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 under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy adheres to the highest standards of pharmaceutical production, providing healthcare providers and patients with medications that meet rigorous quality and safety protocols.
The core function of a 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. This is conducted in a controlled environment at the 2160 W State Road 434 facility. The 503B outsourcing facility designation means the pharmacy follows Current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This ensures that every batch of medication produced is consistent, pure, and precisely formulated. The 503B Compounding Pharmacy provides these medications for office use by healthcare practitioners, as well as for individual patient-specific prescriptions.
Patients and medical professionals who utilize the services of this 503B Compounding Pharmacy at 2160 W State Road 434 can have confidence in the integrity of their medications. The facility's commitment to compliance with federal regulations provides an added layer of assurance. For more information on the specific services available or to inquire about medication availability, please contact the 503B Compounding Pharmacy directly. The team is available to assist you via phone at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434 is an FDA-registered outsourcing facility that compounds medications on a larger scale while adhering to strict federal Current Good Manufacturing Practices (cGMP) for safety, sterility, and quality control.
Who can receive medications from this 503B Compounding Pharmacy?
Medications are typically dispensed pursuant to a patient-specific prescription from a licensed healthcare provider. The 503B Compounding Pharmacy also supplies medications for office use to healthcare practices located at 2160 W State Road 434 and other medical professionals.
How do I get a medication from the 503B Compounding Pharmacy?
Your healthcare provider can prescribe a compounded medication and send the prescription directly to the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779. You may also contact them at (407)993-1381 with prescription questions.
Are the medications from a 503B outsourcing facility safe?
Yes. The 503B Compounding Pharmacy operates under heightened FDA oversight and cGMP standards, which include rigorous testing for sterility, potency, and purity to ensure patient safety for all medications produced at this location.
How can I contact the 503B Compounding Pharmacy?
You can reach the 503B Compounding Pharmacy by calling (407)993-1381. You can also visit their website for more information at https://503bcompoundingpharmacy.com/. The facility is physically located at 2160 W State Road 434, Longwood, FL 32779.