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 that are not available commercially. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing a critical service for healthcare providers and their patients by ensuring access to essential medications.
The core function of 503B Compounding Pharmacy at its Longwood location is the preparation of compounded medications in bulk for office use by healthcare practitioners. This enables physicians, surgeons, veterinarians, and other medical professionals to have vital, ready-to-administer medications on hand for patient care. The pharmacy compounds a significant volume of medications, which are then distributed to healthcare settings for office-based procedures, treatments, and prescriptions. All processes at the 2160 W State Road 434 facility are conducted under strict sterile compounding protocols and current good manufacturing practices (cGMP) to ensure the highest levels of safety, potency, and purity.
By operating as a 503B outsourcing facility, this pharmacy provides a distinct and vital service level. It is subject to oversight by the U.S. Food and Drug Administration (FDA), which includes routine inspections and strict adherence to quality standards that exceed those of traditional compounding. This regulatory framework provides assurance to the medical community that medications sourced from 503B Compounding Pharmacy are produced under the most stringent quality controls. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779, and the patients they serve, benefit from the reliability and consistency of these professionally compounded medications.
For more information about the services provided or to inquire about becoming a client, you can contact 503B Compounding Pharmacy directly. The team is available to discuss specific medication needs and the process for healthcare providers to access compounded pharmaceuticals from this FDA-registered outsourcing facility.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Address: 2160 W State Road 434, Longwood, FL 32779
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 operates in compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration signifies we adhere to heightened current good manufacturing practices (cGMP) and are subject to federal oversight and routine inspections, ensuring the medications we compound meet rigorous quality and safety standards.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Our primary clients are licensed healthcare providers, including physicians, surgeons, hospitals, clinics, and veterinary practices, who require bulk compounded pharmaceuticals for their practice located at 2160 W State Road 434, Longwood, FL 32779. We do not compound medications for individual patients without a prescription from their provider.
What types of medications does 503B Compounding Pharmacy prepare?
As a 503B outsourcing facility, we compound a wide array of sterile and non-sterile medications in larger quantities. This includes, but is not limited to, sterile injectables, ophthalmics, hormone therapy preparations, and other formulations that are not readily available from commercial manufacturers. All compounding is performed at our facility on State Road 434 under strict sterile and non-sterile compounding guidelines.
How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can initiate an order or inquire about our services by contacting our facility directly. Our team will guide you through the required documentation and process for establishing an account. You can reach us by phone at (407)993-1381 or through the contact information available on our website at https://503bcompoundingpharmacy.com/.
Why should a healthcare provider choose a 503B outsourcing facility over other compounders?
Choosing an FDA-registered 503B outsourcing facility like ours at 2160 W State Road 434, Longwood, FL 32779, provides an added layer of quality and safety assurance. Our compliance with federal cGMP standards means every batch of medication is rigorously tested for potency, sterility, and purity. This reduces risk for healthcare providers and ensures their patients receive the highest quality compounded medications available.