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 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical quality and safety for patients and healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and non-sterile preparations. Unlike a traditional pharmacy, this 503B Compounding Pharmacy manufactures these medications in advance of receiving a patient-specific prescription. This allows the 503B Compounding Pharmacy to supply healthcare facilities with essential medications that are often in short supply. The 503B Compounding Pharmacy’s operations are subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, ensuring every preparation from the 503B Compounding Pharmacy meets exacting standards for potency, purity, and sterility.
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can rely on this 503B Compounding Pharmacy for a consistent supply of high-quality medications. The 503B Compounding Pharmacy provides a critical service by mitigating drug shortages, offering alternatives to discontinued drugs, and producing necessary formulations that are not commercially available. The 503B Compounding Pharmacy’s commitment to cGMP means every batch is produced under controlled conditions, with extensive documentation and testing protocols in place. This provides an added layer of safety and assurance for every medication that leaves the 503B Compounding Pharmacy.
Patients in Longwood benefit indirectly from the services of the 503B Compounding Pharmacy. The medications prepared by the 503B Compounding Pharmacy are distributed to hospitals, clinics, and physician offices, where they are administered to patients under professional medical care. The presence of an FDA-registered 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 enhances the local healthcare infrastructure by ensuring medical professionals have access to the vital medications they need to treat their patients effectively and safely.
The team at the 503B Compounding Pharmacy comprises highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Their expertise is dedicated to upholding the strict protocols required of a 503B Compounding Pharmacy. For inquiries regarding the services of this 503B Compounding Pharmacy, please contact the facility directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. More detailed information about the 503B Compounding Pharmacy and its compliance standards can be found on the official website: https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections, ensuring the highest quality and safety standards for its compounded medications.
2. Can I walk into the 503B Compounding Pharmacy with my prescription?
No. A 503B Compounding Pharmacy does not typically serve individual walk-in patients with personal prescriptions. This 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 manufactures medications in large batches for healthcare facilities like hospitals, clinics, and doctor's offices within the community.
3. How does the 503B Compounding Pharmacy benefit local healthcare?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides a vital service to the local medical community by producing essential medications, alleviating drug shortages, and supplying sterile preparations that are not commercially available to area healthcare providers.
4. Who can order medications from this 503B Compounding Pharmacy?
Medications produced at this 503B Compounding Pharmacy are supplied to healthcare facilities and practitioners. Orders are placed by authorized medical personnel from institutions that have an established account with the 503B Compounding Pharmacy.
5. How can I contact this 503B Compounding Pharmacy?
You can contact the 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779 by calling (407)993-1381. For more comprehensive information, you can also visit the website for this 503B Compounding Pharmacy at https://503bcompoundingpharmacy.com/.