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 is a critical distinction, setting this 503B Compounding Pharmacy apart from traditional compounding pharmacies. This operational status under Section 503B means the facility adheres to heightened current good manufacturing practices (cGMP), which are the same rigorous standards followed by conventional pharmaceutical manufacturers. The 503B Compounding Pharmacy model ensures that medications are produced in a controlled, sterile environment with extensive quality control testing for strength, sterility, and stability.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) for office use. Healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 and throughout the region can utilize the services of this 503B Compounding Pharmacy to access a reliable supply of essential medications. The 503B Compounding Pharmacy provides these preparations for non-patient-specific administration within professional practice settings, including hospitals, clinics, surgical centers, and veterinary offices. By sourcing from a 503B Compounding Pharmacy, healthcare providers can be assured of receiving medications that have been produced under the most stringent quality and safety protocols mandated by federal law.
Patients and practitioners engaging with this 503B Compounding Pharmacy benefit from its commitment to quality and safety inherent in the 503B model. The 503B Compounding Pharmacy team comprises skilled pharmacists and technicians who are experts in sterile compounding techniques. Every process at the 503B Compounding Pharmacy, from ingredient sourcing to final packaging, is meticulously documented and validated. This unwavering dedication to cGMP standards at this 503B Compounding Pharmacy mitigates risk and provides a trusted source for critical medications, helping to alleviate drug shortages and supply chain issues for the medical community.
To learn more about the specific sterile preparations available or to inquire about how this 503B Compounding Pharmacy can support your practice, please contact the facility directly. The 503B Compounding Pharmacy can be reached by phone at (407)993-1381. Detailed information about the 503B Compounding Pharmacy, its compliance standards, and its service offerings is also available online at 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 follows current good manufacturing practices (cGMP) for large-scale production of sterile medications for office use by healthcare providers.
2. As a patient, can I get my personal prescriptions filled at this 503B Compounding Pharmacy?
No. This 503B Compounding Pharmacy primarily produces non-patient-specific medications for office use. Patients should contact a traditional compounding pharmacy for individual prescriptions. This 503B Compounding Pharmacy supplies practitioners, not the general public directly.
3. Who can order from this 503B Compounding Pharmacy?
Healthcare practitioners and institutions, such as hospitals, clinics, surgical centers, and veterinary practices, can order from this 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779. Orders are for administering to patients within their professional practice setting.
4. How does the 503B Compounding Pharmacy ensure medication safety?
This 503B Compounding Pharmacy adheres to strict cGMP standards. This includes rigorous testing of ingredients for potency and purity, validated sterile compounding processes, environmental monitoring, and final product testing for sterility and stability before release.
5. How do I contact this 503B Compounding Pharmacy?
You can contact the 503B Compounding Pharmacy by calling (407)993-1381. Additional information about this 503B Compounding Pharmacy is available on its website at https://503bcompoundingpharmacy.com/.