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, distinct from traditional compounding pharmacies. The primary mission of 503B Compounding Pharmacy is to provide healthcare providers with access to high-quality, compounded medications that are essential for patient care, particularly when commercially manufactured drugs are unavailable, discontinued, or do not meet specific patient needs.
The services provided at the 2160 W State Road 434, Longwood, FL 32779 location are defined by its regulatory designation. This includes the compounding of medications in bulk for office use by healthcare practitioners. Physicians, surgeons, dermatologists, and other medical professionals can rely on 503B Compounding Pharmacy for a consistent supply of sterile injectables, ophthalmics, and other preparations necessary for their practice. All products are created in a controlled environment following current Good Manufacturing Practices (cGMP), which ensures each batch meets strict specifications for potency, purity, and sterility. This level of quality assurance provides practitioners with confidence in the medications they administer to their patients.
503B Compounding Pharmacy serves a critical role in the local healthcare ecosystem at 2160 W State Road 434, Longwood, FL 32779. By supplying healthcare facilities and practices with essential medications, it supports the community's medical providers in delivering effective and personalized treatment options. The facility's commitment to compliance, safety, and reliability makes it a trusted partner for practitioners who require compounded pharmaceuticals that are not readily available through standard commercial channels. For more information or to inquire about services, please contact 503B Compounding Pharmacy directly at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
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 compounds medications in accordance with Section 503B of the FD&C Act. We operate under current Good Manufacturing Practices (cGMP), which involve rigorous quality control, testing, and reporting standards that exceed those of traditional compounding pharmacies.
Who can order medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Our services are designed for healthcare practitioners for office use. Medications compounded at our Longwood location are supplied to physicians, hospitals, clinics, and other healthcare providers to administer to patients within their practice. We do not typically dispense medications directly to individual patients.
What types of medications does 503B Compounding Pharmacy produce?
As a 503B outsourcing facility, we specialize in the large-scale compounding of both sterile and non-sterile preparations. This includes, but is not limited to, sterile injectables, ophthalmics, and other dosage forms that are essential for healthcare providers practicing at or near 2160 W State Road 434, Longwood, FL 32779.
How does the quality assurance at a 503B outsourcing facility benefit healthcare providers?
The cGMP standards enforced at our location ensure every batch of medication is tested for sterility, potency, and endotoxins. This provides healthcare providers with the assurance that the medications they receive from us are of consistently high quality and purity, reducing risk and enhancing patient safety.
How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers interested in our services can initiate the process by contacting 503B Compounding Pharmacy directly. Please call us at (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more detailed information on our ordering procedures and available formulations.