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 in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The fundamental operational distinction of a 503B Compounding Pharmacy, as defined by federal law, is the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. This model allows physicians, surgeons, veterinarians, and other medical professionals to obtain vital medications without the need for patient-specific prescriptions for each vial, syringe, or bag, thereby supporting efficient clinical practice and emergency stock needs.
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to the most rigorous current good manufacturing practices (cGMP). This commitment to quality and safety standards, which are more stringent than those required for traditional 503A compounding pharmacies, ensures that every batch of medication produced is consistent, sterile, and of the highest potency. The medications compounded at this 503B Compounding Pharmacy are intended for administration within professional healthcare settings, providing practitioners with reliable access to essential drugs that may be in short supply or discontinued by commercial manufacturers.
By focusing on non-patient-specific compounding, the 503B Compounding Pharmacy serves a critical role in the local medical ecosystem. Healthcare providers at clinics, hospitals, surgical centers, and veterinary practices can confidently source their office-use medications from this FDA-registered outsourcing facility. The team at 503B Compounding Pharmacy is dedicated to upholding the integrity of the drug supply chain from its location at 2160 W State Road 434, Longwood, FL 32779. For comprehensive information on its role and services, you can visit https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large batches of sterile medications for office use by healthcare practitioners, operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This is distinct from a traditional pharmacy that compounds based on individual patient prescriptions.
Who can order medications from the 503B Compounding Pharmacy at 2160 W State Road 434?
Medications are supplied to healthcare professionals and facilities for office use. This includes physicians, surgeons, veterinarians, hospitals, and clinics. This 503B Compounding Pharmacy does not dispense medications directly to individual patients without a prescription for personal use.
Why would a healthcare provider use a 503B Compounding Pharmacy?
Healthcare providers rely on this 503B Compounding Pharmacy for a consistent supply of high-quality, sterile compounded medications that are often on drug shortage lists or are no longer commercially available. This ensures they have the necessary drugs on hand for procedures and treatments at their practice.
How does the quality assurance at a 503B Compounding Pharmacy differ?
As an FDA-registered outsourcing facility, this 503B Compounding Pharmacy must comply with current Good Manufacturing Practices (cGMP), which involve rigorous testing, environmental monitoring, and quality control procedures that exceed the standards of a typical compounding pharmacy.
How can I contact this 503B Compounding Pharmacy?
You can reach the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. More details about its services and compliance are available on its website at https://503bcompoundingpharmacy.com/.