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The Peptide Problem | Essential: The Pharmacy Compounding Podcast · Pharmacy Podcast Network

• 0:05
  Speaker 1: You are listening to the global network of podcasters dedicated
• 0:09
  Speaker 1: to the pharmacy profession. Welcome to the Pharmacy podcast Network.
• 0:28
  Speaker 2: Welcome back to Essential, the Pharmacy compounding podcast with the
• 0:32
  Speaker 2: latest news and analysis from you know It, the Alliance
• 0:36
  Speaker 2: for Pharmacy Compounding, the voice for compounding pharmacy. I'm your host,
• 0:40
  Speaker 2: Andrew Canter, and after the news today, we've got peptides
• 0:44
  Speaker 2: like everything you need to know about them, what they are,
• 0:47
  Speaker 2: why people are so interested in them, and from a
• 0:50
  Speaker 2: compounding point of view, what's happening with them. But first
• 0:53
  Speaker 2: let's do a few bits of pharmacy compounding news. There's
• 1:03
  Speaker 2: a great op ed in stat News you want to
• 1:05
  Speaker 2: check out. It's all about the revolving door at the FDA,
• 1:09
  Speaker 2: and by that we mean how it seems that a
• 1:11
  Speaker 2: lot of FDA officials are leaving the agency and then
• 1:15
  Speaker 2: going to work for the companies they were just supposed
• 1:17
  Speaker 2: to be regulating. In one case, an official in the
• 1:20
  Speaker 2: FDA's compounding division was what's the phrase, reduced in force
• 1:25
  Speaker 2: laid off anyway, she went to work as a lobbyist
• 1:28
  Speaker 2: for a GLP one drug maker, where suddenly she became
• 1:32
  Speaker 2: quite anti compounding. Not surprisingly, the thing is, federal law
• 1:36
  Speaker 2: prohibits ex government employees from representing private parties in the
• 1:41
  Speaker 2: issues they worked on while working for the government. It's
• 1:44
  Speaker 2: a lifetime ban, but laws are only laws if they're
• 1:48
  Speaker 2: actually enforced. Caces like that are why the authors of
• 1:51
  Speaker 2: the stat News column that's Lee rose Bush, who's chairman
• 1:55
  Speaker 2: of the Outsourcing the Facilities Association, and pharmacist attorney Mac Wagner,
• 2:00
  Speaker 2: say it's kind of hard to have a lot of
• 2:01
  Speaker 2: respect or trust in an agency when you think people
• 2:04
  Speaker 2: there are just auditioning for a spot with a private company.
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  Speaker 3: The interesting thing is rose Bush and Wagner have a plan.
• 2:11
  Speaker 3: Check it out. The link to the article and the
• 2:13
  Speaker 3: column is in the show notes.
• 2:17
  Speaker 2: In California, the Board of Pharmacy there is proposing a
• 2:20
  Speaker 2: rule that would require central pill pharmacies not only to
• 2:24
  Speaker 2: be licensed in California, but operate within California, so non
• 2:29
  Speaker 2: resident pharmacies wouldn't be allowed to act as central fill providers.
• 2:33
  Speaker 2: You can see why this would be a problem with
• 2:36
  Speaker 2: our friends at NCPA. We reached out to the Board
• 2:38
  Speaker 2: of Pharmacy there to formally oppose the rule, but also
• 2:42
  Speaker 2: to suggest a simple alternative. Any law already puts requirements
• 2:47
  Speaker 2: on non resident pharmacies that dispense in California, so why
• 2:50
  Speaker 2: not just apply those same requirements to central pill pharmacies.
• 2:54
  Speaker 2: It's a lot simpler and honestly a lot better for patients.
• 2:57
  Speaker 2: But then again, this is the California Board of Pharmacy,
• 3:00
  Speaker 2: which seldom tells us why. There's a little problem in
• 3:06
  Speaker 2: Illinois that's really about, well, I guess it's kind of
• 3:09
  Speaker 2: a bit of government inefficiency.
• 3:12
  Speaker 3: There's a new.
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  Speaker 2: Law there that requires out of state pharmacies that want
• 3:15
  Speaker 2: to dispense into Illinois to have a pharmacist in charge
• 3:18
  Speaker 2: whose license in the state makes perfect sense. The problem
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  Speaker 2: is that the law takes effect on January first, twenty
• 3:25
  Speaker 2: twenty six, but even pharmacists who have put in their
• 3:28
  Speaker 2: applications for Illinois licenses months ago, they haven't heard back.
• 3:32
  Speaker 2: We're hoping the state won't jump into enforcing the new
• 3:35
  Speaker 2: law right away. We and NCPA have asked the Illinois
• 3:39
  Speaker 2: Board for a bit of enforcement discretion, give the state
• 3:42
  Speaker 2: time to process those licensed applications without punishing the pharmacists
• 3:46
  Speaker 2: who are trying to follow the law. Ah accreditation the
• 3:51
  Speaker 2: best part of the job for any pharmacy owner.
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  Speaker 3: And yes that was sarcasm.
• 3:56
  Speaker 2: We know how big a hassle it is, plus the
• 3:58
  Speaker 2: frustration knowing that there's so much overlap, plus the whole
• 4:02
  Speaker 2: mix of deadlines and this huge time sink. APC is
• 4:06
  Speaker 2: run by pharmacists, you know, and a lot of our
• 4:09
  Speaker 2: members are pharmacy owners, so yeah, they're dealing with the
• 4:12
  Speaker 2: same thing, and that is why we have come up
• 4:15
  Speaker 2: with something better. It's a new accreditation from the Coalition
• 4:18
  Speaker 2: for Compounding Excellence or CCE, and it's got some teeth.
