Spring 2026 503B Update

To our partners and friends,

Today marks an exciting milestone for McGuff Outsourcing Solutions.

After years of planning, facility improvements, regulatory approvals, equipment qualification, process validation, and product development, McGuff Outsourcing Solutions is now commercially operational.

Thank you for your patience, encouragement, and confidence throughout this journey.

Built for the Long Term

From the beginning, our goal was never to be first to market. Our goal was to build a 503B outsourcing facility that healthcare professionals could depend on for consistent quality, reliable supply, and exceptional service.

That meant taking the time to validate our manufacturing processes, strengthen our quality systems, and build the operational foundation necessary to support long-term growth.

Today, that foundation is in place.

Looking Ahead

Our recent 2026 California State Board of Pharmacy inspection marks another important milestone as we continue to strengthen our quality and compliance programs.

In addition, Ascor® (Ascorbic Acid Injection) is now manufactured exclusively in our 4040 facility, allowing our newly refurbished 2921 facility to focus on expanding production of McGuff Outsourcing Solutions products.

We also expect additional state licenses to be issued as commercial operations continue, allowing us to serve healthcare providers in more states across the country.

One Account. More Products. Greater Convenience.

McGuff Outsourcing Solutions is now fully integrated with McGuff Medical Products, allowing customers to seamlessly purchase products from both companies through a single account and sign-on.

Whether you’re purchasing sterile injectable medications from McGuff Outsourcing Solutions or everyday medical products from McGuff Medical Products, our goal is to make purchasing easier by giving your practice access to everything it needs through one trusted organization.

In addition to our growing portfolio of 503B sterile injectable medications, healthcare providers have convenient access to more than 4,000 medical products used every day in physician offices and clinics.

Methylcobalamin is only the beginning. Additional sterile injectable products are progressing through development as we continue expanding our portfolio:

Thank You

Whether you’ve been a McGuff customer for many years or are placing your first order today, we sincerely appreciate the opportunity to earn your confidence.

Our commitment remains simple: to manufacture high-quality sterile injectable medications supported by disciplined pharmaceutical manufacturing, comprehensive quality systems, reliable supply, and exceptional customer service.

Thank you for your trust and support.