Frequently asked questions
Questions, answered from the record.
Where an answer depends on a product’s FDA status, its price or whether it can be shipped to your state, it is generated from the same records the rest of the site uses, so it changes when they do. Some of these answers are inconvenient for a business that sells these products. They are printed anyway.
FDA status
What each product is, and what it is not.
Every product page shows the product’s FDA status next to the button that starts an evaluation. These answers say the same thing in one place.
- Are the products PEPLUX offers approved by FDA?
No. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.
Every product PEPLUX offers is compounded. Where a molecule is also the active ingredient of an approved branded drug, the compounded version is a different product, and its product page says what that approval does and does not cover.
The FDA status of each product, as its product page shows it:
- Sermorelin: In FDA's 503B Category 1: interim enforcement discretion, not the bulks list.
- NAD+: In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.
- Glutathione: In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.
- Methylcobalamin B12: In FDA's Category 1 for 503A pharmacies and 503B outsourcing facilities: interim enforcement discretion, not the bulks list.
- CJC-1295 and Ipamorelin: No compounding pathway today.
- MOTS-c: No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- BPC-157 Injection: No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- Epitalon: No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- Semax: No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- Selank: No compounding pathway today.
- AOD-9604: No compounding pathway today.
- PT-141: Narrow 503A pathway as a component of an FDA-approved drug, limited by the rule on copies of approved drugs. Compounded versions are not FDA-approved.
- GHK-Cu Injection: No compounding pathway today.
- BPC-157 Capsules: No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- Topical GHK-Cu: In FDA's 503A Category 1: interim enforcement discretion, not the bulks list.
- Wolverine Stack: No compounding pathway today. An FDA advisory committee recommendation is not a listing.
- GLOW Stack: No compounding pathway today.
- KLOW Stack: No compounding pathway today.
- Semax / Selank Injection: No compounding pathway today.
- Kisspeptin Injection: No compounding pathway today.
- DSIP Injection: No compounding pathway today.
- Why does PEPLUX offer products that have no lawful compounding pathway?
PEPLUX chose to offer the peptides people most often ask about, including several that have no lawful compounding pathway today. That was a business decision, and we would rather state it plainly than suggest these products are something they are not.
15 products are in that position. Each of those product pages shows the following next to the button that starts an evaluation:
- The CJC-1295 and Ipamorelin combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- MOTS-c is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- BPC-157 Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Epitalon is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Semax is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Selank is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- AOD-9604 is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- GHK-Cu Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- BPC-157 Capsules is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- The Wolverine Stack combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- The GLOW Stack combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- The KLOW Stack combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- The Semax / Selank Injection combination is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- Kisspeptin Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
- DSIP Injection is not FDA-approved, and there is no lawful pathway for a US pharmacy to compound it today. Its safety and effectiveness in people have not been established.
Nothing on this site claims these products are approved, legal to compound or safe, and a prescription is not a finding that they are. A provider can decline to prescribe any of them. If you would rather consider only products that are within FDA's interim enforcement discretion or a narrow statutory pathway, the status line on each product page tells you which those are. Either way, the compounded product is not FDA-approved.
- FDA removed several peptides from its Category 2. Does that mean they can be compounded now?
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
A withdrawn nomination is an administrative event. It is not a safety finding.
- What is the FDA status of CJC-1295 and ipamorelin?
CJC-1295, with or without DAC, is not FDA-approved, and there is no pathway for a US pharmacy to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against every form it reviewed on December 4, 2024. Nothing favorable is pending.
Ipamorelin is not FDA-approved, and there is no pathway for a US pharmacy or a 503B outsourcing facility to compound it today. FDA removed it from its 503A Category 2 under a notice dated September 27, 2024, after the nominations were withdrawn, and FDA's Pharmacy Compounding Advisory Committee voted against it on October 29, 2024. Ipamorelin acetate is still in FDA's 503B Category 2, the category for substances that may present significant safety risks.
PEPLUX offers them together as CJC-1295 and Ipamorelin. That product page shows this status next to the button that starts an evaluation.
- Why is sermorelin routed to a 503B outsourcing facility?
Sermorelin acetate is in FDA's 503B Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503B outsourcing facility that compounds it while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Sermorelin does not appear in any of FDA's 503A categories. Compounded sermorelin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
The planned route for Sermorelin is a 503B outsourcing facility.
No facility is named yet, and its intake does not open until one is.
- Can I use these products if I am drug tested in sport?
Check first. These products each contain a substance on the WADA 2026 Prohibited List:
- Sermorelin
- CJC-1295 and Ipamorelin
- MOTS-c
- BPC-157 Injection
- AOD-9604
- BPC-157 Capsules
- Wolverine Stack
- GLOW Stack
- KLOW Stack
- Kisspeptin Injection
Each product page and status record shows the WADA 2026 status of every substance in it, including where the list does not name a substance.