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  Speaker 2: The idea is to make your life easier by cutting
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  Speaker 2: down on hassle. CCE accreditation ticks all the boxes. There's
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  Speaker 2: a USB, adherence, facilities, equipment, personnel processes, basically the whole
• 4:34
  Speaker 2: gamut of what today's regulations are expecting. It means you
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  Speaker 2: can spend less time dealing with the fun paperwork of
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  Speaker 2: a stack of accreditations and more time, you know, helping
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  Speaker 2: your patients.
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  Speaker 3: One big thing.
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  Speaker 2: CCEE focuses on, and this is something pharmacy owners can appreciate,
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  Speaker 2: is multi state licensure. Why deal with separate evaluations for
• 4:55
  Speaker 2: every state you want a dispense to When CCE can
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  Speaker 2: do that in one visit.
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  Speaker 3: Bet that got your attention. How about this.
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  Speaker 2: CCEES inspectors are actually pharmacists, compounding pharmacists.
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  Speaker 3: They know what's what.
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  Speaker 2: They get the reality of your back room, and this
• 5:12
  Speaker 2: is important. They're not just looking to find problems. They
• 5:15
  Speaker 2: want to help you resolve them. The whole idea is
• 5:17
  Speaker 2: to make your life easier. Remember, all right, obviously this
• 5:21
  Speaker 2: sounds good, but and you know there's a butt. CCEE
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  Speaker 2: accreditation is only available for APC members. In fact, APC
• 5:29
  Speaker 2: Pharmacy Facility members get a pretty big discount, like up
• 5:32
  Speaker 2: to half the price of other accreditation programs. So if
• 5:36
  Speaker 2: you're an APC member and you own a pharmacy, you
• 5:38
  Speaker 2: probably want to check this out. There is a link
• 5:40
  Speaker 2: in the show notes. And if you're not an APC member, well,
• 5:44
  Speaker 2: this is just another reason you ought to be. And
• 5:48
  Speaker 2: now it is onto this episode's deep dive. There's a
• 5:53
  Speaker 2: lot of talk out there about peptides. If you believe
• 5:56
  Speaker 2: what you see on TikTok, which you shouldn't, always, peptides
• 6:00
  Speaker 2: are the cure for everything from bad breath to osteoporosis.
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  Speaker 2: But in the real world there are a lot of
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  Speaker 2: restrictions on working with peptides.
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  Speaker 3: There are a lot of rules and honestly a bit
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  Speaker 3: of confusion.
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  Speaker 2: So here today we've got a couple of folks to
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  Speaker 2: talk the peptide talk. What they are, how they work,
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  Speaker 2: what's happening with regulation, and what looks like it maybe
• 6:20
  Speaker 2: coming down the pike. This will be a pretty geeky discussion,
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  Speaker 2: no offense to our experts, so get ready. You know
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  Speaker 2: Tanil Davis, she's APC's Chief Advocacy Officer, and she's also
• 6:31
  Speaker 2: a longtime pharmacist with a boatload of regulatory experience, including
• 6:35
  Speaker 2: attending the Pharmacy Compounding Advisory Committee meetings when they talked
• 6:39
  Speaker 2: about peptides. Like a lot of you, she is well
• 6:42
  Speaker 2: aware that prescribers and patients really really want access to
• 6:46
  Speaker 2: compounded peptide therapies. And Matt Johnson, he's president of farm
• 6:51
  Speaker 2: Source Direct. It's an FDA registered API wholesaler. He's got
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  Speaker 2: years of experience as a supplier to compounding pharmacies and
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  Speaker 2: he is all a member of APC's board of Directors.
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  Speaker 2: Welcome to the podcast, both of you. So why don't
• 7:06
  Speaker 2: we start at the very beginning, A very good place
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  Speaker 2: to start tell us what peptides actually are and why
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  Speaker 2: there's all this interest these days in using them as treatments.
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  Speaker 4: Sure, thanks, Andrew.
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  Speaker 5: Peptides are, you know, short chains of amino acids. They
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  Speaker 5: act in our body as a signaling hormone to tell
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  Speaker 5: our body to do lots of things.
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  Speaker 4: But when we hear about peptides on TikTok.
• 7:30
  Speaker 5: Or on Instagram or in the news, we're hearing about
• 7:33
  Speaker 5: peptides a certain category of peptides. Those are ones like
• 7:38
  Speaker 5: BPC one fifty seven, cjc kiss, peptin ipomorlan. So even
• 7:43
  Speaker 5: though there's a lot of peptide drugs that are FDA
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  Speaker 5: approved that are used to treat patients, now that when
• 7:50
  Speaker 5: you hear the word peptides in the you know, the
• 7:54
  Speaker 5: online being advertised to you, they're really talking about this
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  Speaker 5: certain group of anti aging peptides like BPC one fifty
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  Speaker 5: seven MATT.
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  Speaker 4: So these are chains of amino acids.
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  Speaker 5: Can you explain the difference between an amino acid and
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  Speaker 5: a protein and what the cutoff is for the amino
• 8:14
  Speaker 5: acid length that makes peptides peptides and proteins biologics and
• 8:19
  Speaker 5: drug categorization.
