The additions with a date
Event ·
FDA list snapshot ·

What happened
FDA’s safety table dates several Category 2 additions to 29 September 2023. Compounding means preparing a medicine rather than manufacturing an approved finished product. Category 2 covers ingredients proposed for compounding that FDA identified as posing significant safety risks.
The entries include kisspeptin-10 under section 503A, the rules for patient-specific pharmacy and physician compounding. Ipamorelin acetate appears under section 503B, the rules for FDA-registered outsourcing facilities that can make larger batches. Neither entry is a drug approval.
What it means
The ingredient’s form and the rule applying to it matter. Ipamorelin acetate appears in Category 2 under 503B, but its 503A nomination is listed as withdrawn. A claim that ipamorelin changed status loses that distinction.
A withdrawn request isn’t a safety clearance
Source snapshot only
Content current as of ·
What the record says
On FDA’s page current as of 22 April 2026, the nominated but withdrawn table includes BPC-157, CJC-1295, injectable GHK-Cu, the TB-500 fragment and ipamorelin acetate, among other entries. These were requests to consider ingredients for compounding that their nominators took back.
The page gives no withdrawal date for each ingredient. The April date tells you how recent the page is; it doesn’t tell you when any particular request was withdrawn.
What it means
Withdrawal is not FDA clearance, drug approval or a move to Category 1. FDA still prints its safety concerns beside the entries. The shorter list in this report gives examples; the linked FDA table has the full list.
For BPC-157, those concerns include possible immune reactions and limited human safety information. FDA also raises concerns about clumping and impurities in certain peptides. A name leaving one table doesn’t make those questions go away.
The shortage decisions are a separate story
Event ·
FDA chronology updated ·
What happened
FDA’s shortage record gives separate decisions for tirzepatide on 19 December 2024 and semaglutide injections on 21 February 2025. Those decisions changed the basis for making certain compounded copies.
Semaglutide’s original pharmacy grace period ran to 22 April 2025, or the court’s ruling if later. After the 24 April ruling, FDA confirmed it had ended. Outsourcing facilities had until 22 May 2025.
What it means
In its 1 April 2026 update, FDA said neither ingredient was on the shortage list or the 503B list of permitted bulk ingredients. Compounded versions are not FDA-approved. A licensed U.S. clinician can assess personal treatment questions; a table entry can’t do that.