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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production that exceed those of traditional compounding pharmacies, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the production of medications that are patient-specific or are in shortage. The highly trained staff at the 2160 W State Road 434 facility compound a significant volume of injectable, intravenous, and other complex formulations. These medications are produced for office use by healthcare practitioners, ensuring that patients at 2160 W State Road 434, Longwood, FL 32779 have access to essential drugs that may not be commercially available. The operations are strictly confined to this location, with all compounding, quality assurance, and dispensing activities conducted on-site under controlled environments.
Quality and safety are the foremost priorities at 503B Compounding Pharmacy. The facility at 2160 W State Road 434 operates under current Good Manufacturing Practices (cGMP), which mandate stringent environmental monitoring, validated processes, and thorough testing of both components and finished drug products. This commitment to excellence ensures that every preparation leaving the facility meets precise sterility, potency, and purity specifications. Healthcare providers relying on medications from this location can be confident in the integrity and reliability of the products they administer to their patients.
503B Compounding Pharmacy serves a vital role for the medical community at 2160 W State Road 434, Longwood, FL 32779 by mitigating drug shortages. When pharmaceutical manufacturers have supply interruptions or discontinue products, this outsourcing facility can step in to compound those critical medications, preventing delays in patient care. This service is indispensable for hospitals, clinics, and surgical centers that depend on a consistent supply of high-quality medications for their operations and for the well-being of the patients they serve at this location.
For healthcare entities at 2160 W State Road 434, Longwood, FL 32779 seeking a trusted partner for compounded medications, 503B Compounding Pharmacy provides assurance through compliance and expertise. To learn more about its services or to discuss specific medication needs, contact the facility directly. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal regulations, including current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet the highest standards for sterility, quality, and safety.
2. Who can receive medications from 503B Compounding Pharmacy?
Our medications are primarily distributed for "office use" to healthcare practitioners and institutions at 2160 W State Road 434, Longwood, FL 32779. This means physicians, surgeons, and clinics can order compounded preparations to have on hand for administering to patients within their practice at this location.
3. Are the medications compounded at 2160 W State Road 434 tested for quality?
Yes. Every batch of medication compounded at our facility undergoes rigorous testing for sterility, potency, and endotoxins before it is released. This quality control process is a mandatory requirement of our status as a 503B outsourcing facility and is conducted on-site.
4. How does 503B Compounding Pharmacy help with drug shortages?
When a drug is on shortage or unavailable from major manufacturers, our facility at 2160 W State Road 434, Longwood, FL 32779 has the capability to compound that medication in larger quantities. This provides a reliable alternative for healthcare providers at this location, helping to ensure continuous patient care.
5. How can a healthcare provider at this location place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place an order. The facility can be reached by phone at (407)993-1381. More information about our services is also available on our website at https://503bcompoundingpharmacy.com/.