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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our unwavering commitment to the highest standards of quality, safety, and consistency, exceeding the requirements of traditional compounding. We serve the specific needs of healthcare providers and their patients by producing medications that are not commercially available or are in shortage.
The core function of 503B Compounding Pharmacy is the production of medications for office use. This means we provide physicians, surgeons, and other healthcare practitioners with essential medications that they can keep on hand at their practices for immediate administration to patients. By operating as a 503B outsourcing facility, we adhere to rigorous current Good Manufacturing Practices (cGMP), which include extensive testing of components and finished products, robust quality control procedures, and detailed reporting of adverse events. This level of oversight provides an additional layer of safety and assurance for the medical community we serve.
Our location at 2160 W State Road 434, Longwood, FL 32779 is a state-of-the-art facility designed for precision and sterility. We specialize in compounding a wide array of preparations, including sterile injectables, ophthalmics, and other dosage forms that are critical for patient care. The team at 503B Compounding Pharmacy consists of highly skilled pharmacists and technicians who utilize advanced technology and proven methodologies to ensure every preparation meets exact specifications. We are a vital partner to local healthcare providers, helping to ensure they have reliable access to the necessary medications to treat their patients effectively.
For healthcare providers seeking a trusted source for high-quality compounded medications, 503B Compounding Pharmacy is the definitive choice. We invite you to learn more about our services and our commitment to excellence. You can reach us by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
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 FDA and complies with stricter federal standards under Section 503B. We follow current Good Manufacturing Practices (cGMP), which involve rigorous testing, quality control, and adverse event reporting, providing a higher level of assurance than traditional compounding pharmacies.
2. Can I, as a patient, order medication directly from 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Your physician, surgeon, or other healthcare provider will order and keep our compounded medications at their practice for administration to you during your appointments and procedures.
3. What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 typically produce?
Our facility specializes in producing large batches of sterile injectable medications, ophthalmics, and other preparations that are often on drug shortage lists or are not commercially available. These are provided in ready-to-use formats for healthcare providers.
4. How does a healthcare provider at 2160 W State Road 434 place an order with your facility?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. Our team will guide them through the ordering process, which is designed for medical practices and institutions.
5. Why would a healthcare provider choose 503B Compounding Pharmacy over other compounders?
Healthcare providers choose our facility because of our 503B outsourcing designation, which guarantees adherence to the highest federal quality and safety standards. This provides them with confidence in the medications they use to treat their patients at their practice.