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  Speaker 6: Yes, certainly, I think this definition became more prevalent about
• 8:25
  Speaker 6: six years ago when FDA reclassified hCG. At that point
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  Speaker 6: in time, they defined the difference between a biologic and
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  Speaker 6: peptide as forty branch chain amino acids or less. So
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  Speaker 6: anything above the forty branch chain amino acids would be
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  Speaker 6: considered a biologic. Anything below that is going to be
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  Speaker 6: considered a peptide. I think the primary difference is going
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  Speaker 6: to be when synthesizing the material. It is made either
• 8:55
  Speaker 6: from recombinant material or completely synthesized through the pharmaceutical pross.
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  Speaker 5: Yeah, in the last ten years, there's been a lot
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  Speaker 5: of advancement in the manufacturing processes for peptide drugs. It
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  Speaker 5: used to be that all manufacturing was done via the
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  Speaker 5: right recombinant technology, which is basically training a type of
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  Speaker 5: bacteria to produce chains of amino acids in a certain sequence.
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  Speaker 5: But now pharmaceutical companies have the ability to do all
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  Speaker 5: of that synthetically. FDA doesn't differentiate between recombinant and synthetic
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  Speaker 5: manufacturing processes when there's a drug that is getting approval
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  Speaker 5: as a new generic, So if the brand name product
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  Speaker 5: was synthesized via recombinant technology, but the new generic that's
• 9:42
  Speaker 5: looking for abbreviated new drug approval.
• 9:45
  Speaker 4: Is done via synthetic.
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  Speaker 5: The FDA as long as the API is the same
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  Speaker 5: at the end, the FDA doesn't differentiate between those two
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  Speaker 5: manufacturing processes, and the synthetic process is a lot easier.
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  Speaker 4: So there's been.
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  Speaker 5: A big boom in peptide manufacturing over the last ten
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  Speaker 5: years and a lot of interest in peptides.
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  Speaker 6: Ultimately, as long as the molecular structure, as you indicated,
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  Speaker 6: remains the same, then it will be considered similar or
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  Speaker 6: same to whatever was approved through the recumbinant process. And
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  Speaker 6: that's what we're seeing is the majority of manufacturers are
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  Speaker 6: now releasing the synthetic versions of these recumbitant molecules that
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  Speaker 6: do follow the same molecular structure. They have the same
• 10:26
  Speaker 6: optical rotation, they have the same molecular weight, and they
• 10:29
  Speaker 6: have the same branch of amino acids making up that
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  Speaker 6: unique peptide.
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  Speaker 5: So I'm going to talk about these this group of peptides.
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  Speaker 5: So right here, we're not talking about the kind of
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  Speaker 5: peptides that you all know and love, like oxytocin or vasopressin.
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  Speaker 5: We're talking about this kind of anti aging group of peptides.
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  Speaker 4: But prior to twenty twenty three.
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  Speaker 5: These peptides were available more often because the FDA had
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  Speaker 5: yet to take action to normally categorize them on one
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  Speaker 5: of its bulk lists for compounding. Even though before twenty
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  Speaker 5: twenty three, these peptides like BPC one fifty seven didn't
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  Speaker 5: meet the criteria for compounding at the time, Matt, can
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  Speaker 5: you explain what three criteria and API has to meet
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  Speaker 5: in order to be used in a compounded product?
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  Speaker 6: Yes, Presently, the criteria to meet a human compounded product
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  Speaker 6: would be that it has to either have a USP monograph,
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  Speaker 6: it has to be a component of an approved human drug,
• 11:31
  Speaker 6: or it has to appear on the bulks list otherwise
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  Speaker 6: known as List one.
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  Speaker 5: Yeah. So these peptides never appeared on the List one.
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  Speaker 5: But in twenty twenty three, in the fall, the FDA
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  Speaker 5: quietly moved a big group of these peptides to List.
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  Speaker 4: Two in the Interim List two.
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  Speaker 5: Those are the API that are not allowed to be
• 11:53
  Speaker 5: used in a compounded product.
• 11:56
  Speaker 4: A lot of.
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  Speaker 5: People thought the FDA violated the Administrative Act because they
• 12:01
  Speaker 5: did this without notice and comment rulemaking, and they were
• 12:05
  Speaker 5: subsequently sued by a group of interested parties. That lawsuit
• 12:11
  Speaker 5: was eventually settled and the FDA conceded that it needed
• 12:14
  Speaker 5: to go through the Pharmacy Compounding Advisory Committee process review
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  Speaker 5: for some of these peptides. So in late twenty twenty four,
• 12:24
  Speaker 5: the FDA held peak AC or Pharmacy Compounding and Advisory
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  Speaker 5: Committee meetings to evaluate four of this more than a
• 12:30
  Speaker 5: dozen peptides. The outcome of those Advisory Committee meetings is
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  Speaker 5: that the FDA recommended that these peptides not be placed
• 12:40
  Speaker 5: on the List one or the interim list that allows
• 12:44
  Speaker 5: compounders to use these products in in compounding. So it
• 12:51
  Speaker 5: caused a lot of, you know, kind of rage in
• 12:55
  Speaker 5: the wellness industry because there's a lot of interest in
• 12:58
  Speaker 5: these kind of peptides drugs, and now they became officially
• 13:03
  Speaker 5: off limits for compounding. So even though they didn't meet
• 13:05
  Speaker 5: their criteria before, no one had come out and say
• 13:08
  Speaker 5: that these are absolutely against the rules until this PACAC
• 13:12
  Speaker 5: meeting and then placing them on list too.
