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 from its location 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. As a 503B outsourcing facility, this pharmacy adheres to the most stringent federal standards for quality, safety, and production. This includes compliance with Current Good Manufacturing Practices (cGMP), which govern the manufacturing of sterile and non-sterile medications in larger batches for office use by healthcare practitioners. The primary function of the 503B Compounding Pharmacy is to provide physicians, surgeons, hospitals, and clinics with access to high-quality, compounded medications that are not commercially available.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are specifically designed for the medical community. The 503B Compounding Pharmacy prepares medications in advance of receiving a prescription, allowing for immediate availability for healthcare providers. This is essential for surgical packs, emergency kits, and commonly used formulations in clinical settings. The facility specializes in sterile compounding, a complex process that requires a controlled environment to ensure the final product is free of contaminants. This includes IV bags, injectable medications, ophthalmic drops, and other preparations that must be sterile for patient safety. The ability to supply these vital medications directly supports the operational needs of medical practices located near 2160 W State Road 434, Longwood, FL 32779.
Quality assurance is the cornerstone of the operation at this 503B Compounding Pharmacy. Every batch of medication produced undergoes rigorous testing and quality control procedures to verify potency, purity, and sterility. The facility's commitment to cGMP standards ensures a level of consistency and reliability that is paramount for healthcare providers who depend on these medications for their patients. By operating as a 503B outsourcing facility, this pharmacy provides a vital link in the healthcare chain, ensuring that practitioners have access to necessary medications that are manufactured under the highest possible regulatory oversight. The team at 2160 W State Road 434, Longwood, FL 32779 is comprised of skilled pharmacists and technicians dedicated to upholding these exacting standards.
For healthcare providers seeking a reliable source for compounded medications, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 represents a partner in patient care. The facility's services are tailored to meet the specific demands of the local medical community, providing essential medications with guaranteed quality. To learn more about the available formulations or to discuss your practice's needs, you can contact the facility directly. The website at https://503bcompoundingpharmacy.com/ provides detailed information, and the pharmacy can be reached by phone at (407)993-1381.
Frequently Asked Questions
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility that operates under Section 503B of the Federal Food, Drug, and Cosmetic Act. This registration requires compliance with stricter federal standards, including Current Good Manufacturing Practices (cGMP), for producing compounded medications for office use by healthcare practitioners.
2. Can I, as an individual patient, get a prescription filled at 2160 W State Road 434, Longwood, FL 32779?
No. The 503B Compounding Pharmacy primarily supplies medications in bulk for office use to healthcare providers. Individual patient prescriptions are typically handled by traditional 503A compounding pharmacies. This facility's services are directed at the medical community.
3. What types of medications does the 503B Compounding Pharmacy at this location produce?
The facility specializes in producing sterile compounded medications, including intravenous (IV) bags, injectables, surgical irrigations, and ophthalmic solutions. These are prepared in batches for healthcare providers to have on hand for procedures and treatments at their practices.
4. How does the 503B Compounding Pharmacy ensure medication quality and safety?
As an FDA-registered outsourcing facility, it follows rigorous cGMP protocols. This involves stringent environmental controls, validated processes, and comprehensive testing of raw materials and finished batches to ensure sterility, potency, and purity for every medication produced.
5. How can a medical practice at 2160 W State Road 434, Longwood, FL 32779 order from the 503B Compounding Pharmacy?
Healthcare providers and practices can place orders directly with the facility. You can initiate the process by calling (407)993-1381 to speak with a representative or by visiting the website at https://503bcompoundingpharmacy.com/ for more information on available medications and ordering procedures.