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 at 2160 W State Road 434, Longwood, FL 32779. This designation under Section 503B of the Federal Food, Drug, and Cosmetic Act establishes a critical distinction, setting this facility apart from traditional compounding pharmacies. The operations at 2160 W State Road 434 are conducted on a larger scale, producing medications for office use by healthcare practitioners and for distribution to hospitals and clinics. The core mission of 503B Compounding Pharmacy is to provide practitioners with access to high-quality, compounded medications that are not commercially available, thereby fulfilling specific patient needs that mass-produced drugs cannot meet.
The facility at 2160 W State Road 434 adheres to the most rigorous standards in the compounding industry. As an FDA-registered outsourcing facility, 503B Compounding Pharmacy is subject to current Good Manufacturing Practices (cGMP). This means every process, from sourcing raw ingredients to final product testing, is meticulously controlled and documented to ensure sterility, potency, and purity. This level of oversight provides an additional layer of safety and reliability for the healthcare providers who utilize these medications for their patients. The team at the Longwood location comprises skilled pharmacists and technicians who are experts in aseptic processing and quality control, dedicated to upholding the strictest protocols.
503B Compounding Pharmacy provides essential medications for a variety of medical needs. This includes sterile injectables, such as hormone replacement therapy (HRT) solutions, intravenous medications, and other critical injectable preparations required in clinical settings. The facility’s work directly supports local healthcare providers by supplying them with office-use medications, enabling them to offer more comprehensive and immediate care. By focusing on non-patient-specific, office-use compounding, 503B Compounding Pharmacy serves as a vital backbone for the medical community, ensuring that practitioners have the necessary tools to treat their patients effectively.
For healthcare providers and facilities seeking a trusted source for compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434 represents a commitment to excellence, safety, and reliability. To learn more about the services or to inquire about becoming a client, you can visit the official website at https://503bcompoundingpharmacy.com/ or contact the facility directly by phone at (407)993-1381.
Frequently Asked Questions
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 operates under Section 503B of the FD&C Act. We comply with current Good Manufacturing Practices (cGMP), which are stringent federal regulations for drug manufacturing that ensure the highest standards of quality, sterility, and safety for the medications we produce.
Can I as an individual patient pick up my prescription at 2160 W State Road 434?
No. 503B Compounding Pharmacy operates as an outsourcing facility that produces medications for office use by healthcare practitioners. We do not compound patient-specific prescriptions for individual pick-up. Your healthcare provider will order and administer our medications directly within their practice or clinic setting.
What types of medications does 503B Compounding Pharmacy at this location produce?
Our facility at 2160 W State Road 434 specializes in the large-scale production of sterile injectable medications. This includes, but is not limited to, hormone replacement therapies, IV nutrition preparations, and other injectable drugs that are supplied to hospitals, clinics, and healthcare providers for use in their practice.
How can my medical practice or clinic order from 503B Compounding Pharmacy?
Healthcare providers and facilities can initiate orders by contacting 503B Compounding Pharmacy directly. You can reach our team at (407)993-1381 to discuss your needs and establish an account. Detailed product information and ordering procedures are also available on our website at https://503bcompoundingpharmacy.com/.
Why should a healthcare provider choose 503B Compounding Pharmacy for office-use medications?
Choosing our facility at 2160 W State Road 434 ensures you are receiving medications produced under the highest level of federal oversight. Our commitment to cGMP standards provides assurance of product quality, consistency, and safety, allowing you to confidently administer these medications to your patients.