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 facility is dedicated to the large-scale compounding of sterile and non-sterile medications. Unlike traditional pharmacies, a 503B outsourcing facility provides medications for office use by healthcare practitioners, meaning physicians and clinics at 2160 W State Road 434, Longwood, FL 32779 can obtain essential medications without needing a patient-specific prescription in hand for immediate administration.
The core function of 503B Compounding Pharmacy is to produce medications that are not commercially available or are in shortage. This is a critical service for the medical community at 2160 W State Road 434, Longwood, FL 32779, ensuring that healthcare providers have access to the necessary drugs to treat their patients effectively. By operating under strict FDA regulations, 503B Compounding Pharmacy adheres to Current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional 503A compounding pharmacies. This ensures a higher level of quality control, sterility assurance, and consistency in every batch of medication produced for practitioners at this location.
For healthcare professionals practicing at 2160 W State Road 434, Longwood, FL 32779, partnering with 503B Compounding Pharmacy offers significant advantages. The facility provides access to a reliable source of high-quality compounded medications that are essential for various procedures and treatments. This includes sterile injectables, ophthalmics, and other preparations that are often on national drug shortage lists. By sourcing from an FDA-registered 503B outsourcing facility, practitioners can be confident in the quality, safety, and identity of the medications they use in their practice, mitigating risk and enhancing patient care.
The team at 503B Compounding Pharmacy is comprised of skilled pharmacists, technicians, and quality assurance professionals who are dedicated to precision and excellence. Every process, from ingredient sourcing to final product testing, is meticulously documented and controlled. This unwavering commitment to compliance and quality makes 503B Compounding Pharmacy a trusted partner for the medical offices and clinics at 2160 W State Road 434, Longwood, FL 32779. Healthcare providers can focus on patient care with the confidence that their compounded medications are prepared to the highest possible standards.
To learn more about the services available or to place an order, healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381 or through their official website 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 U.S. Food and Drug Administration and compounds medications in accordance with Section 503B of the FD&C Act. We operate under stricter Current Good Manufacturing Practice (cGMP) regulations compared to traditional pharmacies, ensuring a higher standard of quality and safety for the medications we provide to healthcare practitioners.
2. Can I, as a patient, order medication directly from 503B Compounding Pharmacy?
No. As an outsourcing facility, 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Medications are supplied to physicians and clinics at 2160 W State Road 434, Longwood, FL 32779 for administration to patients within their practice. Patients must work directly with their healthcare provider to receive these medications.
3. What types of medications does 503B Compounding Pharmacy provide for practitioners?
503B Compounding Pharmacy specializes in compounding sterile injectable medications, including IV bags, syringes, and ophthalmics. We focus on producing drugs that are currently on shortage or are not available from commercial manufacturers, providing a critical supply for medical procedures and treatments at 2160 W State Road 434, Longwood, FL 32779.
4. How does a healthcare provider at this location place an order?
Healthcare providers and clinics at 2160 W State Road 434, Longwood, FL 32779 can place orders for office-use medications by contacting our facility directly. You can call us at (407)993-1381 to speak with a representative or visit our website at https://503bcompoundingpharmacy.com/ for more information on our ordering process.
5. Why should a practitioner at 2160 W State Road 434 choose your facility?
Choosing 503B Compounding Pharmacy ensures you are sourcing medications from an FDA-registered facility that adheres to the highest cGMP standards. This provides assurance of product quality, sterility, and purity, which is essential for patient safety and effective treatment outcomes within your practice at this specific location.