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 specializes in the large-scale, non-patient-specific compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, providing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with a reliable source for high-quality compounded medications.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for office use by healthcare practitioners. This means physicians, surgeons, veterinarians, and other medical professionals operating at or near 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications for their practice without the need to compound them in-house. This service is critical for ensuring that medical facilities have immediate access to necessary drugs for procedures, treatments, and patient care, all while maintaining the highest standards of safety and sterility mandated by the FDA.
For clients at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy offers a vital service by helping to alleviate drug shortages. When commercially manufactured drugs are on backorder or discontinued, this facility can often compound a suitable alternative, preventing interruptions in patient treatment plans. The pharmacy's operations are strictly confined to its registered location at 2160 W State Road 434, Longwood, FL 32779, where it focuses on producing medications that meet specific strength, dosage form, and formulation needs that are not readily available from traditional pharmaceutical manufacturers.
The team at 503B Compounding Pharmacy is comprised of experienced pharmacists and technicians who are experts in aseptic processing and quality assurance. Every batch of medication produced at the 2160 W State Road 434, Longwood, FL 32779 facility undergoes stringent testing to ensure potency, purity, and sterility. This commitment to excellence provides healthcare providers with the confidence that the medications they use on their patients are safe, effective, and produced under the most controlled conditions.
To learn more about the services available from 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them directly by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
1. What exactly is a 503B outsourcing facility?
A 503B outsourcing facility is an FDA-registered pharmacy that compounds large volumes of sterile and non-sterile medications. Unlike traditional pharmacies, 503B facilities like the one at 2160 W State Road 434, Longwood, FL 32779 operate under federal oversight and must comply with Current Good Manufacturing Practices (cGMP), which include rigorous testing and quality control standards.
2. Can I, as an individual patient, order medication directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides medications exclusively for office use by healthcare providers. Individual patients must receive their compounded medications through their physician, surgeon, or other medical professional who has ordered the medication for office administration.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 produce?
The facility compounds a wide range of sterile preparations, including injectables, ophthalmics, and irrigations, as well as non-sterile medications. These are produced for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to use in their practice for procedures, treatments, and patient care.
4. How does using a 503B outsourcing facility benefit my medical practice at 2160 W State Road 434?
Utilizing 503B Compounding Pharmacy ensures your practice has access to high-quality, FDA-regulated medications for office use. It eliminates the need for in-house compounding, reduces liability, and provides a critical solution during national drug shortages, all from a local source at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. You can visit their website at https://503bcompoundingpharmacy.com/ for more information or call them at (407)993-1381 to speak with a representative.