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Current U.S. access evidence

United States only

Each summary covers one molecule and the access route named. It sets out what the cited records establish, what they do not, and the most useful next check. It is not a medical evaluation or a legal opinion.

How to read each requirement

Supported
The cited evidence shows the requirement is met.
Contradicted
The cited evidence shows the requirement is not met.
Unresolved
The evidence we have does not settle it, or it needs review we have not obtained.
Conflicting
Sources disagree, and we show both.
Not applicable
This does not provide an access basis, whatever its outcome.

BPC-157

Routine U.S. dispensing route: not verified

United StatesChecked Source dates: FDA staff evaluation dated May 11, 2026; eCFR displayed as up to date as of October 8, 2026

Route considered
Compounding from the bulk substance under section 503A, or enrollment in a registered clinical study
What this covers
Covers BPC-157 free base and BPC-157 acetate, the two forms FDA evaluated.Source 1

What the records establish

  • No FDA-approved BPC-157 drug: FDA staff state that neither form is a component of an approved drug and that no applicable USP or NF monograph exists.Source 1
  • BPC-157 is not on FDA’s final list of bulk substances that 503A pharmacies may use, in the version displayed as up to date as of October 8, 2026.Source 2
  • FDA lists BPC-157 among nominations that were withdrawn and describes possible risks, including immunogenicity for certain routes of administration and peptide-related impurities.Source 3
  • FDA’s compounding advisory committee discussed BPC-157 on July 23, 2026. Its recommendations are non-binding; the meeting is not an approval or a listing decision.Source 4

What they do not establish

  • Whether a particular pharmacy or clinic may supply BPC-157 to you. FDA describes an interim policy for certain nominated substances; how it applies after a withdrawn nomination is a regulatory interpretation we have not had reviewed, so we state no conclusion.Source 5
  • Whether BPC-157 is effective or safe for anyone. We do not assess either.
  • The status of products marketed as dietary supplements or for research use. This summary covers prescription compounding only.

Study registry records

  • The one U.S. registry record we reviewed, a University of Arkansas study after rotator-cuff surgery, was not yet recruiting when checked. Its summary describes 20 patients; its enrollment field lists 30 (estimated).Source 6
  • A recruiting BPC-157 record we reviewed lists only a site in China.Source 7

Next check

Ask any clinic advertising BPC-157 to name the exact form, the dispensing pharmacy, and the specific source that supports supplying it. Discuss whether any peptide is appropriate for you with a qualified clinician.

Still unresolved
Interim-policy status after the withdrawn nomination is unresolved pending competent regulatory review.
We will revise this after
A final FDA action after the July 2026 meeting, an amendment to 21 CFR 216.23, a change to FDA’s safety-risk page, or a registry update.
Requirement-by-requirement Access Check: BPC-1576 requirements
  1. Requirement: An applicable USP or NF monograph exists

    Contradicted

    FDA staff state that no applicable monograph exists for either form.Source 1

    What we checked
    Read the monograph statement in FDA’s briefing (PDF page 9).
    Next question
    Has USP or NF published a monograph since the briefing?
    What would change this
    Publication of an applicable USP or NF monograph.
  2. Requirement: BPC-157 is a component of an FDA-approved drug

    Contradicted

    FDA staff state that neither form is a component of an FDA-approved drug.Source 1

    What we checked
    Read the approval statement in FDA’s briefing (PDF page 9).
    Next question
    Has FDA approved a drug containing BPC-157 since then?
    What would change this
    FDA approval of a drug that contains BPC-157.
  3. Requirement: BPC-157 appears on the 503A bulks list (21 CFR 216.23)

    Contradicted

    BPC-157 is not on the list.Source 2

    What we checked
    Searched the codified list in the version displayed as up to date as of October 8, 2026.
    Next question
    Has FDA published a final rule adding it?
    What would change this
    A final rule adding BPC-157 to 21 CFR 216.23.
  4. Requirement: FDA’s interim policy covers compounding with BPC-157