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  Speaker 6: Yeah, that's correct, And I think one of the biggest
• 13:18
  Speaker 6: challenges for compounding pharmacies is that they were successfully utilizing
• 13:23
  Speaker 6: these peptides for a significant amount of time and had
• 13:28
  Speaker 6: limited reported adverse reactions at that time, So the pharmacists
• 13:33
  Speaker 6: were kind of blindsided by this as it was a
• 13:36
  Speaker 6: large part of their business models. The patients were also
• 13:40
  Speaker 6: really requesting refills on these items because they were relying
• 13:44
  Speaker 6: on these prescriptions for a significant amount of time, and
• 13:47
  Speaker 6: then they were immediately yanked away from these patients. So
• 13:50
  Speaker 6: at the end of the day, the patients were the
• 13:52
  Speaker 6: ones that were suffering from the results of this decision.
• 13:57
  Speaker 5: Yeah, and so the outcome now is that it's forced
• 14:00
  Speaker 5: all the people interested in using these kinds of medications
• 14:04
  Speaker 5: down the research use pathway. So instead of getting these
• 14:08
  Speaker 5: medications filled by a legitimate, state licensed compounding pharmacies that
• 14:12
  Speaker 5: have all sorts of standards that they have to follow,
• 14:15
  Speaker 5: now patients are able to order these kind of peptide
• 14:18
  Speaker 5: drugs online over TikTok without a prescription at all, and
• 14:23
  Speaker 5: there's no guarantee that what the patient is receiving in
• 14:26
  Speaker 5: the mail contains what it's purported to contain at all.
• 14:30
  Speaker 5: So in essence, it's this action by the FDA has
• 14:34
  Speaker 5: made the peptide industry less safe.
• 14:38
  Speaker 7: Yeah, I couldn't agree more.
• 14:40
  Speaker 6: Unfortunately, patients are going to find whatever it is that
• 14:43
  Speaker 6: they're looking for, and they turn to sources that they
• 14:46
  Speaker 6: assume to trust, but they don't really have the regulatory
• 14:51
  Speaker 6: purview or perspective on what's good what's bad. A website
• 14:55
  Speaker 6: is out there selling them on what they need to
• 14:58
  Speaker 6: hear and how they need to hear it. But the
• 15:00
  Speaker 6: reality is, and through some significant research in communicating with
• 15:04
  Speaker 6: a lot of these manufacturers to prepare GMP and pharmaceutical
• 15:08
  Speaker 6: grade material, it doesn't exist right now. The majority of
• 15:11
  Speaker 6: the material is either dietary supplement grade or it is
• 15:15
  Speaker 6: research and development grade. It's not for human use, and
• 15:19
  Speaker 6: that leads to a lot of risk for these patients.
• 15:22
  Speaker 7: They don't know what they're getting, they don't know.
• 15:23
  Speaker 6: How it was made, they don't even know the potency
• 15:26
  Speaker 6: of the products that they are receiving. Whereas at a
• 15:29
  Speaker 6: compounding pharmacy, especially in a sterile environment, the pharmacies are
• 15:34
  Speaker 6: going to be beholden to the regulations that oversee their
• 15:36
  Speaker 6: practice to ensure sterility, to ensure potency, to ensure that
• 15:41
  Speaker 6: the identity of the material that they're receiving is truly
• 15:44
  Speaker 6: what they were receiving. So at that point in time,
• 15:46
  Speaker 6: there's been a huge uprising of pharmacies that are lobbying
• 15:52
  Speaker 6: to bring a number of these peptides back on the
• 15:55
  Speaker 6: improved list so that they can prevent patient harm, so
• 15:58
  Speaker 6: that they can educate patients. And I think that obviously
• 16:02
  Speaker 6: APC does a good job trying to educate patients on
• 16:06
  Speaker 6: where to find or not necessarily where to find, but
• 16:09
  Speaker 6: the criteria associated with what would be safe and effective
• 16:15
  Speaker 6: use of drugs, and because there's no real legal definitions
• 16:19
  Speaker 6: of how to utilize these, it's difficult to comment. It's
• 16:22
  Speaker 6: difficult to guide on these. The only guidance we really
• 16:25
  Speaker 6: have is through the GMP, through good manufacturing practices, and
• 16:29
  Speaker 6: as I indicated before, with the dietary supplement grade material
• 16:32
  Speaker 6: that exists out there in the market right now, that
• 16:33
  Speaker 6: follows a completely different set of standards. Those standards do
• 16:38
  Speaker 6: not achieve the same safety aspects that a pharmaceutically the
• 16:44
  Speaker 6: pharmaceutical grade manufactured item would meet. So what we've done
• 16:49
  Speaker 6: is we've been anticipating some movement within the government to
• 16:55
  Speaker 6: bring the allowance of some of these peptides back into
• 16:59
  Speaker 6: the eligible for compounding. In doing so, we've been communicating
• 17:02
  Speaker 6: with a number of manufacturers to convert these from their
• 17:06
  Speaker 6: R and D grade material into a pharmaceutical grade material,
• 17:09
  Speaker 6: and it's not as turnkey as easy as one would suspect.
• 17:12
  Speaker 6: There's a lot of method validation and method development testing
• 17:16
  Speaker 6: and ultimately verifying that what they're doing can still meet
• 17:21
  Speaker 6: the standards, can still be safe by the regulations that
• 17:25
  Speaker 6: are set forth, and continue to ensure that what patients
• 17:29
  Speaker 6: will ultimately receive is going to be suitable for what
• 17:33
  Speaker 6: they're expecting.
• 17:35
  Speaker 4: Yeah, Matt.
• 17:36
  Speaker 5: The industry argues that the Pharmacy Compounding and Advisory Committee
• 17:40
  Speaker 5: didn't give these peptide drugs a fair shake and that
• 17:42
  Speaker 5: the process itself needs to be overhauled.
• 17:46
  Speaker 4: So how this.
