As the “ALA Saga” progresses, we wanted to update you on the current status of 503B outsourcing facilities’ ability to produce Alpha Lipoic Acid (ALA).
We’ve been actively working with the FDA to keep ALA on the ‘able-to-be-compounded list’ (Category 1 of the Bulk Drugs List for 503B Outsourcing Facilities). This allows all outsourcing facilities to compound ALA for you and your patients.
Recently, per the request of the FDA, we submitted an enhanced version of our nomination to the FDA for ALA in order to ensure ALA remains in the 503B Category 1 list. We are awaiting their response.
Nominating a bulk drug for FDA consideration is a comprehensive process that involves meticulous research, stringent testing, data analysis, and adherence to regulatory guidelines. A nomination identifies that there is a clinical need, as well as demonstrated safety and effectiveness for the drug substance. We’re dedicated to this rigorous process to assure continued access to ALA (and other compounded drugs.)
It’s important to note that the FDA stated they would move ALA to the ‘Do Not Compound’ list by September 1, 2023, which compressed our time to respond significantly. Their website shows that ALA is still a part of the able-to-be-compounded list (Category 1 list) as of the date of this email.
We remain cautiously optimistic that ALA will not be removed from Category 1 as we have sent the FDA the information they are lacking. We are closely following this ‘ALA saga’ and will continue to update you as we learn new information.
We appreciate your support!
- Your friends at McGuff
Last week, we received an email from the FDA detailing their reasons why Alpha Lipoic Acid (ALA) Active Pharmaceutical Ingredient (API) will be removed from the Category 1 List for 503B Compounding.
We appreciate the FDA providing us with this detailed and timely information. We have responded to the FDA not only by addressing their concerns about ALA API, but also by providing scientifically reliable evidence to support our position and nomination.
The decision now rests with the FDA. It is our hope that we will receive a response from the FDA that ALA API will remain on the Category 1 List and be available for continued compounding. We realize how important this drug is for our doctors and their patients and continue to advocate for them.
As usual, we will keep you up to date on this Alpha Lipoic Acid issue.
We appreciate your support!
We have always said, “More than sales and service, we are involved.” We are now at a time of increased involvement.
We have just discovered that the FDA has said they will be preventing 503B outsourcing facilities from compounding Alpha Lipoic Acid (ALA). This would prohibit McGuff (and all other 503Bs) to compound ALA.
Although this is extremely concerning, McGuff is directly involved in working with the FDA to provide the necessary additional information needed to allow 503B outsourcing facilities to be able to continue to compound ALA. As the initial nominator of ALA to the FDA, we are extremely dedicated to ensuring continued patient access to this beneficial drug. At this moment, we feel confident that we will be able to convince the FDA to allow 503Bs to continue to compound it.
Nothing is needed from our customers at the present time. We just want you to be aware of what’s happening and what we’re doing to resolve it. However, please stay tuned as we may need to enlist the support of our customers and patients in the near future.
McGuff was the initial nominator to the Compounding Pharmacy Advisory Committee (CPAC) four years ago. McGuff has over 20 years of experience successfully compounding ALA, as well as working directly with many key opinion leaders on ALA. It has been and always will be a very important drug to ensure continued patient access.
We also wanted to keep you informed on the latest updates affecting the launch of our new 503B outsourcing facility and reassure you that we’re still on track to launch. We are currently undergoing the extensive regulatory process in order to transition to an FDA-registered 503B Outsourcing Facility in anticipation of approval by the CA State Board of Pharmacy. We hope to be approved in the next two months and able to start accepting orders for Glutathione, Methylcobalamin, Methionine, Inositol, Choline Chloride (M.I.C.), Edetate Calcium Disodium (Calcium EDTA) and Procaine. ALA is another drug that we’ve had under development that we’ll have to wait and see what the outcome with the FDA will be.
