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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, sterility assurance, and testing that exceed those of traditional compounding pharmacies. The medications produced are distributed to healthcare providers for office use and administration to patients within their care, ensuring a reliable and compliant source for critical medicines.
The core service of 503B Compounding Pharmacy at its Longwood location is the preparation of medications in bulk for healthcare practices. This includes a significant focus on sterile injectable compounds, which are prepared in a controlled environment with stringent protocols to prevent microbial contamination. The facility provides healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with access to a consistent supply of high-quality, compounded medications that are essential for various treatments and procedures. This model allows physicians and clinics to obtain necessary medications without the burden and regulatory complexity of in-house compounding.
Operating from 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy is committed to upholding the highest standards of pharmaceutical science. The facility's processes are designed to ensure every product meets precise specifications for potency, purity, and stability. By focusing on the specific regulatory designation of a 503B outsourcing facility, this pharmacy provides a vital service to the local medical community, ensuring patient safety and supporting the operational needs of healthcare providers. For more information or to inquire about services, please contact 503B Compounding Pharmacy at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal current Good Manufacturing Practices (cGMP) for drug manufacturing. This ensures a higher level of quality control and sterility assurance for the medications we compound and supply.
Who can receive medications from 503B Compounding Pharmacy?
Our medications are provided to healthcare providers and practices for "office use." This means physicians and clinics at 2160 W State Road 434, Longwood, FL 32779 can order and administer these medications to their patients within the clinical setting, rather than dispensing them for patient self-administration at home.
What types of medications does 503B Compounding Pharmacy prepare?
Our primary focus at our Longwood facility is on compounding sterile injectable medications in larger quantities. This includes preparations like hormone injections, nutritional IV therapies, and other sterile solutions that are commonly used in clinical practices located at 2160 W State Road 434, Longwood, FL 32779.
How does a 503B outsourcing facility differ from a traditional compounding pharmacy?
A traditional 503A pharmacy compounds medications based on specific, patient-specific prescriptions. Our 503B facility at 2160 W State Road 434, Longwood, FL 32779 compounds medications in larger batches for healthcare providers to have on hand for office use, and we operate under federal cGMP standards similar to those required of major drug manufacturers.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or learn more about our available formulations by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team can provide detailed information on ordering procedures and product availability for your practice.