Sorry for the length and possible duplication. Did anyone mention this event?
Updated September 29, 2023
1 Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Includes three categories of bulk drug substances:
• Category 1: Bulk Drug Substances Under Evaluation
• Category 2: Bulk Drug Substances that Raise Significant Safety Concerns
• Category 3: Bulk Drug Substances Nominated Without Adequate Support
Notice of Updates to Section 503A Categories
• Additions to Category 1
o GHK-Cu (except for injectable routes of administration) - This bulk drug substance was nominated
with sufficient supporting information to permit FDA to evaluate it and may be eligible for
inclusion on the 503A Bulks List. FDA will add GHK-Cu for injectable routes of administration to
Category 2 due to significant safety risks associated with its use in compounding.
o L-Theanine - This bulk drug substance was nominated with sufficient supporting information to
permit FDA to evaluate it and may be eligible for inclusion on the 503A Bulks List.
• Additions to Category 2
The following substances will be added to Category 2 because FDA has identified significant safety risks
with these substances:
o AOD 9604
o BPC-157
o Cathelicidin LL-37
o CJC-1295
o Dihexa Acetate
o Emideltide (DSIP)
o Epitalon
o GHK-Cu (for injectable routes of administration)
o Ibutamoren Mesylate
o Ipamorelin Acetate
o Kisspeptin-10
o KPV
o Melanotan II
o Mechano Growth Factor, Pegylated (PEG-MGF)
o MOTs-C
o Selank Acetate (TP-7)
o Semax (heptapeptide)
o Thymosin Alpha-1 (Ta1)
o Thymosin Beta-4, Fragment (LKKTETQ)
Updated September 29, 2023
2
• Additions to Category 3
The substances listed below will be placed in Category 3 because they were nominated with insufficient
supporting information for FDA to evaluate them:
o Aluminum Phosphate Adjuvant
o Attapulgite
o Carbolic Acid
o Carbomer Gel - Aqueous
o Carbomer Gel – Hydroalcoholic
o Cibinetide (ARA-290)
o Ethanolamine
o Folinic Acid Calcium Salt
o Fructose and Pregelatinized Starch
o Gum Arabic
o Iodochlorhydroxyquin
o Lactose, Monohydrate and Corn Starch
o Lactose, Monohydrate and
Microcrystalline Cellulose
o Lactose, Monohydrate and Powdered
Cellulose
o Lactose, Spray-Dried
o L-Aspartic Acid Sodium Salt
o Levomenthol
o Liquid Paraffin
o Lysine aspirin
o Magnesium Glycinate 15%
o Mechano Growth Factor (MGF)
o Menthol/peppermint oil
o Mercury-containing ingredient
o Milk of Sulfur
o Mineral Oil and Lanolin Alcohols
o Peruvian balsam oil
o Petrolatum and Lanolin Alcohols
o Protease
o Secretin, human 99%
o Selenium
o Shark liver oil (combination only)
o Skin protectant
o Sodium
o Sodium salicylic acid phenolate
o Soft Paraffin
o Thymulin acetate
o Turpentine oil (oral)
o Turpentine oil (rectified)
o Turpentine oil (spirits of turpentine)
o Turpentine oil (spirits of turpentine)
(oral)
o Turpentine oil (spirits of turpentine)
(topical)
o Uva ursi, potassium extract
o Vegetable (green)
o Wax, Anionic Emulsifying
o Zinc
• Revisions to Category 3
o “Asefetida Tincture” will be corrected to “Asafetida tincture” to correct a spelling error.
o “Methypyrilene Hydrochloride” will be corrected to “Methapyrilene Hydrochloride” to correct a
spelling error.
FDA will not consider biological products subject to licensure under section 351 of the PHS Act for inclusion on
the 503A Bulks List because such products are not eligible for the exemptions in section 503A of the FD&C Act.1
FDA will remove the following substances from Category 3 because they are biological products:
o Aspergillus oryza enzymes
o Pepsin
For more information, please see the Interim Policy on Compounding Using Bulk Drug Substances Under
Section 503A and the final rule on bulk drug substances that can be used for compounding under section 503A,
which became effective on March 21, 2019.
