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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest federal standards for quality control, sterility testing, and production processes, providing healthcare providers and patients with medications they can trust.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals located at and serving patients from our local address can utilize our services to obtain essential medications for their practice needs. This allows healthcare providers to have a consistent, reliable, and high-quality supply of necessary drugs for procedures, treatments, and prescriptions without the burden of in-office compounding.
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding a significant volume of medications that are often on national drug shortage lists. By focusing on these critical drugs, 503B Compounding Pharmacy provides a vital service to the local medical community, ensuring that patient care is not interrupted due to supply chain issues. Every batch of medication produced undergoes rigorous testing to ensure potency, purity, and sterility, meeting the strict FDA requirements mandated for a 503B outsourcing facility.
Healthcare providers who utilize the services of 503B Compounding Pharmacy benefit from the assurance that comes with FDA oversight. Our processes are designed for efficiency and scale, enabling us to support the operational needs of medical practices efficiently. For any inquiries regarding our available formulations, ordering processes, or regulatory compliance, please contact our facility directly. We are committed to supporting the healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779 with uncompromising quality and reliability.
To learn more about our compounding services or to place an order for your practice, visit our website at https://503bcompoundingpharmacy.com/ or call us at (407)993-1381. The team at 503B Compounding Pharmacy is ready to assist you.
Frequently Asked Questions
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our specific 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 standards for compounding medications on a large scale, including current Good Manufacturing Practices (cGMP).
Who can order medications from 503B Compounding Pharmacy?
Our medications are compounded for office use and are available for order by licensed healthcare providers with practices at or serving patients from our local address for administration or dispensing within their professional practice.
Does 503B Compounding Pharmacy serve individual patients directly?
No. As a 503B outsourcing facility, we provide compounded medications in bulk to healthcare practitioners for office use. Individual patients should receive their medications directly from their prescribing healthcare provider.
What types of medications does 503B Compounding Pharmacy produce?
We compound a wide range of sterile and non-sterile medications, with a focus on those that are often on drug shortage lists, to ensure a reliable supply for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider at this location place an order?
Healthcare providers can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to initiate the process.