The US Food and Drug Administration has sent the White House a draft plan about pharmacies making certain peptides that the agency has never approved. On October 14, 2026, the FDA submitted a document titled “Interim Access Policy for Compounding Using Certain Peptides” for review, and its text has not been made public1. Reports say the plan would let specialty pharmacies mix some of these injectable compounds, even though at least one of them sits on an FDA list of substances that “may present significant safety risks”2.
This is the first Biohack article following this policy. Here is what is known, what is reported but not confirmed, and what is still missing.
What happened
The White House regulatory office lists the filing from the Department of Health and Human Services (HHS) and the FDA as received on October 14, at the “notice” stage and pending review1. The listing gives only the title. It names no peptides and no start date1.
A notice is not a final rule. Nothing changes for pharmacies until the White House clears it and the FDA publishes the text1.
The health news outlet STAT reported, citing people familiar with the plan, that the policy would tell compounding pharmacies the FDA will not pursue them for making certain peptides1. “Compounding” means a pharmacy mixes a drug itself for a patient3. CNBC described the reported move as an interim access policy covering some specific peptides not currently approved by the FDA2.
CNBC also reported that the peptides in question have the support of Health Secretary Robert F. Kennedy Jr., who told podcaster Joe Rogan in a February 2026 interview that he is a “big fan” of the injectables2.
What peptides are, and why they are popular
Peptides are short chains of amino acids2. Dr. Alison Dempsey, a dermatologist at Weill Cornell Medicine and NewYork-Presbyterian Hospital, told CNBC they are “kind of like the building blocks of proteins”2. The body makes many naturally, such as insulin and endorphins2.
Some lab-made peptides are heavily studied and approved. Ozempic-style drugs, used for weight loss and diabetes, are FDA-approved synthetic peptides2. Others are not approved. The ones in the headlines now are unapproved injectables such as BPC-157 and GHK-Cu, the second of which has been marketed as a possible anti-aging drug, according to Dr. Pieter Cohen of Harvard Medical School2.
Cohen told CNBC that the success of drugs like Ozempic may have fed interest in other peptides. But he said a compound being a peptide “doesn’t mean it’s close to Ozempic in any way, shape or form” in its chemical structure or its effects on the body2. Online sellers market these products for longer life, better sleep, a stronger immune system, skin health and sexual function, according to Dr. Caleb Alexander of the Johns Hopkins Bloomberg School of Public Health2.
The evidence and the safety question
The FDA keeps a list it calls “category 2”: bulk ingredients it says may present significant safety risks when used in compounding1. The agency does not give pharmacies its usual leeway (called “enforcement discretion”) for compounding with category 2 substances3. Its public safety page cites risks such as immune reactions, impurities related to the peptides, and a lack of human safety data3.
BPC-157, TB-500, CJC-1295, GHK-Cu for injection and 13 other substances currently appear on that FDA page under a heading for substances whose nominations were withdrawn1. The FDA’s note on BPC-157 reads: “FDA has identified no, or only limited, safety-related information for the proposed routes of administration”1.
BPC-157 has shown possible anti-inflammatory effects in some animal and lab dish studies. It has not been tested for safety or effectiveness in large human trials2. Asked why it is on the risk list, Alexander told CNBC that “one of the main ones is the absence of evidence,” including solid human studies2.
Doctors also raise concerns about where products come from. Cohen said that people buying peptides on the gray market, often from overseas sellers outside the US drug system, can receive different compounds or doses than expected, and some products may be contaminated with bacteria2. Pharmacy-made drugs in general are not FDA-approved, which means the FDA does not review them for safety, effectiveness or quality before they are sold3.
What is still unknown
- Which peptides. The public listing names none1. Only BPC-157 has been reported by name as part of the proposal2.
- The exact terms. The claim that the FDA would not pursue pharmacies comes from STAT’s unnamed sources, not from the listing itself1.
- Timing. No start date is listed, and the White House has not finished its review1.
- Whether any peptide works. A policy on who may make a product does not test whether it is safe or does what sellers claim.
The sources also differ on the current status of the risk list. A guide published in April 2026 said the FDA removed 12 peptides from category 2 that month, calling the picture “mixed”3. An October 2026 report describes BPC-157 and others still appearing on the FDA’s category 2 page, under the withdrawn-nominations heading1.
How this fits years of FDA action on peptides
The reported plan would mark a shift in tone. In 2023 the FDA placed more than a dozen peptides into category 23. Substances such as GHRP-2, GHRP-6, kisspeptin-10 and ibutamoren (MK-677) carry a placement date of September 29, 20233.
The agency later ended shortages of the weight-loss drugs tirzepatide and semaglutide, which had allowed mass pharmacy copies, and it won the resulting lawsuits from a compounders’ trade group3. In August 2026, the FDA sent warning letters to five online sellers of so-called “research use only” peptides. It said those labels did not change what the products were really for, pointing to dosing guidance and calculators sold alongside them3.
The new filing does not affect the approved weight-loss drugs. Semaglutide and tirzepatide are peptides, but the listing does not name them and the filing does not change how they are sold1.
Who is behind it
The filing comes from HHS and the FDA1. CNBC tied the peptides involved to the stated support of Health Secretary Kennedy2. No company is named in the sources as backing the policy.
Readers should know where the reporting comes from. One of the outlets cited here, GLP Chart, is a price-comparison site that carries listings for telehealth programs selling pharmacy-made weight-loss drugs1. Its account of the filing matches the details in CNBC’s reporting on the plan2.
What to watch next
- Whether the White House clears the notice, and when the FDA publishes the text1.
- Which peptides the final list includes, and whether any of them remain on the FDA’s category 2 safety-risk page1.
- What conditions, if any, the policy attaches to pharmacies, such as quality or sourcing rules.
- Reactions from doctors and researchers, who told CNBC that marketing for peptides has run far ahead of research. As Dempsey put it, “word of mouth has strongly surpassed where we are with any type of research”2.
Biohack will update this thread when the policy text is published.
