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, the pharmacy adheres to the highest standards of quality, safety, and compliance as mandated by federal law. The 503B outsourcing facility provides bulk compounded medications for office use, supplying healthcare practitioners with essential drugs that are not commercially available or are in shortage.
The core mission of 503B Compounding Pharmacy is to support the local medical community by producing large quantities of sterile and non-sterile compounded preparations without patient-specific prescriptions. These medications are then available for healthcare providers to keep in their offices for immediate administration to patients. The facility at 2160 W State Road 434, Longwood, FL 32779 utilizes state-of-the-art technology and rigorous testing protocols to ensure every preparation meets stringent potency, sterility, and purity standards. This process provides a vital link in the patient care chain, ensuring practitioners have access to necessary medications when they are needed most.
By focusing on the specific regulatory framework of a 503B outsourcing facility, this pharmacy offers a reliable source for compounded medications that are essential for many medical practices and procedures. The team of highly trained pharmacists and technicians at the Longwood location is dedicated to a culture of continuous quality improvement, operating under current Good Manufacturing Practices (cGMP). For healthcare providers seeking a trusted partner for their office-use medication needs, 503B Compounding Pharmacy at 2160 W State Road 434 stands as a local resource of uncompromising quality and reliability.
To learn more about the services available from this specific outsourcing facility or to inquire about becoming a client, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
FAQ
What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
An outsourcing facility registered under Section 503B of the FD&C Act is an FDA-registered entity that compounds drugs for office use in a healthcare setting. The facility at 2160 W State Road 434, Longwood, FL 32779 must comply with current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections, ensuring a higher level of regulatory oversight for bulk compounded medications.
Who can order medications from 503B Compounding Pharmacy?
Medications from 503B Compounding Pharmacy are intended for office use by healthcare practitioners. Orders are placed by licensed medical professionals and healthcare facilities for administration to patients within their practice located near 2160 W State Road 434, Longwood, FL 32779. The pharmacy does not compound medications based on individual patient prescriptions for direct-to-patient dispensing.
What types of medications does the Longwood facility compound?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds a wide range of sterile and non-sterile preparations in larger quantities. This includes medications that are on the FDA drug shortage list or medications that are not available from commercial manufacturers, providing essential solutions for local healthcare providers.
How does the quality control process work at this facility?
As an FDA-registered 503B outsourcing facility, the pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under strict cGMP guidelines. This involves rigorous testing of raw materials, in-process testing, and finished preparation testing for sterility, potency, and endotoxins to ensure the safety and efficacy of every product released.
How can a healthcare provider set up an account with 503B Compounding Pharmacy?
Healthcare providers interested in the services offered at 2160 W State Road 434, Longwood, FL 32779 can initiate the process by contacting the facility directly at (407)993-1381. The business development team will guide them through the necessary credentialing and account setup process to begin ordering.