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 its mission of providing high-quality, compounded medications to healthcare providers and their patients. Located at 2160 W State Road 434, Longwood, FL 32779, this facility adheres to stringent federal quality standards, including current Good Manufacturing Practices (cGMP), which are more rigorous than the standards applied to traditional 503A compounding pharmacies. This ensures that every preparation leaving the facility is consistent, sterile, and of the highest possible quality.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs) and compounded non-sterile preparations. This bulk compounding is performed for office use, meaning healthcare practitioners at local medical and veterinary practices can order these medications to have on hand for immediate patient needs. This service is vital for procedures, treatments, or situations where a commercially available drug is not suitable or is unavailable. By serving the specific needs of practitioners in the area of 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy acts as a critical support system for the local healthcare community.
The operations at 2160 W State Road 434, Longwood, FL 32779 are defined by a commitment to compliance, safety, and reliability. The facility’s status as a 503B outsourcing facility means it is subject to regular FDA inspections and must meet clearly defined benchmarks for quality control. This provides assurance to local healthcare providers that the medications they receive are produced in a state-of-the-art environment with robust quality assurance protocols. The pharmacy does not typically serve individual patients directly but works closely with prescribers to supply them with the necessary medications for their practice.
For healthcare providers seeking a dependable source for compounded medications at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy represents a resource built on regulatory excellence and pharmaceutical expertise. To learn more about its services or to initiate an order, local practitioners are encouraged to make contact directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
Frequently Asked Questions for 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779
1. What does it mean that this is a 503B Compounding Pharmacy?
It means this facility is an FDA-registered outsourcing facility operating 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), and subjects the facility to regular FDA inspections. This ensures a higher level of quality and consistency for the compounded medications produced at 2160 W State Road 434, Longwood, FL 32779.
2. Can I as an individual patient pick up my prescription at this location?
No. 503B Compounding Pharmacy primarily compounds medications in bulk for office use by healthcare providers. Individual patients should not visit 2160 W State Road 434, Longwood, FL 32779 for prescription pickup. Your healthcare provider orders from this facility and then dispenses the medication to you directly from their practice.
3. What types of medications does this 503B Compounding Pharmacy provide?
The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 provides a wide range of compounded sterile preparations (CSPs) and compounded non-sterile preparations. These are typically produced in larger quantities for healthcare providers to have on hand for procedures, injections, and other immediate patient care needs within their local practice.
4. How do I place an order as a local healthcare provider?
Local healthcare providers can place orders by contacting 503B Compounding Pharmacy directly. The facility works with prescribers and their offices to process orders for compounded medications. You can initiate the process by calling (407)993-1381 or by visiting their website at https://503bcompoundingpharmacy.com/ for more information.
5. Why should a practice near Longwood use a 503B outsourcing facility?
Using a 503B outsourcing facility like the one at 2160 W State Road 434, Longwood, FL 32779 provides assurance of quality and regulatory compliance. The medications are produced under cGMP standards, which include rigorous testing and environmental controls. This reduces the burden on the prescribing practice and ensures patients receive medications that meet exacting federal quality benchmarks.