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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction, signifying our adherence to the most rigorous standards of pharmaceutical compounding. Our facility in Longwood is not a traditional pharmacy; it is a large-scale manufacturing operation that produces compounded sterile preparations (CSPs) for office use by healthcare practitioners. We serve as a vital support system for the medical community at 2160 W State Road 434, Longwood, FL 32779, providing bulk quantities of essential medications that are often in short supply or unavailable from conventional manufacturers.
The core mission of 503B Compounding Pharmacy is to ensure patient safety and support healthcare providers through the reliable production of high-quality medications. Every process within our facility at 2160 W State Road 434, Longwood, FL 32779 is governed by strict Current Good Manufacturing Practices (cGMP). This encompasses everything from the sourcing of pure, high-grade active pharmaceutical ingredients (APIs) to the stringent environmental controls, validated sterilization processes, and comprehensive quality control testing that each batch of medication must pass before release. This unwavering commitment to cGMP standards provides physicians and clinics with the confidence that the medications they administer meet the highest possible standards for purity, potency, and sterility.
Healthcare professionals utilizing our services at 2160 W State Road 434, Longwood, FL 32779 benefit from access to a consistent supply of critical drugs. We specialize in compounding preparations that are on the FDA drug shortage list, helping to mitigate gaps in the supply chain that can disrupt patient care. Furthermore, we provide commonly used office-based medications in ready-to-use formats, enhancing efficiency and workflow for medical practices. By outsourcing their compounding needs to our 503B outsourcing facility, practitioners can redirect their valuable time and resources toward direct patient care, assured that their pharmaceutical requirements are being managed by experts in a federally regulated environment.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical offices. Our operations are designed for bulk distribution to healthcare settings, not direct-to-patient sales. Providers can place orders through our dedicated channels and have them delivered for office use. Our team is committed to being a reliable partner for the medical community at 2160 W State Road 434, Longwood, FL 32779, offering consistent quality and dependable service.
For more information or to discuss your practice's specific needs, please contact 503B Compounding Pharmacy. We are located at 2160 W State Road 434, Longwood, FL 32779. You can reach us by phone at (407)993-1381 or visit our website to learn more about our services and compliance standards at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
What does it mean that you are a 503B outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with stringent Current Good Manufacturing Practices (cGMP). This regulatory status allows us to compound large volumes of sterile medications for office use by healthcare practitioners without needing patient-specific prescriptions.
Who can order medications from your facility?
Our services are exclusively for healthcare practitioners and institutions for office use. We distribute compounded medications in bulk to medical practices, hospitals, and clinics. We do not dispense medications directly to individual patients from our location at 2160 W State Road 434, Longwood, FL 32779.
What kinds of medications do you compound at your Longwood facility?
As a 503B outsourcing facility, we specialize in producing compounded sterile preparations (CSPs). This includes a range of medications often used in clinical settings, such as injectables and infusions, particularly those that are currently on the FDA’s drug shortage list.
How does using a 503B pharmacy benefit my practice?
Utilizing our services at 2160 W State Road 434, Longwood, FL 32779 ensures your practice receives medications produced under the highest quality controls. It provides a reliable source for drugs in short supply, improves office efficiency with ready-to-use formulations, and reduces the compounding burden on your own staff.
How can I place an order or get more information?
Healthcare providers can contact us directly at (407)993-1381 to speak with a representative. You can also visit our website at https://503bcompoundingpharmacy.com/ for more detailed information about our capabilities and compliance.