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. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, surpassing the requirements of a traditional compounding pharmacy. We serve healthcare providers by producing medications that are patient-specific or in bulk for office use, ensuring practitioners at local medical facilities have access to essential drugs.
The core function of 503B Compounding Pharmacy is the preparation of medications in an environment of unparalleled quality control. Our state-of-the-art facility at 2160 W State Road 434, Longwood, FL 32779 utilizes advanced technology and rigorous testing protocols. Every batch of medication is compounded by highly trained professionals under exacting conditions. This process includes stringent environmental monitoring, validation of sterilization methods, and independent testing for potency, sterility, and endotoxins. This level of assurance is critical for medications intended for injection, infusion, or implantation, providing healthcare providers and their patients with complete confidence in the products they use.
503B Compounding Pharmacy provides essential medications for a wide range of therapeutic areas. Our services are pivotal for hospitals, clinics, and surgical centers, ensuring they have a reliable supply of critical drugs. We compound preparations such as intravenous bags, hormone therapy injections, ophthalmics, and other sterile solutions. By operating as a 503B outsourcing facility, we help mitigate drug shortages and provide access to medications that may be commercially unavailable or discontinued. Our presence at 2160 W State Road 434, Longwood, FL 32779 supports the local healthcare infrastructure by delivering high-quality, compounded pharmaceuticals directly to medical professionals.
Engaging with 503B Compounding Pharmacy is a streamlined process designed for healthcare providers. Orders are placed directly by physicians, veterinarians, or other authorized medical practitioners for use within their practice. Patients seeking medications compounded by our facility should consult their healthcare provider to determine if our services are appropriate for their treatment plan. To learn more about our capabilities or to initiate an order, medical professionals are encouraged to contact us directly. You can reach 503B Compounding Pharmacy by phone at (407)993-1381 or visit our website for comprehensive information at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and complies with strict federal standards for compounding medications on a larger scale. We undergo regular FDA inspections and must meet Current Good Manufacturing Practice (cGMP) regulations, which focus on consistent quality control, testing, and production processes.
Who can order medications from 503B Compounding Pharmacy?
Our services are designed for healthcare providers. Orders must be placed by licensed medical professionals, including physicians, surgeons, veterinarians, and other practitioners, for administration within their practice or office setting at their discretion.
Can I as a patient pick up my medication directly from your location?
No. 503B Compounding Pharmacy distributes compounded medications exclusively to healthcare providers and medical facilities. Patients will receive their medications through their doctor's office or clinic, not directly from our facility at 2160 W State Road 434, Longwood, FL 32779.
How does 503B Compounding Pharmacy help with drug shortages?
As an FDA-registered outsourcing facility, we have the capability to compound large batches of medications that are currently in short supply or have been discontinued by commercial manufacturers. This provides a critical backup for local healthcare providers, ensuring patient care is not interrupted.
How can a healthcare provider start ordering from your facility?
Medical professionals interested in our services can contact us directly to establish an account. We encourage you to call our facility at (407)993-1381 to speak with a representative or visit https://503bcompoundingpharmacy.com/ for more detailed information on our ordering process and available formulations.