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. Our facility is precisely located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. We provide bulk compounded medications for healthcare providers, serving a critical role in the medical community by producing large-scale preparations that are not commercially available.
The operations at 2160 W State Road 434, Longwood, FL 32779 are conducted under rigorous quality control protocols that meet and exceed federal regulations. As a 503B compounding pharmacy, our processes are subject to current Good Manufacturing Practices (cGMP), ensuring every preparation is sterile and potent. The medications produced at this location are distributed for office use by physicians and other healthcare practitioners, enabling them to have essential drugs on hand for immediate patient care.
Our facility at 2160 W State Road 434, Longwood, FL 32779 is equipped with state-of-the-art technology and staffed by a team of highly skilled pharmacists and technicians. This team is dedicated to the precise science of compounding, creating formulations that address specific clinical needs. The scope of our work supports various medical specialties by providing them with reliable access to high-quality medications that are essential for patient treatment plans.
503B Compounding Pharmacy provides a vital service from our location at 2160 W State Road 434, Longwood, FL 32779. We understand the critical nature of the medications we produce and the importance of their availability for healthcare providers. Our commitment is to unwavering quality, safety, and reliability in every preparation that leaves our facility.
For more detailed information about our services or to speak with our team, please contact us directly. You can reach us by phone at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stricter federal standards, including current Good Manufacturing Practices (cGMP), for the large-scale compounding of sterile medications intended for office use by healthcare providers.
2. Can I, as a patient, pick up a prescription directly from your location?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 distributes medications exclusively to healthcare providers for office use. Patients must receive their medications directly from their physician or clinic.
3. How does a healthcare provider place an order with your pharmacy?
Healthcare providers can initiate orders by contacting our facility at 2160 W State Road 434, Longwood, FL 32779 directly via phone at (407)993-1381. Our team will guide them through the ordering process specific to 503B compounded medications.
4. What quality controls are in place at your specific location?
Our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to rigorous cGMP standards. This includes extensive testing of components, in-process monitoring, and finished preparation testing to ensure sterility, potency, and stability of all medications we compound.
5. Are the medications compounded at this location sterile?
Yes. As an FDA-registered 503B outsourcing facility, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in the compounding of sterile injectable medications, following strict aseptic processing techniques to ensure patient safety.