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 designation as a 503B outsourcing facility differentiates this pharmacy from traditional compounding pharmacies, as it signifies adherence to the highest level of federal regulation, which includes current Good Manufacturing Practices (cGMP). The 503B Compounding Pharmacy provides healthcare practitioners with access to a reliable source of high-quality, compounded medications that are essential for patient care.
The core function of the 503B Compounding Pharmacy is the large-scale compounding of sterile and non-sterile medications. This 503B Compounding Pharmacy prepares these medications for office use, allowing healthcare providers at 2160 W State Road 434, Longwood, FL 32779 to maintain an inventory of necessary drugs for immediate administration to patients. The 503B Compounding Pharmacy does not typically provide medications directly to individual patients based on a prescription, but rather supplies them in bulk to hospitals, clinics, and physician practices. The operations at this 503B Compounding Pharmacy are subject to rigorous FDA oversight, which includes routine inspections to ensure the sterility, potency, and purity of all preparations.
By operating under Section 503B, this 503B Compounding Pharmacy can address critical drug shortages by compounding medications that are identified on the FDA's drug shortage list. This vital service ensures that medical professionals at 2160 W State Road 434, Longwood, FL 32779 have continued access to essential Compounding Pharmacy’s commitment to cGMP standards provides an additional layer of safety and quality assurance for the healthcare community it serves.
The team at the 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 consists of highly trained pharmacists, pharmacy technicians, and quality assurance professionals. Their collective expertise is dedicated to the precise and accurate compounding of medications. Every batch produced by the 503B Compounding Pharmacy undergoes stringent quality control testing before it is released for distribution, ensuring that every product meets its defined specifications for identity, strength, quality, and purity.
For healthcare facilities and practitioners seeking a trusted partner for their medication needs, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a commitment to excellence, safety, and reliability. To learn more about the services provided by this 503B Compounding Pharmacy or to inquire about becoming a client, please contact them directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381 or through their 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 medications in large volumes under Section 503B of the Federal Food, Drug, and Cosmetic Act. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 adheres to current Good Manufacturing Practices (cGMP) and is subject to regular FDA inspections.
2. Can I, as an individual patient, get a prescription filled at this 503B Compounding Pharmacy?
No. The 503B Compounding Pharmacy primarily supplies compounded medications for office use by healthcare practitioners. Individual patients should contact a traditional 503A compounding pharmacy for prescription services.
3. What types of medications does this 503B Compounding Pharmacy produce?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 compounds both sterile and non-sterile medications in bulk quantities. These are supplied to hospitals, clinics, and physician offices for use within their practice.
4. How does the 503B Compounding Pharmacy help during a drug shortage?
When a drug appears on the FDA's shortage list, this 503B Compounding Pharmacy is authorized to compound that medication, helping to ensure local healthcare providers at 2160 W State Road 434, Longwood, FL 32779 maintain access for their patients.
5. How can a healthcare practice at this location order from the 503B Compounding Pharmacy?
Healthcare practices and facilities can contact the 503B Compounding Pharmacy directly to establish an account and discuss their specific needs. You can reach them at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for more information.