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 is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality, safety, and production, providing healthcare providers with a reliable source for compounded medications that are not commercially available.
The core function of 503B Compounding Pharmacy is the production of medications in larger batches for office use by healthcare practitioners. This model is distinct from traditional compounding, as it is subject to Current Good Manufacturing Practice (CGMP) regulations, mandatory FDA inspections, and reporting of adverse events. For medical professionals at 2160 W State Road 434, Longwood, FL 32779, this means access to high-quality, consistent, and safe medications for their patients without the need to individually compound them in-house. The pharmacy compounds a significant volume of medications, ensuring a ready supply for clinics and practices that require specific formulations.
Services provided at the 2160 W State Road 434 location are centered on this bulk compounding model. This includes the sterile compounding of injectable medications, such as hormone replacement therapies, vitamins, and other sterile preparations essential for various treatments. Furthermore, the facility engages in non-sterile compounding, creating topical creams, ointments, and other formulations in larger quantities. All processes are conducted under strict environmental controls and quality assurance testing to ensure each batch meets precise specifications and is free from contaminants.
503B Compounding Pharmacy serves as a critical partner for healthcare providers by offering medications for office use. This allows physicians and clinicians to have essential compounded preparations readily on hand for immediate administration to patients during office visits at their own practices. The facility's operational focus is on supplying other medical businesses, not on direct consumer retail. Patients seeking medications compounded by this facility typically receive them through their trusted healthcare provider, who sources from this FDA-registered outsourcing facility.
For more information about the services and operations of 503B Compounding Pharmacy, healthcare providers are encouraged to contact the facility directly. The team at 2160 W State Road 434, Longwood, FL 32779 is available to discuss specific compounding needs and capabilities. The pharmacy can be reached by phone at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this 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. This registration requires compliance with stricter federal standards, including Current Good Manufacturing Practices (CGMP), regular FDA inspections, and adverse event reporting, which are not mandatory for traditional compounding pharmacies.
2. Can I walk into the location at 2160 W State Road 434 to pick up a prescription?
No. 503B Compounding Pharmacy operates as a bulk manufacturer for office use by healthcare providers. It does not function as a retail pharmacy where individual patients can present prescriptions for fulfillment. Medications are supplied in larger quantities to medical practices and clinics.
3. How do I, as a healthcare provider, order compounded medications from this facility?
Healthcare providers can initiate orders by contacting 503B Compounding Pharmacy directly at (407)993-1381. The team will provide information on available formulations, ordering procedures, and discuss your specific practice needs for medications to be used within your office at 2160 W State Road 434, Longwood, FL 32779.
4. What types of medications does the Longwood facility compound?
The 503B Compounding Pharmacy at 2160 W State Road 434 compounds a wide range of sterile and non-sterile medications in bulk. This includes, but is not limited to, sterile injectables like hormone therapies and vitamin cocktails, as well as non-sterile preparations such as topical creams and ointments, all produced for office use by medical professionals.
5. Why would a healthcare provider choose a 503B outsourcing facility over other compounders?
Healthcare providers choose an FDA-registered outsourcing facility like this one because it provides an additional layer of quality and safety assurance. The mandatory adherence to CGMP standards, FDA oversight, and batch-level quality control testing ensures the medications received are consistently compounded, high-quality, and safe for patient administration.