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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility is located at 2160 W State Road 434, Longwood, FL 32779. This designation signifies our commitment to the highest standards of quality, safety, and consistency in pharmaceutical compounding. As a 503B outsourcing facility, we produce large batches of compounded medications without patient-specific prescriptions, which are then distributed to healthcare practitioners for office use. Our operations are subject to rigorous current Good Manufacturing Practice (cGMP) regulations and regular FDA inspections, ensuring that every preparation leaving our facility meets exacting standards for potency, purity, and sterility.
The services provided by 503B Compounding Pharmacy at our Longwood location are distinct from traditional compounding. We specialize in the large-scale production of sterile injectable medications, which are essential for physician offices, hospitals, and clinics. Our portfolio includes a wide array of preparations, such as hormone replacement therapy solutions, ophthalmics, and other critical injectable medications that are often in short supply. By operating from our facility at 2160 W State Road 434, we provide a reliable, domestic source of these vital drugs, helping to mitigate drug shortages and ensure that healthcare providers in our community have consistent access to the medications their patients need.
Quality assurance is the cornerstone of everything we do at 503B Compounding Pharmacy. Our state-of-the-art facility at 2160 W State Road 434 is designed to maintain the highest levels of environmental control. Every batch of medication is rigorously tested for sterility, potency, and endotoxin levels in our advanced in-house laboratory. This meticulous process, governed by cGMP, provides an additional layer of safety and reliability for the healthcare providers we serve. Our dedicated team of pharmacists, chemists, and quality control professionals works tirelessly to uphold these standards, ensuring that every product is safe and effective for its intended use.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can confidently order the compounded medications they require for their office practice directly from our facility. Our team is committed to providing exceptional service, from order placement to prompt delivery. We encourage you to learn more about our specific offerings and regulatory standing by visiting our website or calling us directly. For detailed information and to place an order, please contact 503B Compounding Pharmacy at (407)993-1381 or visit our website at https://503bcompoundingpharmacy.com/. Our location is 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
1. 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 FD&C Act. This requires us to adhere to strict current Good Manufacturing Practice (cGMP) regulations, which govern the production of drugs for office use by healthcare practitioners.
2. Who can order medications from 503B Compounding Pharmacy?
Medications produced at our facility are intended for office use and are distributed to healthcare practitioners. We provide our medications to licensed practitioners for administration to patients within their practice setting at 2160 W State Road 434, Longwood, FL 32779.
3. How does the quality control process work at your facility?
Quality control is integral to our operation. Every batch of medication compounded at 2160 W State Road 434, Longwood, FL 32779 undergoes rigorous testing in our on-site laboratory for sterility, potency, and endotoxins to ensure it meets all cGMP standards and is safe for patient use.
4. Can I visit 503B Compounding Pharmacy to pick up an order?
As a bulk manufacturer operating from 2160 W State Road 434, Longwood, FL 32779, our business model is based on distribution to healthcare providers. Orders are typically shipped directly to medical practices. Please contact us at (407)993-1381 to discuss specific logistics.
5. How can I see a list of medications you compound at your Longwood location?
A comprehensive list of the products we compound at our FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779 is available for healthcare providers on our website at https://503bcompoundingpharmacy.com/ or by calling us at (407)993-1381.