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 means we adhere to the highest current good manufacturing practices (cGMP), providing healthcare practitioners and patients with medications that meet rigorous quality and safety standards. We serve a critical role in the healthcare ecosystem by preparing medications that are not commercially available, addressing specific patient needs as prescribed by physicians.
The core function of 503B Compounding Pharmacy is the production of compounded medications in bulk for office use by healthcare providers. Physicians, surgeons, dermatologists, and other medical professionals located at or serving patients from 2160 W State Road 434, Longwood, FL 32779 can utilize our services to obtain essential medications for their practice. This includes a wide array of preparations such as sterile injectables, ophthalmics, topicals, and other dosage forms that are often on shortage or discontinued by major manufacturers. By outsourcing their compounding needs to our 503B outsourcing facility, healthcare providers can be assured of receiving a consistent, reliable, and high-quality product.
Patients who receive medications prepared by 503B Compounding Pharmacy benefit from the assurance of quality that comes with federal oversight. Every batch produced within our facility undergoes stringent testing and quality control procedures. For individuals in the local community requiring specialized medications, their trusted healthcare provider can dispense or administer a drug compounded at our location with confidence. Our operations are designed to support the medical community at 2160 W State Road 434, Longwood, FL 32779, ensuring they have access to the necessary tools for patient care.
Engaging with 503B Compounding Pharmacy is a streamlined process for medical practices. Healthcare providers can place orders directly for office stock, enabling them to have vital medications on hand for procedures and treatments. Our team is committed to supporting the local medical community with efficient service and reliable compounding. To learn more about our available formulations or to initiate an order, medical professionals are encouraged to contact us directly. We are here to serve the specific compounding needs of practitioners operating at 2160 W State Road 434, Longwood, FL 32779.
Website: https://503bcompoundingpharmacy.com/
Phone: (407)993-1381
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means our compounding pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act and is subject to federal oversight. We comply with Current Good Manufacturing Practices (cGMP), which includes rigorous testing and quality control standards beyond those of traditional compounding pharmacies.
2. As a patient, how can I get a medication compounded by 503B Compounding Pharmacy?
Medications from our facility are provided directly to healthcare providers for office use. Your physician, surgeon, or other medical practitioner located at 2160 W State Road 434, Longwood, FL 32779 can order and then dispense or administer our compounded preparations to you as part of your treatment plan.
3. What types of medications does 503B Compounding Pharmacy typically prepare?
Our facility specializes in preparing large-scale batches of sterile injectables, ophthalmics, and topical medications. These are often drugs that are on national shortage or are not commercially available, providing essential options for healthcare providers at 2160 W State Road 434, Longwood, FL 32779.
4. Who can place an order with 503B Compounding Pharmacy?
Orders are accepted from licensed healthcare providers and medical practices. We serve doctors, clinics, and surgical centers that are located at or provide services from 2160 W State Road 434, Longwood, FL 32779 and require compounded medications for their patients.
5. How does the quality assurance at a 503B outsourcing facility benefit me?
The federal cGMP standards enforced at our location ensure that every batch of medication is consistently produced and controlled to quality standards. This provides an added layer of safety and reliability for patients receiving treatments from medical professionals at 2160 W State Road 434, Longwood, FL 32779.