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 is an FDA-registered outsourcing facility operating under 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. As a 503B outsourcing facility, it adheres to stringent federal current Good Manufacturing Practices (cGMP), ensuring the highest standards of quality, purity, and potency for the compounded medications it produces. This distinguishes its operations from traditional compounding pharmacies, focusing on providing bulk quantities for healthcare providers.
The services provided at the 2160 W State Road 434 location are centered on the production of medications for office use. This means healthcare practitioners in the area can obtain reliable, high-quality compounded preparations to have on hand for immediate patient needs. The facility's core function is to support local clinics, hospitals, and healthcare practices by acting as a trusted, compliant source for a wide range of compounded sterile preparations, including injectables, infusions, and ophthalmics, all produced under a rigorous quality framework.
Patients receiving care from a provider who utilizes medications from 503B Compounding Pharmacy benefit from the assurance that comes with FDA-registered oversight. The facility’s commitment to cGMP standards involves extensive testing, environmental monitoring, and validated processes to mitigate the risk of contamination and ensure medication consistency. For healthcare providers at 2160 W State Road 434, this translates to confidence in the medications they administer, allowing them to focus on patient care without compromising on medication quality or safety.
Engaging with 503B Compounding Pharmacy is designed for healthcare entities. Providers can place orders directly through the facility's official channels. The team at the Longwood location is equipped to handle inquiries from medical professionals regarding product availability, formulations, and ordering procedures. The facility operates with a clear focus on its role within the healthcare supply chain, providing essential medications to practitioners for office use from its specific operational base at 2160 W State Road 434, Longwood, FL 32779.
For more information on services and to understand how 503B Compounding Pharmacy can support your practice, you are encouraged to make direct contact. The facility can be reached via phone at (407)993-1381. Detailed information about its capabilities and compliance status is also available on its official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and compounds medications in bulk for office use by healthcare providers. It operates under stricter federal standards known as Current Good Manufacturing Practices (cGMP), which are comparable to those followed by pharmaceutical manufacturers.
2. As a patient, can I walk into the 2160 W State Road 434 location to get a prescription filled?
No. 503B Compounding Pharmacy does not typically dispense medications directly to individual patients. It provides compounded medications in bulk to licensed healthcare providers for use in their practices. You would receive a medication compounded here through your doctor's office or clinic.
3. What types of medications does 503B Compounding Pharmacy produce at its Longwood facility?
The facility focuses on compounding sterile preparations, which can include a wide array of injectable medications, intravenous (IV) bags, and ophthalmic solutions. These are produced for healthcare providers at 2160 W State Road 434 to have available for procedures and immediate patient treatment needs.
4. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place orders. The primary points of contact for ordering and inquiries are the phone number, (407)993-1381, and the official website, https://503bcompoundingpharmacy.com/.
5. Why would a provider choose a 503B outsourcing facility over a traditional compounding pharmacy?
Providers choose a 503B outsourcing facility like this one for the enhanced level of quality control and regulatory oversight. The cGMP standards enforced at this location ensure a higher assurance of sterility, potency, and purity for office-use medications, which is critical for patient safety and effective treatment.