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
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 503B compounding pharmacy specializes in the large-scale compounding of sterile medications. As a 503B outsourcing facility, the pharmacy adheres to stringent federal quality standards, including current Good Manufacturing Practices (cGMP), which are designed to ensure the safety, potency, and purity of every preparation. The primary focus of a 503B compounding pharmacy is to provide bulk quantities of compounded medications to healthcare practitioners and facilities, helping to address drug shortages and supply critical medications that may not be commercially available.
The services provided by 503B Compounding Pharmacy are distinct from those of a traditional retail or 503A compounding pharmacy. This 503B compounding pharmacy does not typically serve individual patients with custom-prescribed formulations. Instead, the 503B outsourcing facility model is dedicated to producing medications for office use by physicians, hospitals, clinics, and other healthcare providers in Longwood, FL. This allows medical professionals to have essential medications on hand for immediate administration to patients during procedures, treatments, or in response to urgent needs. The operations at this 503B compounding pharmacy are critical for supporting the local healthcare infrastructure.
Patients and healthcare providers in Longwood can have confidence in the medications produced at this 503B compounding pharmacy. The registration as a 503B outsourcing facility with the FDA signifies a commitment to a higher level of oversight and quality control. The facility at 2160 W State Road 434 is subject to regular FDA inspections to verify compliance with all regulations governing a 503B compounding pharmacy. This provides an additional layer of assurance regarding the quality and safety of the sterile compounded medications supplied to the medical community. The team at 503B Compounding Pharmacy is dedicated to upholding the standards expected of a leading 503B outsourcing facility.
For more information about the services offered by this 503B compounding pharmacy, healthcare entities are encouraged to make direct contact. The dedicated team at 503B Compounding Pharmacy is available to discuss how their 503B outsourcing facility can meet specific medication supply needs. You can reach them by phone at (407) 993-1381 or visit their website for comprehensive details at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions for 503B Compounding Pharmacy
What is a 503B compounding pharmacy?
A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds large volumes of sterile medications in advance of or without receiving a patient-specific prescription. 503B Compounding Pharmacy operates under this federal designation, adhering to strict quality standards.
Who does 503B Compounding Pharmacy serve?
503B Compounding Pharmacy primarily serves healthcare providers and facilities, such as hospitals, clinics, and physician practices. The medications compounded by this 503B outsourcing facility are intended for office use by medical professionals in Longwood, FL.
Can individual patients get prescriptions filled at this 503B compounding pharmacy?
No. 503B Compounding Pharmacy is an outsourcing facility that supplies medications in bulk to healthcare providers. Individual patients should contact a traditional 503A compounding pharmacy for personalized prescriptions.
What are the benefits of using a 503B outsourcing facility?
Using a 503B outsourcing facility like 503B Compounding Pharmacy ensures healthcare providers receive medications produced under federal cGMP regulations. This provides assurance of quality, potency, and sterility for medications used in a clinical setting.
How can I contact 503B Compounding Pharmacy?
503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. Healthcare providers can contact the 503B compounding pharmacy by phone at (407) 993-1381 or visit their website at https://503bcompoundingpharmacy.com/.