1 See 503A Bulks Interim Policy Guidance at 6.
Updated September 29, 2023
3
503A Category 1 – Bulk Drug Substances Under Evaluation
• 7 Keto Dehydroepiandrosterone
• Acetyl L Carnitine/Acetyl-L- carnitine
Hydrochloride
• Alanyl-L-Glutamine
• Aloe Vera/ Aloe Vera 200:1 Freeze Dried
• Alpha Lipoic Acid
• Ammonium Tetrathiomolybdate
• Artemisia/Artemisinin
• Astragalus Extract 10:1
• Boswellia
• Choline Chloride
• Chondroitin Sulfate
• Chrysin
• Coenzyme Q10
• Creatine Monohydrate
• Curcumin
• Deoxy-D-Glucose
• Dichloroacetate
• Diindolylmethane
• Dimercapto-1- propanesulfonic acid (DMPS)
• EGCg
• Enclomiphene Citrate
• Ferric Subsulfate
• GHK-Cu (except for injectable routes of
administration)
• Glutaraldehyde
• Glutathione
• Glycolic Acid
• Glycyrrhizin
• Kojic Acid
• L-Citrulline
• L-Theanine
• Melatonin
• Methylcobalamin
• Methylsulfonylmethane (MSM)
• Nettle leaf (Urtica dioica subsp. dioica leaf)
• Nicotinamide Adenine Dinucleotide (NAD)
• Nicotinamide Adenine Dinucleotide Disodium
Reduced (NADH)
• Pregnenolone
• Pyridoxal 5-Phosphate Monohydrate
• Pyruvic Acid
• Quercetin/Quercetin Dihydrate
• Quinacrine Hydrochloride (except for
intrauterine administration)
• Resveratrol
• Ribose (D)
• Rubidium Chloride
• Tea tree oil (Melaleuca alternifolia leaf oil)
• Trichloroacetic Acid
• Ubiquinol 30% Powder
• Vanadium
• Vasoactive Intestinal Peptide
Updated September 29, 2023
4
503A Category 2: Bulk Drug Substances that Raise Significant Safety Risks
• AOD-9604
• BPC-157
• Cathelicidin LL-37
• Cesium Chloride
• CJC-1295
• Dihexa Acetate
• Domperidone
• Emideltide (DSIP)
• Epitalon
• Germanium Sesquioxide
• GHK-Cu (for injectable routes of administration)
• Ibutamoren Mesylate
• Ipamorelin Acetate
• Kisspeptin-10
• KPV
• Melanotan II
• Mechano Growth Factor, Pegylated (PEG-MGF)
• MOTs-C
• Quinacrine Hydrochloride for intrauterine administration
• Selank acetate (TP-7)
• Semax (heptapeptide)
• Thymosin-Alpha 1 (Ta1)
• Thymosin Beta-4, Fragment (LKKTE
Hi Jay,
Thank you for your response, I used these peptides for the eyes a few years ago as an alternative to I Suppliments that I could buy locally. I decided to try them again, approximately four months ago on my next appointment at My Eye Doctor for my glucoma, which is controlled, my vision was unbelievable, I read off the letters, fast, and some of the letters were very small, the doctor was shocked, he asked me what had I been doing at the time I had not thought about the peptides, I could not understand why, other than the fact that I do meditate and repeat over and over again that my eyesight has improved, so I put it down to the mind. However, after thinking about it, perhaps it was the peptides, so I have just ordered them again . The peptides are used for a month and then you have a break and then you start again. I believe that they come from Cyprus., sales@peptidestore.com is their website. If you need any more info please ask
Regarding the FDA list, it almost immediately caused many compounding pharmacies to stop offering Cat2 peptides, forcing the consumer to use gray market sources.
The FDA has taken a “guilty until proven innocent” position on peptides (and compounded hormones, which is more concerning) as part of its ongoing battle against compounding pharmacies. Big pharma has noticed the public’s growing interest in peptides and sees cash grab opportunities, so the FDA is again acting as their proxy agent.