We will continue to send updates as we learn more. You can also visit this page for the latest details. In the meantime, if you have any questions about ALA or about MOS, please don’t hesitate to contact us.
We have some promising news on the status of our CA Board of Pharmacy (CA BoP) application. We hope to be able to start shipping to our California customers as soon as we receive official approval.
Recently, the CA BoP responded to our April 18th application with a few additional questions about McGuff Outsourcing Solutions (MOS), which we promptly responded to. We are anxiously awaiting their response so we can proceed.
In the meantime, we also wanted to keep you updated with the current drug list we will have available at launch!
Compounded Drugs Nearing Development Completion:
We are optimistic for the CA BoP to quickly approve our application. We know how important it is to have these drugs available to your patients and have reiterated this throughout our application process. Once we’re approved for California, we can begin submitting to all the other states and protectorate licenses. These state-specific applications are already created and ready to submit for approval!
Be sure to reach out with any questions. We are here for you!
By creating an online account at McGuff Medical you will automatically have an online account at McGuff Outsourcing.
FDA has scheduled McGuff Outsourcing Solutions for a pre-site evaluation/inspection in the next few weeks. This is amazing news as welcome having inspections! The more eyes on us and the product will only increase the quality of the drugs we produce! It will also hopefully help with the process of becoming licensed by the CA State Board of Pharmacy.
Validation and Stability Batches has been produced for:
Near future Validation and Stability batches will be produced in the next few weeks:
Additional Validation and Stability batches to follow on shortly.
As of right now we are moving forward with additional product development as we await license approval from the State of California. All other state and protectorate applications are being created but cannot be submitted until we are licensed in California.
More to follow. Hang tight! We are just as excited as you to get McGuff Outsourcing Solutions up and running.
If you have additional questions, feel free to reach out! We love hearing from you!
We continue to appreciate all the love and excitement for McGuff Outsourcing Solutions. The day cannot get here fast enough when we are able to start shipping these compounded drugs.
|CA State Board of Pharmacy License Application||Submitted|
|CA State Board of Pharmacy Expedited License Application||Submitted|
|CA State Board of Pharmacy Inspection||Awaiting being scheduled|
We are very hopeful that the CA state Board of Pharmacy will quickly turn around our application so that we can begin to submit for all other states and protectorate licenses.
New 503B website is still under construction and we are anticipating going live in June.
If you have any additional questions, please feel free to reach out. We love hearing from you!
We appreciate all the love and excitement for McGuff Outsourcing Solutions. The new 503B website for McGuff Outsourcing Solutions is currently under construction. We will utilize www.mcguffpharmacy.com as a place to show updates about the 503B transition process and historical information about products we made as a compounding pharmacy.
We have some exciting changes that we will be releasing shortly about the functionality of McGuff Outsourcing Solutions and McGuff Medical being your one stop show for compounded product and wholesale drugs and device products.
What does this mean?
McGuff Outsourcing Solutions is currently open, but we are still pending California State Board of Pharmacy (SBoP) licensing and all other state licensing before we can start shipping product. Crossing our fingers this will be very soon!
I have ordered from McGuff Pharmacy before, do I need to create a new account?
Nope! If you have ordered from McGuff Compounding Pharmacy Services, Inc. in the last 3 years, your information will automatically be opened at the new 503B company!
Can I register for an online account?
Currently our new 503B website is under construction. Stay tuned for updates! In the meantime, you can create an online account with mcguffmedical.com. All online accounts will be transferred over to the new website. All mcguffpharmacy.com accounts will unfortunately not be able to be transferred to the new website.
What is McGuff Outsourcing Solutions contact information?
We are open for you to contact us and answer any questions!
When can I place a preorder?
Shortly. We are finalizing a few things and will announce shortly when we open up preorders for both office use and prescription.
What compounded drugs do you anticipate coming out with?
*These products are not yet available
Give us a call or send us an email! We are still here and happy to answer any and all questions you may have!