    Unresolved

    FDA lists BPC-157 among withdrawn nominations that were previously in category 2.Source 3 What that means under the interim policy requires regulatory review we have not obtained, so we state no conclusion.Source 5

    What we checked
    Read FDA’s description of the interim policy and its list of withdrawn nominations.
    Next question
    What does a qualified pharmacy-law or regulatory reviewer conclude?
    What would change this
    Competent regulatory review, or an FDA statement that addresses BPC-157 under the interim policy.
  5. Requirement: The July 2026 advisory meeting provides an access basis

    Not applicable

    Advisory committees make non-binding recommendations. A meeting or vote is not an approval or a listing.Source 4

    What we checked
    Read the meeting page and FDA’s description of advisory committees.
    Next question
    Has FDA taken a final action since the meeting?
    What would change this
    A final FDA action, such as a rule adding BPC-157 to the list.
  6. Requirement: A registered clinical study is enrolling U.S. participants

    Unresolved

    The U.S. record we reviewed was not yet recruiting, and its summary (20 patients) conflicts with its enrollment field (30, estimated).Source 6 The recruiting record we reviewed lists only a site in China.Source 7

    What we checked
    Read the status, location, and enrollment fields of two registry records. This was not a comprehensive registry search.
    Next question
    Is a U.S. study now enrolling? Only the study team can confirm eligibility.
    What would change this
    A U.S. registry record showing active recruitment, confirmed by the study team.

TB-500

Routine U.S. dispensing route: not verified

United StatesChecked Source dates: FDA staff evaluation dated May 15, 2026; eCFR displayed as up to date as of October 8, 2026

Route considered
Compounding from the bulk substance under section 503A, or enrollment in a registered clinical study
What this covers
Covers TB-500 as FDA evaluated it: a synthetic fragment of thymosin beta-4 (residues 17–23, LKKTETQ), in free base and acetate forms. We do not apply evidence about full-length thymosin beta-4 to this fragment.Source 8

What the records establish

  • No FDA-approved drug for this fragment: FDA staff state that neither form is a component of an approved drug and that no applicable USP or NF monograph exists.Source 8
  • TB-500 is not on FDA’s final 503A bulks list, in the version displayed as up to date as of October 8, 2026.Source 2
  • FDA lists the fragment among withdrawn nominations, describes possible immunogenicity and peptide-related impurities, and says it has not identified human exposure data for drug products containing it.Source 3
  • The advisory committee discussed TB-500-related substances on July 23, 2026. Its recommendations are non-binding.Source 4

What they do not establish

  • Whether a particular pharmacy or clinic may supply it. How FDA’s interim policy applies after a withdrawn nomination needs regulatory review we have not obtained.Source 5
  • Whether a product sold as “TB-500” contains the fragment FDA evaluated. Ask for the exact substance.
  • Whether TB-500 is effective or safe for anyone. We do not assess either.

Study registry records

  • The one recruiting TB-500 registry record we found calls itself a fictional example in its own summary. We exclude it from access evidence.Source 9

Next check

Ask the clinic to name the exact substance (the fragment or full-length thymosin beta-4), its form, the dispensing pharmacy, and the source that supports supplying it.

Still unresolved
Interim-policy status after the withdrawn nomination is unresolved pending competent regulatory review.
We will revise this after
A final FDA action after the July 2026 meeting, an amendment to 21 CFR 216.23, a change to FDA’s safety-risk page, or a registry update.
Requirement-by-requirement Access Check: TB-5006 requirements
  1. Requirement: An applicable USP or NF monograph exists

    Contradicted

    FDA staff state that no applicable monograph exists.Source 8

    What we checked
    Read the approval and monograph statement in FDA’s briefing (PDF page 7).
    Next question
    Has USP or NF published a monograph since the briefing?
    What would change this
    Publication of an applicable USP or NF monograph.
  2. Requirement: The TB-500 fragment is a component of an FDA-approved drug

    Contradicted

    FDA staff state that neither TB-500 free base nor acetate is a component of an FDA-approved drug.Source 8

