503B Compounding Pharmacy

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.

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Contact Information

Address:

2160 W State Road 434, Longwood, FL 32779

Phone:

(407)993-1381

Website

https://503bcompoundingpharmacy.com/

Location

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 compounding pharmacy specializes in the preparation of sterile and non-sterile compounded medications that are not commercially available. As a 503B outsourcing facility, the pharmacy adheres to rigorous current good manufacturing practices (cGMP) to ensure the highest standards of quality, safety, and potency for the medications it produces.

The primary focus of 503B Compounding Pharmacy is to provide bulk quantities of compounded medications for healthcare facilities. This includes hospitals, clinics, and other healthcare providers in need of specific formulations that are essential for patient care but are not readily available from traditional pharmaceutical manufacturers. By operating under the 503B designation, the pharmacy is subject to federal oversight and must comply with strict manufacturing and quality control standards, providing an additional layer of assurance for the healthcare professionals who rely on its products.

Services at the Longwood location are centered on the large-scale compounding of medications. This involves creating customized formulations in larger batches, which are then distributed to healthcare facilities for administration to patients. The pharmacy's role is crucial in situations where there is a drug shortage, a need for a specific strength or dosage form not commercially marketed, or when a particular allergen needs to be excluded from a medication. The team at 503B Compounding Pharmacy works closely with healthcare providers to ensure the medications meet the specific needs of their patient populations.

For more information about the services provided by 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779, you can visit their website at https://503bcompoundingpharmacy.com/ or contact them by phone at (407)993-1381.

Frequently Asked Questions

What is a 503B compounding pharmacy? A 503B compounding pharmacy is an FDA-registered outsourcing facility that compounds medications in bulk quantities for healthcare facilities. It operates under stricter federal regulations than a traditional 503A pharmacy, which compounds medications for individual patients based on specific prescriptions.

What types of medications does 503B Compounding Pharmacy prepare? 503B Compounding Pharmacy prepares sterile and non-sterile compounded medications that are not commercially available. These are typically produced in larger quantities for use by hospitals, clinics, and other healthcare providers to address specific clinical needs.

Who can order from 503B Compounding Pharmacy? Orders are typically placed by healthcare facilities and licensed medical practitioners, such as hospitals, surgery centers, and clinics, for use within their practice. The pharmacy does not generally dispense medications directly to individual patients.

What are the benefits of using a 503B outsourcing facility? The primary benefits include access to high-quality, compounded medications that adhere to current good manufacturing practices (cGMP). This ensures consistency, potency, and sterility in medications, which is critical for patient safety, especially during drug shortages or when specific formulations are required.