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 central to the operations and services provided at the facility located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, the pharmacy adheres to rigorous federal standards for quality control, sterility, and safety that exceed those of traditional compounding pharmacies. This ensures that every preparation leaving the facility meets the highest level of pharmaceutical quality and reliability for its recipients.
The core function of 503B Compounding Pharmacy is the large-scale compounding of medications that are patient-specific but are not available commercially. This includes the preparation of sterile injectables, intravenous (IV) medications, and other complex formulations that are essential for hospital, clinic, and physician office use. The team at the Longwood location is comprised of highly skilled pharmacists and technicians who utilize state-of-the-art technology and strict aseptic techniques to compound medications in a controlled environment. This process is continuously monitored to ensure compliance with all current Good Manufacturing Practices (cGMP).
By focusing on non-patient-specific compounding, 503B Compounding Pharmacy provides healthcare providers with a critical resource. Physicians and medical facilities at 2160 W State Road 434, Longwood, FL 32779 can confidently source essential medications that are ready for office use, knowing they are produced under the strict oversight mandated for a 503B outsourcing facility. This model enhances patient safety, improves access to necessary medications, and provides a reliable supply chain for healthcare professionals in the area.
The commitment of 503B Compounding Pharmacy is to uphold the integrity of the pharmaceutical supply chain. Every batch of medication is tested for potency, sterility, and purity, providing an additional layer of safety and assurance. The facility at 2160 W State Road 434 is dedicated to serving the specific needs of the local medical community with efficiency and an unwavering commitment to quality.
For more detailed information about the services and standards of 503B Compounding Pharmacy, or to inquire about becoming a client, you are encouraged to contact the facility directly. The team is available to answer questions and provide support to healthcare providers. The website at https://503bcompoundingpharmacy.com/ offers further resources, and you can also reach the pharmacy by phone at (407)993-1381.
FAQ
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means the facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates under Section 503B of the FD&C Act. This requires compliance with stringent current Good Manufacturing Practices (cGMP) for sterility, testing, and quality control that are more rigorous than those applied to traditional pharmacies.
2. Who can receive medications from 503B Compounding Pharmacy?
Medications compounded at the 2160 W State Road 434 facility are intended for office use by healthcare providers, such as physicians and clinics. These are not patient-specific prescriptions for individual consumers to pick up directly; they are supplied in bulk to medical professionals for administration to their patients within their practice.
3. What types of medications does 503B Compounding Pharmacy prepare?
The pharmacy specializes in compounding sterile preparations, including injectable medications, IV bags, and other formulations that are not available off-the-shelf from commercial manufacturers. All preparations are made in batches within the controlled environment of the Longwood facility.
4. How does 503B Compounding Pharmacy ensure the safety of its compounded medications?
Safety is ensured through strict adherence to cGMP standards. This includes rigorous testing of components, environmental monitoring, validation of sterility processes, and end-product testing for potency, purity, and sterility before any batch is released from the 2160 W State Road 434 location.
5. How can a healthcare provider at 2160 W State Road 434 order from 503B Compounding Pharmacy?
Healthcare providers can initiate orders and establish an account by contacting 503B Compounding Pharmacy directly. You can visit the website at https://503bcompoundingpharmacy.com/ for more information or call the facility at (407)993-1381 to speak with a representative.