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 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality, safety, and production, providing healthcare providers with a reliable source for compounded medications that are not commercially available.
The operations at 2160 W State Road 434 are distinct from traditional compounding. This 503B Compounding Pharmacy prepares medications in bulk for office use, meaning healthcare professionals in Longwood can stock these essential preparations for immediate patient need without the delay of patient-specific compounding. This model is crucial for practices requiring readily available, high-quality medications for procedures, treatments, and therapies. The facility's commitment to current Good Manufacturing Practices (cGMP) ensures every product meets strict specifications for potency, purity, and sterility.
Patients and healthcare providers visiting or utilizing the services of the location at 2160 W State Road 434 benefit from a specialized pharmaceutical service. The 503B Compounding Pharmacy provides a critical link, ensuring that when a commercially manufactured drug is not suitable or available, there is a compliant, quality-assured alternative produced under the highest standards. This local facility is an integral part of the healthcare infrastructure, supporting the specific medical needs of the community it serves directly from its Longwood address.
For more information about the services available from this specific location, or to speak with a representative, please contact 503B Compounding Pharmacy directly. Visit the website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381.
Frequently Asked Questions
What does it mean that this facility is a 503B outsourcing facility?
It means our operation at 2160 W State Road 434 is registered with the FDA and complies with stricter federal standards for compounding, including current Good Manufacturing Practices (cGMP). This ensures a higher level of quality control and safety for the medications we compound in bulk for office use.
Can I, as a patient, pick up my prescription directly from your location?
No. As a 503B outsourcing facility at 2160 W State Road 434, we compound medications in bulk for office use. These medications are distributed to healthcare providers, who then dispense them to their patients. You must receive your medication through your prescribing healthcare professional.
What types of medications does the Longwood 503B facility compound?
Our FDA-registered facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications that are not available commercially. This includes various formulations needed by local clinics, hospitals, and practices for their patients.
How does a healthcare provider at a local practice order from your pharmacy?
Healthcare providers and institutions can place orders for compounded medications by contacting our facility at 2160 W State Road 434 directly. They can initiate the process by calling us at (407)993-1381 or through the protocols outlined on our website, https://503bcompoundingpharmacy.com/.
Why should a healthcare provider choose your 503B Compounding Pharmacy?
Choosing our specific location at 2160 W State Road 434 ensures that the medications are produced under the highest federal compliance standards (cGMP). This provides assurance of quality, safety, and consistency for the medications used in their practice, benefiting both the provider and their patients.