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. This designation is a critical distinction that sets this facility apart from traditional compounding pharmacies, ensuring the highest standards of quality, safety, and regulatory oversight for every preparation. Located at 2160 W State Road 434, Longwood, FL 32779, this facility specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially or are in shortage. The core mission is to provide healthcare providers with reliable access to essential medications for their patients.
The operations at the 2160 W State Road 434 facility are governed by Current Good Manufacturing Practices (cGMP), which are the same rigorous standards required of major pharmaceutical manufacturers. This commitment to cGMP means every batch of medication is produced in a controlled, monitored environment with extensive documentation and testing protocols. For healthcare professionals seeking a trusted source for compounded medications, this provides unparalleled assurance in the integrity, potency, and sterility of the products they administer. The 503B Compounding Pharmacy model is designed to support hospitals, clinics, and other healthcare entities by acting as an extension of their own pharmacy services, ensuring patient needs are met with the highest quality preparations.
Services provided from this specific location focus on the compounding and distribution of medications in larger volumes for office use by medical practitioners. The portfolio includes a wide array of preparations, such as sterile injectables, ophthalmics, and other dosage forms that are essential for various medical treatments and procedures. By centralizing the compounding process in an FDA-registered outsourcing facility, the 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, enhances efficiency and safety within the local healthcare ecosystem, allowing providers to focus on patient care with confidence in their medication supply chain.
Engaging with the 503B Compounding Pharmacy is a streamlined process for medical practices. Orders are managed through dedicated channels to ensure accuracy and timely delivery to the 2160 W State Road 434 address or directly to the prescribing facility. The team of highly trained pharmacists and technicians is committed to excellence, leveraging advanced technology and meticulous processes to meet specific patient needs. For more detailed information on services or to initiate an order, healthcare providers are encouraged to contact the facility directly.
To learn more about the specific compounded medications available or to discuss your practice's needs, please contact 503B Compounding Pharmacy. Website: https://503bcompoundingpharmacy.com/ | Phone: (407)993-1381
FAQ
What does it mean that this is a 503B compounding pharmacy?
It means this facility is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. This requires adherence to Current Good Manufacturing Practices (cGMP), which involves stricter production standards, quality control, and reporting compared to a traditional 503A pharmacy.
Who can order medications from the 503B Compounding Pharmacy at 2160 W State Road 434?
Medications compounded at this facility are intended for office use by licensed healthcare practitioners and are distributed to hospitals, clinics, and other healthcare facilities. Individual patient prescriptions are not dispensed directly to the public from this location.
What types of medications are compounded at this location?
The 503B Compounding Pharmacy specializes in preparing sterile injectables, ophthalmics, and other formulations that are often on drug shortage lists or are not commercially available. All preparations are made in batches within the controlled environment of the facility at 2160 W State Road 434, Longwood, FL 32779.
How does the 503B Compounding Pharmacy ensure medication safety?
Safety is ensured through strict compliance with cGMP standards. This includes rigorous environmental monitoring, validated sterilization processes, extensive testing of components and finished products, and comprehensive documentation for every batch produced at the facility.
How can a healthcare facility place an order?
Healthcare facilities can place orders by contacting the 503B Compounding Pharmacy directly via the provided contact information. Inquiries and orders can be initiated through the website at https://503bcompoundingpharmacy.com/ or by calling the facility at (407)993-1381.