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 current good manufacturing practices (cGMP) mandated by the FDA. This ensures that every preparation leaving the facility meets the highest standards of quality, purity, and potency for the patients and healthcare providers it serves.
The core function of 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, it prepares medications that are not commercially available, such as those that have been discontinued by manufacturers or those needed in a specific strength or dosage form not found on the market. This is essential for patients with unique medical needs, including allergies to certain dyes or preservatives, or those who require a different delivery method. By providing these tailored medications, 503B Compounding Pharmacy plays a vital role in the local healthcare ecosystem, supporting personalized patient care.
As an outsourcing facility, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides these medications for office use by healthcare practitioners. This allows physicians, dermatologists, veterinarians, and other medical professionals in the area to obtain necessary compounded medications for their patients without having to write individual patient-specific prescriptions in advance. This model is crucial for maintaining inventory for in-office procedures, emergency kits, and other clinical scenarios where immediate access to a specific compounded medication is required for effective patient treatment.
The commitment to quality at 2160 W State Road 434, Longwood, FL 32779 is paramount. The facility's 503B status means it undergoes regular FDA inspections and must comply with stringent testing, environmental monitoring, and documentation standards. This provides an additional layer of safety and assurance for both prescribers and patients, confirming that the medications are compounded in a controlled, validated, and monitored environment. The highly trained staff utilizes state-of-the-art technology and equipment to ensure precision and sterility in every preparation.
Healthcare providers and patients seeking the services of this FDA-registered outsourcing facility can initiate the process through their prescribing physician. For more information on available formulations or to discuss needs, contact 503B Compounding Pharmacy directly. The team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist with inquiries and support the medical community with high-quality, compounded pharmaceutical preparations.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B outsourcing facility?
It means our 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. We operate under Section 503B of the FD&C Act, which requires adherence to current Good Manufacturing Practices (cGMP) for enhanced quality and safety.
2. Who can order medications from 503B Compounding Pharmacy?
Medications compounded at our location, 2160 W State Road 434, Longwood, FL 32779, are intended for office use by licensed healthcare practitioners. Patients must work with their doctor, who can order the necessary compounded medications for their treatment directly from our facility.
3. Are the medications prepared at 2160 W State Road 434 tested for quality?
Yes. As an FDA-registered 503B outsourcing facility, we are required to perform rigorous testing for sterility, potency, and endotoxins on our preparations. This ensures every medication that leaves our facility meets the highest quality and safety standards.
4. How do I get a medication from your pharmacy?
Your healthcare provider can contact 503B Compounding Pharmacy at (407)993-1381 to determine if we compound the specific medication you need. They will then handle the ordering process directly from our facility at 2160 W State Road 434, Longwood, FL 32779.
5. Can I walk into the facility at 2160 W State Road 434 to pick up a prescription?
No. 503B Compounding Pharmacy operates as an outsourcing facility that supplies medications to healthcare providers for office use. We do not dispense medications directly to the public from this location. All orders must be placed by a licensed medical professional.