    What we checked
    Read the approval statement in FDA’s briefing (PDF page 7).
    Next question
    Has FDA approved a drug containing the fragment since then?
    What would change this
    FDA approval of a drug that contains the fragment.
  3. Requirement: TB-500 appears on the 503A bulks list (21 CFR 216.23)

    Contradicted

    Neither TB-500 nor a thymosin beta-4 fragment is on the list.Source 2

    What we checked
    Searched the codified list in the version displayed as up to date as of October 8, 2026.
    Next question
    Has FDA published a final rule adding it?
    What would change this
    A final rule adding the fragment to 21 CFR 216.23.
  4. Requirement: FDA’s interim policy covers compounding with the TB-500 fragment

    Unresolved

    FDA lists the fragment among withdrawn nominations that were previously in category 2.Source 3 What that means under the interim policy requires regulatory review we have not obtained, so we state no conclusion.Source 5

    What we checked
    Read FDA’s description of the interim policy and its list of withdrawn nominations.
    Next question
    What does a qualified pharmacy-law or regulatory reviewer conclude?
    What would change this
    Competent regulatory review, or an FDA statement that addresses the fragment under the interim policy.
  5. Requirement: The July 2026 advisory meeting provides an access basis

    Not applicable

    Advisory committees make non-binding recommendations. A meeting or vote is not an approval or a listing.Source 4

    What we checked
    Read the meeting page and FDA’s description of advisory committees.
    Next question
    Has FDA taken a final action since the meeting?
    What would change this
    A final FDA action, such as a rule adding the fragment to the list.
  6. Requirement: A registered clinical study is enrolling U.S. participants

    Unresolved

    The only recruiting record we found calls itself a fictional example and is excluded.Source 9

    What we checked
    Read the summary and status fields of the one recruiting record we found. This was not a comprehensive registry search.
    Next question
    Is a genuine U.S. study now enrolling? Only the study team can confirm eligibility.
    What would change this
    A U.S. registry record showing active recruitment, confirmed by the study team.

Sermorelin

Advertised compounded care: provider-publishedAccess basis unresolved

United StatesChecked

Route considered
Clinician-prescribed compounded sermorelin from an online clinic
What this covers
Covers compounded sermorelin injections as advertised by one online clinic. We have not reviewed sermorelin’s ingredient-specific regulatory status for this release.

What the records establish

  • AgelessRx advertises clinician-guided sermorelin injection plans dispensed by a U.S.-licensed compounding pharmacy.Source 10
  • Compounded drugs are not FDA-approved: FDA does not verify their safety, effectiveness, or quality before they are marketed.Source 11
  • AgelessRx says some treatments are not available in all states and lists availability for each treatment.Source 12

What they do not establish

  • Which pharmacy would dispense the product, or its license status. The sections of the offer page we reviewed do not name the pharmacy, and we have not checked any license.
  • The ingredient-specific basis for compounding sermorelin. We have not reviewed it.
  • Whether sermorelin is appropriate, effective, or safe for you.

Next check

Before paying, confirm the formulation, the dispensing pharmacy, availability in your state, and the full amount you would be charged.

Still unresolved
The compounding basis for sermorelin has not been reviewed.
We will revise this after
A change to the provider’s page, or a completed review of sermorelin’s regulatory status.
Requirement-by-requirement Access Check: Sermorelin5 requirements
  1. Requirement: A provider advertises sermorelin care

    Supported

    AgelessRx advertises clinician-guided sermorelin injection plans. This is provider-published.Source 10

    What we checked
    Read the provider’s sermorelin page.
    Next question
    Does checkout show the same plan and terms?
    What would change this
    A change to the provider’s page.
  2. Requirement: The advertised compounded product is FDA-approved

    Contradicted

    Compounded drugs are not FDA-approved.Source 11

    What we checked
    Read FDA’s explanation of compounded drugs.
    Next question
    Is the product compounded, and by which pharmacy?
    What would change this
    The offer changing to an FDA-approved product, documented by the provider.
  3. Requirement: The ingredient-specific basis for compounding sermorelin is documented

