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 a critical distinction that sets this facility apart from traditional compounding pharmacies. Located at 2160 W State Road 434, Longwood, FL 32779, this outsourcing facility adheres to the most rigorous federal standards for quality, safety, and production. The 503B model is designed for the large-scale compounding of medications that are distributed to healthcare providers for office use, ensuring that practitioners at local clinics and practices have access to essential, high-quality medications for their patients.
The core function of 503B Compounding Pharmacy is the production of sterile and non-sterile compounded medications in bulk. This is fundamentally different from a retail pharmacy that compounds on a individual, prescription-by-prescription basis. By operating as a 503B outsourcing facility, this location is subject to current Good Manufacturing Practices (cGMP), which are the same stringent quality standards required of major pharmaceutical manufacturers. This includes rigorous testing of components, meticulous environmental monitoring of its cleanrooms, and thorough validation of all processes and equipment to ensure every batch of medication is pure, potent, and free from contamination.
Healthcare professionals in the vicinity of 2160 W State Road 434, Longwood, FL 32779 rely on 503B Compounding Pharmacy for a consistent and reliable supply of critical medications. The pharmacy compounds a significant volume of injectable medications, including hormone replacement therapy (HRT), peptides, vitamins, and other office-administered treatments. These ready-made medications allow doctors, dermatologists, wellness clinics, and veterinarians to efficiently treat their patients without the logistical challenges of in-house compounding. The assurance of FDA-registered, cGMP-compliant production provides these practitioners with the highest level of confidence in the medications they use.
Patients who receive treatments at a local medical practice that sources from 503B Compounding Pharmacy benefit indirectly from this elevated standard of care. They can be assured that the compounded medication administered to them has been produced under the most scrupulous conditions. The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists and technicians who are experts in their field, dedicated to the science of compounding and a unwavering commitment to patient safety. For healthcare providers seeking a trusted partner for their compounding needs, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is a vital resource.
To learn more about its services for healthcare entities or to inquire about becoming a client, please contact 503B Compounding Pharmacy directly. The facility can be reached by phone at (407)993-1381 or through its official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an FDA-registered outsourcing facility?
It means this facility at 2160 W State Road 434, Longwood, FL 32779 is registered with the U.S. Food and Drug Administration and complies with strict federal standards known as current Good Manufacturing Practices (cGMP). This ensures large-scale compounded medications are produced with the highest levels of quality, sterility, and consistency.
2. Can I, as an individual patient, get a prescription filled directly at 503B Compounding Pharmacy?
No. 503B Compounding Pharmacy primarily distributes compounded medications in bulk to licensed healthcare providers for office use. Individual patients should have their prescriptions filled at a traditional retail or compounding pharmacy that serves the public directly.
3. What types of medications does 503B Compounding Pharmacy at this location produce?
The facility specializes in compounding a wide array of sterile injectable medications, including hormone replacement therapies, peptides, vitamins, and other custom formulations. These are supplied to medical practices, clinics, and hospitals for administration to patients within a clinical setting.
4. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from you?
Licensed healthcare providers and medical practices can establish an account by contacting 503B Compounding Pharmacy directly. Orders are typically placed through dedicated channels for healthcare professionals. Inquiries can be made by calling (407)993-1381.
5. Why should a local clinic choose 503B Compounding Pharmacy as their supplier?
Clinics and practices choosing 503B Compounding Pharmacy gain a partner that guarantees cGMP-quality medications. This reduces the clinic's operational burden and liability, allowing medical staff to focus on patient care with the confidence that their compounded medications meet the most rigorous federal safety and quality standards.