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 provide healthcare practitioners with access to critical medications that are often on shortage or unavailable from conventional manufacturers, directly supporting patient care from our specific location.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare providers. Physicians, surgeons, dermatologists, and other medical professionals serving patients in our community can utilize our services to ensure they have the necessary medications on hand for immediate administration during procedures, treatments, or appointments. By sourcing from our 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, practitioners can be confident in the integrity of the medications they use, as every batch undergoes rigorous testing and quality control processes mandated by the FDA.
Our state-of-the-art facility is designed to prevent contamination and ensure patient safety. The sterile compounding suites are maintained with strict environmental controls, and our processes are executed by highly trained pharmacists and technicians following current good manufacturing practices (cGMP). This level of operational excellence guarantees that every preparation leaving our pharmacy meets precise sterility, potency, and stability specifications. For healthcare providers at our location, this translates to reliable access to essential medications they can trust for their patients.
503B Compounding Pharmacy plays a vital role in mitigating drug shortages that can disrupt patient treatment plans. When commercially manufactured drugs become unavailable, our facility can step in to compound these necessary medications, preventing delays in care for the local patient population. We work closely with the medical community at 2160 W State Road 434, Longwood, FL 32779 to understand their needs and respond proactively to supply chain challenges, ensuring continuity of therapy and supporting positive health outcomes.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders directly with our facility for office-use medications. To discuss your practice's specific needs, inquire about our current product listings, or initiate an order, please contact us directly. We are here to serve the medical community from our location at 2160 W State Road 434, Longwood, FL 32779.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that this is a 503B compounding pharmacy?
It means our facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B. We compound medications in larger batches for office use by healthcare providers and adhere to stringent federal quality standards, including current good manufacturing practices (cGMP).
2. Who can order medications from 503B Compounding Pharmacy?
Our services are designed for licensed healthcare practitioners, including physicians, surgeons, and other medical professionals, who require office-use medications for their practice. Medications are dispensed for administration to patients within a clinical setting at 2160 W State Road 434, Longwood, FL 32779.
3. Does 503B Compounding Pharmacy serve individual patients directly?
No. As a 503B outsourcing facility, our primary function is to supply medications to healthcare providers for office use. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. We support providers so they can directly treat their patients.
4. How does ordering work for a local medical practice?
Healthcare providers at our location can contact 503B Compounding Pharmacy directly via phone to discuss available medications, place orders, and arrange for pickup or delivery to their practice at 2160 W State Road 434, Longwood, FL 32779.
5. Why should a provider choose a 503B outsourcing facility?
Choosing our 503B pharmacy ensures the medications you use in your practice meet the highest federal standards for safety, quality, and purity. This provides critical assurance for medications used in procedures and treatments, especially for products that are on national shortage.