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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies a commitment to the highest standards of quality, safety, and consistency, providing healthcare providers with a reliable source for patient-specific medications that are not commercially available. The operations at this specific location are focused on supplying these critical preparations directly to healthcare practitioners for office use, ensuring they have the necessary medications on hand for their patients.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the production of medications in anticipation of receiving a prescription. This model allows for a more efficient and immediate response to patient needs within the local medical community. By adhering to Current Good Manufacturing Practices (cGMP), the facility ensures every batch of medication produced meets rigorous standards for potency, purity, and sterility. This level of quality control is a fundamental aspect of the 503B compounding process, providing practitioners and their patients with a level of confidence in the medications they use. The team at this location includes skilled pharmacists and technicians who are experts in the complex science of pharmaceutical compounding.
Services provided by 503B Compounding Pharmacy are essential for many medical practices. These include the compounding of sterile injectables, ophthalmics, and other preparations that are vital for various treatments and procedures. The facility at 2160 W State Road 434, Longwood, FL 32779, is equipped with state-of-the-art technology and environmental controls to ensure the integrity of every product. Healthcare providers can rely on this 503B outsourcing facility as a key partner in patient care, offering a vital alternative when mass-produced, FDA-approved drugs are not suitable or available for their specific clinical requirements.
For more information about the services available from this specific facility, visit the website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly by phone at (407)993-1381. The team at 503B Compounding Pharmacy is available to answer questions and provide support to healthcare professionals.
What does it mean that this facility is a 503B outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434 is an FDA-registered facility that compounds large volumes of sterile and non-sterile medications for office use by healthcare practitioners. It operates under stricter federal regulations, specifically Section 503B, and Current Good Manufacturing Practices (cGMP) to ensure the highest quality and safety standards.
Who can receive medications from this 503B Compounding Pharmacy location?
This location provides medications to licensed healthcare practitioners for office use. Medications are not dispensed directly to individual patients at the facility; instead, they are supplied to prescribers who then administer or dispense them to their patients within their practice.
What types of medications are compounded at the Longwood location?
The 503B Compounding Pharmacy at 2160 W State Road 434 specializes in compounding a range of preparations, including sterile injectables and ophthalmics. These are produced for healthcare providers when there is a clinical need that cannot be met by an FDA-approved commercially available drug.
How does the quality control process work at this facility?
As an FDA-registered 503B outsourcing facility, this location follows rigorous cGMP protocols. This involves extensive testing of ingredients (APIs), stringent environmental monitoring, and validated processes to ensure every batch of medication meets precise specifications for potency, purity, and sterility before it is released.
How can a healthcare provider place an order with this pharmacy?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly at (407)993-1381 or by visiting the official website at https://503bcompoundingpharmacy.com/ to learn more about the ordering procedure for their practice.