legalities of peptides!

[Eric Fete]

Hi all

 

Any advice or legal backup/support that we can use for peptide use.  I see and hear about this often from other physicians and even some attorneys.  See the exchange below from a Hormone Practice group (and forum) that I, and several other SSRP membes, belong to:

 

• I currently work at a compounding pharmacy and try to keep up to date on regulations. My understanding is that the only two peptides that are legally able to be compounded sermorelin and tesamorelin. While you may find some compounding pharmacies that compound other peptides, they are not doing so legally in the eyes of the FDA and I would question their quality processes.

  Tailor Made recently got in serious trouble for compounding peptides, warning letter is here https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

  If you find a pharmacy that can compound these, they just haven’t been caught yet. From the FDA Warning Letter:

  “Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA-approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. GHRP-2 and GHRP-6 were nominated for inclusion on the 503A bulks list; however, they were not nominated with adequate support for FDA to evaluate the substance. Follistatin, Endurobal, AOD 9604, BPC 157, Bremelanotide (PT-141), Cerebrolysin, DSIP, Epitalon, GHK-Cu, IGF1-LR3, Ipamorelin, LL-37, Melanotan II, PEG-MGF, Selank, Semax, CJC 1295, SARMS, LGD-4033, and MK 677 have not been nominated for inclusion on the 503A bulks list.”

  • That’s very interesting. A quick google search results in several wellness clinics that still advertise they provide many if not most of those peptides listed in bold. I reached out to Tailor Made yesterday and heard back from them this morning and was told something similar about the FDA crackdown. They offer GHK-cu creams, but not injectables. Same for a few other peptides.

    Ah, that’s very interesting. The wellness clinics most likely fit under the purview of the Medical Boards (maybe some Boards of Pharmacy, depending on the state), and therefore are completely off the FDA’s radar. I would imagine they are compounding in-house, not sure where they are getting them from or how they are vetting their raw ingredients. It looks like peptides used to be available via Amazon for “research” purposes as recently as last year and most likely are being sold that way from whatever vendor they come from.

    https://themarkup.org/banned-bounty/2020/09/17/amazon-sales-peptides-doping-drugs

• Member

   July 26, 2021 at 9:32 pm

  Of the 2 FDA approved peptides, there is profound tachyphylaxis using them. Better to just use HGH instead.

  Hi

  I have been using them for some time now with much success. Several pharmacies have them and are very safe. Several are FDA approved and more are GRAS. All the pharmacies I use have been inspected and have had no issues. Very very safe and effective.

   

  There is not much tachyphylaxis when used properly. Unlike HGH there is no adverse side effects and are much cheaper (and no crazy hoops to jump through like GH). GH actually can causes senescence with long term usage, as well as IR and other complications.

  Eric

  I agree with Eric. There are a number of safe, effective and legal to prescribe peptides.

  But like anything else, you MUST educate yourself on how to use them PROPERLY. This forum is great for guidance , but I would not rely on anecdotal comments on how to proceed. Try https://seeds.md/ as a resource for education. There are others. But, like anything else, you must read, study and learn them well to use effectively and then you MUST use a good vendor. There are a FEW, so vet them carefully

  John and Eric,

  So to prescribe a non FDA approved peptide how are you documenting it in the chart. The non FDA approved peptides are “for research purposes only and not for human consumption” from the bottles I have seen. My biggest concern is Rick Collins Esq (most well known attorney for PEDs and other related issues) who lectured at Hormones and Beyond where he told us not to prescribe them. He specifically told me “Keith dont do it because if anyone has a problem and they Blame it on you and the peptide I can’t defend you”.How would you respond to what he is saying. I am genuinely curious. We now see many clinic offering anabolic steroids as part of their “muscle wasting program” etc…We see many clinics billing insurance inappropriately. My concern is that just because a lot of people are doping these things doesnt make it right. who will come to your defense if there is a problem and what literature will they use to support you? That is a sincere question. Can anyone answer it?

