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.

← Back to directory

Contact Information

Address:

2160 W State Road 434, Longwood, FL 32779

Phone:

(407)993-1381

Website

https://503bcompoundingpharmacy.com/

Location

503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation is central to the operations at 2160 W State Road 434, Longwood, FL 32779. The 503B outsourcing facility status signifies a commitment to a higher level of regulatory oversight, ensuring that medications are produced in a controlled environment with rigorous quality assurance standards. This facility specializes in the large-scale compounding of sterile and non-sterile medications that are not available commercially, providing essential pharmaceutical options for specific patient needs.

The services provided by 503B Compounding Pharmacy are distinct from traditional compounding. As a 503B outsourcing facility, this location focuses on producing medications for office use by healthcare practitioners. This means that healthcare providers in the area can source high-quality, compounded medications directly from 503B Compounding Pharmacy to have on hand for their patients' immediate needs. The production at 2160 W State Road 434 adheres to current good manufacturing practices (cGMP), which are enforced by the FDA. This ensures consistency, sterility, and potency in every batch of medication prepared.

For patients and medical practices at 2160 W State Road 434, Longwood, FL 32779, this translates to access to reliable and professionally compounded pharmaceutical products. The team at 503B Compounding Pharmacy works directly with physicians and healthcare facilities, compounding medications such as sterile injectables, hormone replacement therapy preparations, and other customized formulations that are prescribed for specific clinical situations. The focus remains on fulfilling the requirements set forth by Section 503B, providing a critical service component to the local medical community.

Contacting 503B Compounding Pharmacy is straightforward for those at this location. The facility can be reached for professional inquiries via phone at (407)993-1381. Additional information regarding the scope of compounding services and regulatory compliance can be found on the official website at https://503bcompoundingpharmacy.com/. The operations and services are exclusively tied to the facility at 2160 W State Road 434, Longwood, FL 32779, ensuring dedicated support for the local healthcare network.

Frequently Asked Questions

What does the "503B" in 503B Compounding Pharmacy mean? The "503B" refers to the specific section of the Federal Food, Drug, and Cosmetic Act under which this outsourcing facility is registered. This designation means the pharmacy at 2160 W State Road 434, Longwood, FL 32779 operates under FDA oversight and must comply with current good manufacturing practices (cGMP).

Who can order medications from 503B Compounding Pharmacy? 503B Compounding Pharmacy provides medications for office use by healthcare practitioners. Orders are typically placed by physicians, hospitals, and clinics that require compounded medications for their patients at 2160 W State Road 434, Longwood, FL 32779.

What types of medications does 503B Compounding Pharmacy compound? As an FDA-registered 503B outsourcing facility, this location compounds a range of sterile and non-sterile medications. This includes but is not limited to sterile injectables, ophthalmics, and hormone preparations, all produced under cGMP standards at 2160 W State Road 434, Longwood, FL 32779.

How does the 503B model benefit healthcare providers at this location? The 503B model ensures that healthcare providers at 2160 W State Road 434, Longwood, FL 32779 have access to high-quality, pre-made compounded medications for immediate patient use. This saves time and resources while guaranteeing the medications meet stringent federal quality and safety standards.