    Unresolved

    We have not reviewed sermorelin’s status against the three section 503A conditions for bulk substances.Source 5

    What we checked
    Not checked for this release.
    Next question
    Which section 503A condition does the dispensing pharmacy rely on?
    What would change this
    Competent pharmacy-law review of sermorelin’s status.
  4. Requirement: The dispensing pharmacy is named and licensed for your state

    Unresolved

    The page describes a U.S.-licensed compounding pharmacy partner without naming it in the sections we reviewed.Source 10

    What we checked
    Read the offer page for a pharmacy name. No license check was performed.
    Next question
    Which pharmacy would dispense my order, and can it ship to my state?
    What would change this
    A named pharmacy and a dated license check.
  5. Requirement: The treatment is available in your state

    Unresolved

    AgelessRx says some treatments are not available in all states and lists availability for each treatment.Source 12

    What we checked
    Read the provider’s state-availability statement. We did not record the state list.
    Next question
    Is sermorelin available where I live?
    What would change this
    A dated record of the provider’s state list for sermorelin.

If no route fits, that is still a useful answer. Ask the clinic for its source, and discuss alternatives with a qualified clinician. Products labeled for research use are a different product category; this guide does not cover or recommend them.

Check the exact service before you pay

A listing or a consultation offer does not show that a clinic can supply a particular peptide to you. Ask for these details about the exact service you are considering.

  1. Legal entityWhich company provides the service and takes your payment?
  2. Clinician roleWho evaluates you and writes any prescription, and are they licensed where you live?
  3. Pharmacy roleWhich pharmacy would dispense the product, and can it ship to your state?
  4. Service statesWhich states does the provider say it serves for this treatment?
  5. Exact productWhich peptide, which form (for example, free base or acetate), what strength, and what quantity?
  6. Ingredient-specific supportWhich specific source supports supplying that ingredient by the route being advertised?
  7. Consultation scopeWhat does the consultation include, and is it charged separately?
  8. If nothing is prescribed or filledWhat happens to your payment if no prescription is written or the pharmacy cannot supply it?

See the three published offers we compared

Understand the fees

Ask for each charge separately, with what it covers and when it is billed. If a required charge is not disclosed, the total is incomplete, not zero. We do not estimate a monthly or course cost by assuming a quantity.

  1. ConsultationIs it charged separately, and is it credited toward treatment?
  2. Product and quantityWhich product, strength, and quantity does the price cover?
  3. MembershipIs a membership or program fee required?
  4. Required labs and follow-upWhich tests or visits are required, and who bills them?
  5. ShippingIs shipping charged, including any cold-chain shipping?
  6. First versus recurring chargesWhat is charged today, and what renews automatically?
  7. CancellationHow, and how far ahead of the next charge, can you cancel?
  8. Refund conditionsWhich payments are refundable, and when does that stop?

Reading a published offer: AgelessRx sermorelin

This shows how one provider-published offer maps onto the checklist. It is an example, not a recommendation, and it is not a BPC-157 or TB-500 price. We have not recorded a price for either; we do not estimate one.

Reading a published offer: AgelessRx sermorelin. Charges as published by the provider, checked October 13, 2026. Amounts are not added together.
ChargeAmountWhat it applies toStatus
Introductory price

$99Source 10

First month

Applies to a three-month plan billed in full

Price published by provider

Recurring price

$149Source 10

Month, after the first month

Price published by provider

Amount charged upfront for the three-month plan

Not statedSource 10

Three-month plan

Not stated as a single amount in the section we reviewed

Not disclosed

Required labs, if any

Not statedSource 10

Per test

The offer section does not say whether labs are required

Not disclosed

Total:Incomplete. The upfront charge for the three-month plan and any required lab fees are not stated in the section we reviewed, so we do not calculate a total.

Cancellation
Subscriptions can be cancelled, postponed, or paused before the next refill date. Where possible, AgelessRx asks for at least 48 hours’ notice before the next order processes.Source 12
Refunds
Refunds are not guaranteed for cancellation requests received after the pharmacy partner has received the order.Source 12
Support after you pay
Unlimited protocol adjustments and messaging, as advertised.Source 10
Checked
. Provider-published terms; we have not confirmed them with AgelessRx.

