The voice for pharmacy compounding │ 10 June 2022

From APC’s President

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A win for Glutathione 


Look at that graphic on the right: does it represent one of the most dangerous substances on earth? It is made from glycine, cysteine, and glutamic acid. It is produced by the liver and involved in many body processes.


But lately, some regulators have taken extreme enforcement positions against this “dangerous substance” when used in pharmacy compounding.


Of course, this substance is glutathione. You can purchase glutathione from any health food store or vitamin shop in the country. Yet, the position of some is that it is illegal to compound.


This week, the FDA’s Pharmacy Compounding Advisory Committee met to discuss changing the status of glutathione from a 503A Category I substance to inclusion on FDA’s list of bulk substances that can be used in compounding. 


APC board member A.J. Day gave compelling evidence in support of glutathione to the PCAC. Even though his testimony was hurried by the PCAC hosts, he did a fantastic job.  


For once, sanity seemed to prevail. The PCAC voted 8 to 5 to add glutathione to the FDA’s list of bulk substances that can be used in compounding. We are hopeful that the FDA will accept the recommendation of the PCAC, although the agency is not bound to do so.


APC and our allies will continue to fight for your right to make customized medications. Thank you for your membership. It’s only with you and your generosity that we can fight these fights. Thank you for your investments in CompPAC, One Fund and the Legal Action Fund. You make these fights happen.


• • •


David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at

This week


PCAC recommends glutathione for bulks list

FDA’s Pharmacy Compounding Advisory Committee this week voted to recommend that FDA add glutathione to the final 503A Bulks List, signaling that it can be compounded. The 8-5 vote, with one abstention, is not binding on FDA, however.


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


Representing PCCA and NCPA, APC board member and PCCA Vice President of Clinical Services A.J. Day made a case to the committee for why the substance should be added to the bulks list.


“A.J. did a heroic job dismantling FDA’s inaccurate assessments of research that the agency referenced to argue against the addition of glutathione,” said Brunner, “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.”


“This is a win, thanks to A.J., and we’ll take it,” added Brunner. “But we simply must protest this PCAC process, from the insufficient time to review materials prior to the meeting to the limit of a 10-minute presentation per substance to the lack of any deliberation at all among committee members. We will raise it at next week’s compounding listening session with FDA for sure.”


In addition to glutathione, PCAC considered three additional substances for the 503A Bulks List in its meeting this week. The other three are ferric subsulfate, enclomiphene citrate, and ammonium tetrathiomolybdate. Only glutathione received the committee’s recommendation. PCAC also voted to add lorcaserin hydrochloride to the Withdrawn or Removed List, which affects 503A and 503B compounders.

Got “the right stuff”?

APC Fellow nominations due June 30

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The APC Fellows Program recognizes pharmacists and pharmacy technicians who are exemplary in their professionalism and commitment to the practice of pharmacy compounding.


Interested candidates must be registered pharmacists or pharmacy technicians who are APC members and who have practiced pharmacy for at least five years and practiced in the compounding pharmacy profession for at least three years.


The application deadline is June 30, 2022. Click here to learn more about the requirements and to submit an application.

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Show your APC membership pride


Want to flaunt your APC membership on your website, business card and/or email signature? Individual and Pharmacy/Facility Members (PFMs) can do just that.


Click on the appropriate link below, then complete, sign and return the agreement. Upon completion, we’ll send you the appropriate logos so you can start showing your APC pride.



Pharmacy/Facility Members featured benefit: HealNow


A Pharmacy/Facility Membership provides many benefits, including fee waivers with HealNow, a HIPAA-compliant online payment solution for pharmacies.


HealNow enables pharmacies to offer online payments of prescriptions for a faster on-boarding and payments process, in a frictionless way. Want to learn how HealNow is working for a fellow APC member? Click here to watch a video of one of your compounding pharmacy peers talk about her pharmacy’sHealNow experience.


Not a PFM yet? Click here to learn more or you can contact APC’s Jason Dunn at or 918.770.6333.

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Save these dates

June 21–22: Informa Connect’s Compounding Pharmacy Compliance, College Park, MD


June 23: An APC Webinar, 503A Compounding for Shortages – What Can (and Can’t) You Do?


June 30: APC Fellows Program application deadline.


September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC


Short takes

Town Hall today, Capitol Hill tomorrow: Thanks to all who attended CompPAC’s Town Hall with pharmacist and congressional candidate Chris Schiller. In case you missed it, here’s the recording.


Compounding makes the list: In response to requests from stakeholders, FDA recently added a search function to the National Drug Code (NDC) Directory webpage for human drugs compounded by outsourcing facilities that assign NDC numbers to their products.


Well, it’s about time: Earlier this week, the Federal Trade Commission announced its intent to scrutinize the impact of vertically integrated pharmacy benefit managers on the access and affordability of medicine. Read the full announcement here.


Pharmacy groups ask Biden to keep PREP Act around until 2024: APC was among nearly 100 patient, public health, and state and national pharmacy groups that signed a letter to the Biden Administration requesting that PREP Act authorities remain in place through Oct. 1, 2024. Full story here.


To end on a good note: Start your weekend off with a most excellent cat video

Quick links

APC Career Center


Compounding Connections archive


Compounders on Capitol Hill 2022


Continuing education

Invest in APC efforts



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