• 17:47
  Speaker 5: Meeting worked where they evaluated these peptides and determined not
• 17:51
  Speaker 5: to include them on List one. The FDA has unlimited
• 17:56
  Speaker 5: time to make our presentation to the Pharmacy Compounding Advisory
• 17:59
  Speaker 5: commit about its concerns with these certain peptide drugs, But
• 18:03
  Speaker 5: industry only has a limited amount of time to respond,
• 18:06
  Speaker 5: So even if there's multiple people wanting to comment to
• 18:10
  Speaker 5: the Advisory Committee, they have to share that amount of time.
• 18:13
  Speaker 5: I think it was limited to about ten minutes worth
• 18:15
  Speaker 5: of presentation time and the FDA can talk for as
• 18:18
  Speaker 5: long as they want to try to convince the Advisory
• 18:21
  Speaker 5: Committee to not include these substances on the interim list.
• 18:25
  Speaker 4: One.
• 18:26
  Speaker 5: We also have concerns over the makeup of the Pharmacy
• 18:28
  Speaker 5: Compounding Advisory Committee. So obviously they're all smart people, but
• 18:33
  Speaker 5: a lot of them exist in academia. They've never practiced
• 18:36
  Speaker 5: with this group of treating patients or using these kind
• 18:40
  Speaker 5: of therapy, seeing these kind of drugs in action. So
• 18:43
  Speaker 5: we're looking for an overhaul of the whole process and
• 18:46
  Speaker 5: an overhaul of the makeup of the Advisor Committee. And
• 18:49
  Speaker 5: it looks promising. So what you were saying earlier about
• 18:53
  Speaker 5: kind of movement within the industry, it looks like the
• 18:56
  Speaker 5: Advisory Committee right now has six openings. So we're hoping
• 19:00
  Speaker 5: that this new administration, this new AHHS nominates some kind
• 19:04
  Speaker 5: of new faces into that role so these substances can
• 19:07
  Speaker 5: be reevaluated by the committee.
• 19:10
  Speaker 6: Yeah, and if I could comment on that too, to
• 19:12
  Speaker 6: nail from what I recall, at the time of that
• 19:14
  Speaker 6: peak at committee, there were no compounding voting members that
• 19:19
  Speaker 6: sat on that committee, and which they're the ones with
• 19:23
  Speaker 6: the expertise, they're the ones with the experience, and they
• 19:26
  Speaker 6: weren't even given the opportunity to vote. Year nay, they
• 19:29
  Speaker 6: are given a voice to a certain aspect, but without
• 19:32
  Speaker 6: being too biased. I've sat in on a number of
• 19:34
  Speaker 6: these meetings, and what I've seen is that the presenters
• 19:37
  Speaker 6: do a tremendous job providing information that indicates suitability of
• 19:43
  Speaker 6: the materials that they're presenting, But it always appears as
• 19:47
  Speaker 6: if the committee has already come into the meeting with
• 19:50
  Speaker 6: their answers and their decisions already made.
• 19:53
  Speaker 7: No matter how.
• 19:54
  Speaker 6: Good the presentations are, it appears that they're going to
• 19:57
  Speaker 6: be denied. There's been very few cases in which I've
• 20:01
  Speaker 6: seen a legitimate argument has made it through, or that
• 20:03
  Speaker 6: the committee has already made a decision ahead of time
• 20:06
  Speaker 6: that was positive for the compounding industry. But these experts
• 20:09
  Speaker 6: that are submitting these and nominating these drugs spend an
• 20:12
  Speaker 6: incredible amount of time researching, trying to find a balanced
• 20:16
  Speaker 6: presentation on adverse events versus positive patient outcomes so that
• 20:21
  Speaker 6: they can receive an unbiased vote on these and unfortunately,
• 20:25
  Speaker 6: we've just seen the outcome on the negative side of that.
• 20:29
  Speaker 6: And so yes, as you indicated, with these six open seats,
• 20:32
  Speaker 6: the hope is that we get some legitimate practitioners that
• 20:35
  Speaker 6: can sit on this board, help to educate the academia
• 20:39
  Speaker 6: members as well, and get more of a fair trial,
• 20:41
  Speaker 6: so to speak.
• 20:42
  Speaker 5: Yeah, you're exactly right. So moving forward, where is the
• 20:47
  Speaker 5: industry going to go?
• 20:49
  Speaker 4: I don't know if you.
• 20:50
  Speaker 5: All saw, but there was kind of a really viral
• 20:52
  Speaker 5: tweet that Robert F. Kennedy Junior made at the beginning
• 20:57
  Speaker 5: of the administration about bringing back certain therapy and he
• 21:00
  Speaker 5: specifically called out peptides. There have been multiple letters written
• 21:05
  Speaker 5: by members of Congress to the FDA asking for some
• 21:08
  Speaker 5: sort of movement in this peptide space, so enforcement discretion
• 21:13
  Speaker 5: to allow compounders to compound with these peptides while they're
• 21:17
  Speaker 5: being re evaluated by a new and improved Pharmacy Compounding
• 21:21
  Speaker 5: and Advisory Committee process. We've heard whispers and rumors through
• 21:26
  Speaker 5: the industry that there's something forthcoming from from the FDA
• 21:29
  Speaker 5: that is going to make these peptides available for use
• 21:32
  Speaker 5: in compounding, and we're.
• 21:34
  Speaker 4: All, you know, we're all excited about that.
