PCAC Votes To Add Compounded Glutathione On “Able To Compound” List

Pharmacy Compounding Advisory Committee Votes Yes on Glutathione

On June 8th 2022, the FDA’s Pharmacy Compounding Advisory Committee, or PCAC, voted 8-5 with one abstention to add glutathione to the final 503A Bulk Drug Substance List. In the same meeting, PCAC voted against the inclusion of the three other substances (ammonium tetrathiomolybdate, enclomiphene citrate, and ferric subsulfate) under review for consideration onto the final 503A Bulks List. They also voted to add lorcaserin hydrochloride to the Removed/Withdrawn List, which would affect both 503A and 503B compounders.

The Nomination, Evaluation, and Voting Process

The final 503A Bulk Drug Substance List is in current development. During this interim period, FDA consistently evaluates nominated substances for safety and clinical utility. In order for a bulk substance such as glutathione to be considered for inclusion onto the final 503A Bulk Drug Substance List, it has to be nominated with sufficient evidentiary support. In this case,

glutathione was independently nominated by the following associations and compounding entities:

  • Alliance for Natural Health USA

  • American Association of Naturopathic Physicians (AANP)

  • American College for Advancement in Medicine (ACAM)

  • Integrative Medical Consortium

  • McGuff Compounding Services, Inc.

  • National Community Pharmacists Association (NCPA)

  • Professional Compounding Centers of America (PCCA)

It was proposed for treatment of numerous conditions including:

Asthma, autism spectrum disorder, chronic obstructive pulmonary disease, cystic fibrosis, Parkinson’s disease, peripheral obstructive arterial disease, reduction of chemotherapy side effects, skin lightening, and more.

And in the following dosage forms:

Oral (capsule/troche), sublingual, topical (cream/gel), ophthalmic, nasal spray, rectal, injection (intravenous [IV], intramuscular [IM]), and inhalation preparations.

FDA evaluates each bulk substance under the following criteria:

  1. The physical and chemical characterization of the substance;

  2. Any safety issues raised by the use of the substance in compounded drug products;

  3. The available evidence of effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and

  4. Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature.

FDA and PCAC Arrive at Different Conclusions

In its evaluation, FDA found there to be a lack of effectiveness and safety data of glutathione and recommended against its inclusion onto the final 503A Bulks List. While PCAC rarely votes against FDA’s direction, that is exactly what happened in this instance.

One member of the PCAC committee remarked that FDA’s review of glutathione’s efficacy was “superficial and narrow.” Because of the overwhelming statements and over 8,000 comments received from providers and patients highlighting the historical and clinically significant use of glutathione, it appeared that the majority of PCAC members disagreed with FDA’s conclusion and voted to include it on the final list.

Proponents of the Clinical Use of Glutathione Rejoice the Decision

The CEO at the Alliance for Pharmacy Compounding (APC), Scott Brunner, said, “As with methylcobalamin last year, the committee bucked the FDA staff’s recommendation against adding glutathione to the bulks list. And just as with methylcobalamin, now we wait to see what formal action FDA may take on PCAC’s recommendation.”

A.J. Day, who represents PCCA, NCPA and is an APC Board Member, made his case to the committee for why the substance should be added to the bulks list. Brunner praised Day commenting, “A.J. did a heroic job dismantling FDA’s inaccurate assessments of research that the agency referenced to argue against the addition of glutathione, and he did it under duress. While the FDA had a fairly unlimited time to present to the committee, A.J.’s presentation was limited, and he was cut off before completion. He was forced to speak incredibly rapidly, yet still made a thorough case for why FDA was off base in its recommendation.”

When Does Glutathione Become Formally Placed Onto the Final Bulks List?

Although PCAC’s vote is not binding, it influences FDA’s decision to include or prohibit the use of these bulk substances in compounding. As of now, the interim and final Bulks Lists have not been updated to reflect a final rule for glutathione. FDA is expected to update the final Bulks List in the Spring of 2023.

Does Your Facility Produce Quality Preparations?

If you’re ready to bring quality to the center of your compounding operations, consultants at Restore Health Consulting LLC can help you design a robust quality management system to promote patient safety and regulatory compliance.

Resources:

·      FDA Backs Glutathione Ban

·      FDA seeks to ban compounded glutathione, AANP responds with call-to-action

·      Glutathione For Liver Protection

·      PCAC Has Voted YES to Include Compounded Glutathione on the "Able to Compound" List

·      PCAC recommends glutathione for bulks list

·      Pharmacy Compounding Advisory Committee: IND Drug Development and Expanded Access (EA)

·      Pharmacy Evaluation Team Says Yes to Compounded Glutathione, Despite FDA

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Amy Summers