FDA compounding status
Sermorelin Acetate
Also listed as Sermorelin.
Sermorelin acetate is in FDA's 503B Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503B outsourcing facility that compounds it while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Sermorelin does not appear in any of FDA's 503A categories. Compounded sermorelin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
Checked against the primary sources on .
The record
- FDA status
- FDA interim enforcement discretion (Category 1). Not a listing. Not FDA-approved.
- Compounding basis
- 503B outsourcing facility (Category 1, interim policy)Compounded by a 503B outsourcing facility registered with FDA and inspected on a risk-based schedule. The substance is in FDA's 503B Category 1, under FDA's interim policy for substances under evaluation. This is enforcement discretion, not the bulks list.
- FDA advisory committee
- Not reviewed
- Sport (WADA 2026)
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
- Offered by PEPLUX
- Yes, as Sermorelin
- Checked on
Offered by PEPLUX
Sermorelin
PEPLUX offers Sermorelin Acetate as Sermorelin. The product page covers what it is, its risks, and how prescribing and pricing work.
Status as offered
In FDA's 503B Category 1: interim enforcement discretion, not the bulks list.
Basis
What this status traces to.
FDA's 503B categories document (updated March 21, 2025) lists "Sermorelin Acetate" in Category 1, bulk drug substances under evaluation, marked as a component of an FDA-approved drug. Sermorelin does not appear in Category 1, 2 or 3 of FDA's 503A categories document (updated May 14, 2026). It is not on the 503A bulks list in 21 CFR 216.23 and not on the 503B bulks list. Category 1 is FDA's interim enforcement discretion, not a statutory pathway.
Primary sources
- FDA 503B categoriesBulk drug substances nominated for use in compounding under section 503B (categories), updated March 21, 2025Document dated . Checked .
- FDA 503A categoriesBulk drug substances nominated for use in compounding under section 503A (categories), updated May 14, 2026Document dated . Checked .
- FDA503B Bulk Drug Substances ListDocument dated . Checked .
- eCFR21 CFR 216.23, Bulk drug substances that can be used to compound drug productsDocument dated . Checked .
- FDACompounding and the FDA: Questions and AnswersDocument dated . Checked .
- WADAWorld Anti-Doping Code, 2026 Prohibited ListDocument dated . Checked .
Context
A removal or a committee vote is not a listing.
Removal from FDA's Category 2 is not FDA approval and not a listing. FDA removed several peptides from its 503A Category 2 after their nominators withdrew the nominations, not because the substances were found safe: BPC-157, TB-500, MOTS-c, semax and epitalon among others (removal noticed April 15, 2026, effective after 7 days), and CJC-1295 and ipamorelin earlier (removal notice dated September 27, 2024). None was added to the 503A bulks list, so none has a compounding pathway today. A favorable vote by FDA's Pharmacy Compounding Advisory Committee is a recommendation, not a listing: nothing changes unless FDA publishes a final rule.
FDA advisory committee
FDA's Pharmacy Compounding Advisory Committee has not reviewed it.
If you are subject to anti-doping rules
Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
Pending or unconfirmed
Whether a 503A pharmacy can rely on the route for components of approved drugs for sermorelin has not been confirmed. Until it is, the 503B route is the default.
Common questions
Sermorelin Acetate, answered plainly.
- What is the FDA compounding status of Sermorelin Acetate?
- Sermorelin acetate is in FDA's 503B Category 1. FDA is still evaluating it and has said it does not intend to take action against a 503B outsourcing facility that compounds it while the interim policy's conditions are met. That is enforcement discretion, not a listing, and FDA can change it. Sermorelin does not appear in any of FDA's 503A categories. Compounded sermorelin is not FDA-approved. FDA does not check the safety, effectiveness or quality of compounded drugs before they are sold.
- What does the status of Sermorelin Acetate trace to?
- FDA's 503B categories document (updated March 21, 2025) lists "Sermorelin Acetate" in Category 1, bulk drug substances under evaluation, marked as a component of an FDA-approved drug. Sermorelin does not appear in Category 1, 2 or 3 of FDA's 503A categories document (updated May 14, 2026). It is not on the 503A bulks list in 21 CFR 216.23 and not on the 503B bulks list. Category 1 is FDA's interim enforcement discretion, not a statutory pathway. Checked against the primary sources on October 13, 2026.
- Does PEPLUX offer Sermorelin Acetate?
- PEPLUX offers Sermorelin Acetate as Sermorelin. Compounded medications are not approved by the FDA and have not been reviewed for safety, effectiveness, or quality.
- Is Sermorelin Acetate prohibited in sport?
- Prohibited at all times under WADA class S2.2.4 (growth hormone releasing factors).
- Is anything about the status of Sermorelin Acetate pending or unconfirmed?
- Whether a 503A pharmacy can rely on the route for components of approved drugs for sermorelin has not been confirmed. Until it is, the 503B route is the default.