Questions to ask before paying

Nonclinical questions you can send to any clinic or take to an appointment.

  1. What exact service does this fee buy?
  2. Which pharmacy would dispense the exact formulation, and can it ship to my state?
  3. What source supports the access route you are advertising for this product?
  4. Which charges recur, and how do I cancel?
  5. What happens to my payment if the treatment is not prescribed or cannot be supplied?
  6. Which payments are refundable, and who answers clinical questions after the appointment?

Ask a qualified clinician whether any peptide is appropriate for you, what the evidence shows, and what the alternatives are. This guide does not recommend a peptide or a dose.

Sources and check dates

These records support the access statements above. Each was checked October 13, 2026. FDA briefings are staff analysis prepared for an advisory meeting, not final decisions. A registry listing is not proof of active enrollment or an authorized treatment pathway.

  1. 1

    U.S. Food and Drug Administration. BPC-157 briefing for the July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting.

    What it supports: FDA staff state that neither BPC-157 free base nor BPC-157 acetate is a component of an FDA-approved drug, and that no applicable USP or NF monograph exists for either form.

    Where to look: Approval and monograph statement: printed page 9, PDF page 9Staff evaluation dated May 11, 2026Checked

    Limits: FDA staff analysis prepared for an advisory committee meeting. It is not a final agency decision.

    Back to text:abcd
  2. 2

    Electronic Code of Federal Regulations. 21 CFR 216.23: Bulk drug substances that can be used to compound drug products in accordance with section 503A.

    What it supports: Neither BPC-157 nor TB-500 appears on the list in the version displayed as up to date as of October 8, 2026.

    Where to look: § 216.23(a), the list of bulk drug substancesDisplayed as up to date as of October 8, 2026Checked

    Limits: Shows the codified list as of the date displayed. A later amendment would appear in a newer version.

    Back to text:abcd
  3. 3

    U.S. Food and Drug Administration. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks.

    What it supports: BPC-157 and the TB-500 fragment are listed among substances previously in category 2 of FDA’s interim policies whose nominations were withdrawn by the nominators. For both, FDA describes possible immunogenicity for certain routes of administration and peptide-related impurities, and reports little or no human safety information.

    Where to look: “Bulk drug substances nominated but withdrawn” table: the BPC-157 row and the “Thymosin beta-4, fragment (LKKTETQ), also known as TB-500” rowChecked

    Limits: Describes FDA’s safety concerns about nominated substances. It does not, on its own, say whether a particular pharmacy may compound a substance.

    Back to text:abcd
  4. 4

    U.S. Food and Drug Administration. July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting.

    What it supports: On July 23, 2026, the committee discussed BPC-157- and TB-500-related bulk drug substances for the 503A bulks list. Advisory committees make non-binding recommendations to FDA.

    Where to look: Meeting agenda for July 23, 2026; “What is an advisory committee?”Checked

    Limits: Describes the meeting and its materials. A discussion or vote is not an FDA approval or a listing decision. We do not report a vote outcome.

    Back to text:abcd
  5. 5

    U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act.

    What it supports: Under section 503A, a bulk drug substance must comply with an applicable USP or NF monograph, be a component of an FDA-approved drug, or appear on FDA’s 503A bulks list. FDA also describes an interim policy, organized in three categories, for certain nominated substances that cannot otherwise be used.

    Where to look: Opening list of the three conditions for bulk drug substances; “Interim Policy on Compounding Drugs Using Bulk Drug Substances”Checked

    Limits: Explains the framework. Applying the interim policy to a specific substance is a regulatory interpretation, which we have not obtained.

    Back to text:abcde
  6. 6

    ClinicalTrials.gov. Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery (NCT07803250).

    What it supports: A University of Arkansas pilot study listing one site, the University of Arkansas for Medical Sciences Medical Center in Little Rock, Arkansas. Status when checked: not yet recruiting, with an estimated start of January 1, 2027.

