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. This designation signifies a commitment to the highest standards of quality and safety in the preparation of compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B outsourcing facility specializes in the large-scale compounding of sterile medications, providing a critical service for healthcare providers. The operations at this specific location are distinct from traditional compounding pharmacies, as they are subject to current Good Manufacturing Practice (cGMP) regulations enforced by the FDA.
The primary function of the 503B Compounding Pharmacy is to produce medications for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other qualified healthcare professionals can obtain necessary medications for their patients without the need for patient-specific prescriptions in advance. The facility at 2160 W State Road 434, Longwood, FL 32779 compounds medications in bulk, ensuring that healthcare providers have access to essential drugs that may be in short supply or are not commercially available. This service is vital for supporting the operational needs of clinics and surgical centers, allowing them to maintain an inventory of critical medications.
As an FDA-registered outsourcing facility, 503B Compounding Pharmacy adheres to rigorous testing and quality control protocols. Every batch of medication produced is subject to stringent sterility testing, potency verification, and endotoxin testing to ensure patient safety. The environment at the Longwood facility is meticulously controlled, with cleanrooms that meet ISO Class 7 standards to prevent contamination during the compounding process. The staff at 503B Compounding Pharmacy includes highly trained pharmacists and technicians who are experts in sterile compounding techniques, further guaranteeing the integrity of every product that leaves the facility.
503B Compounding Pharmacy provides an essential link in the healthcare supply chain, particularly for medications that are on the FDA’s drug shortage list. By compounding these vital drugs, the facility helps to mitigate shortages and ensures continuity of care for patients. Healthcare providers relying on the services of 503B Compounding Pharmacy can be confident in the quality, safety, and reliability of the medications they administer. The focus remains on serving the specific needs of practitioners who require compounded sterile preparations for their practice at 2160 W State Road 434, Longwood, FL 32779.
For more information or to inquire about services, 503B Compounding Pharmacy can be contacted directly. The website at https://503bcompoundingpharmacy.com/ provides detailed information about compliance and capabilities. Alternatively, you can reach the facility by phone at (407)993-1381. The team at 503B Compounding Pharmacy is dedicated to supporting the healthcare community with high-quality compounded medications from their location in Longwood.
Frequently Asked Questions
What is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered entity that compounds large volumes of sterile medications for office use by healthcare practitioners. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under this federal designation, adhering to strict cGMP standards.
Who can order from this 503B Compounding Pharmacy?
Orders are accepted from healthcare providers, including physicians, hospitals, and veterinary clinics, for office use. The medications are intended for administration to patients within a clinical setting and are not dispensed directly to individual patients at the Longwood location.
What types of medications does this facility compound?
503B Compounding Pharmacy specializes in sterile preparations, such as injectables, infusions, and ophthalmic solutions. These are compounded in bulk quantities to support healthcare practices located near 2160 W State Road 434, Longwood, FL 32779.
How does this 503B facility ensure medication quality?
Quality is ensured through rigorous adherence to cGMP regulations. This includes comprehensive testing for sterility, potency, and endotoxins on every batch of medication produced at the Longwood facility, providing a level of assurance beyond traditional pharmacy compounding.
How can a healthcare provider place an order?
Healthcare providers can initiate an order or request more information by contacting 503B Compounding Pharmacy directly at (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/. The team will provide guidance on the ordering process specific to the needs of your practice.