Latest Updates:

October 10, 2023

Promising Outlook for Alpha Lipoic Acid

Since our last update on Alpha Lipoic Acid (ALA), we have seen the FDA has made multiple updates to its able-to-be compounded list. We are now over a month past when the FDA stated they would remove ALA.

At this time, we feel confident that the FDA accepted our submission of supporting information and that with our efforts, ALA will remain on the able-to-be-compounded list. This leads us to breathe a little easier and proceed with our production plans.

It is astonishing how easily the FDA can remove a drug from the market. However, we have learned that if we provide solid evidence to the FDA, they are willing to work with the industry to allow these drugs to be compounded if they are deemed safe. This is terrific news that they are not unilaterally removing ALA from the market and that doctors and their patients who need it will continue to have access to it!

Previously, we looked at the not-able-to-be-compounded list as a “death sentence”. With our continued experience with this process, we’ve learned that with the necessary additional steps and communication, we may affect change, allowing for continued access and “bringing the drugs back to life.” We are now going to continually look at what drugs are on this list that potentially show promise to revive and start up the conversation with the FDA.

Are there any compounded drugs that you would like made available again for your patients? Let us know! Your support helps us maintain patient access to beneficial compounded drugs.

We appreciate your support!

- Your friends at McGuff

September 22, 2023

Alpha Lipoic Acid Remains on the FDA’s Category 1 Bulk Drugs List

We wanted to share our latest update on the current status of 503B outsourcing facilities to compound Alpha Lipoic Acid (ALA).

As of September 21st, the day the FDA typically updates its lists, ALA continues to be on the able-to-be-compounded list. However, we do not know for certain if the FDA has made its final decision, but it continues to look very promising. (Category 1 of the Bulk Drugs List for 503B Outsourcing Facilities).

We’ve been communicating with the FDA advocating to keep ALA on its able-to-be-compounded list. We want to make sure that all outsourcing facilities can continue compounding ALA for the benefit of medical providers and their patients.

As a result of McGuff’s continued efforts, we remain optimistic. As we get further from their original deadline of September 1st, it continues to look more and more promising. We are currently awaiting a direct response about this from the FDA, so while we wait, we are using key milestones to glean the FDA’s opinion on it.

ALA Milestones

August 9 – FDA responds with a detailed email indicating the need for ‘adequate supporting data’ required to consider ALA further for inclusion on the list.

September 1 – 30-day mark at which FDA stated they would remove ALA. ALA continues to remain on the able-to-be-compounded list

September 21 – Date the FDA typically updates its lists. ALA continues to remain on the able–to–be–compounded list.

October 21 (upcoming) – Two review cycles past when the FDA announced they would remove ALA from the able–to–be–compounded list (just to be safe)

Brief History

July 21 – FDA announced its intention to remove ALA from its able-to-be-compounded list within the next 30 business days.

July 29 – McGuff Outsourcing Solutions advised the FDA that McGuff Outsourcing Solutions, Inc. (MOS), a 503B entity, has performed significant cGMP testing of ALA Active Pharmaceutical Ingredient (API) to assure the API meets requirements for the intended purpose of sterile injection. Asked FDA for a clear definition of what information is needed.

August 9 – FDA responds with a detailed email indicating the need for ‘adequate supporting data’ required to consider ALA further for inclusion on the list.

August 9 – McGuff Outsourcing Solutions responds to the FDA with scientifically reliable information about ALA Active Pharmaceutical Ingredient (API).

August 17 – McGuff Outsourcing Solutions submits a technical nomination package for ALA Bulk Drug Substance to FDA that included nine categories of scientific documentation.

September 21 – McGuff Outsourcing Solutions requests confirmation from the FDA that the McGuff supporting data provided to the FDA was adequate to resolve the issues related to ALA API. Further, a request to understand what issues remain, if any.

We remain cautiously optimistic.

We appreciate your support!

- Your friends at McGuff

September 6, 2023

Leading the Charge: Our Commitment to Maintaining Patient Access to Alpha Lipoic Acid (ALA)

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

August 14, 2023

Update on FDA Alpha Lipoic Acid Removal

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!

August 7, 2023

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.

What Is Needed From You:

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.

McGuff Outsourcing Solutions Update:

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

Additional questions?

Give us a call at (877) 444-1133 or send us an email! We are still here and happy to answer any and all questions you may have!