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 designation is a critical distinction that sets this facility apart from traditional compounding pharmacies, ensuring the highest standards of quality, safety, and consistency for its preparations. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy provides bulk compounded medications for healthcare providers to administer to patients within an office or clinical setting, or to dispense pursuant to a prescription.
The core function of the 503B Compounding Pharmacy is the large-scale production of sterile and non-sterile compounded drugs. This process is conducted under rigorous quality control protocols in a controlled environment that meets or exceeds current Good Manufacturing Practices (cGMP). By operating as a 503B outsourcing facility, the pharmacy can provide healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 with access to medications that may be in shortage, not commercially available, or require a specific formulation not offered by standard pharmaceutical manufacturers. This service is vital for practitioners who need reliable, high-quality medications to support their patient care protocols.
Clients of the 503B Compounding Pharmacy can expect a commitment to uncompromising quality. Every batch of medication produced is subject to stringent testing and quality assurance measures. This includes stability testing, sterility testing, and endotoxin testing for injectable medications, ensuring that every preparation meets precise specifications for potency, purity, and safety. The facility at 2160 W State Road 434, Longwood, FL 32779 is designed to prevent contamination, with advanced air filtration systems and environmental monitoring to maintain the integrity of all sterile compounds throughout the production process.
The services provided by this 503B Compounding Pharmacy are integral to the local healthcare infrastructure at 2160 W State Road 434, Longwood, FL 32779. By supplying hospitals, clinics, and physician offices with essential medications, the facility supports the broader medical community in delivering effective and safe patient care. The team at the 503B Compounding Pharmacy comprises highly trained pharmacists and technicians who are experts in the science of compounding, dedicated to upholding the strict regulations that govern an FDA-registered outsourcing facility.
For more information about the services available or to discuss your specific needs, you can contact the 503B Compounding Pharmacy directly. The team is available to provide detailed information and support to healthcare providers. Visit the website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
Being a 503B Compounding Pharmacy means this facility is an FDA-registered outsourcing facility that compounds medications in large volumes under strict federal regulations, specifically Section 503B of the FD&C Act. This ensures all preparations meet current Good Manufacturing Practices (cGMP) for heightened quality and safety.
2. Who can receive medications from the 503B Compounding Pharmacy at 2160 W State Road 434?
This 503B Compounding Pharmacy provides medications to healthcare professionals and entities, such as hospitals, clinics, and physician offices. Medications are not dispensed directly to individual patients at this location but are supplied to practitioners for office use or administration.
3. What types of medications does this 503B Compounding Pharmacy produce?
The 503B Compounding Pharmacy at this location produces a range of sterile and non-sterile compounded medications. This often includes preparations that are on the FDA drug shortage list or are necessary for patient treatment but are not available from standard commercial manufacturers.
4. How does the 503B Compounding Pharmacy ensure the quality of its compounds?
Quality is ensured through rigorous adherence to cGMP standards. This involves extensive testing of raw materials, in-process testing, and finished preparation testing for sterility, potency, and endotoxins. The facility environment is continuously monitored to prevent contamination.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place orders by contacting the 503B Compounding Pharmacy directly. For ordering information and to discuss specific medication needs, please call (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/.