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.
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 current Good Manufacturing Practices (cGMP), which are the highest standards for quality and safety in pharmaceutical production. This ensures that every preparation leaving the facility meets stringent specifications for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy is to provide healthcare providers with access to medications that are not commercially available. This includes producing formulations without certain allergens like dyes or preservatives, creating specific dosage strengths that are discontinued by major manufacturers, or compounding a medication into a more accessible form, such as a liquid suspension for patients who cannot swallow pills. The team at the 503B Compounding Pharmacy location at 2160 W State Road 434, Longwood, FL 32779 works directly with physicians, hospitals, and clinics to fulfill these specific patient needs.
Patients and prescribers who utilize the services of this 503B Compounding Pharmacy can have confidence in the quality of the medications. The facility undergoes regular FDA inspections and is subject to strict quality control protocols. This level of oversight provides an additional layer of safety and reliability compared to traditional pharmacy compounding. For healthcare providers seeking a trusted source for compounded medications for their patients, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a vital resource.
To learn more about the services available or to speak with a representative, you can contact 503B Compounding Pharmacy directly. The phone number is (407)993-1381. Additional information can also be found on their website at .
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
Being a 503B Compounding Pharmacy means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility. We operate under the highest manufacturing standards (cGMP) and are subject to federal oversight, ensuring the medications we compound meet rigorous quality and safety protocols.
2. Can I walk into the 503B Compounding Pharmacy to get a prescription filled?
No, 503B Compounding Pharmacy primarily operates on a bulk basis for healthcare facilities and providers. Medications are compounded based on orders from physicians, hospitals, and clinics. Patients should have their prescriber contact our facility at 2160 W State Road 434, Longwood, FL 32779 to initiate an order.
3. What kinds of medications does this 503B Compounding Pharmacy prepare?
Our 503B Compounding Pharmacy specializes in preparing medications that are not commercially available. This includes creating specific dosage forms, altering strengths, or removing allergens as prescribed by a healthcare provider to meet the unique needs of their patients.
4. How does the quality at a 503B Compounding Pharmacy differ?
As an FDA-registered 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we follow current Good Manufacturing Practices (cGMP). This involves extensive testing, environmental monitoring, and validation processes that exceed the standards of traditional compounding, providing an extra layer of quality assurance.
5. How can my medical practice start ordering from your facility?
Healthcare providers interested in our services can contact 503B Compounding Pharmacy directly at (407)993-1381. Our team will provide information on our ordering process, available formulations, and how we can support your patient care needs from our location at 2160 W State Road 434, Longwood, FL 32779.