Brigham Butler discussed this with Joe Rogan recently: Spotify
Yes - I can see how you might think that. And we should always take commentary here by people as only possible ideas to consider, and keep in mind that a person on the forum may not be who they say they are… but in “DeeinFlorida”'s case - you can click on her avatar (D), or name and see that she’s been on this forum for a year and a half and has contributed many posts about herself: Habits/routines you attribute to your overall health - #34 by Deeinflorida
So, I don’t think its an ad. Its just one person’s perspective on what she’s tried, and her interpretation of possible cause and effect. Like all experiences here (including my own, with rapamycin), I always keep in mind that there is a reasonable chance its placebo effect, or some other factor, that explains results. Don’t take any single experience (good or bad) too seriously… but hopefully over time we can build up some good data with measurable results on any interventions we are trying.
On this vein - @Deeinflorida can you share any eye measurements before and after that the eye doctor may have measured? Also - are there other factors (like rapamycin) that might have contributed to any improvement you had? Please report back over time if things continue to get better or degrade.
Thank you for the response . I replied to a question about ‘ had anyone tried Peptides’ I responded with my experience and yes, it could be Rapamycin , however it was such a sudden change , I did consider both, I have nothing to gain by my response to Peptides , I did not tell my eye doctor that I was taking Rapamycin or peptides, as it was a complete shock to me and my husband, my ability to read those charts bearing in mind I have had macular degeneration and borderline glucoma for 11 years, and have had continual appointments, including injections in the eyes to improve my vision, but this never worked. I have end stage macular degeneration, so the possibilities of an improvement in vision is somewhat extraordinary, so it has to be either meditation, rapamycin or peptides.
Thanks @Deeinflorida - your experience and sharing here is fabulous information.
Yes, as Rap Admin says…we will all have differing responses to Rapa, peptides, meformin, Acarbose etc
Some will be negative, some will be life changing positive.
Feedback like this will help us all make our own educated decisions.
I appreciate everyones feedback in this post thus far.
Looking forward to hearing more peoples Peptides and Bioregulators [very different but somehow always gets clumped in together]
I am paying $145 for one months supply so I’m not sure how many pills You are getting for that price. I certainly think it is worth trying peptides as a last resort, I tried everything else, including. Advanced bio nutritionals Advanced iHealth, which I believe is an excellent company. Something has improved my vision. I cannot put my finger on it. However, I take rubber mycin to milligrams a week and I take peptides one month on and one month off. My eyesight has improved in my last eye chart test, I had 2020 vision however I do wear specially made magnifying glasses to read the chart. I have been using these magnifying glasses for the last two years and it has been obvious that my eyesight has improved tremendously in the last three months. I really do not know whether this improvement has to do with my meditation, which I do regularly every day, whether it’s the rapamycin that I take 2 mg a week or whether it is the peptides or whether it is the buonuetricianal eye iHealth pills from Dr. Schellenberger . Even so I will continue to take those supplements and continue to meditate and hope that I can maintain my eyesight until I am much older. I am 80 years old. I hope this helps.
Yes that is the product, I’m surprised that your neighbour only has blurred vision, normally, with wet macular degeneration, which I have, you maintain your peripheral vision maybe your neighbor has a different macular degeneration to what I have. I had a. special telescope, lens implanted into my one eye, which did not work, however, I see everything, but it has a cloud over it just like your neighbor. Both eyes have improved in the last three months to the degree that both my macular degeneration doctor and my glucoma doctor have said I have 2020 vision when wearing my special magnifying glasses. This is an improvement a considerable improvement in the last three months. I hope this helps.
I’m happy to hear Visoluten A improved vision so dramatically.
I did a quick google search but the quality of information I found was substantially lacking, so maybe I’ll just ask this here: is Visoluten A only good for macular degeneration or for other eye issues as well? I am most concerned with age related vision declines such as presbyopia (which pisses me off given the work I’ve put into feeling younger and being in shape and then I can’t read a pill bottle in dim light?!?!). I have also asked questions on this site on the same topic regarding carnosine drops (I believe they are a dog eye drop) but the few people who tried these said no real results.
So does Visoluten A impact presbyopia? Or is there another peptide?
I’m fascinated by peptides and agree they show great promise, and am very close to trying bpc-157 (or the Wolverine nasal spray) but the lack of accountability by some of the sellers scares me. Plus, even when body builders have been using them for years I question whether this is a good group to follow unless a research group has verified their claims (given most of them take tren and other compounds that are terrible for you).
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