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 the operations and services provided at our specific location: 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, we engage in the non-patient-specific, large-scale compounding of sterile and non-sterile medications. This distinguishes our activities from traditional compounding pharmacies and mandates that we adhere to the FDA's stringent Current Good Manufacturing Practices (cGMP). Our primary function is to supply these compounded medications to healthcare practitioners and facilities, ensuring they receive bulk quantities of high-quality, consistent drug products for office use or in anticipation of patient need.
The services at 2160 W State Road 434, Longwood, FL 32779 are defined by our regulatory status. We produce a significant volume of medications, including sterile injectables, ophthalmics, and other dosage forms that are essential for physician offices, hospitals, and clinics. Every batch of medication compounded at this facility is subject to rigorous testing and quality control protocols as required by the FDA. This process ensures potency, purity, and sterility, providing practitioners with a reliable and trusted source for medications that may be in short supply or unavailable from conventional pharmaceutical manufacturers. The focus of 503B Compounding Pharmacy is on the large-scale production and distribution of these vital medications directly from our Longwood facility.
Healthcare providers seeking a dependable source for office-use medications will find 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 to be a critical partner. Our operations are designed to support the medical community by alleviating drug shortage challenges and providing access to essential compounded preparations. The entire process, from sourcing quality ingredients to final product release, is conducted under a quality management system that meets federal oversight standards. For more information on our available formulations or to discuss your facility's needs, we encourage you to contact us directly.
To learn more about the specific services and products available from our outsourcing facility, or to place an order for your practice, please use the following contact details for 503B Compounding Pharmacy: Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381. Our team at 2160 W State Road 434, Longwood, FL 32779 is prepared to assist healthcare professionals with their medication requirements.
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. This requires us to comply with more rigorous federal standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications that are distributed to healthcare providers without patient-specific prescriptions.
Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications compounded at our facility are distributed to healthcare practitioners and facilities for office use or in anticipation of patient need. This includes physicians, clinics, hospitals, and other healthcare entities. We do not dispense medications directly to individual patients based on a prescription at this location.
What types of medications does 503B Compounding Pharmacy produce?
As an outsourcing facility, we specialize in the non-patient-specific compounding of medications, often focusing on sterile injectables and other formulations that are on drug shortage lists or are not commercially available. The specific product list available from our Longwood location can be obtained by contacting us directly.
How does the quality control process work at your facility?
In compliance with FDA cGMP regulations, every batch of medication produced at 2160 W State Road 434, Longwood, FL 32779 undergoes strict testing for sterility, potency, and purity before it is released for distribution. This ensures that healthcare providers receive a consistently high-quality and reliable product.
How can a healthcare facility place an order with 503B Compounding Pharmacy?
Healthcare providers and facilities can place orders for compounded medications by contacting our facility directly at (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ to initiate the process. All services are provided from our location at 2160 W State Road 434, Longwood, FL 32779.