  Keith

I currently work at a compounding pharmacy and try to keep up to date on regulations. My understanding is that the only two peptides that are legally able to be compounded sermorelin and tesamorelin. While you may find some compounding pharmacies that compound other peptides, they are not doing so legally in the eyes of the FDA and I would question their quality processes.

Tailor Made recently got in serious trouble for compounding peptides, warning letter is here https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tailor-made-compounding-llc-594743-04012020

If you find a pharmacy that can compound these, they just haven’t been caught yet. From the FDA Warning Letter:

“Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA-approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. GHRP-2 and GHRP-6 were nominated for inclusion on the 503A bulks list; however, they were not nominated with adequate support for FDA to evaluate the substance. Follistatin, Endurobal, AOD 9604, BPC 157, Bremelanotide (PT-141), Cerebrolysin, DSIP, Epitalon, GHK-Cu, IGF1-LR3, Ipamorelin, LL-37, Melanotan II, PEG-MGF, Selank, Semax, CJC 1295, SARMS, LGD-4033, and MK 677 have not been nominated for inclusion on the 503A bulks list.”

That’s very interesting. A quick google search results in several wellness clinics that still advertise they provide many if not most of those peptides listed in bold. I reached out to Tailor Made yesterday and heard back from them this morning and was told something similar about the FDA crackdown. They offer GHK-cu creams, but not injectables. Same for a few other peptides.

Ah, that’s very interesting. The wellness clinics most likely fit under the purview of the Medical Boards (maybe some Boards of Pharmacy, depending on the state), and therefore are completely off the FDA’s radar. I would imagine they are compounding in-house, not sure where they are getting them from or how they are vetting their raw ingredients. It looks like peptides used to be available via Amazon for “research” purposes as recently as last year and most likely are being sold that way from whatever vendor they come from.

https://themarkup.org/banned-bounty/2020/09/17/amazon-sales-peptides-doping-drugs

[Member]

Of the 2 FDA approved peptides, there is profound tachyphylaxis using them. Better to just use HGH instead.

Hi

I have been using them for some time now with much success. Several pharmacies have them and are very safe. Several are FDA approved and more are GRAS. All the pharmacies I use have been inspected and have had no issues. Very very safe and effective.

 

There is not much tachyphylaxis when used properly. Unlike HGH there is no adverse side effects and are much cheaper (and no crazy hoops to jump through like GH). GH actually can causes senescence with long term usage, as well as IR and other complications.

Eric

I agree with Eric. There are a number of safe, effective and legal to prescribe peptides.

But like anything else, you MUST educate yourself on how to use them PROPERLY. This forum is great for guidance , but I would not rely on anecdotal comments on how to proceed. Try https://seeds.md/ as a resource for education. There are others. But, like anything else, you must read, study and learn them well to use effectively and then you MUST use a good vendor. There are a FEW, so vet them carefully

[Member]

John and Eric,

So to prescribe a non FDA approved peptide how are you documenting it in the chart. The non FDA approved peptides are “for research purposes only and not for human consumption” from the bottles I have seen. My biggest concern is Rick Collins Esq (most well known attorney for PEDs and other related issues) who lectured at Hormones and Beyond where he told us not to prescribe them. He specifically told me “Keith dont do it because if anyone has a problem and they Blame it on you and the peptide I can’t defend you”.How would you respond to what he is saying. I am genuinely curious. We now see many clinic offering anabolic steroids as part of their “muscle wasting program” etc…We see many clinics billing insurance inappropriately. My concern is that just because a lot of people are doping these things doesnt make it right. who will come to your defense if there is a problem and what literature will they use to support you? That is a sincere question. Can anyone answer it?

Keith

[William Seeds, MD]

@ejfete71gmail-com-2

Hey Dr. Fete,

I don’t think the person fully understands what the 503A bulks list is.

If a drug is not included in the bulks list, which many of drugs are not, then a compounding pharmacy must follow the guidelines of 503A in order to be exempt.

