[Skip to the reading](/regulatory#reading) [Peptide Therapy News](/) [Regulatory](/regulatory) [Research](/research) [Archive](/#event-index) [About](/about) Source review through 27 October 2026 · Event dates appear with reports [Home](/) / Regulatory # FDA’s peptide lists have two kinds of dates A decision date tells you when something happened. A page date tells you how recent the record is. Mixing them up changes the story. ## The additions with a date Event · 29 September 2023 FDA list snapshot · 22 April 2026 ![An illustrative view of FDA’s White Oak campus and its connected office buildings.](/press-desk-66428b6910dc/regulatory.webp) Illustration: FDA’s White Oak campus, not the list announcement. ### What happened FDA’s [safety table](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) 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 Ipamorelin acetate appears in Category 2 under 503B, but its 503A nomination is listed as withdrawn.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 ## A withdrawn request isn’t a safety clearance Source snapshot only Content current as of · 22 April 2026 ### What the record says On FDA’s page current as of 22 April 2026, the [nominated but withdrawn table](https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks) includes BPC-157,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 The April date tells you how recent the page is; it doesn’t tell you when any particular request was withdrawn.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 · 21 February 2025 FDA chronology updated · 1 April 2026 ### What happened FDA’s [shortage record](https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize) 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. ## On this page - [The additions with a date](/regulatory#dated-additions) - [A withdrawn request isn’t a safety clearance](/regulatory#withdrawn-record) - [The shortage decisions are a separate story](/regulatory#shortage-record) Source review 27 October 2026 [Open the source desk](/references) [Follow the event dates](/#event-index) Peptide Therapy News is a guide for reading the record, not a clinic, pharmacy or seller. © 2026 Peptide Therapy News [References](/references) [About](/about) [Contact](/contact) [Event index](/#event-index)