A Complete Directory of 503B Pharmacies in Colorado

Colorado is an emerging hub for pharmaceutical compounding, with a growing concentration of FDA-registered 503B outsourcing facilities along the Front Range corridor. Anchored by the Denver metropolitan area, the state's healthcare market serves major hospital systems, specialty clinics, and ambulatory surgery centers that depend on reliable access to sterile compounded medications. For these providers, 503B outsourcing facilities offer a critical supply of compounded drugs produced under FDA oversight and Current Good Manufacturing Practices (cGMP).

This page provides a comprehensive, up-to-date directory of all FDA-registered 503B outsourcing facilities located in Colorado. Each facility listed below is registered with the FDA and subject to federal inspection standards.

Official List of FDA-Registered 503B Facilities in Colorado

Why Partner with a Colorado-Based 503B Facility?

For hospitals, clinics, and health systems operating in Colorado and the Rocky Mountain region, sourcing compounded medications from an in-state 503B outsourcing facility offers several key advantages:

• Logistical Efficiency: Shorter shipping distances mean faster delivery times and reduced shipping costs, especially for temperature-sensitive sterile preparations that require cold-chain management. Colorado's central location also enables efficient distribution to neighboring states like Wyoming, Utah, New Mexico, and Kansas.
• Regional Expertise: Colorado-based facilities understand the unique needs of the state's healthcare market, including the high-altitude clinical considerations and the concentration of major hospital systems along the Front Range from Fort Collins to Colorado Springs.
• Simplified Audits: Many healthcare systems conduct on-site vendor audits before adding a 503B facility to their approved supplier list. Partnering with a local facility makes these audits more practical and cost-effective, without requiring expensive out-of-state travel.
• Supporting the Local Economy: Partnering with Colorado-based compounding facilities keeps healthcare dollars within the state and supports the growth of Colorado's pharmaceutical manufacturing sector.

Denver's Growing Pharmaceutical Sector

The Denver metropolitan area has emerged as a significant center for pharmaceutical compounding in the western United States. All four of Colorado's FDA-registered 503B outsourcing facilities are located within the greater Denver metro area, spanning Golden, Lakewood, Englewood, and Denver proper.

This concentration reflects Denver's broader strength as a life sciences hub. The region benefits from a highly educated workforce, proximity to research institutions like the University of Colorado Anschutz Medical Campus, and a robust healthcare infrastructure that includes major systems like UCHealth, SCL Health, and Centura Health. The Anschutz Medical Campus in Aurora is one of the largest academic health centers in the country, driving demand for specialized compounded medications.

Colorado's pharmaceutical sector continues to grow, supported by the state's business-friendly environment, access to talent from top-tier universities, and strategic geographic position for serving the Rocky Mountain and Great Plains regions. For healthcare providers looking for compounding partners in the western U.S., Denver-area 503B facilities offer a compelling combination of quality, proximity, and regulatory oversight.

Navigating Compounding Regulations in Colorado

503B outsourcing facilities in Colorado operate under a dual regulatory framework. At the federal level, they are overseen by the FDA and must comply with Current Good Manufacturing Practices (cGMP). At the state level, they must also maintain licensure and good standing with the Colorado State Board of Pharmacy, which operates under the Colorado Division of Professions and Occupations.

The Colorado State Board of Pharmacy oversees all pharmacy operations in the state, including licensing, inspections, and enforcement of state pharmacy laws. While the FDA is the primary regulatory authority for 503B facilities with respect to cGMP compliance and product quality, the state board ensures that these facilities also meet Colorado-specific requirements for pharmacy operations, pharmacist oversight, and record-keeping.

Healthcare providers in Colorado should verify that any 503B facility they partner with is both FDA-registered and in good standing with the Colorado State Board of Pharmacy. For more on the differences between federal and state oversight of compounding pharmacies, see our guide to 503A vs. 503B pharmacies.

Find a 503B Pharmacy Near You

New to 503B outsourcing facilities? Read our comprehensive guide: What is a 503B Pharmacy? Or learn about the key differences between traditional compounding and outsourcing facilities in our 503A vs. 503B comparison guide.