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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation means we adhere to the highest current good manufacturing practices (cGMP), providing healthcare practitioners and patients with medications that meet rigorous quality and safety standards. We are not a retail pharmacy; we are a manufacturing-level operation that supports local healthcare providers by producing medications that are often unavailable commercially.
The core function of 503B Compounding Pharmacy is to provide bulk compounded medications for office use by healthcare providers. Physicians and practitioners in Longwood can utilize our services to obtain essential medications for their practice needs, ensuring they have the necessary supplies on hand for patient treatments and procedures. Our location at 2160 W State Road 434 is designed for efficiency and sterility, featuring state-of-the-art cleanrooms and environmental monitoring systems to ensure every preparation meets its required strength, identity, and purity. We serve a critical role in the local healthcare ecosystem by mitigating drug shortages and providing access to vital medications.
Patients in Longwood benefit indirectly through their trusted healthcare providers who source medications from our 503B outsourcing facility. The medications compounded at our location on W State Road 434 are used by local clinics, hospitals, and practices for administration to their patients. This model allows for a reliable supply of high-quality compounded preparations, supporting effective treatment plans and positive patient outcomes. Our commitment is to the healthcare professionals of our community, ensuring they have access to the compounded medications they need to serve their patients effectively and safely.
To learn more about the specific services and products available from our 503B outsourcing facility, we encourage healthcare providers to contact us directly. You can reach our team by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy?
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 adheres to the highest level of pharmaceutical compounding standards, following current good manufacturing practices (cGMP) for sterility, potency, and quality assurance.
2. Can I as a patient walk into the facility to get a prescription filled?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for office use by healthcare providers. We do not dispense medications directly to individual patients. Your healthcare provider in Longwood can order medications from our facility for use within their practice.
3. What types of medications does this 503B pharmacy compound?
Our FDA-registered outsourcing facility at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications in larger quantities. This includes preparations often used in clinics and medical offices, such as injectables, ophthalmics, and other formulations that address specific clinical needs and drug shortages.
4. How do I know the medications from this facility are safe?
As a 503B outsourcing facility, we are subject to rigorous FDA oversight and must comply with strict cGMP regulations. This includes extensive testing, environmental monitoring, and quality control processes at our Longwood location to ensure every medication meets defined specifications for purity, strength, and sterility.
5. How can a healthcare provider at my local clinic order from you?
Healthcare providers and medical practices can contact 503B Compounding Pharmacy directly to establish an account and place orders. They can reach our dedicated team for information and ordering by calling (407)993-1381 or by visiting our website at https://503bcompoundingpharmacy.com/.