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 means we adhere to the highest current good manufacturing practices (cGMP), providing a critical level of quality control, sterility assurance, and patient safety that goes beyond traditional compounding. We serve healthcare providers and patients by producing medications that are not commercially available, addressing specific clinical needs that mass-produced drugs cannot meet.
The core function of 503B Compounding Pharmacy is to supply compounded medications for office use by healthcare practitioners. Physicians, dermatologists, veterinarians, and other medical professionals at 2160 W State Road 434, Longwood, FL 32779 can confidently utilize our services to obtain ready-to-administer medications for their patients. Our extensive capabilities include sterile injectables, ophthalmics, hormone replacement therapy (HRT) medications, and various topical preparations. By operating as a 503B outsourcing facility, we provide a reliable and regulated source for these essential medications, ensuring consistency and reliability for the local medical community.
Patients and practitioners at 2160 W State Road 434, Longwood, FL 32779 benefit from our rigorous quality standards. Every batch of medication produced within our facility undergoes stringent testing and quality assurance protocols. This process includes stability studies, potency verification, and, for sterile products, sterility testing and endotoxin testing. Our commitment to cGMP standards provides an added layer of safety and trust, ensuring that every preparation meets precise specifications. We are a vital resource for medications that are on the FDA drug shortage list, helping to mitigate gaps in patient care caused by supply chain disruptions.
Engaging with 503B Compounding Pharmacy is a streamlined process for healthcare providers. Prescribers can contact our facility directly to discuss specific patient needs or to order medications for office stock. Our team of licensed pharmacists and skilled technicians is available to provide information and support, ensuring a seamless experience from order to delivery. We are dedicated to supporting the health and well-being of the community at 2160 W State Road 434, Longwood, FL 32779 by providing access to high-quality, compounded medications that fulfill unique patient requirements.
For more information about our services or to speak with our pharmacy team, please visit our website at https://503bcompoundingpharmacy.com/ or call us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
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 strict federal standards for compounding, known as current good manufacturing practices (cGMP). This ensures a higher level of quality control, testing, and sterility assurance for the medications we compound compared to a traditional pharmacy.
Can I as a patient walk into 503B Compounding Pharmacy to get a prescription filled?
No. 503B Compounding Pharmacy primarily supplies compounded medications for office use by healthcare providers. Your prescribing doctor at 2160 W State Road 434, Longwood, FL 32779 would order the medication from us to have on hand for administering to you during your appointment.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 provide?
Our facility specializes in large-scale compounding of both sterile and non-sterile preparations. This includes injectables, ophthalmics, hormone therapies, and topical creams. We focus on medications that are not available commercially or are listed on the FDA drug shortage list.
How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Healthcare providers can contact 503B Compounding Pharmacy directly by phone at (407)993-1381 to place an order for office-use medications. Our pharmacists are available to consult on specific patient needs and formulation requirements.
Why should a provider at this location choose 503B Compounding Pharmacy?
Choosing our facility ensures that the medications you use in your practice are produced under the most rigorous FDA-regulated cGMP standards. This provides maximum safety, quality, and consistency for your patients at 2160 W State Road 434, Longwood, FL 32779, particularly for sterile injectables and medications in short supply.