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 compounding pharmacy specializes in the preparation of sterile and non-sterile compounded medications. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality, safety, and production consistency. This designation signifies a commitment to providing healthcare facilities and practitioners with medications that are produced on a larger scale than traditional compounding, ensuring reliability and broad access to essential drugs.
The services at 2160 W State Road 434, Longwood, FL 32779 are centered on the core function of a 503B compounding pharmacy. This includes the compounding of medications that may be in short supply, allowing for continuity of care for patients in need. The pharmacy operates under current Good Manufacturing Practices (cGMP), which are enforced by the FDA. This ensures that every preparation meets strict specifications for sterility, potency, and purity. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community by providing high-quality compounded pharmaceuticals.
For more information about the services provided at this location, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly by phone at (407)993-1381. The professionals at 2160 W State Road 434, Longwood, FL 32779 are focused on the specific regulatory and quality standards that define a 503B outsourcing facility.
Frequently Asked Questions
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds medications in accordance with Section 503B of the Federal Food, Drug, and Cosmetic Act. The pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under these specific federal regulations.
What types of medications are compounded at this facility?
As a 503B outsourcing facility, the pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds medications, including those that may be in shortage, for healthcare providers. All preparations are made under strict cGMP standards.
Who can receive medications from a 503B compounding pharmacy?
Medications compounded at the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 are typically distributed to healthcare facilities and practitioners for patient use, in accordance with federal law.
How does the 503B designation ensure quality?
The 503B designation requires the pharmacy at 2160 W State Road 434, Longwood, FL 32779 to comply with current Good Manufacturing Practices (cGMP) and undergo FDA oversight, which ensures consistent quality, sterility, and strength of compounded medications.
How can I contact the 503B Compounding Pharmacy in Longwood?
You can contact the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/.