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 signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Located at 2160 W State Road 434, Longwood, FL 32779, this facility provides a critical service by producing medications that are not commercially available, thereby meeting specific patient needs as determined by healthcare providers.
The operations at 2160 W State Road 434 are distinct from traditional compounding. As a 503B outsourcing facility, the pharmacy adheres to rigorous current good manufacturing practices (cGMP). This ensures that medications are produced in a controlled, sterile environment with extensive quality control testing, including sterility and endotoxin testing, for each batch. This level of oversight provides assurance to healthcare professionals and their patients regarding the safety and potency of the medications they receive from this specific location.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications for office use. This means healthcare practitioners in the vicinity can obtain essential medications directly for administration to patients within their practice settings. The facility at 2160 W State Road 434 compounds a significant volume of sterile injectable medications, which are often in short supply from conventional manufacturers. By providing these vital drugs, 503B Compounding Pharmacy supports the local medical community in maintaining uninterrupted patient care.
Healthcare providers seeking a reliable source for compounded medications can partner with 503B Compounding Pharmacy at 2160 W State Road 434. The facility's processes are designed for efficiency and scale, enabling it to fulfill the demands of medical practices. All products are prepared under a prescription order from a licensed practitioner, ensuring appropriate use. The team of highly trained pharmacists and technicians utilizes advanced technology and follows strict protocols to guarantee the integrity of every preparation that leaves the facility.
For more information on the services provided or to initiate an order, you can contact 503B Compounding Pharmacy directly. The team is available to answer questions and discuss specific needs. Reach out via their website at https://503bcompoundingpharmacy.com/ or by phone at (407)993-1381. The facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to upholding the standards expected of an FDA-registered 503B outsourcing facility.
FAQ
1. What does it mean that this facility is a 503B outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434 is registered with the FDA and operates under strict federal regulations, including current good manufacturing practices (cGMP). This ensures medications are produced in a controlled environment with batch-level testing for quality, sterility, and strength.
2. Who can order medications from 503B Compounding Pharmacy?
Medications are prepared for office use by licensed healthcare practitioners. Orders are based on a prescription order from a practitioner for their patients and are typically administered within the practitioner's facility at 2160 W State Road 434.
3. What types of medications are compounded at the Longwood location?
The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in the large-scale compounding of sterile injectable medications, particularly those that are on shortage or not available from standard pharmaceutical manufacturers.
4. How does the quality control process work at this facility?
As an FDA-registered 503B outsourcing facility, every batch of medication produced at 2160 W State Road 434 undergoes rigorous quality control testing, including assays for potency, sterility testing, and bacterial endotoxin testing, to meet cGMP standards.
5. How can a healthcare provider place an order?
Healthcare providers can place orders for their practice by contacting 503B Compounding Pharmacy directly at (407)993-1381 or through their website at https://503bcompoundingpharmacy.com/. The team will assist with the ordering process.