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 at 2160 W State Road 434, Longwood, FL 32779. This designation, defined under Section 503B of the Federal Food, Drug, and Cosmetic Act, establishes a specific and critical standard for pharmaceutical compounding. Unlike a traditional 503A pharmacy, this 503B Compounding Pharmacy prepares medications in advance of receiving a prescription and in large batches, adhering to rigorous federal current Good Manufacturing Practices (cGMP). This ensures a level of quality, sterility, and consistency that is vital for healthcare providers at 2160 W State Road 434, Longwood, FL 32779 and their patients.
The core function of 503B Compounding Pharmacy is the large-scale production of compounded sterile preparations (CSPs). This includes a range of essential medications such as intravenous (IV) bags, hormone therapy injections, ophthalmics, and other injectable drugs that are in significant demand. By operating as a 503B outsourcing facility, this location provides a reliable and scalable source of these critical medications, which are then distributed to healthcare facilities for administration to patients under professional care. The operations at 2160 W State Road 434, Longwood, FL 32779 are subject to regular and unannounced inspections by the FDA, providing an additional layer of oversight and assurance.
Healthcare professionals can rely on the services of 503B Compounding Pharmacy for a consistent supply of high-quality compounded medications. The team at this location is comprised of skilled pharmacists and technicians who utilize advanced technology and strict aseptic techniques to compound each preparation. Every step, from sourcing pure, high-grade active pharmaceutical ingredients (APIs) to the final product release testing, is meticulously controlled and documented. This commitment to cGMP standards at 2160 W State Road 434, Longwood, FL 32779 minimizes the risk of contamination and ensures dose accuracy, which is paramount for patient safety.
Engaging with 503B Compounding Pharmacy offers distinct advantages. The large-volume production model helps mitigate drug shortages by providing an alternative supply chain for essential medications that may be commercially unavailable or discontinued. For medical practices, this translates to greater practice efficiency, reduced compounding burden on internal staff, and the confidence that comes with using an FDA-regulated source. Patients ultimately benefit from access to necessary treatments that are prepared under the highest standards of pharmaceutical compounding.
To learn more about the specific formulations and services available from this FDA-registered outsourcing facility, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team is available to discuss needs and provide information. You can reach them at (407)993-1381 or visit their website at https://503bcompoundingpharmacy.com/ for further details. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
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 compounds medications in accordance with Section 503B of the FD&C Act. This requires adherence to strict current Good Manufacturing Practices (cGMP), which are more rigorous standards than those applied to traditional compounding pharmacies, focusing on large-scale production, sterility assurance, and rigorous quality control.
2. Who can receive medications from 503B Compounding Pharmacy at 2160 W State Road 434?
Medications compounded at this location are typically distributed to healthcare facilities and practitioners for office use and administration to their patients. Patients do not order directly from 503B Compounding Pharmacy with an individual prescription. Instead, your healthcare provider will source these medications from this facility for your treatment.
3. What types of medications does this 503B Compounding Pharmacy produce?
As an outsourcing facility, 503B Compounding Pharmacy specializes in producing large batches of compounded sterile preparations (CSPs). This includes injectable medications, intravenous (IV) therapies, hormone replacement injections, ophthalmics, and other sterile drugs that are in high demand by medical practices serving patients in the area.
4. How does the quality control at 2160 W State Road 434, Longwood, FL 32779 ensure safety?
Quality and safety are paramount. The facility operates under cGMP, which mandates extensive testing of components, in-process testing, finished product testing for potency, sterility, and endotoxins, and thorough environmental monitoring of the cleanrooms. This multi-layered quality system ensures every preparation leaving the facility meets its specified identity, strength, quality, and purity.
5. How can a healthcare provider at 2160 W State Road 434 place an order?
Healthcare providers and facilities can initiate orders or make inquiries by contacting 503B Compounding Pharmacy directly at (407)993-1381. The professional staff will provide information on available formulations, ordering procedures, and delivery options specific to this location. More information is also available on their website at https://503bcompoundingpharmacy.com/.