• 21:36
  Speaker 5: One of APC's kind of big asks at the beginning
• 21:39
  Speaker 5: of this administration in our blueprint document was that peacack
• 21:44
  Speaker 5: review these kind of substances for use in compounding with
• 21:47
  Speaker 5: a kind of a different lens than they have in
• 21:50
  Speaker 5: the past. Because compounded medications and the API like this
• 21:53
  Speaker 5: that are not part of FDA approved products do not
• 21:56
  Speaker 5: have USP monographs, they don't have large scale, double blind,
• 22:01
  Speaker 5: placebo controlled trials, so the FDA can't really evaluate them
• 22:05
  Speaker 5: for safety and effectiveness the same way they are able
• 22:07
  Speaker 5: to evaluate drugs that are submitted for formal FDA approval.
• 22:11
  Speaker 5: We're asking for the FDA to kind of change the
• 22:14
  Speaker 5: perspective and look for demonstrable safety risks and if those
• 22:17
  Speaker 5: can't be proven, to not require effectiveness data in order
• 22:22
  Speaker 5: to allow these compounds to be used or these API
• 22:25
  Speaker 5: to be used in compounds. That way, pharmacies can start
• 22:28
  Speaker 5: treating these patients. These doctors are asking for these medications
• 22:32
  Speaker 5: to be available for use in their patients. It's something
• 22:35
  Speaker 5: that is so wanted out there in the industry. As
• 22:39
  Speaker 5: someone who worked in a compounding pharmacy, I can tell
• 22:41
  Speaker 5: you that it felt like some days every other phone
• 22:44
  Speaker 5: call was someone asking if we made these kind of
• 22:46
  Speaker 5: medications at my pharmacy.
• 22:48
  Speaker 4: Who are really looking forward to things changing. So what next?
• 22:52
  Speaker 5: If the FDA does announce a period of enforcement discretion. Matt,
• 22:57
  Speaker 5: you are a wholesaler, so you source API from FDA
• 23:00
  Speaker 5: registered manufacturers.
• 23:02
  Speaker 4: How would you go about trying to.
• 23:03
  Speaker 5: Source API that would be appropriate for use and say
• 23:07
  Speaker 5: a sterile compounded product when there is no API grade
• 23:12
  Speaker 5: materials out there yet because these are not currently authorized
• 23:17
  Speaker 5: for use.
• 23:18
  Speaker 6: Well, it's a great question, and I want to compliment
• 23:20
  Speaker 6: you on your summary of what is occurring right now,
• 23:22
  Speaker 6: because I think it's very apt. I think that this
• 23:24
  Speaker 6: new administration, in this MAHA movement, is taking a different
• 23:27
  Speaker 6: approach than what we've seen in the past. Are a
• 23:29
  Speaker 6: little bit more sympathetic and open eared to some of
• 23:33
  Speaker 6: the experts that live within this industry that do have
• 23:36
  Speaker 6: significant evidence that can suggest that these are legitimate therapies
• 23:42
  Speaker 6: and that they should be utilized more. You know, I've
• 23:46
  Speaker 6: first heard about and a lot of this was all hearsay.
• 23:49
  Speaker 6: Most of it is hearsay until it becomes published. But
• 23:52
  Speaker 6: we heard that they were going to release a list
• 23:54
  Speaker 6: in November, and then it was December. Originally, I actually
• 23:57
  Speaker 6: heard of February, and that's what I've been planning for
• 24:00
  Speaker 6: and really hoping that we have that amount of time
• 24:02
  Speaker 6: to convert everybody or individuals or individual manufacturers who are
• 24:07
  Speaker 6: willing to participate in this. Obviously, the gops are where
• 24:12
  Speaker 6: we begin. That's how we're going to find these sources. Normally,
• 24:14
  Speaker 6: what we would do is look for FDA registered manufacturers
• 24:17
  Speaker 6: who also have registered NDCs for particular APIs. In this case,
• 24:23
  Speaker 6: it's very difficult because since they're not currently prescription drugs
• 24:28
  Speaker 6: at least not categorized by the regulatory bodies, legally, they
• 24:32
  Speaker 6: should not have registered NDC members listed on those And
• 24:35
  Speaker 6: for folks who are listening who don't understand what an
• 24:37
  Speaker 6: NDC is, it's.
• 24:38
  Speaker 7: A National Drug code.
• 24:40
  Speaker 6: The National Drug Code is registered by every manufacturer to
• 24:43
  Speaker 6: identify through segments of an NDC. The first segment identifies
• 24:49
  Speaker 6: it's a code that identifies the original manufacturer. The second
• 24:52
  Speaker 6: set of numbers in an NDC code identifies the specific
• 24:55
  Speaker 6: product produced by that manufacturer, and the third set of
• 24:58
  Speaker 6: numbers identifies the pasackage size. There's a data bank on
• 25:02
  Speaker 6: the federal website that identifies folks who have these numbers registered,
• 25:06
  Speaker 6: So normally we would start there. We want to start
• 25:07
  Speaker 6: with folks who are already manufacturing this material that already
• 25:11
  Speaker 6: have them registered appropriately and also allows us to investigate
• 25:16
  Speaker 6: these manufacturers to determine when was their last FDA inspection,
• 25:19
  Speaker 6: what is the risk associated with these manufacturers. Any firm
• 25:23
  Speaker 6: can register with the FDA. FDA does not issue licensing.
• 25:27
  Speaker 6: FDA does not inspect your facility before issuing the registration.
• 25:32
  Speaker 6: So the concern is how many of these folks have
• 25:35
  Speaker 6: recently registered based on the GLP one craze that was
• 25:38
  Speaker 6: taking the world and especially the country by storm, and
• 25:41
  Speaker 6: how many of these are legitimate. Well, that's where the
• 25:44
  Speaker 6: wholesalers come in. It's our job to go in. We
• 25:47
  Speaker 6: do an initial paper audit to ensure that they're following GMP.
