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 is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies, ensuring that healthcare providers at our location receive the highest quality pharmaceutical products for their patients.
The core mission of the 503B Compounding Pharmacy at 2160 W State Road 434 is to provide a reliable source of compounded medications that are often in shortage or unavailable from conventional manufacturers. This facility serves an essential role for the local medical community by producing bulk quantities of critical drugs, including sterile injectables, ophthalmics, and other formulations, which are then distributed to healthcare settings for office use. The operations at this specific location are pivotal in helping to prevent treatment delays and support continuous patient care within its service area.
By focusing on compliance with current Good Manufacturing Practices (cGMP), the 503B Compounding Pharmacy ensures every product leaving its facility at 2160 W State Road 434 is consistently produced and controlled according to the strictest quality standards. This involves extensive environmental monitoring, validated sterilization processes, and stringent purity and potency testing on all finished preparations. For medical professionals seeking a trusted partner for compounded medications, the 503B Compounding Pharmacy at this address represents a commitment to safety, reliability, and excellence in pharmaceutical compounding.
To learn more about the services available from this specific facility or to inquire about its products, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly by phone at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434 is an FDA-registered outsourcing facility that compounds large volumes of sterile and non-sterile medications in accordance with strict federal current Good Manufacturing Practices (cGMP), which are different from the standards applied to traditional compounding pharmacies.
Who can order medications from the 503B Compounding Pharmacy?
Medications compounded at our facility at 2160 W State Road 434 are intended for office use and are distributed to licensed healthcare providers and healthcare facilities for administration to their patients within a clinical setting; they are not dispensed directly to individual patients.
What types of medications does the 503B Compounding Pharmacy produce?
The 503B Compounding Pharmacy specializes in producing medications that are on drug shortage lists or are otherwise commercially unavailable, including various sterile injectables, ophthalmics, and other formulations needed by healthcare providers serving the local area.
How does the 503B Compounding Pharmacy ensure product quality and safety?
Our facility at 2160 W State Road 434 follows rigorous cGMP protocols, which include comprehensive testing of raw materials, in-process testing, and finished product potency and sterility testing to ensure every batch meets exacting quality and safety standards before it is released.
How can a healthcare provider at your location place an order?
Healthcare providers interested in the products available from our specific location can initiate the process by contacting the 503B Compounding Pharmacy directly at (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/ for more information.