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. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications. The 503B designation signifies adherence to the highest level of federal regulation, which includes rigorous testing for potency, sterility, and purity, providing healthcare providers and patients with an elevated standard of quality and safety assurance not always present in traditional compounding.
The core function of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for office use by healthcare practitioners. This means that physicians, surgeons, veterinarians, and other medical professionals at practices and clinics can obtain essential medications directly from this Longwood facility to administer to patients within their care settings. By operating as a 503B outsourcing facility, this pharmacy is authorized to compound medications without patient-specific prescriptions for office stock, ensuring that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have immediate access to critical drugs, such as injectables, ophthalmics, and other preparations needed for procedures and treatments.
Patients seeking personalized compounded medications are served through their healthcare providers. A physician practicing at 2160 W State Road 434, Longwood, FL 32779 can partner with 503B Compounding Pharmacy to have specific patient formulations created. This process begins when a healthcare provider identifies a unique patient need that cannot be met by an commercially available, FDA-approved drug. The provider then submits a prescription to 503B Compounding Pharmacy, where the dedicated team of pharmacists and technicians utilizes their expertise and advanced technology to prepare a customized medication. This ensures that individuals receiving care at this location have access to tailored therapeutic solutions.
The operations at 2160 W State Road 434, Longwood, FL 32779 are defined by a commitment to precision and regulatory excellence. The facility's status as a 503B outsourcing facility mandates current Good Manufacturing Practices (cGMP), which are the same standards required of major pharmaceutical manufacturers. This involves extensive environmental monitoring, validated sterilization processes, and robust quality control testing on every batch of medication produced. For the medical community at this location, this translates to an unparalleled level of confidence in the medications they use in practice.
To learn more about the services available from this specific facility or to initiate an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The team is available to discuss specific compound formulations, bulk ordering processes, and delivery logistics to 2160 W State Road 434, Longwood, FL 32779. The official website at https://503bcompoundingpharmacy.com/ provides detailed information on capabilities and compliance, and the facility can be reached by phone at (407)993-1381 for immediate assistance.
FAQ
1. What does it mean that this is a 503B outsourcing facility?
It means this pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under strict federal regulations known as current Good Manufacturing Practices (cGMP). This ensures every batch of medication is tested for sterility, potency, and purity before it is released, providing a higher level of safety than traditional compounding pharmacies.
2. As a patient, can I walk into the facility at 2160 W State Road 434 to get a prescription filled?
No. 503B Compounding Pharmacy primarily supplies medications in bulk for "office use" by healthcare practitioners. Patients must work through their local healthcare provider, who can then order the necessary compounded medication on their behalf from this facility.
3. What types of medications can healthcare providers at this location order?
Healthcare providers at 2160 W State Road 434, Longwood, FL 32779 can order a wide range of sterile and non-sterile compounded preparations. This includes injectables, ophthalmics, topical creams, oral suspensions, and other formulations that are not commercially available or are in shortage, all produced under rigorous FDA-registered facility standards.
4. How does a healthcare provider at this address place an order?
A healthcare provider can place an order by contacting 503B Compounding Pharmacy directly at (407)993-1381 or through the website at https://503bcompoundingpharmacy.com/. The team will assist with setting up an account and processing orders for delivery to 2160 W State Road 434, Longwood, FL 32779.
5. Why would a provider at this location choose a 503B facility over other compounders?
Choosing the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 ensures access to medications produced under the highest level of federal oversight. The mandatory cGMP standards and batch testing provide critical risk mitigation and quality assurance for practitioners administering medications to their patients.