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 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 provides a critical service by producing large batches of compounded sterile preparations (CSPs) for office use by healthcare practitioners. The core function of this 503B Compounding Pharmacy is to supply physician offices, hospitals, and clinics with essential medications that are not readily available from traditional manufacturers, ensuring that medical professionals at 2160 W State Road 434, Longwood, FL 32779 have the necessary tools for patient care.
The operations at this 503B Compounding Pharmacy are held to the highest standards of pharmaceutical compounding. As an FDA-registered 503B outsourcing facility, this 503B Compounding Pharmacy adheres to rigorous current good manufacturing practices (cGMP), which far exceed the standards applied to traditional compounding. This ensures that every medication produced at 2160 W State Road 434, Longwood, FL 32779 meets stringent requirements for sterility, potency, and purity. The 503B Compounding Pharmacy model provides healthcare providers with a reliable and compliant source for medications that are often in short supply or discontinued.
Healthcare practitioners who utilize the services of this 503B Compounding Pharmacy benefit from the assurance of working with an FDA-registered entity. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is subject to regular FDA inspections, providing an additional layer of safety and quality control. This 503B Compounding Pharmacy is dedicated to supporting the local medical community by delivering high-quality, compounded medications in a timely and efficient manner, directly contributing to enhanced patient outcomes in the area.
For more information about the services provided or to inquire about how this 503B Compounding Pharmacy can support your practice, please contact the facility directly. The team at this 503B Compounding Pharmacy is ready to assist you. You can reach them at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for further details. 503B Compounding Pharmacy is your trusted, local FDA-registered outsourcing facility at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions for 503B Compounding Pharmacy
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA as an outsourcing facility under Section 503B of the FD&C Act. This 503B Compounding Pharmacy operates under stricter cGMP standards compared to traditional compounding pharmacies, focusing on producing large batches of medications for office use by healthcare providers.
Who can order from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy provides its compounded medications exclusively to healthcare practitioners for office use. Orders are placed by physicians, hospitals, clinics, and other healthcare entities for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. This 503B Compounding Pharmacy does not dispense medications directly to individual patients.
What types of medications does this 503B Compounding Pharmacy produce?
This 503B Compounding Pharmacy specializes in compounding sterile preparations (CSPs). These are typically injectable medications, including IV bags, syringes, and other sterile solutions that are essential for medical procedures and treatments performed by healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779.
Why should a practice use a 503B Compounding Pharmacy instead of a 503A pharmacy?
Utilizing this 503B Compounding Pharmacy offers practices at 2160 W State Road 434, Longwood, FL 32779 several advantages. As an FDA-registered 503B outsourcing facility, this 503B Compounding Pharmacy is required to comply with cGMP regulations, which provide greater assurance of consistency, sterility, and quality in every batch of medication produced compared to the patient-specific formulations of a 503A pharmacy.
How can I place an order with this 503B Compounding Pharmacy?
Healthcare practitioners interested in the services of this 503B Compounding Pharmacy can initiate an order by contacting the facility directly. You may call (407)993-1381 to speak with a representative from this 503B Compounding Pharmacy or visit https://503bcompoundingpharmacy.com/ for more information on becoming a client of this 503B Compounding Pharmacy located at 2160 W State Road 434, Longwood, FL 32779.