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. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this 503B Compounding Pharmacy adheres to the most rigorous federal standards for sterility, quality, and safety. The primary function of this 503B Compounding Pharmacy is the large-scale production of compounded medications, which are then distributed to healthcare providers for office use and to other healthcare facilities.
The operations at 2160 W State Road 434 are governed by strict Current Good Manufacturing Practices (cGMP). This ensures that every batch of medication produced by this 503B Compounding Pharmacy meets consistent and reproducible quality standards. The facility is subject to regular and unannounced inspections by the FDA, providing an additional layer of assurance for the medical community. For practitioners and clinics, sourcing from this 503B Compounding Pharmacy means accessing a reliable supply of high-quality, sterile compounded preparations without the burden and liability of in-office mixing.
The services provided at this specific 503B Compounding Pharmacy location are exclusively for healthcare providers and facilities. The 503B Compounding Pharmacy does not serve individual patients directly for prescription fulfillment from this address. Instead, it supports the local medical ecosystem by providing physicians, surgeons, dermatologists, veterinarians, and hospitals with the essential medications they need to treat their patients effectively. The inventory includes a range of sterile preparations, such as injections, infusions, and ophthalmic solutions, all compounded under the stringent protocols required of an FDA-registered 503B outsourcing facility.
Engaging with the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, offers numerous advantages for healthcare professionals. It mitigates the risks associated with office-based compounding, ensures regulatory compliance, and enhances patient safety through superior quality control. The dedicated team at this 503B Compounding Pharmacy is committed to supporting the local healthcare community with dependable service and uncompromising quality in every preparation.
To learn more about the services or to place an order, healthcare providers can contact the 503B Compounding Pharmacy directly. The team is available to answer questions and provide detailed information about the available formulations and ordering process.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy
1. What does it mean that this is a 503B Compounding Pharmacy?
This 503B Compounding Pharmacy is an FDA-registered outsourcing facility. This federal designation means our operations at 2160 W State Road 434, Longwood, FL 32779, are subject to strict Current Good Manufacturing Practices (cGMP) and regular FDA inspections, ensuring the highest standards of quality, sterility, and safety for all compounded medications we produce.
2. Can I, as a patient, pick up a prescription directly from the 503B Compounding Pharmacy?
No. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, does not dispense medications directly to patients. We compound medications in large batches for healthcare providers and facilities. Your healthcare provider will order and receive the medication from us for administration in their office or clinic.
3. What types of healthcare providers does this 503B Compounding Pharmacy serve?
This 503B Compounding Pharmacy serves licensed healthcare providers and facilities, including physicians, surgeons, dermatologists, ophthalmologists, veterinarians, and hospitals. Our services are designed to supply these professionals with high-quality, sterile compounded medications for office use.
4. How do I place an order with the 503B Compounding Pharmacy?
Healthcare providers can place orders with the 503B Compounding Pharmacy by contacting our facility directly. You can reach our team by phone at (407)993-1381 to discuss your needs, available formulations, and the ordering process. Our website at https://503bcompoundingpharmacy.com/ also provides information for prospective clients.
5. Why should a healthcare provider choose this specific 503B Compounding Pharmacy?
Choosing this 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, ensures you are sourcing medications from an FDA-registered facility that operates under the most stringent federal quality controls. This reduces your practice's liability, ensures regulatory compliance, and guarantees your patients receive medications produced to the highest possible standards of purity and potency.