• 25:51
  Speaker 6: We audit their products to also ensure that those products
• 25:54
  Speaker 6: are following the appropriate processes to enter into the public market,
• 25:58
  Speaker 6: and ultimately we want to get on site. We want
• 26:01
  Speaker 6: to see if they look as good in person as
• 26:04
  Speaker 6: they do on paper. What we're finding right now is
• 26:08
  Speaker 6: that a number of these manufacturers have either recently entered
• 26:11
  Speaker 6: the market, they're not familiar with the documentation we're requesting,
• 26:14
  Speaker 6: which ironically the documentation we're requesting is in the federal guidelines,
• 26:19
  Speaker 6: or we're being told well, other people that we're selling
• 26:23
  Speaker 6: to or not requesting this information. Why are you We
• 26:26
  Speaker 6: explain to them that this is the regulatory process. If
• 26:29
  Speaker 6: they want to sell legally inside the United States, this
• 26:31
  Speaker 6: is the process they have to follow.
• 26:33
  Speaker 5: This is a great time to bring up the fact
• 26:35
  Speaker 5: that APC is releasing a new best practices document to
• 26:38
  Speaker 5: help pharmacies with this very issue, Matt.
• 26:41
  Speaker 4: So it's a best practices for Vendor Validation.
• 26:44
  Speaker 5: It helps pharmacies with the tools that they need to
• 26:47
  Speaker 5: determine if the vendors that they're working with to order
• 26:51
  Speaker 5: things like API are following all the steps that they need,
• 26:54
  Speaker 5: so they're getting a product that meets all the specifications,
• 26:58
  Speaker 5: they have all the correct licensing and read reustration, they've
• 27:01
  Speaker 5: got the inspection reports forty three, is anything they might need.
• 27:04
  Speaker 4: To evaluate it?
• 27:05
  Speaker 5: So I just wanted to put a little plug there
• 27:07
  Speaker 5: for our vendor validation best practices. So if they do
• 27:11
  Speaker 5: order API, or they are looking to order API in
• 27:15
  Speaker 5: these peptide space for these peptides that may have enforcement discretion,
• 27:19
  Speaker 5: can you go over, just very briefly some of the
• 27:21
  Speaker 5: things on a CVA a pharmacy might look for to
• 27:24
  Speaker 5: determine if that could be appropriate for use in compounding.
• 27:28
  Speaker 6: Yes, absolutely, and I'm glad you brought up that best
• 27:30
  Speaker 6: practice form. I've had the opportunity to review it. I
• 27:34
  Speaker 6: think it's very well put together, and I think it's
• 27:37
  Speaker 6: guidance that has absolutely been needed for a long time.
• 27:40
  Speaker 7: Pharmacists follow USP.
• 27:41
  Speaker 6: They don't know what they don't know in terms of
• 27:44
  Speaker 6: some of these certificates of analysis, And one big distinction
• 27:47
  Speaker 6: here is that peptides, because they do not have a
• 27:50
  Speaker 6: USP monograph, we have to go based on manufacturer standards
• 27:54
  Speaker 6: in manufactured criteria. That can create risk because some manufacturers
• 27:59
  Speaker 6: might not want to analyze these APIs to the extent
• 28:02
  Speaker 6: to which would be intended to ensure safety. But fortunately
• 28:06
  Speaker 6: the USP has identified at minimum certain criteria that needs
• 28:11
  Speaker 6: to appear on a certificate of analysis. Obviously, the name
• 28:16
  Speaker 6: is one of those, so that we can be able
• 28:17
  Speaker 6: to identify that product specifically the manufacturer's information as well,
• 28:22
  Speaker 6: so that we can track and trace the manufacture and
• 28:25
  Speaker 6: determine that they're FDA registered. But more so, you have
• 28:29
  Speaker 6: your assay, you have your peptide purity, you have your
• 28:33
  Speaker 6: water content, you have your elemental impurities, and you also
• 28:37
  Speaker 6: have your residual solvents. At minimum, those have to appear
• 28:40
  Speaker 6: on a certificate of analysis or it's not a valid
• 28:43
  Speaker 6: certificate of analysis, whether it be an item that has
• 28:46
  Speaker 6: a monograph or if it's a non monographed item. I
• 28:50
  Speaker 6: think a lot of pharmacists they are more concerned with
• 28:53
  Speaker 6: what they're going to be utilizing in their formulations, and
• 28:55
  Speaker 6: they'll look at the purity so that they can count
• 28:56
  Speaker 6: the purity or the water content so that they can
• 28:59
  Speaker 6: formulate their pccription, and if those results test within the
• 29:04
  Speaker 6: criteria or the specifications assigned on that c OFA, they're
• 29:08
  Speaker 6: going to assume everything is on the up and up
• 29:11
  Speaker 6: and that the quality is good. But ultimately it has
• 29:14
  Speaker 6: to have this other criteria, and I have seen some
• 29:16
  Speaker 6: c OFAs that were so nominal that we just had
• 29:19
  Speaker 6: to kick them back and immediately disqualify these manufacturers. We've
• 29:22
  Speaker 6: gone to great lengths to have conversations and educate these manufacturers,
• 29:26
  Speaker 6: but at the end of the day, it's not our
• 29:27
  Speaker 6: job to educate these manufacturers. These manufacturers are beholden to
• 29:31
  Speaker 6: these requirements and they should be providing this information upfront
• 29:35
  Speaker 6: without a significant number of questions or concerns associated with
• 29:38
  Speaker 6: the documentation.
