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 pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The operations at this specific 503B Compounding Pharmacy location are conducted under the rigorous oversight of the U.S. Food and Drug Administration, ensuring the highest standards of quality, sterility, and potency for every preparation that leaves the facility.
The core mission of this 503B Compounding Pharmacy is to provide healthcare providers with access to essential medications, particularly those experiencing shortages or discontinuations. By functioning as a 503B outsourcing facility, this 503B Compounding Pharmacy can proactively compound and hold inventory of critical medications, allowing for immediate availability when a practitioner identifies a patient need. This capability is central to the service provided by the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, supporting the local medical community with reliable access to necessary drugs. The 503B Compounding Pharmacy adheres to current Good Manufacturing Practices (cGMP), which are more stringent than the standards applied to traditional 503A compounding pharmacies, providing an additional layer of safety and consistency for all preparations.
Patients and practitioners engaging with this 503B Compounding Pharmacy benefit from the assurance that comes with FDA registration and inspection. Every batch of medication produced is subject to robust quality control testing, including sterility testing, endotoxin testing, and potency verification. The 503B Compounding Pharmacy’s commitment to these protocols ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize these medications for their patients. The 503B Compounding Pharmacy does not provide medications directly to the public on an individual patient-specific basis; instead, it supplies medications in bulk to medical facilities and practices for office use. For more detailed information about the specific services and available preparations, please contact the 503B Compounding Pharmacy directly at (407)993-1381 or visit the official website at https://503bcompoundingpharmacy.com/.
FAQ
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that compounds large volumes of sterile medications for office use by healthcare practitioners. This 503B Compounding Pharmacy operates under federal oversight and follows current Good Manufacturing Practices (cGMP).
2. Can I, as a patient, order my prescriptions directly from this 503B Compounding Pharmacy?
No. A 503B Compounding Pharmacy supplies medications in bulk for office use to healthcare facilities and practices. Your healthcare provider at their office on 2160 W State Road 434, Longwood, FL 32779 would utilize medications from this 503B Compounding Pharmacy for administering to patients during appointments.
3. How does the 503B Compounding Pharmacy ensure the safety of its medications?
This 503B Compounding Pharmacy is subject to FDA inspection and must comply with strict cGMP standards. This includes rigorous environmental monitoring, validated processes, and extensive testing of finished preparations for sterility, potency, and purity before they are released.
4. What is the primary advantage of a healthcare provider using a 503B Compounding Pharmacy?
The primary advantage is reliable access to high-quality, compounded medications, especially those on drug shortage lists. This allows providers at 2160 W State Road 434, Longwood, FL 32779 to have essential medications immediately available for patient procedures and treatments without delay.
5. How can a medical practice at this location order from the 503B Compounding Pharmacy?
Healthcare practices and facilities can initiate orders by contacting the 503B Compounding Pharmacy directly via the phone number (407)993-1381. More information for providers is also available on the website at https://503bcompoundingpharmacy.com/.