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Update on McGuff's 503B Outsourcing Facility for Compounded Drugs

Update on McGuff's 503B Outsourcing Facility for Compounded Drugs

McGuff Outsourcing Solutions Nearing 503B Licensing Completion 

We’re in the process of upgrading to a 503B outsourcing facility and are looking forward to launching McGuff Outsourcing Solutions (MOS) very soon. MOS is the newest company in the McGuff Family of Companies. We are in the process of finalizing our facility inspection from the California State Board of Pharmacy (CA SBoP) which is a crucial step toward beginning operations and shipping compounded drugs to healthcare facilities and providers​​.

Previously operating as McGuff Compounding Pharmacy, a 503A, we look forward to continuing our 20+ years legacy of producing quality compounded drugs that medical providers can trust. The 503B designation, a mark of compliance and quality, allows us to produce large-scale compounded drugs under stringent FDA guidelines, meeting an urgent need for hospitals and clinics. The facility has already completed FDA registration and anticipates a quick turnaround on its CA SBoP application​ once inspected​.

As an FDA-registered outsourcing facility, MOS can compound drugs for hospitals, clinics and office use. We can compound drugs from bulk drug substances that are on the FDA’s clinical need list, or that meet the criteria for inclusion on that list, or that appear on the FDA’s drug shortage list.

Benefits of 503B Outsourcing Facilities:

  • No prescriptions needed - order for office use
  • Higher quality control and assurance
  • Free, 3-day shipping

Upon license approval, we anticipate offering the following compounded drugs to start:

  • Alpha Lipoic Acid (ALA)
  • Glutathione
  • Methylcobalamin
  • Methione, Inositol, Choline Chloride (M.I.C.)
  • Procaine HCL

We’ve been proactive in our efforts to prepare for the launch. Here are the key milestones we've achieved in 2023:

  • FDA Registration Completion: Our facility has met the stringent requirements set by the FDA, ensuring we operate at the highest standards.
  • Submission of CA State Board of Pharmacy License Application: This pivotal step was carefully prepared and submitted, bringing us closer to operational status.
  • Response to CA State Board of Pharmacy's Additional Queries: We promptly addressed a few more questions from the CA SBoP, showing our commitment to transparency and compliance.
  • Preparation for CA SBoP Inspection: We are ready and looking forward to the CA SBoP's inspection, which will validate our practices and procedures.
  • Product Development Progress: Validation and stability batches of essential drugs like Glutathione and Methylcobalamin have been produced, with more in the pipeline.

Stay Informed of Our Progress

MOS Status TrackerMOS U.S. Map

Thank You for Your Patience!

As we await final approval from the CA SBoP, we'd like to express our appreciation to our customers for their continued support. Be sure to bookmark this page to check back for ongoing updates, sign up to receive our emails and contact us if you have additional questions.

Register for Your Account 

Also, if you haven’t already, register for your account at McGuff.com and you will automatically have an account set up with McGuff Outsourcing Solutions.

Are You a Patient?

If you are a previous McGuff Compounding Pharmacy patient who is looking for a pharmacy to fill your prescription, we will soon have a list of partner pharmacies for you to reference and will post the link here in this article.

Learn More About the Benefits of 503Bs

503B Benefits

Coronavirus (COVID-19)

Due to the Coronavirus (COVID-19) outbreak worldwide, the global demand for some Personal Protective Equipment (PPE) is exceeding current supply availability.

In addition, the manufacturing of the PPE and many other wound care/infection prevention products have been impacted by the global response to the Coronavirus. While you may see product availability reduction in the near-term, please be assured that we at McGuff Medical are continuing to work diligently to ensure an uninterrupted supply of products and alternative products to you.

Additionally, in order to ensure healthcare providers have access to the PPEs they need, the McGuff Company is temporarily limiting PPEs to healthcare providers.

As always, please feel free to reach out to our McGuff Customer Service team with any questions that you may have.

Click here for updates regarding Coronavirus Pandemic and Your Supplies and a message from our President