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
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 503B compounding pharmacy specializes in the large-scale compounding of sterile medications. As a 503B outsourcing facility, the pharmacy adheres to stringent federal quality standards, including current Good Manufacturing Practices (cGMP), which are designed to ensure the safety, potency, and purity of every preparation. The primary focus of a 503B compounding pharmacy is to provide bulk quantities of compounded medications to healthcare providers and facilities, rather than directly to individual patients. This model supports hospitals, clinics, and other healthcare entities by ensuring a reliable supply of essential, high-quality compounded drugs that may not be commercially available.
The services at 2160 W State Road 434, Longwood, FL 32779 are defined by the regulatory framework of a 503B compounding pharmacy. This includes the compounding of sterile injectables, intravenous (IV) bags, ophthalmics, and other preparations necessary for medical procedures and patient care. The operations at this 503B compounding pharmacy are subject to regular FDA inspections and rigorous quality control testing, providing an additional layer of assurance for the healthcare professionals who depend on its products. By centralizing compounding activities under a robust quality system, the 503B compounding pharmacy helps mitigate risks associated with drug shortages and ensures consistent product quality for the medical community it serves.
For healthcare facilities and practitioners seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to compliance and patient safety. The team at this 503B compounding pharmacy possesses specialized expertise in sterile compounding processes within a controlled environment. To learn more about the specific formulations and capabilities of this 503B outsourcing facility, healthcare providers are encouraged to contact the pharmacy directly. You can visit their website at https://503bcompoundingpharmacy.com/ or call (407)993-1381 for detailed information.
Frequently Asked Questions for 503B Compounding Pharmacy
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds large volumes of sterile medications in accordance with federal standards, including current Good Manufacturing Practices (cGMP).
Who can receive medications from a 503B compounding pharmacy?
503B compounding pharmacies typically supply compounded medications to healthcare facilities and practitioners, such as hospitals, clinics, and surgery centers, for office use or administration to patients within those settings.
What types of medications does a 503B compounding pharmacy prepare?
A 503B compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779 specializes in sterile preparations, which can include injectables, IV solutions, and ophthalmic drops that are essential for various medical treatments and procedures.
How does a 503B outsourcing facility ensure quality?
This 503B compounding pharmacy ensures quality through adherence to cGMP, which involves rigorous environmental monitoring, sterility testing, and endotoxin testing on all batches of compounded medications produced at the facility.
How can a healthcare facility place an order with this 503B compounding pharmacy?
Healthcare facilities can contact the 503B compounding pharmacy directly to discuss their needs. For ordering information and specific formulary details, please call (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/.