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 pharmaceutical compounding, focusing on the large-scale production of compounded sterile preparations for office use by healthcare practitioners. The 503B Compounding Pharmacy is distinct from a traditional 503A pharmacy, as it adheres to more rigorous federal manufacturing standards set forth by the US Food and Drug Administration.
The core mission of this 503B Compounding Pharmacy is to provide healthcare providers with access to a consistent and reliable supply of high-quality, sterile medications. The medications prepared by this 503B Compounding Pharmacy are essential for various medical procedures and treatments administered in clinical settings. By operating as a 503B outsourcing facility, this 503B Compounding Pharmacy undergoes regular FDA inspections to ensure compliance with Current Good Manufacturing Practices. This provides an additional layer of safety and quality assurance for the medications dispensed from 2160 W State Road 434, Longwood, FL 32779.
The services provided by this 503B Compounding Pharmacy are exclusively tailored for physician offices, hospitals, and other healthcare facilities. The 503B Compounding Pharmacy does not typically serve individual patients directly but works as a crucial partner to the local medical community. The product portfolio of a 503B Compounding Pharmacy often includes a wide array of sterile injectables, such as hormone injections, ophthalmics, and other office-use medications that are in constant demand. The team at this 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in sterile compounding techniques and quality control protocols.
Quality is the foundational principle of every operation at this 503B Compounding Pharmacy. Every batch of medication produced is subject to stringent testing and validation processes to ensure sterility, potency, and purity. The 503B Compounding Pharmacy facility at 2160 W State Road 434, Longwood, FL 32779 is designed with controlled environments to prevent contamination. For healthcare providers seeking a trusted source for compounded medications, this 503B Compounding Pharmacy represents a commitment to excellence, safety, and reliability. To learn more about the specific services available, please contact the 503B Compounding Pharmacy directly.
To inquire about the services provided by this 503B Compounding Pharmacy, you can visit their website at https://503bcompoundingpharmacy.com/ or call the facility at (407)993-1381. The professionals at this 503B Compounding Pharmacy are available to assist healthcare providers with their medication needs.
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this facility is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This 503B Compounding Pharmacy adheres to stricter federal standards, including Current Good Manufacturing Practices, and is subject to routine FDA inspections to ensure the quality and safety of its compounded medications.
2. Who can receive medications from this 503B Compounding Pharmacy?
This 503B Compounding Pharmacy primarily supplies medications for office use to healthcare practitioners and facilities. Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and other medical practices can order compounded sterile preparations from this 503B Compounding Pharmacy for administration to patients within their clinical settings.
3. What types of medications does this 503B Compounding Pharmacy typically compound?
As a 503B Compounding Pharmacy, the focus is on producing large-scale batches of sterile preparations, such as injectable hormones, ophthalmic solutions, and other injectable medications that are commonly used by physicians and surgeons in their practice at 2160 W State Road 434, Longwood, FL 32779.
4. How does the quality assurance process work at this 503B Compounding Pharmacy?
The 503B Compounding Pharmacy implements a rigorous quality assurance program. This includes environmental monitoring, validation of sterilization processes, and end-product testing for sterility and potency. These protocols are mandated by federal regulations for all 503B outsourcing facilities to ensure patient safety.
5. How can a healthcare provider place an order with this 503B Compounding Pharmacy?
Healthcare providers interested in the services of this 503B Compounding Pharmacy can initiate contact by calling (407)993-1381 or by visiting the website at https://503bcompoundingpharmacy.com/ for more information. The staff at this 503B Compounding Pharmacy will guide you through the ordering process.