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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act signifies a commitment to the highest standards of quality, safety, and compliance in the preparation of compounded medications. Unlike traditional compounding pharmacies, an outsourcing facility like 503B Compounding Pharmacy is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations, and provides medications for office use by healthcare practitioners. The facility at 2160 W State Road 434 serves a critical role in the local healthcare ecosystem by providing practitioners with access to high-quality, sterile and non-sterile compounded preparations that are not otherwise commercially available.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications in anticipation of patient need, without the requirement for patient-specific prescriptions. This model allows healthcare providers at their practices to have essential medications readily on hand for immediate administration. The services provided from the location at 2160 W State Road 434 are integral for many medical offices, clinics, and hospitals, ensuring they have a reliable and compliant source for these vital preparations. The pharmacy's operations are dedicated to supporting the medical community by compounding preparations that are often in short supply or discontinued by large manufacturers, thereby helping to prevent treatment delays for patients.
Quality assurance is the foundation of everything done at 503B Compounding Pharmacy. The facility at 2160 W State Road 434 adheres to strict sterility testing, potency verification, and endotoxin testing protocols to ensure every preparation meets exacting specifications. This unwavering commitment to quality provides healthcare practitioners with the confidence that the medications they use are pure, potent, and safe for patient care. The team of highly trained pharmacists and technicians utilizes state-of-the-art equipment within a controlled environment to maintain the integrity of every compound from inception to delivery.
For healthcare providers seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a pivotal resource. The pharmacy is dedicated to upholding the highest ethical and professional standards in the compounding industry. To learn more about its services or to initiate an order, healthcare practices can contact the facility directly. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
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 operates under Section 503B of the FD&C Act, adhering to stricter federal standards, including current Good Manufacturing Practices (cGMP), and is subject to routine FDA inspections. This ensures a higher level of quality control for the compounded preparations we provide.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for healthcare practitioners and institutions. We provide compounded medications for office use, meaning healthcare providers can order and keep our preparations in stock at their practice for administration to their patients as needed.
Can individual patients pick up prescriptions directly from your location?
No. As a 503B outsourcing facility, our primary function is to supply medications for office use to licensed practitioners. Patients should receive their medications directly from their healthcare provider's office, not from our facility at 2160 W State Road 434.
How does the quality control at a 503B outsourcing facility differ?
Our facility at 2160 W State Road 434 follows rigorous cGMP standards mandated by the FDA. This includes extensive testing for sterility, potency, and endotoxins on every batch of medication we compound, providing an added layer of safety and quality assurance beyond traditional pharmacy compounding.
How can a healthcare practice place an order with your facility?
Healthcare practices interested in our services can contact us directly to establish an account. You can reach our team at 2160 W State Road 434 by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/ for more information.