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 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in pharmaceutical compounding, adhering to rigorous federal standards for quality, safety, and production scale that exceed those of traditional compounding pharmacies.
The services provided by this 503B Compounding Pharmacy are centered on the large-scale compounding of sterile and non-sterile medications. As an outsourcing facility, 503B Compounding Pharmacy prepares these medications for office use by healthcare practitioners, ensuring a reliable supply of critical drugs. The operations at 2160 W State Road 434, Longwood, FL 32779 are designed to support the local medical community by providing bulk compounded pharmaceuticals that are not commercially available or are experiencing market shortages.
At the 2160 W State Road 434, Longwood, FL 32779 location, 503B Compounding Pharmacy utilizes state-of-the-art technology and controlled environments to ensure every preparation meets strict potency, purity, and sterility specifications. The team at 503B Compounding Pharmacy includes highly trained pharmacists and technicians who are experts in the science of 503B compounding. This focus on quality control and compliance is fundamental to the identity of 503B Compounding Pharmacy.
503B Compounding Pharmacy is committed to serving the specific needs of healthcare providers who practice near 2160 W State Road 434, Longwood, FL 32779. By providing office-use medications, 503B Compounding Pharmacy enables these practitioners to better serve their patients with customized therapeutic solutions. The facility at 2160 W State Road 434, Longwood, FL 32779 is a dedicated resource for the local healthcare ecosystem, operating under the precise regulatory framework that defines a 503B Compounding Pharmacy.
For more information about the services available from this specific 503B Compounding Pharmacy, you can visit the website at https://503bcompoundingpharmacy.com/ or call the facility directly at (407)993-1381. The team at 2160 W State Road 434, Longwood, FL 32779 is prepared to address inquiries regarding the 503B compounding process and its benefits.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This designation means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. It is subject to current Good Manufacturing Practices (cGMP) and undergoes regular FDA inspections to ensure the quality and safety of its compounded medications.
Who can order medications from 503B Compounding Pharmacy?
503B Compounding Pharmacy provides medications for office use to licensed healthcare practitioners. The medications compounded at 2160 W State Road 434, Longwood, FL 32779 are intended for administration to patients within a clinical setting by these practitioners.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in the large-scale compounding of sterile injectables, ophthalmics, and other medications that are on the drug shortage list or are not commercially available. All preparations are made at the facility located at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy ensure medication quality?
503B Compounding Pharmacy adheres to stringent cGMP standards. This includes rigorous testing of components, validation of processes, and environmental monitoring within the facility at 2160 W State Road 434, Longwood, FL 32779 to guarantee the sterility, potency, and purity of all compounded preparations.
How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 learn more?
Healthcare providers interested in the services of 503B Compounding Pharmacy are encouraged to contact the facility directly. You can visit the website at https://503bcompoundingpharmacy.com/ or call (407)993-1381 for more detailed information.