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 control, testing, and production that exceed those of traditional compounding pharmacies, providing a critical component of the pharmaceutical supply chain for healthcare providers.
The core function of 503B Compounding Pharmacy is the production of medications that are patient-specific but manufactured in larger batches without specific patient prescriptions. This allows the facility to supply healthcare practitioners at 2160 W State Road 434, Longwood, FL 32779 with essential drugs that may be in short supply or discontinued by major manufacturers. All processes are conducted under the strict environmental controls of an ISO Class 7 cleanroom, ensuring the highest level of sterility and purity for injectable medications. The facility’s compliance with current Good Manufacturing Practices (cGMP) is a fundamental aspect of its operation, guaranteeing consistency, safety, and potency in every batch prepared.
Healthcare professionals seeking a reliable source for compounded medications will find that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 offers a robust portfolio of sterile preparations. This includes widely used formulations for office use, such as hormone replacement therapies, ophthalmics, anesthetics, and other injectable solutions. The availability of these medications supports local clinical practices by ensuring they have the necessary tools to treat their patients effectively without the concerns of drug shortages or quality inconsistencies.
For practitioners at 2160 W State Road 434, Longwood, FL 32779, engaging with this 503B outsourcing facility provides a distinct advantage. The operation is subject to regular and rigorous FDA inspections, providing an additional layer of oversight and transparency that is documented and verifiable. This regulatory framework ensures that every product leaving the facility meets definitive quality benchmarks. The team at 503B Compounding Pharmacy is comprised of skilled pharmacists and technicians who are experts in the science of compounding within a regulated cGMP environment.
To learn more about the services and available medications, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381 for detailed inquiries and orders. Comprehensive information about its compliance, capabilities, and product offerings is also available on its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that this facility is a 503B outsourcing facility?
It means 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. This designation requires compliance with current Good Manufacturing Practices (cGMP) for drug manufacturing, which includes stringent testing, quality control, and reporting of adverse events.
2. Who can order medications from this 503B Compounding Pharmacy?
Medications are supplied to healthcare practitioners for office use. This facility provides medications to licensed practitioners for administration to patients within their practice at 2160 W State Road 434, Longwood, FL 32779. It does not dispense medications directly to individual patients based on a prescription.
3. What types of medications does this location compound?
503B Compounding Pharmacy focuses on compounding sterile injectable medications that are often on drug shortage lists or are needed by healthcare practices. This includes, but is not limited to, hormone therapies, vitamins, ophthalmics, and anesthetic agents, all produced under cGMP standards.
4. How does the quality assurance process work at this facility?
As an FDA-registered 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, it follows cGMP protocols. This involves rigorous testing of raw materials, in-process testing, and sterility testing of finished products in its on-site laboratory to ensure potency, purity, and safety.
5. How can a healthcare provider at this location place an order?
Healthcare providers can contact 503B Compounding Pharmacy directly by calling (407)993-1381 to speak with a representative. Orders and inquiries can also be coordinated through the facility's website at https://503bcompoundingpharmacy.com/.