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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile medications, providing a critical component of the healthcare supply chain for practitioners and patients who rely on these essential preparations.
The 503B outsourcing facility designation signifies that 503B Compounding Pharmacy adheres to the highest standards of pharmaceutical compounding. This includes rigorous testing, robust quality control protocols, and compliance with Current Good Manufacturing Practices (cGMP). For healthcare providers seeking compounded medications, this ensures a level of safety, sterility, and potency that is consistently monitored and verified. The medications produced by 503B Compounding Pharmacy are intended for office use, allowing physicians and clinicians to have vital drugs readily available for administration to their patients.
Located at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy serves the specific needs of the local medical community. The scope of 503B compounding primarily involves producing medications that are often on drug shortage lists or are necessary for specific medical procedures. By operating as a 503B outsourcing facility, 503B Compounding Pharmacy helps to mitigate drug shortages and provides healthcare professionals with access to medications that may otherwise be difficult to obtain, thereby supporting continuous patient care.
The operations at 503B Compounding Pharmacy are distinct from traditional pharmacy compounding. The 503B model involves compounding medications without patient-specific prescriptions in advance of receiving orders, but solely for distribution to healthcare facilities and practitioners for office use. This process is governed by federal regulations and subject to FDA oversight. The team at 503B Compounding Pharmacy comprises skilled professionals who are experts in sterile compounding techniques, ensuring every preparation meets exacting specifications.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and the surrounding professional community, partnering with 503B Compounding Pharmacy offers a reliable source for high-quality compounded medications. The commitment of 503B Compounding Pharmacy is to uphold the standards set forth by Section 503B, providing assurance and confidence in the medications utilized in clinical settings. To learn more about the services provided by this specific outsourcing facility, or to inquire about available medications, please contact 503B Compounding Pharmacy directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration signifies compliance with stringent federal standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of sterile medications intended for office use by healthcare practitioners.
2. Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
503B Compounding Pharmacy distributes compounded medications to healthcare facilities and licensed practitioners for office use. These medications are not dispensed directly to individual patients without a prescription from their provider. The primary clients are typically hospitals, clinics, and physician offices that utilize these preparations for administration during patient visits.
3. What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, the focus is on compounding sterile medications that are often essential yet may be in short supply. This includes injectable drugs, ophthalmics, and other sterile preparations needed for various medical treatments and procedures. The specific drug formulations available can be discussed by contacting 503B Compounding Pharmacy.
4. How does the quality control process work at this facility?
503B Compounding Pharmacy implements a comprehensive quality control system as required by federal regulation. This involves rigorous testing of components, in-process monitoring, and final product sterility and potency testing to ensure every batch of medication leaving the facility at 2160 W State Road 434, Longwood, FL 32779 meets the highest safety and quality standards.
5. How can a healthcare provider at this location place an order?
Healthcare providers interested in the services of 503B Compounding Pharmacy can initiate the process by contacting the facility directly. Inquiries and orders can be made by phone at (407)993-1381. The team will provide information on available medications, ordering procedures, and distribution specifics for the 2160 W State Road 434, Longwood, FL 32779 location.