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. This 503B Compounding Pharmacy is situated at 2160 W State Road 434, Longwood, FL 32779. The 503B Compounding Pharmacy model represents a significant advancement in the compounding field, adhering to the highest standards of pharmaceutical production. As a 503B outsourcing facility, this 503B Compounding Pharmacy is subject to rigorous FDA oversight, including current Good Manufacturing Practice (cGMP) regulations, which are the same standards applied to major pharmaceutical manufacturers. This ensures that every preparation leaving the 503B Compounding Pharmacy meets exceptional standards of quality, purity, and potency.
The core function of this 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) that are distributed to healthcare providers for office use. The 503B Compounding Pharmacy provides these medications to physician practices, hospitals, clinics, and other healthcare providers serving the local community at 2160 W State Road 434, Longwood, FL 32779. By operating as a 503B Compounding Pharmacy, the facility can compound medications in larger volumes before a patient-specific prescription is received, which is essential for healthcare providers who need to have critical medications readily available for immediate administration to patients. The 503B Compounding Pharmacy plays a vital role in mitigating drug shortages by providing a reliable source of essential medications that may be unavailable or discontinued by commercial manufacturers.
Patients benefit indirectly from the services of this 503B Compounding Pharmacy through their trusted healthcare providers. When a physician at a local clinic uses a medication sourced from this 503B Compounding Pharmacy, the patient receives a product of the highest integrity. The 503B Compounding Pharmacy’s commitment to cGMP standards means every batch is meticulously produced, tested, and documented. This process at the 503B Compounding Pharmacy includes stringent environmental monitoring, validation of sterilizing equipment, and stability testing to assign appropriate beyond-use dates. For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, partnering with this 503B Compounding Pharmacy means accessing a dependable supply of high-quality compounded medications while mitigating the risks associated with in-office compounding.
The team at this 503B Compounding Pharmacy comprises highly skilled pharmacists, pharmacy technicians, and quality assurance professionals dedicated to the mission of patient safety. The 503B Compounding Pharmacy leverages advanced technology and sterile compounding techniques within its controlled environment to ensure patient safety is never compromised. The 503B Compounding Pharmacy is a pivotal resource for the local medical community, reinforcing the infrastructure of patient care. For more information about the specific services available from this 503B Compounding Pharmacy, healthcare providers are encouraged to visit the website at https://503bcompoundingpharmacy.com/ or contact the facility directly at (407)993-1381.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this facility is a 503B Compounding Pharmacy?
This designation means our facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. As a 503B Compounding Pharmacy, we adhere to current Good Manufacturing Practices (cGMP) and are subject to FDA inspection, ensuring the highest level of quality and safety for the compounded sterile preparations we produce.
2. Can I, as an individual patient, get a prescription filled directly at this 503B Compounding Pharmacy?
No. A 503B Compounding Pharmacy primarily distributes compounded medications to healthcare providers for "office use." This means we supply medications in bulk to physicians, hospitals, and clinics at 2160 W State Road 434, Longwood, FL 32779, who then administer them to their patients within their practice. Patients must receive these medications through their healthcare provider.
3. What kinds of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy specializes in producing large-scale batches of compounded sterile preparations (CSPs). This often includes hormone injections, ophthalmics, injectable antibiotics, and other medications that are in shortage or are not commercially available. All products from this 503B Compounding Pharmacy are prepared for administration by medical professionals.
4. How does the 503B Compounding Pharmacy ensure the quality of its products?
Quality is paramount at this 503B Compounding Pharmacy. Our processes include rigorous testing of components, environmental monitoring of our cleanrooms, validation of sterilization equipment, and thorough end-product testing. As a 503B Compounding Pharmacy, we are required to report adverse events and provide the FDA with a list of the medications we compound, ensuring full transparency and accountability.
5. How can a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your 503B Compounding Pharmacy?
Healthcare providers can initiate the process by contacting our 503B Compounding Pharmacy directly. We encourage providers to visit our website at https://503bcompoundingpharmacy.com/ for more detailed information or to call us at (407)993-1381 to speak with a representative about establishing an account and discussing specific medication needs.