    Where to look: Overall status, start date, enrollment, brief summary, and location fieldsLast update posted September 3, 2026Checked

    Limits: A registry record shows what a study sponsor submitted. It is not proof of active enrollment or an authorized treatment pathway.

    Conflicting source information The brief summary says twenty patients will be enrolled; the enrollment field lists 30 (estimated).

    Back to text:ab
  7. 7

    ClinicalTrials.gov. BPC 157 for Acute Hamstring Muscle Strain Repair (NCT07437547).

    What it supports: Listed as recruiting, with one site: Peking University Shenzhen Hospital in Shenzhen, China. It is not a U.S. study option.

    Where to look: Overall status and location fieldsLast update posted February 27, 2026Checked

    Limits: A registry record shows what a study sponsor submitted. It is not proof of active enrollment or an authorized treatment pathway.

    Back to text:ab
  8. 8

    U.S. Food and Drug Administration. TB-500 briefing for the July 23–24, 2026 Pharmacy Compounding Advisory Committee meeting.

    What it supports: FDA staff state that neither TB-500 free base nor TB-500 acetate is a component of an FDA-approved drug and that no applicable USP or NF monograph exists. The briefing describes TB-500 as a synthetic N-acetylated fragment of thymosin beta-4 (residues 17–23, LKKTETQ), distinct from the full-length 43-amino-acid peptide.

    Where to look: Approval statement: printed page 7, PDF page 7; Fragment versus full-length thymosin beta-4: printed page 25, PDF page 25Staff evaluation dated May 15, 2026Checked

    Limits: FDA staff analysis prepared for an advisory committee meeting. It is not a final agency decision.

    Back to text:abcd
  9. 9

    ClinicalTrials.gov. TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD (NCT07487363).

    What it supports: The record’s own summary calls it a fictional example. We exclude it from access evidence.

    Excerpt: This fictional study is an example of a ClinicalTrials.gov-style record.

    Where to look: Brief summary and overall status fieldsLast update posted March 23, 2026Checked

    Limits: A registry record shows what a study sponsor submitted. It is not proof of active enrollment or an authorized treatment pathway.

    Conflicting source information Listed as recruiting at a site in Shenzhen, China, while its brief summary calls the study fictional.

    Excluded from access evidence

    Back to text:ab
  10. 10

    AgelessRx. Sermorelin Injection.

    What it supports: A $99 first month that applies to a three-month plan billed in full, then $149 per month; a clinician-guided plan dispensed by a U.S.-licensed compounding pharmacy; unlimited protocol adjustments and messaging.

    Provider-publishedWhere to look: “Expert care that starts with you” section: offer, upfront-plan qualification, recurring price, and messaging termsChecked

    Limits: Shows what the provider says about its own service. It is not an independent license check, pharmacy inspection, or clinical endorsement.

    Back to text:abcdefgh
  11. 11

    U.S. Food and Drug Administration. Compounding and the FDA: Questions and Answers.

    What it supports: Compounded drugs are not FDA-approved, which means FDA does not verify their safety, effectiveness, or quality before they are marketed.

    Excerpt: Compounded drugs are not FDA-approved.

    Where to look: Answer to “Are compounded drugs approved by FDA?”Checked

    Limits: A general explanation of compounding. It does not address any particular substance, pharmacy, or offer.

    Back to text:ab
  12. 12

    AgelessRx. Frequently Asked Questions.

    What it supports: Subscriptions can be cancelled, postponed, or paused before the next refill date, and AgelessRx asks, where possible, for at least 48 hours’ notice before the next order processes. Refunds are not guaranteed for cancellation requests received after the pharmacy partner has received the order. Some treatments are not available in all states; availability is listed per treatment.

    Provider-publishedWhere to look: Orders: “What is the AgelessRx refund/cancellation policy?”; “Does AgelessRx service all 50 states?”Checked

    Limits: Shows what the provider says about its own service. It is not an independent license check, pharmacy inspection, or clinical endorsement.

    Back to text:abcd
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