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, providing essential pharmaceutical services from its location 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. The 503B Compounding Pharmacy model is distinct, focusing on the large-scale compounding of medications that are distributed to healthcare providers for office use, rather than being patient-specific. This ensures that physicians and practitioners at local clinics and practices have immediate access to the sterile and non-sterile compounded preparations they require for their patients.
The core mission of 503B Compounding Pharmacy is to uphold the strict protocols mandated by the FDA for outsourcing facilities. This involves rigorous testing of components, meticulous environmental monitoring, and adherence to current Good Manufacturing Practices (cGMP). Every batch of medication produced at the 2160 W State Road 434 facility is crafted with precision and undergoes stringent quality control checks to ensure potency, purity, and sterility. This level of oversight provides healthcare professionals with the confidence that the medications they administer meet exacting federal standards, directly benefiting patient care in the local community.
Services provided by 503B Compounding Pharmacy are exclusively tailored for healthcare providers. The facility compounds a significant volume of medications, including sterile injectables, ophthalmics, and other formulations that are in short supply or unavailable from conventional manufacturers. By addressing these critical drug shortages, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 plays a vital role in the local healthcare infrastructure, ensuring that practitioners have the necessary tools to treat their patients effectively without interruption.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders directly with the facility to have compounded medications delivered for office use. The team at 503B Compounding Pharmacy is dedicated to supporting the medical community, offering a reliable and compliant source for essential medications. For more detailed information on available formulations or to initiate an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly.
To learn more about the services or to speak with a representative, please visit the official website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound for healthcare providers meet rigorous standards for safety, quality, and purity.
2. Who can order medications from 503B Compounding Pharmacy?
Our services are exclusively for healthcare providers and medical practices. We compound medications in large batches for office use, which are then administered to patients by physicians and practitioners at their facilities located near 2160 W State Road 434, Longwood, FL 32779.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we focus on compounding sterile and non-sterile preparations, often those that are on drug shortage lists or are not commercially available. This includes various injectables, ophthalmics, and other formulations required by local healthcare providers.
4. How does a healthcare provider place an order with your facility?
Healthcare providers can place orders directly through our facility at 2160 W State Road 434, Longwood, FL 32779. We recommend contacting us via phone at (407)993-1381 to discuss specific medication needs and to initiate the ordering process.
5. Can patients directly pick up prescriptions from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy does not dispense medications directly to patients. We are an outsourcing facility that supplies compounded medications exclusively to healthcare providers for use within their practice. Patients receive their treatments directly from their physician at the medical practice.