Update on McGuff's 503B Outsourcing Facility for Compounded Drugs
Current Status as of 2/21/24:
On-Site Inspection Complete
We’ve received the inspection report from the CA State Board of Pharmacy (CA SBoP) on-site inspection. This achievement brings us closer to our goal of providing medical professionals with the drugs they need to support patient care.
We appreciate the time and attention to detail the inspectors put into the on-site inspection. We continue to collaborate with the CA SBoP to assure McGuff Outsourcing Solutions will provide the finest quality drugs. We believe this collaboration will result in approval for our California license. Once we receive CA SBoP approval, we will immediately submit to all other states for licensure.
We’re Committed to Staying the Course
This has been a longer process than we originally anticipated, but we’re committed to staying the course! We’re excited to launch and provide our customers with the products their patients need. We appreciate everyone’s continued patience throughout the past year and look forward to reconnecting and doing business with everyone again.
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). 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 Compared to a Compounding Pharmacy:
- No prescriptions needed - order for office use
- Higher quality control and assurance
- Longer product shelf life
- 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:
- 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 prepared and anticipated the CA SBoP's inspection, which validated 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
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
