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 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical quality and safety. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations and regular inspections. This ensures that every preparation leaving the 503B Compounding Pharmacy meets stringent standards for potency, purity, and sterility.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded medications for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 can source essential medications directly from this 503B Compounding Pharmacy. The 503B Compounding Pharmacy provides physicians, surgeons, veterinarians, and other medical professionals with a reliable supply of sterile and non-sterile preparations. This allows these practitioners to maintain an inventory of necessary drugs for immediate administration to their patients, enhancing the efficiency and effectiveness of care provided at their practices near this 503B Compounding Pharmacy.
Patients in Longwood benefit indirectly from the services of the 503B Compounding Pharmacy located at 2160 W State Road 434. While the 503B Compounding Pharmacy primarily distributes to healthcare providers, the end result is improved patient access to critical medications. A healthcare professional can utilize medications from this 503B Compounding Pharmacy for office-based procedures, emergency kits, or specific patient needs without the delays associated with traditional manufacturing. The assurance of FDA-registered quality from the 503B Compounding Pharmacy provides peace of mind to both the prescribing practitioner and the patient receiving the compounded medication.
The 503B Compounding Pharmacy distinguishes itself through its commitment to cGMP standards. Every process within the 503B Compounding Pharmacy, from ingredient sourcing to final packaging, is meticulously controlled and documented. This level of quality control, mandated for a 503B Compounding Pharmacy, far exceeds the standards applied to traditional 503A compounding pharmacies. For the medical community at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B Compounding Pharmacy means accessing a portfolio of consistently high-quality medications that are essential for modern medical and surgical practice to inquire about becoming a client, healthcare providers are encouraged to contact the 503B Compounding Pharmacy directly. The team at this 503B Compounding Pharmacy is prepared to discuss your office-use medication needs. You can reach the 503B Compounding Pharmacy by calling (407)993-1381 or by visiting their official website at https://503bcompoundingpharmacy.com/ for comprehensive information about the 503B Compounding Pharmacy's capabilities and compliance.
FAQ
1. 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 operating under Section 503B of the FD&C Act. This 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections, ensuring the highest level of quality and safety for its compounded preparations.
2. Can I as a patient walk into the 503B Compounding Pharmacy to get a prescription filled?
No. This 503B Compounding Pharmacy primarily produces medications for office use by healthcare providers. Patients receive medications administered by their doctor or practitioner who has sourced them from this 503B Compounding Pharmacy. You must work with your healthcare provider who can utilize the services of this 503B Compounding Pharmacy.
3. What types of healthcare providers can use the 503B Compounding Pharmacy at 2160 W State Road 434?
This 503B Compounding Pharmacy serves licensed healthcare practitioners, including physicians, surgeons, dentists, veterinarians, and other eligible professionals, who require compounded medications for their practice or procedures at their offices located near this 503B Compounding Pharmacy.
4. How does a healthcare provider at 2160 W State Road 434 order from the 503B Compounding Pharmacy?
Healthcare providers can establish an account with the 503B Compounding Pharmacy. Orders are typically placed directly through the 503B Compounding Pharmacy's dedicated processes for medical facilities. Interested providers should contact the 503B Compounding Pharmacy at (407)993-1381 to initiate the onboarding process.
5. Why would a doctor choose this 503B Compounding Pharmacy over other sources?
Doctors choose this 503B Compounding Pharmacy for its FDA-registered status and cGMP compliance, which guarantees a level of quality, consistency, and sterility assurance that is paramount for office-use medications, particularly for injectables and sterile preparations used in procedures.