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 operational standards of the facility 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 assurance, and production consistency that exceed those of traditional compounding pharmacies. The core function of this facility is the large-scale compounding of medications for office use, which are then distributed to healthcare providers for administration to patients within their clinical practice.
The services provided at the 2160 W State Road 434 location are defined by its 503B status. This includes the non-sterile and sterile compounding of medications in bulk quantities. These preparations are not dispensed directly to individual patients but are instead supplied to hospitals, clinics, surgery centers, and physician offices. The medications produced are essential for a wide range of medical treatments and procedures, including hormone replacement therapy, ophthalmologic solutions, injectable pain management medications, and other customized formulations that may be in short supply or unavailable from conventional pharmaceutical manufacturers. The facility's commitment is to provide healthcare practitioners with reliable access to high-quality, compounded medications they need for their practice.
Quality and safety are the foremost priorities at 503B Compounding Pharmacy. The operation at 2160 W State Road 434 is subject to current Good Manufacturing Practice (cGMP) regulations enforced by the FDA. This involves a comprehensive quality assurance program, stringent environmental monitoring, validated sterilization processes, and robust testing of both raw materials and finished products. By operating under these strict protocols, the pharmacy ensures that every batch of medication meets precise identity, strength, quality, and purity standards. This provides local healthcare providers with the confidence that the medications they use in patient care are produced under the highest level of regulatory oversight.
The team at the Longwood facility comprises skilled pharmacists, pharmacy technicians, and quality control professionals dedicated to the science of compounding. Their expertise allows them to work closely with healthcare providers to meet specific clinical needs. For medical professionals seeking a trusted source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434 represents a critical partner in patient care. To learn more about its services or to initiate an order, healthcare entities can contact the facility directly.
Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means this facility is registered with the FDA under Section 503B of the Federal Food, Drug, and Cosmetic Act. The 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 follows current Good Manufacturing Practices (cGMP) and is subject to federal oversight, ensuring the highest standards of quality, sterility, and consistency for the medications it compounds.
2. Can I, as an individual patient, pick up my prescription at this location?
No. The 503B Compounding Pharmacy at 2160 W State Road 434 compounds medications exclusively for office use by healthcare providers. Individual patients do not receive medications directly from this facility. Your healthcare provider will administer the medication within their practice.
3. What types of medications does this 503B facility compound?
The 503B Compounding Pharmacy at this location compounds a wide array of sterile and non-sterile medications in bulk for healthcare settings. This includes, but is not limited to, hormone therapies, ophthalmologic solutions, injectable pain medications, and other formulations that are often on drug shortage lists or are not commercially available.
4. How does a medical practice at 2160 W State Road 434 order from you?
Healthcare practices and facilities can place orders by contacting the 503B Compounding Pharmacy directly via phone at (407)993-1381 or through the official website at https://503bcompoundingpharmacy.com/. The team will work with you to fulfill your specific medication needs for office use.
5. Why should a healthcare provider choose your 503B facility?
Choosing the 503B Compounding Pharmacy at 2160 W State Road 434 ensures you are sourcing medications from an FDA-registered outsourcing facility that operates under the strictest cGMP standards. This provides a critical layer of safety and quality assurance for the medications you use in your practice, protecting both your patients and your profession.