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 designation is central to our mission at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we adhere to the most rigorous federal standards for quality, safety, and production. Our operations are distinct from traditional compounding pharmacies, as we produce large batches of compounded sterile preparations (CSPs) and non-sterile preparations without patient-specific prescriptions. These batches are made for office use by healthcare providers, ensuring they have immediate access to vital medications for their patients.
The services provided at 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are defined by our regulatory framework. We specialize in the large-scale compounding of medications that are often in short supply or otherwise unavailable from conventional manufacturers. Our state-of-the-art facility is designed to maintain the highest levels of environmental control and sterility assurance. Every process, from ingredient sourcing to final packaging, is governed by strict current Good Manufacturing Practices (cGMP). This ensures that every preparation leaving our facility meets precise identity, strength, quality, and purity standards.
Healthcare providers who source medications from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 can be confident in the integrity of the products they administer. Our portfolio includes a range of essential medications critical for various medical practices. By providing a reliable source for these high-quality compounded preparations, we support the local medical community in delivering effective and safe patient care. Our role is to be a trusted partner to practitioners, allowing them to focus on patient treatment with the assurance that their medications are produced under the highest regulatory oversight.
Engaging with 503B Compounding Pharmacy is a straightforward process for medical practices. Orders for our office-use compounded preparations are placed directly by healthcare providers or their authorized staff. Our team is dedicated to providing responsive service and support for all inquiries related to our available preparations, regulatory documentation, and order processes. We invite local healthcare providers to connect with us to learn how our services can support their practice. The team at 503B Compounding Pharmacy is ready to assist you.
For comprehensive information on our preparations and regulatory compliance, visit our website at https://503bcompoundingpharmacy.com/. To speak directly with our team regarding orders or questions, please call us at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. 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 under Section 503B of the FD&C Act. We operate under current Good Manufacturing Practices (cGMP) for the large-scale compounding of medications for office use by healthcare providers.
2. Who can order preparations from 503B Compounding Pharmacy at 2160 W State Road 434?
Our preparations are made for office use and are ordered directly by healthcare providers with prescribing authority or their authorized facility staff. We serve the medical community that utilizes our compounded preparations in their practice located at 2160 W State Road 434, Longwood, FL 32779.
3. What types of preparations does 503B Compounding Pharmacy compound?
As a 503B outsourcing facility, we compound both sterile and non-sterile preparations in batches. These are medications that are often on drug shortage lists or are not commercially available, providing a critical supply for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
4. How does 503B compounding differ from traditional pharmacy compounding?
Traditional 503A compounding is typically patient-specific. In contrast, our 503B compounding at 2160 W State Road 434, Longwood, FL 32779 is for office use, produced in larger batches without individual prescriptions, and is subject to federal cGMP regulations and heightened FDA oversight.
5. How can I place an order or get more information?
You can obtain more information about our preparations and services by visiting our website at https://503bcompoundingpharmacy.com/. To place an order or speak with our team directly, please call us at (407)993-1381. We are located at 2160 W State Road 434, Longwood, FL 32779.