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 from its location at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction in the pharmacy sector, setting this facility apart from traditional compounding pharmacies. As an outsourcing facility, 503B Compounding Pharmacy adheres to rigorous federal standards for current good manufacturing practices (cGMP), ensuring that every preparation is produced in a controlled, sterile environment with the highest level of quality assurance, consistency, and sterility testing. This commitment to excellence provides healthcare providers and patients at 2160 W State Road 434, Longwood, FL 32779 with a trusted source for medications that are often essential yet commercially unavailable.
The core service of 503B Compounding Pharmacy is the large-scale compounding of sterile medications. This process is conducted for office use, meaning the medications are prepared in bulk for physician offices, hospitals, and clinics, rather than for individual patient-specific prescriptions. Healthcare professionals serving the community at 2160 W State Road 434, Longwood, FL 32779 can reliably source essential injectable drugs, including hormone replacements, ophthalmics, dermatological injectables, and other critical care medications. By providing these vital preparations, 503B Compounding Pharmacy supports local medical practices by ensuring they have the necessary tools to treat their patients effectively, without the delays and shortages often associated with large pharmaceutical manufacturers.
Patients and providers who utilize the services of 503B Compounding Pharmacy benefit from the assurance of quality that comes with federal oversight. Every batch of medication is meticulously prepared and undergoes stringent testing to verify its potency, purity, and sterility before it is released for distribution. This level of quality control is a fundamental aspect of the 503B outsourcing facility model and is a primary reason healthcare providers at 2160 W State Road 434, Longwood, FL 32779 choose this pharmacy as their compounding partner. It mitigates risk and provides confidence in the medications administered within their practice.
Engaging with 503B Compounding Pharmacy is a streamlined process designed for healthcare facilities. Orders are managed professionally, and the team is dedicated to supporting the medical community with responsive service and reliable product availability. For more detailed information on available formulations or to initiate an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381 for immediate assistance, or inquiries can be directed through their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
This means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and operates in compliance with Section 503B of the FD&C Act. We adhere to strict current good manufacturing practices (cGMP) for the large-scale compounding of sterile medications, which includes rigorous testing for sterility, potency, and purity.
2. Can I, as an individual patient, get a prescription filled at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy operates as an outsourcing facility that compounds medications for office use by healthcare providers. We supply medications in bulk to physicians, clinics, and hospitals at 2160 W State Road 434, Longwood, FL 32779. Individual patients should have their prescriptions filled by a traditional 503A compounding pharmacy.
3. What types of medications does 503B Compounding Pharmacy prepare?
Our facility at 2160 W State Road 434, Longwood, FL 32779 specializes in compounding sterile injectable medications. This includes a wide range of preparations such as hormone therapy injections, peptides, ophthalmics, and other injectable solutions that are in high demand but may be in short supply from conventional manufacturers.
4. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 place an order?
Healthcare providers can place orders by contacting our facility directly. We can be reached by phone at (407)993-1381 to discuss specific needs and place orders. Providers can also find more information and contact forms on our website at https://503bcompoundingpharmacy.com/.
5. Why should a medical practice choose 503B Compounding Pharmacy as their supplier?
Medical practices choose our facility at 2160 W State Road 434, Longwood, FL 32779 because of our commitment to quality and compliance. As a 503B outsourcing facility, our processes and products meet elevated federal standards, providing assurance that the medications they administer to their patients are sterile, potent, and of the highest quality.