-registered 503B outsourcing facility?
Medications compounded at this location are produced under cGMP guidelines, which provide assurance of consistent quality, sterility, and potency for the healthcare providers who use them in their practice.
5. Is this location a retail pharmacy?
No. The facility at 2160 W State Road 434, Longwood, FL 32779 is not a retail pharmacy. It is an FDA-registered outsourcing facility that compounds medications for distribution to healthcare professionals and their practices.