• 29:39
  Speaker 7: That they present.
• 29:41
  Speaker 6: So I think it's incredibly important that you don't just
• 29:44
  Speaker 6: measure the results of these specifications, that you understand what
• 29:49
  Speaker 6: these ranges are. So, for example, in most cases, APIs
• 29:53
  Speaker 6: have a test range of ninety eight to one hundred
• 29:55
  Speaker 6: and two percent for purity.
• 29:58
  Speaker 7: That's different than pharmacy.
• 30:00
  Speaker 6: When pharmacies send out their prescriptions, typically they have a
• 30:03
  Speaker 6: threshold of ninety to one hundred and ten percent on
• 30:05
  Speaker 6: their purity range because they're dealing with excipients and other
• 30:11
  Speaker 6: elements put into that formulation. When you're dealing with one
• 30:14
  Speaker 6: hundred percent pure material, you get these ranges, and typically
• 30:18
  Speaker 6: it's only a limitation based on the equipment that's being
• 30:22
  Speaker 6: used to analyze these these materials. At the end of
• 30:25
  Speaker 6: the day, we wanted to measure it one hundred percent
• 30:26
  Speaker 6: pure or one hundred percent pure minus any unspecified impurities
• 30:32
  Speaker 6: or any residual solvents that might be components or byproducts
• 30:36
  Speaker 6: of the manufacturing process, and those are allowed. But without
• 30:39
  Speaker 6: the understanding of that, you're going to look at something
• 30:42
  Speaker 6: and even if they have a criteria that's ninety two
• 30:44
  Speaker 6: to one hundred and eighteen, they're going to say, well,
• 30:46
  Speaker 6: it fell in at ninety three percent, So it's good right,
• 30:48
  Speaker 6: it tested within the range, and that's just not it.
• 30:53
  Speaker 6: It's we have to educate further and ensure the integrity
• 30:57
  Speaker 6: of these products that are going to be entering the marketplace.
• 31:00
  Speaker 5: I would like to point out the FDA approved products
• 31:03
  Speaker 5: also have a potency range of ninety two one hundred
• 31:06
  Speaker 5: and ten percent, not just compounded products. That is what
• 31:10
  Speaker 5: is legally required for both FDA approved drugs, finished drugs,
• 31:14
  Speaker 5: and compounded products. So with peptides, we know these are
• 31:19
  Speaker 5: powerful medicines and that there's a lot of interest from
• 31:24
  Speaker 5: the public in having access to these medications, and we
• 31:27
  Speaker 5: really really are pushing for legitimate, state licensed compounding pharmacies
• 31:31
  Speaker 5: to be able to be the ones to fill that
• 31:34
  Speaker 5: role rather than patients ordering these things from who knows
• 31:38
  Speaker 5: where online using research grade products that are manufactured under
• 31:42
  Speaker 5: unknown conditions and contain unknown final final products.
• 31:47
  Speaker 4: But as of right now.
• 31:48
  Speaker 5: They don't currently meet the criteria for compounding. So APC's
• 31:51
  Speaker 5: job is to educate compounding pharmacists what they are allowed
• 31:55
  Speaker 5: to do and what they're not allowed to do. So
• 31:57
  Speaker 5: we wait with baited breath for some announcement from the
• 32:01
  Speaker 5: FDA that these are going to be made available, but
• 32:03
  Speaker 5: as of right now, we still have to wait for
• 32:06
  Speaker 5: that announcement to come. I think that's probably all we
• 32:10
  Speaker 5: need to talk about peptides. So Andrew, if you want
• 32:14
  Speaker 5: to close us out, we can say goodbye.
• 32:16
  Speaker 2: Well, thank you both, daneil Matt, thanks for coming here,
• 32:20
  Speaker 2: sharing the really the kind of expertise we don't get
• 32:23
  Speaker 2: enough of. And based on what you've been saying, it
• 32:27
  Speaker 2: feels like we're on the cusp of something big happening
• 32:31
  Speaker 2: on the peptide front, well at least with some peptides.
• 32:34
  Speaker 3: So I can.
• 32:35
  Speaker 2: Totally see us coming back here in a couple of months,
• 32:38
  Speaker 2: a few months with.
• 32:39
  Speaker 3: A major update. Maybe not, we don't know.
• 32:42
  Speaker 2: Obviously, we'll be keeping an eye on the entire issue
• 32:45
  Speaker 2: and we'll be keeping our members.
• 32:47
  Speaker 3: In the loop.
• 32:49
  Speaker 2: All right, That is it for this episode of Essential,
• 32:53
  Speaker 2: But before we play the end music, something I want
• 32:56
  Speaker 2: to point out. If you are a compounding pharmacist or
• 32:59
  Speaker 2: a technician, or you prescribe compounded meds, APC is almost
• 33:03
  Speaker 2: certainly helping you and helping your patients and helping your
• 33:07
  Speaker 2: practice and your business. I'm not going to go through
• 33:09
  Speaker 2: everything we do, but I will say that APC is
• 33:13
  Speaker 2: the biggest and in a good way, the loudest trade
• 33:16
  Speaker 2: association for the whole compounding profession. If you're not a
• 33:20
  Speaker 2: member of APC, really ought to be. We're working for
• 33:23
  Speaker 2: you and we'd love to have you on board. Head
• 33:26
  Speaker 2: over to A four that's the number, four PC dot org.
• 33:31
  Speaker 2: A four pc dot org. Check us out, and now
• 33:35
  Speaker 2: we can play the end music. Thanks for listening.