If you follow peptide news, you have probably seen headlines about "Category 2" and the "bulks list." These are FDA terms for which raw ingredients a compounding pharmacy may use. They matter a lot right now, because several popular peptides have been moving through this system in 2026. Here is what the categories mean, in plain English. This is general information, not legal advice.
Key takeaways
- A bulk drug substance is the raw active ingredient (the powder) a pharmacy uses to compound a medicine.
- 503A pharmacies may only compound from bulk ingredients that meet specific tests, one of which is being on FDA's 503A bulks list.
- While that list is being built, FDA uses an interim policy with Category 1 (may be compounded under the policy), Category 2 (significant safety concerns) and Category 3 (not enough information).
- In 2026, FDA removed 12 peptides from Category 2 and an advisory committee voted on several of them. As of late October 2026, none had been added to the bulks list or Category 1.
- Category status is about pharmacy ingredients. It never makes a product FDA-approved.
What the 503A bulks list is
Under section 503A of the Food, Drug, and Cosmetic Act, a state-licensed pharmacy can compound with a bulk ingredient only if that ingredient:
- Is a component of an FDA-approved drug, or
- Has a USP or NF monograph (an official quality standard), or
- Appears on FDA's 503A bulks list.
Most peptides people ask about, like BPC-157 or TB-500, are not part of any approved drug and have no USP monograph. That leaves the bulks list as their only possible path.
The list itself is built slowly through formal rulemaking. FDA finalized a first rule in 2019. A second proposed rule from September 2019 still had not been finalized as of FDA's May 2026 page update. To manage the backlog of nominated substances, FDA uses an interim policy with three categories. For background on how compounders differ, see 503A vs. 503B compounding pharmacies explained.
The three interim categories
| Category | What it means | Can a 503A pharmacy compound with it? |
|---|---|---|
| Category 1 | Nominated with enough information, may be eligible for the list, and not flagged for safety | FDA generally does not intend to take action if the policy's conditions are met, while it decides |
| Category 2 | Nominated with enough information, but raises significant safety risks | Not covered by the interim policy |
| Category 3 | Nominated without enough information to evaluate | Not covered by the interim policy (can be renominated with more data) |
Two details often get lost:
- Category 1 is not approval. It is FDA saying it does not plan to act against compounders while it evaluates the substance.
- Leaving a category is not the same as entering another. A substance can be removed from Category 2 and still sit outside Category 1.
FDA has also said it does not intend to place substances nominated on or after January 7, 2025 into these interim categories.
What happened with peptides in 2026
April: 12 peptides removed from Category 2
On April 15, 2026, FDA republished its interim 503A list and announced it would remove 12 peptides from Category 2. According to legal summaries of the notice, they were BPC-157, LL-37, dihexa, emideltide (DSIP), epitalon, GHK-Cu (injectable routes), KPV, PEG-MGF, melanotan II, MOTS-c, semax and TB-500. FDA did not move them to Category 1, so they still were not eligible for compounding under the interim policy.
July: advisory committee votes
On July 23 and 24, 2026, FDA's Pharmacy Compounding Advisory Committee (PCAC) met to review seven of those peptides. The committee narrowly voted in favor of adding six to the bulks list: BPC-157, KPV, TB-500, MOTS-c, semax and epitalon. It voted against emideltide (DSIP). FDA's own scientists had recommended against all seven, citing studies that were too small and too short.
PCAC votes are advice, not law. A second meeting for the remaining peptides (including LL-37, GHK-Cu, PEG-MGF, dihexa and melanotan II) was expected before the end of February 2027.
October: a proposed interim policy
On October 14, 2026, HHS and FDA sent an "Interim Access Policy for Compounding Using Certain Peptides" to the White House Office of Management and Budget for review. As of this writing it had not been published. Legal analysts expect it may work through FDA enforcement discretion, but its exact terms are unknown until FDA releases it.
Meanwhile: enforcement against "research use only" sellers
In August 2026, FDA sent warning letters to online peptide sellers, finding that "research use only" labels did not hide that products were meant for people. A legitimate path, if one opens, runs through licensed prescribers and licensed pharmacies. Our post on prescription vs. research-use-only peptides explains why that matters.
What the categories do not tell you
Even a peptide that reaches Category 1 or the final bulks list:
- Is still not FDA-approved. No one has proven it safe and effective for a specific condition through FDA review.
- Still needs a prescription from a licensed prescriber for an identified patient.
- Still depends on quality ingredients. Analysts have noted that pharmaceutical-grade supplies of some peptides may be limited.
- May not be allowed in sports. WADA anti-doping rules are separate from FDA rules, and several of these peptides are prohibited in tested sports.
For what the research does and doesn't show on specific peptides, see our BPC-157 overview and the rest of our peptide library.
How to keep up with changes
This area is moving fast. A few reliable habits:
- Check FDA's page on bulk drug substances used under section 503A, which shows its last update date.
- Treat social media claims that a peptide is "now legal" with caution until FDA itself publishes a change.
- Ask your prescriber and pharmacist what they are allowed to dispense today in your state.
The bottom line
FDA's bulk drug substance categories decide which raw ingredients pharmacies may use while the official 503A list is built. In 2026, several peptides left Category 2 and won a narrow advisory vote, but as of late October 2026 none had been cleared for compounding. Even if that changes, compounded peptides would not be FDA-approved, so a licensed prescriber should be part of any decision.
Sources
- FDA: Bulk Drug Substances Used in Compounding Under Section 503A
- Frier Levitt: FDA Peptide Update 2026, Removal from Category 2
- AJMC: FDA Panel Backs 6 Peptides for Compounding
- Holland & Knight: Peptides at a Crossroads (October 2026)
Frequently asked questions
Does removal from Category 2 mean a peptide can now be compounded?
No. FDA said in April 2026 that taking peptides off Category 2 did not make them eligible for compounding. Only Category 1 substances fall under FDA's interim enforcement policy, and none of the removed peptides had been moved there as of late October 2026.
Did the July 2026 advisory committee vote make BPC-157 legal to compound?
No. The Pharmacy Compounding Advisory Committee's votes are recommendations only. FDA would still need to act, either through a policy change or formal rulemaking, before compounding is allowed.
Is any of this the same as FDA approval?
No. The bulks list only decides which ingredients a pharmacy may use to compound. A compounded product made from a listed ingredient is still not FDA-approved and has not been reviewed for safety or effectiveness.