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 503B Compounding Pharmacy specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially. As a 503B outsourcing facility, 503B Compounding Pharmacy adheres to stringent federal quality standards, including current Good Manufacturing Practices (cGMP), providing an essential service for healthcare providers and patients at 2160 W State Road 434, Longwood, FL 32779.
The primary function of 503B Compounding Pharmacy is to produce medications in larger batches for office use by healthcare practitioners or for distribution to hospitals and clinics. The medications prepared by 503B Compounding Pharmacy are crucial in situations where a commercially manufactured drug is on shortage, discontinued, or not appropriate for a patient's specific clinical needs. By operating as a 503B outsourcing facility, 503B Compounding Pharmacy ensures that healthcare professionals at 2160 W State Road 434, Longwood, FL 32779 have access to high-quality, compounded medications when they are needed most.
Patients and practitioners visiting 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from the rigorous protocols inherent to an FDA-registered 503B outsourcing facility. Every batch of medication produced by 503B Compounding Pharmacy undergoes thorough testing and quality control checks. This commitment to quality at 503B Compounding Pharmacy provides an added layer of safety and reliability for the medications dispensed from this location. The team at 503B Compounding Pharmacy is dedicated to upholding the highest standards of pharmaceutical compounding.
For healthcare providers seeking a reliable source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 serves as a critical partner. The services provided by this 503B Compounding Pharmacy help ensure continuity of care by mitigating drug shortages and supplying essential medications. To learn more about the services offered by this 503B outsourcing facility or to inquire about specific medications, you can visit the website at https://503bcompoundingpharmacy.com/ or contact the pharmacy directly by phone at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires 503B Compounding Pharmacy to adhere to current Good Manufacturing Practices (cGMP), which are more rigorous than the standards for traditional compounding pharmacies, ensuring a higher level of quality and safety for the medications produced.
Can I, as a patient, walk into 503B Compounding Pharmacy to get a prescription filled?
503B Compounding Pharmacy primarily compounds medications in large batches for healthcare providers for office use or for distribution to hospitals. Prescriptions for individual patients are typically dispensed through their prescribing healthcare provider who sources medications from 503B Compounding Pharmacy. Patients should contact their provider or 503B Compounding Pharmacy at (407)993-1381 for specific guidance related to their medication needs at 2160 W State Road 434, Longwood, FL 32779.
What types of medications does 503B Compounding Pharmacy at 2160 W State Road 434 produce?
503B Compounding Pharmacy specializes in compounding medications that are on a national drug shortage list or are otherwise unavailable from commercial manufacturers. This includes both sterile injectable and non-sterile preparations. The specific medications available from 503B Compounding Pharmacy can change based on current shortages and demand from the healthcare community served by this location.
How does 503B Compounding Pharmacy ensure the sterility of its injectable medications?
As an FDA-registered 503B outsourcing facility, 503B Compounding Pharmacy follows strict cGMP protocols for sterile compounding. This includes using validated sterilization processes, conducting environmental monitoring of cleanrooms, and performing rigorous testing on finished products to ensure sterility and potency. These procedures are central to the operation of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779.
How can a healthcare provider at 2160 W State Road 434 order from 503B Compounding Pharmacy?
Healthcare providers can contact 503B Compounding Pharmacy directly to discuss their needs and place orders. The pharmacy can be reached by phone at (407)993-1381. More information about the ordering process and available medications can also be found on the 503B Compounding Pharmacy website at https://503bcompoundingpharmacy.com/.