According to the warning letter, Tailormade got in trouble for the way they compounded…not simply because they compounded. They did not follow the guidelines of 503a so they got in trouble (adulterated products, non-sterile environment, inadequate usage guidance, etc). You can reference the FDA…pretty hard to refute that – https://www.fda.gov/drugs/human-drug-compounding/fdc-act-provisions-apply-human-drug-compounding

As for prescribing peptides that are “for research purposes only and not for human consumption,” i agree with Keith…they are unsafe and not properly tested (like the bottle label says), which is why one shouldn’t purchase from an online source and rather, go to a compounding pharmacy that can be trusted – like the list found in the trusted sources section.

Check out the forum discussion on “Peptide Sciences”. https://ssrpinstitute.org/srrp-discussion-board/topic/peptide-science/

You can reference more information there about online peptides.

 

 

[Eric Fete]

Hi all

Here are some concerns from other practitioners and attorneys:

“It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”

No matter where you get the non FDA approved peptides from they are for research purposes only.

“As far as acquiring the API – API manufacturers are registered under the FDA. The FDA does not allow manufacturing unapproved new drugs, but they do allow manufacturing for research which is why these are available.”

“If you find a pharmacy that can compound these, they just haven’t been caught yet. From the FDA Warning Letter:

“Specifically, the guidance sets out the conditions under which FDA does not intend to take action against a State-licensed pharmacy, Federal facility, or licensed physician for compounding a drug product using a bulk drug substance that is not the subject of an applicable USP or NF monograph or a component of an FDA-approved drug, until the substance is identified in a final rule as included or not included on the 503A bulks list. These conditions include that the substance may be eligible for inclusion on the 503A bulks list, was nominated with adequate support for FDA to evaluate it, and has not been identified by FDA as a substance that appears to present significant safety risks pending further evaluation. GHRP-2 and GHRP-6 were nominated for inclusion on the 503A bulks list; however, they were not nominated with adequate support for FDA to evaluate the substance. Follistatin, Endurobal, AOD 9604, BPC 157, Bremelanotide (PT-141), Cerebrolysin, DSIP, Epitalon, GHK-Cu, IGF1-LR3, Ipamorelin, LL-37, Melanotan II, PEG-MGF, Selank, Semax, CJC 1295, SARMS, LGD-4033, and MK 677 have not been nominated for inclusion on the 503A bulks list.”

 

Can we get some advice from Dr. S and legal here on this; I think this is very important.

Thanks

Eric

[Eric Fete]

Anyone???

[William Seeds, MD]

Hello @ejfete71gmail-com-2 ,

These are two conversations really…one for online compounding sources and another for compounding pharmacies producing drugs for specific prescriptions and patient use.

Earlier this week I spoke with a compounding pharmacy, that I’ll keep anonymous, who confirmed my above reply and added the following.

Compounding pharmacies must adhere to the guidelines of their classification status. For example, if they are classified as 503B, they must provide specific guidelines for usage (among many other guidelines). Same goes for 503A classified pharmacies and the appropriate list guidelines.

Again, Tailormade got in trouble for the way they compounded (“missing FDA-approved applications on file for compounded products,” adulterated products, non-sterile environment, inadequate usage guidance, resold expired drugs, etc)….not simply because they compounded.

That single excerpt that person pulled is taken out of context. Points B, C, D need to be read.

B. Failure to Meet the Conditions of Section 503A – “drug products produced by your firm failed to meet the conditions of section 503A”

C1. Adulterated Drug Products – “products were prepared, packed, or held under insanitary conditions”

C2. Unapproved New Drug Products – “no approved applications on file”

D. Corrective Actions – everything they attempted to do to be compliant, but failed to do so. Had they been compliant, different story.

Since the above were not met, they can no longer produce said peptides.

Other pharmacies are able to compound the aforementioned peptides granted they adhere to the guidelines set. According to this pharmacy, there are only 3 listed that are banned completely, the third being TA-1, but with a caveat. It cannot be provided or marketed as a cure for covid. Most pharmacies are erring on the side of safety and not producing TA-1 to avoid potential disciplinary measures from the FDA whereas others interpret that as better guidelines on how to compound them.

