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 central to the identity and operations of the pharmacy located at 2160 W State Road 434, Longwood, FL 32779. As a 503B outsourcing facility, this pharmacy adheres to rigorous federal standards for quality control, sterility, and safety that exceed those of traditional compounding pharmacies. The primary function of this facility is the large-scale compounding of medications that are distributed to healthcare providers for office use, ensuring practitioners at local medical practices have access to essential, high-quality compounded drugs for their patients.
The services provided at 2160 W State Road 434, Longwood, FL 32779 are defined by its 503B status. This includes the compounding of sterile injectable medications, which are prepared in a controlled environment with stringent protocols to prevent microbial contamination. The pharmacy also compounds non-sterile medications to meet specific needs. All processes are conducted under the oversight of a licensed pharmacist and a dedicated quality team, ensuring every batch meets precise specifications. The focus is on producing medications that are often in short supply or not commercially available, thereby serving a critical role in the local healthcare infrastructure by supporting physicians, surgeons, and other medical professionals in the area.
Patients and healthcare providers visiting or utilizing the services of 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 benefit from a commitment to transparency and compliance. The facility is subject to regular FDA inspections and must report all compounded drugs to the agency. This level of oversight provides an additional layer of assurance regarding the quality and safety of the medications. For medical practices in need of compounded pharmaceuticals, this location serves as a reliable, compliant, and local source for bulk, office-use medications. The professional staff is available to address inquiries from healthcare providers regarding available formulations and ordering procedures.
To learn more about the specific services available or to place an order, healthcare providers can contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381. Detailed information about the pharmacy’s capabilities, compliance, and the role of a 503B outsourcing facility can be found on the official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
What does it mean that this is a 503B Compounding Pharmacy?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is an FDA-registered outsourcing facility that compounds large volumes of sterile and non-sterile drugs for office use by healthcare practitioners. It operates under stricter federal regulations than a traditional compounding pharmacy.
Who can order medications from this location?
Medications compounded at 2160 W State Road 434, Longwood, FL 32779 are intended for office use by licensed healthcare providers. Orders are typically placed by physicians, clinics, and other medical practices for administering to patients within their care.
Can I as a patient pick up a prescription directly from this location?
No. As a 503B outsourcing facility, this pharmacy does not typically dispense medications directly to individual patients. It provides medications in bulk to healthcare providers. Your prescribing doctor would administer the medication during your appointment.
How does the 503B status ensure medication quality?
The 503B status requires the facility at 2160 W State Road 434, Longwood, FL 32779 to comply with Current Good Manufacturing Practices (cGMP), undergo regular FDA inspections, and report all compounded drugs to the FDA, ensuring a high standard of quality, sterility, and safety.
How can a local healthcare provider place an order?
Healthcare providers can initiate an order or inquire about available formulations by contacting the pharmacy directly at (407)993-1381. The website https://503bcompoundingpharmacy.com/ also provides information for professional inquiries.