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. The 503B designation signifies a commitment to the highest standards of quality, safety, and compliance, exceeding the requirements of traditional compounding pharmacies. The medications produced at this location are intended for office use by healthcare practitioners, providing a critical component of patient care for those in the immediate vicinity of 2160 W State Road 434, Longwood, FL 32779.
The operations at 503B Compounding Pharmacy are distinct in their scale and regulatory oversight. As an outsourcing facility, the pharmacy compounds medications without receiving patient-specific prescriptions. Instead, it prepares batches of medications that are essential for healthcare providers practicing near 2160 W State Road 434, Longwood, FL 32779. These medications are supplied for office-based procedures, treatments, and therapies, ensuring that practitioners have access to vital drugs that may be in short supply or unavailable from conventional manufacturers. The facility's adherence to rigorous Current Good Manufacturing Practice (CGMP) regulations ensures that every batch is consistently produced and controlled to the highest quality standards.
For healthcare professionals serving patients from the 2160 W State Road 434, Longwood, FL 32779 location, 503B Compounding Pharmacy provides a reliable source for high-quality compounded medications. The scope of services includes the compounding of sterile injectables, ophthalmics, and other preparations that are essential for surgical centers, clinics, and medical offices. By operating under the 503B framework, the pharmacy provides an added layer of safety and reliability, with the FDA conducting regular inspections of the facility. This offers peace of mind to practitioners who require medications they can trust for their patients.
Accessing the services of 503B Compounding Pharmacy is designed to be straightforward for qualified healthcare providers. The facility at 2160 W State Road 434, Longwood, FL 32779 works directly with medical practices and institutions. Providers can inquire about available medications, place orders, and coordinate deliveries through dedicated channels. The focus remains on supporting the local medical community with a dependable supply of essential drugs, contributing to the overall standard of care available to patients in the area.
To learn more about the specific medications and services available, or to initiate an order, healthcare providers are encouraged to contact 503B Compounding Pharmacy directly. The primary points of contact are the official website and the main business phone line. The website, https://503bcompoundingpharmacy.com/, serves as a resource for information, while the phone number, (407)993-1381, connects you directly with the facility at 2160 W State Road 434, Longwood, FL 32779.
Frequently Asked Questions
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 subjects the facility to federal oversight, including compliance with Current Good Manufacturing Practice (CGMP) regulations and routine FDA inspections, ensuring a higher level of quality control for compounded medications intended for office use.
Who can purchase medications from 503B Compounding Pharmacy?
Medications compounded at the 2160 W State Road 434, Longwood, FL 32779 location are supplied exclusively to healthcare practitioners for office use. These medications are not dispensed directly to individual patients based on a prescription. Healthcare providers use these drugs for procedures and treatments within their practice.
What types of medications does 503B Compounding Pharmacy produce?
503B Compounding Pharmacy specializes in compounding sterile preparations, such as injectables and ophthalmics, in batches. The facility at 2160 W State Road 434, Longwood, FL 32779 focuses on medications that are often on drug shortage lists or are otherwise unavailable from standard pharmaceutical manufacturers, providing a critical supply for local healthcare providers.
How does a healthcare provider place an order with 503B Compounding Pharmacy?
Healthcare providers interested in the services of 503B Compounding Pharmacy should contact the facility directly. Orders and inquiries are handled through the business contact information. Providers can call (407)993-1381 or visit the website at https://503bcompoundingpharmacy.com/ for more information on ordering from the location at 2160 W State Road 434, Longwood, FL 32779.
What is the advantage of using a 503B outsourcing facility over a traditional compounding pharmacy?
The primary advantage is the enhanced level of regulatory scrutiny and quality assurance. For healthcare providers at practices near 2160 W State Road 434, Longwood, FL 32779, sourcing from a 503B outsourcing facility means the medications are produced under strict CGMP standards, which are comparable to those required of large-scale drug manufacturers, ensuring product consistency, sterility, and purity.