Relying inline:

“It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.”

Absolutely agree, which is why (and this has been discussed before) the function of the peptide should be explained…not as a treatment or cure. “TA-1 is an immune modulator” – not “TA-1 is going to treat/cure your autoimmune disease”.

“No matter where you get the non FDA approved peptides from they are for research purposes only.

If it’s an online source, then correct…which is why we ALWAYS say go to a trusted compounding pharmacy and don’t buy it online where they are sold as bulk and for research purposes only.

As far as acquiring the API – API manufacturers are registered under the FDA. The FDA does not allow manufacturing unapproved new drugs, but they do allow manufacturing for research which is why these are available.”

From the FDA: “Marketing of these products, or other applicable products, without an approved application violates these provisions of the FDCA.” If this is true, then the opposite is true.

“If you find a pharmacy that can compound these, they just haven’t been caught yet. From the FDA Warning Letter:”

Read the above summary breakdown. They’re referencing a single paragraph that’s being taken out of context.

Finally, according to this pharmacy, the last thing they would do is jeopardize the business by compounding drugs that are banned by the FDA. If the FDA  states or even alludes to a ban, it would be business suicide to continue producing it especially when it’s typically a secondary or tertiary revenue stream.

I recommend reaching out to a pharmacy and having a conversation with them because my response does not fully capture the discussion I had, but I hope that helps.

[Eric Fete]

Great thanks

More questions:  I had a colleague (hormone specialist) who was sued and he stated that he was glad he doesn’t use peptides as they are not FDA approved and would likely lose their license.

I guess my concern is that most peptides are not FDA approved so how do we protect ourselves?

Eric

[Chris A Kleronomos]

My opinion is that context matters. As stated above TA1 is immune modulating etc. I have a disclosure in my clinic forms that discusses this and patients sign it.

We use meds off label all the time that aren’t FDA approved so that is not the benchmark. Like anything the documentation should support use & rationale.

 

Acknowledgement and Consent: MediPro Holistic Health is an integrated multi-disciplinary clinic. We incorporate both typical biomedical standards of care as well as Integrated/Naturopathic/Functional Medicine approaches which may NOT be considered standard for conventional care. I authorize providers, their assistants and/or designees to administer any treatment as may be necessary or advisable in my diagnosis and treatment with MPHH.

This authorization includes, but is not limited to, diet/nutrition therapy inclusive of herbs and supplements, standard and specialized lab options and result interpretation, atypical medication options including but not limited to off-label uses and specialized or experimental therapies such as bio-identical hormones, peptides, exosome/stem cells and IV therapies. We strive to provide individualized care relevant to your case which could include external referrals or specialized procedures such as regenerative injections, Acupuncture, Chiropractic/OMT, biotherapies, and physical medicine. Other ancillary treatments may include electro/laser, red-light therapy, Emsella treatments, IR saunas, cryosaunas and hyperbarics as appropriate, and other services or procedures, which my provider considers necessary.

My health care providers will discuss with me the risks, benefits and alternative to recommended treatments. I understand that health care services may be rendered by students, nurses or medical assistants under supervision. Providing us with copies of any pertinent medical records, including tests and imaging will enhance your care. Although we strive to achieve the best possible results, there is no guarantee of outcomes. I acknowledge that no promises or guarantees have been made to me regarding treatment or service rendered by the practice. By signing this document, you acknowledge that you are consenting to this approach for care.*

 

[Eric Fete]

Thanks Chris!

Eric

[tim blend]

so currently most of out trusted sources are not compounding FDA banned peptides but can we still provide some of these products they are being compounded by those pharmacies that “haven’t been caught” or continue to fly under the radar.

Are we “more” liable for continuing to use a product we believe effective but is banned from being compounded?

We have many more patients inquiring at our clinic and probably many of you are in the same predicament while still waiting for a potential solution from SSRP.

What is SSRP’s current position-statement?

thanks to anyone.

 

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