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, safety, and production, providing healthcare providers with a reliable source for compounded medications that are not commercially available.
The core function of 503B Compounding Pharmacy is to produce medications in bulk for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals serving patients from the 2160 W State Road 434, Longwood, FL 32779 location can obtain essential medications for their practice without the need to compound on-site. This service is critical for procedures, treatments, and therapies that require specific drug formulations, strengths, or delivery systems that are not offered by traditional pharmaceutical manufacturers.
Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows Current Good Manufacturing Practices (cGMP). This ensures that every batch of medication is produced under the strictest controls for sterility, potency, purity, and stability. The medications are prepared in a controlled environment with stringent quality assurance testing, including sterility testing and endotoxin testing, providing practitioners and their patients with the highest confidence in the products they use.
For healthcare providers at 2160 W State Road 434, Longwood, FL 32779, accessing these services is streamlined. Orders are placed directly by the medical practice, and the compounded medications are delivered for immediate use in patient care. The pharmacy's services are essential for a wide range of medical needs, including office-based injections, topical preparations for dermatological applications, and specialized solutions for ophthalmic or pain management procedures.
To learn more about the specific formulations available or to place an order for office use, healthcare providers can contact 503B Compounding Pharmacy directly. The facility is a pivotal resource for the medical community operating at and around 2160 W State Road 434, Longwood, FL 32779, ensuring access to high-quality, compounded medications that meet specific patient care needs.
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 that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under Section 503B of the FD&C Act. This registration signifies that the facility complies with stringent federal standards, including Current Good Manufacturing Practices (cGMP), and is subject to regular FDA inspections to ensure the quality, safety, and sterility of its compounded medications.
2. Who can order medications from 503B Compounding Pharmacy?
Medications are ordered by licensed healthcare providers for office use. This includes physicians, surgeons, dentists, veterinarians, and other qualified medical professionals who practice at or serve patients from the 2160 W State Road 434, Longwood, FL 32779 location. Medications are not dispensed directly to individual patients without a prescription from their provider.
3. What types of medications does 503B Compounding Pharmacy provide?
503B Compounding Pharmacy provides bulk compounded medications for office use. This includes sterile preparations like injectables, ophthalmics, and irrigation solutions, as well as non-sterile preparations such as topical creams and ointments. These are formulations that are not commercially available from standard pharmaceutical manufacturers.
4. How does a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers can place orders by contacting 503B Compounding Pharmacy directly via phone at (407)993-1381 or through their official website at https://503bcompoundingpharmacy.com/. The pharmacy will work with the practice to fulfill specific medication needs for office stock.
5. Why would a practice at 2160 W State Road 434 use a 503B outsourcing facility?
Using a 503B outsourcing facility ensures access to high-quality, consistently compounded medications that are essential for specific procedures and treatments. It eliminates the need for individual practices to undertake the complex and resource-intensive process of in-house compounding, allowing them to focus on patient care while relying on a federally regulated source for their medication needs.