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 purity, exceeding the requirements of a traditional compounding pharmacy. We serve healthcare providers and patients by providing essential medications that are often unavailable through conventional commercial channels.
The core mission of 503B Compounding Pharmacy is to ensure a reliable supply of high-quality compounded medications for the local medical community. By operating as a 503B outsourcing facility, we adhere to Current Good Manufacturing Practices (cGMP), which are the strict quality standards enforced by the FDA for drug manufacturers. This involves rigorous testing of raw materials, state-of-the-art environmental controls in our cleanrooms, and meticulous quality assurance procedures for every batch of medication we produce. Patients and practitioners at 2160 W State Road 434, Longwood, FL 32779 can have complete confidence in the integrity of every preparation that leaves our facility.
Our services are specifically tailored to meet the needs of healthcare providers. 503B Compounding Pharmacy provides medications for office use, allowing physicians, dermatologists, veterinarians, and other practitioners to have vital drugs readily available for immediate administration to their patients. This eliminates delays in treatment and ensures that therapeutic protocols can be followed without interruption. The medications compounded at our 2160 W State Road 434 location are critical for a wide range of treatments, including hormone replacement therapy, pain management, ophthalmology, and dermatology.
Accessing the services of 503B Compounding Pharmacy is a streamlined process for medical professionals. Orders are placed directly by the prescribing practitioner or their authorized staff. Our team of licensed pharmacists and skilled technicians works diligently to compound each medication with precision. We are committed to providing exceptional service and support to the healthcare providers who rely on our 2160 W State Road 434, Longwood, FL 32779 facility for their patients' medication needs.
For more information about our services or to speak with our team, please contact 503B Compounding Pharmacy directly. You can reach us by phone at (407)993-1381 or visit our website to learn more about our compliance and quality standards 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 stringent Current Good Manufacturing Practices (cGMP). This ensures the medications we compound meet the highest federal standards for quality, sterility, and strength, providing an extra layer of safety and reliability.
2. Can I, as a patient, order medication directly from 503B Compounding Pharmacy?
No. As a 503B outsourcing facility, we provide medications for office use to licensed healthcare providers. Your physician or other prescribing practitioner will order the medication from our facility at 2160 W State Road 434, Longwood, FL 32779 for your treatment.
3. How do I know if my medication was compounded at your specific facility?
Your healthcare provider can confirm the source of your medication. All preparations from our 2160 W State Road 434, Longwood, FL 32779 location are labeled with our facility's information, including our name, address, and lot number for full traceability.
4. What types of medications does 503B Compounding Pharmacy typically prepare?
Our 503B compounding pharmacy specializes in producing large batches of sterile injectables, ophthalmics, and other non-sterile preparations that are commonly used by healthcare providers in clinical practice, all from our location at 2160 W State Road 434, Longwood, FL 32779.
5. How can a healthcare provider at your location place an order?
Medical practices can contact 503B Compounding Pharmacy directly at (407)993-1381 to establish an account and place orders. Our team at 2160 W State Road 434, Longwood, FL 32779 will guide you through the simple ordering process.