In tested sport, an anti-doping violation can be established without a positive test, for example through possession or an admission. If you are subject to drug testing in sport or at work, tell the provider in your intake.
Prescribing
Who decides, and on what basis.
- Who decides whether I am prescribed anything?
A provider licensed in the state you are in when you are treated reviews your intake and decides whether treatment is appropriate, what to prescribe, and whether to prescribe at all. PEPLUX plans to work with providers from the Arora Health network, an affiliated clinical organization.
Some states require a live audio-video visit before a first prescription. Where yours does, the provider has to hold one before prescribing.
The answer can be no. A provider may decline because of your history, your medications or your test results, and you should expect an explanation rather than a substitute product.
- Will it work?
No one can promise that, and PEPLUX does not. For many products in this catalog, evidence in people is limited or absent, and for several, safety and effectiveness in people have not been established.
Each product page sets out what the evidence does and does not show. A useful question for any provider, including ours: what would count as this not working, and by when?
- Can I take this with my other medications?
That is what the intake medication questions are for. List everything you take, including over-the-counter products, supplements and anything prescribed by someone else. The provider decides whether a combination is appropriate.
Who should not use each product is listed on the safety page. If another specialist is treating you, tell them what you are taking too.
Price and billing
What it costs, and when.
- What does it cost?
Prices, product by product:
- Sermorelin: $229 per month
- NAD+: $229 per month
- Glutathione: $229 per month
- Methylcobalamin B12: $229 per month
- CJC-1295 and Ipamorelin: $229 per month
- MOTS-c: $229 per month
- BPC-157 Injection: $229 per month
- Epitalon: $229 per month
- Semax: $229 per month
- Selank: $229 per month
- AOD-9604: $229 per month
- PT-141: $229 per month
- GHK-Cu Injection: $229 per month
- BPC-157 Capsules: $229 per month
- Topical GHK-Cu: $229 per month
- Wolverine Stack: $229 per month
- GLOW Stack: $229 per month
- KLOW Stack: $229 per month
- Semax / Selank Injection: $229 per month
- Kisspeptin Injection: $229 per month
- DSIP Injection: $229 per month
What each price includes is listed on the pricing page.
- When would I be charged, and can I cancel?
Published prices and included services are on the pricing page. Charge timing, renewal, cancellation and refund terms will be published before intake opens.
No intake is open yet, so no one is being charged.
Safety
Side effects, and what to do about them.
- What are the side effects?
Each product has its own list of reported side effects and of people who should not use it. They are collected, product by product, on the safety page.
Compounded medications do not have labeling that FDA has approved, so there are no validated side-effect frequencies for them. For several products, safety in people has not been established at all.
Signs of a severe allergic reaction, such as swelling of the face or throat, hives or difficulty breathing, need immediate care. If this is a medical emergency, call 911.
- How do I report a side effect?
Tell your provider. You can also report it directly to FDA through MedWatch, its safety information and adverse event reporting program, online or by phone. Reports about compounded medications are accepted.
If this is a medical emergency, call 911.
- Do some products require lab tests?
Yes. A provider reviews baseline labs before a first prescription of each of these products:
- Sermorelin
- Methylcobalamin B12
- CJC-1295 and Ipamorelin
For other products, a provider may order labs based on your history.
Lab coverage is listed with each offered product on the pricing page. Your provider determines which tests are needed.
Pharmacy
Who makes it.
- Who makes my medication?
PEPLUX is a telehealth platform, not a pharmacy or drug manufacturer. Medications are compounded and dispensed by independently licensed US compounding pharmacies.
No dispensing pharmacy is named yet. A product’s intake does not open until its pharmacy is named on its product page and on the pharmacy page.
- How will I know what is in the vial?
Ask for the certificate of analysis for your lot. Each product page lists the tests that certificate is expected to cover, such as potency, sterility, endotoxin and pH for an injection.
Lot documents come from the dispensing pharmacy. No pharmacy is named yet, so none is published.
The information
Where these answers come from.
- How current is the status information?
Every status record shows the date it was last checked against its sources. Records were last checked between October 13, 2026 and October 14, 2026, and each shows its own date.
The site build warns when a record is more than 60 days old, and a production build fails when one is more than 90 days old. A status changes only when FDA itself acts, for example through a final rule or a notice that adds a substance to a list. A proposed rule or an advisory committee vote changes nothing on its own.
Still deciding
If your question is not here, the product page probably answers it.
Each product page carries its own status, risks, price and questions, all from the same records as this page.