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. The 503B designation signifies a commitment to the highest standards of quality, safety, and compliance, operating under current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving the facility meets rigorous testing and quality assurance protocols, providing healthcare providers and patients with medications they can trust.
The core service of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare practitioners. This allows medical professionals at clinics, hospitals, and veterinary practices in the immediate vicinity to access essential medications that are not readily available from commercial manufacturers. By providing these critical preparations, 503B Compounding Pharmacy supports the local medical community at 2160 W State Road 434, Longwood, FL 32779, ensuring they have the necessary tools for patient care without the delays and shortages often associated with traditional pharmaceutical supply chains.
As an outsourcing facility, 503B Compounding Pharmacy provides a vital service that is distinct from traditional 503A compounding pharmacies. The operations are conducted on a larger scale and are subject to federal oversight, including routine FDA inspections. This model is designed for efficiency and reliability, producing batches of medications that are distributed to prescribers for administration within their practice. For healthcare providers seeking a dependable source for high-quality, compounded medications for their office stock, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a pivotal resource.
Patients and healthcare providers can learn more about the specific formulations and services available by contacting the facility directly. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community with consistent, reliable, and quality-assured pharmaceutical compounding. For inquiries, reach out via phone at (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/.
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 under Section 503B of the FD&C Act. We adhere to strict current Good Manufacturing Practices (cGMP) and are subject to federal oversight and inspection, ensuring the highest quality and safety standards for our compounded medications.
Who can receive medications from 503B Compounding Pharmacy?
Our compounded preparations are provided for office use by healthcare practitioners, such as physicians, veterinarians, and hospitals. We supply medications in bulk for their practice stock. Individual patient prescriptions are dispensed through a prescribing physician or a traditional 503A pharmacy, not directly from our 503B facility at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy prepare?
503B Compounding Pharmacy specializes in the large-scale compounding of both sterile and non-sterile medications that are often on shortage or unavailable from commercial manufacturers. This includes a range of preparations necessary for clinics and hospitals serving the area around 2160 W State Road 434, Longwood, FL 32779.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in utilizing our services can initiate the process by contacting our facility directly. We recommend calling (407)993-1381 to speak with a representative who can discuss your practice's specific needs, our available formulations, and the ordering protocol for our location at 2160 W State Road 434, Longwood, FL 32779.
Why should a healthcare provider choose 503B Compounding Pharmacy for office-use medications?
Choosing our 503B outsourcing facility ensures you are sourcing medications that are compounded under the most rigorous quality controls mandated by federal law. This provides a reliable and consistent supply of essential medications for your practice at 2160 W State Road 434, Longwood, FL 32779, mitigating the risks associated with drug shortages and variable product quality.