Tissue repair The briefings

Names and US status

A name is not an approval.

Get the exact substance and the way it would be used. Broad labels hide the details that matter.

Status desk · September 26, 2026.

Ask for the substance and the form

Peptide means a short string of amino acids, which are protein building units.

Write down the full name. Ask whether the proposal is a cream, an injection or another form.

Under US law checked September 26, 2026, a product counts as a drug when its intended use is treating disease or altering the way the body works.

FDA, short for Food and Drug Administration, is the US drug regulator.

When medicine is prepared for a patient’s particular needs, the process is called compounding. The preparation is handled by a pharmacist or doctor.

Read each substance on its own terms

BPC-157: no approved US product

No approved US medicine containing BPC-157 appeared in the FDA approval records checked on September 26, 2026.

The record addresses approval; it cannot establish that BPC-157 works or that a pharmacy has permission to prepare it to order.

TB-500: taking back a request did not make it approved

Groups asked FDA to add TB-500 to the list of raw ingredients allowed for making medicines to order, then took their requests back.

FDA reports those withdrawals on a page dated April 22, 2026, without saying when each request was taken back.

The point for your care: taking back a request did not grant approval or permission to make TB-500 to order, as checked September 26, 2026.

GHK-Cu: injections have a different status

The request to allow GHK-Cu as a raw ingredient for injections was taken back, according to FDA records checked September 26, 2026.

GHK-Cu used without injections is in Category 1: FDA’s temporary group for ingredients it is still reviewing, in its list updated May 14, 2026.

For Category 1 ingredients, FDA does not plan to act against pharmacies making medicines if they meet the conditions in its guidance.

That policy is not FDA approval and does not itself make a preparation lawful, as checked September 26, 2026.

Ask the pharmacist which conditions apply and how the pharmacy meets them. A statement about use without injections does not answer the question for injections.

A prescription alone cannot make these ingredients allowed

For an identified patient whose prescription is valid, section 503A of US law allows a licensed pharmacy or doctor to prepare a medicine.

The medicine does not need its own FDA approval if all the conditions in that law are met, as checked September 26, 2026.

Those conditions include rules about which raw ingredients may be used.

BPC-157 and TB-500 fail those ingredient rules, according to FDA documents checked September 26, 2026.

A prescription therefore does not let a pharmacy make either medicine from those raw ingredients under 503A.

Made to order has a separate meaning

Medicines made to order are not FDA-approved, under US rules checked September 26, 2026.

Before they reach patients, the agency does not verify their quality, safety or ability to work.

A prescription does not turn a medicine made to order into an approved product.

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Endnotes for this chapter

  1. FDA medicine approval search

    Look for an approved medicine containing the named substance.

  2. FDA table of ingredient concerns

    Shows which requests were taken back and how each substance would be used.

  3. FDA ingredient categories

    GHK-Cu used without injections has its own entry.

  4. FDA briefing: rules for raw ingredients

    Explains which ingredients a pharmacy may use to make medicines.

  5. FDA on medicines made to order

    What compounding does and why it differs from approval.

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