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. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy provides a critical service by producing large quantities of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The core function of this 503B Compounding Pharmacy is to supply medications to physician offices, hospitals, and clinics, ensuring they have the necessary sterile preparations on hand for patient care.
The 503B Compounding Pharmacy designation signifies that this facility adheres to the most rigorous federal standards for quality, safety, and production. Unlike a traditional 503A pharmacy, this 503B Compounding Pharmacy is subject to current Good Manufacturing Practices (cGMP), which are the same standards followed by conventional drug manufacturers. This means every batch of medication produced at the 2160 W State Road 434 facility undergoes stringent testing and quality control procedures. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B Compounding Pharmacy ensures access to high-quality, reliable medications that are essential for their practice operations and patient treatment protocols.
The services provided by 503B Compounding Pharmacy are specifically designed for the medical community. This includes the compounding of various injectable medications, such as hormone replacement therapy (HRT) preparations, vitamins, electrolytes, and other sterile solutions. The team of highly trained pharmacists and technicians at 503B Compounding Pharmacy utilizes state-of-the-art equipment within their controlled environment to ensure every preparation meets exacting specifications. The primary clients of 503B Compounding Pharmacy are healthcare professionals who require these medications for office-based procedures and treatments.
Healthcare practitioners located at or serving 2160 W State Road 434, Longwood, FL 32779 can rely on 503B Compounding Pharmacy for a consistent and compliant source of essential medications. The operational model of this 503B Compounding Pharmacy is built on a foundation of trust, quality, and regulatory compliance, providing peace of mind to the local medical community. By focusing exclusively on its role as an outsourcing facility, 503B Compounding Pharmacy supports the efficient and safe delivery of healthcare services directly from its location at 2160 W State Road 434.
To learn more about the services offered or to inquire about becoming a client, healthcare providers can contact 503B Compounding Pharmacy directly. The dedicated team is available to answer questions and provide detailed information about the compounding process and product availability.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434
1. What does it mean that this is a 503B Compounding Pharmacy?
503B Compounding Pharmacy is an FDA-registered outsourcing facility. This federal designation means our operations at 2160 W State Road 434, Longwood, FL 32779 are regulated under Section 503B and we must comply with current Good Manufacturing Practices (cGMP), ensuring the highest standards of quality, sterility, and safety for the medications we produce.
2. As a patient, can I walk into 503B Compounding Pharmacy at 2160 W State Road 434 to get a prescription filled?
No. 503B Compounding Pharmacy does not dispense medications directly to individual patients. Our facility supplies compounded sterile preparations in large quantities to healthcare practitioners for "office use" in their practices located at or near 2160 W State Road 434, Longwood, FL 32779. Patients must receive their medications through their prescribing physician.
3. What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding sterile injectable medications. This includes, but is not limited to, hormone replacement therapies (HRT), vitamin injections, electrolyte solutions, and other customized preparations needed by healthcare providers serving the 2160 W State Road 434 area.
4. How can a healthcare practice at 2160 W State Road 434 order from 503B Compounding Pharmacy?
Healthcare practices can establish an account with 503B Compounding Pharmacy by contacting our facility directly. Our team will guide you through the onboarding process. Orders can be placed by calling (407)993-1381 or through approved channels discussed during setup.
5. Why should a local clinic choose 503B Compounding Pharmacy as their supplier?
Clinics and practices at 2160 W State Road 434, Longwood, FL 32779 choose 503B Compounding Pharmacy because we provide FDA-regulated, cGMP-compliant medications. This ensures product consistency, reliability, and the highest level of safety for their patients, backed by the rigorous standards required of a 503B outsourcing facility.