GHK-Cu
Also known as: Copper peptide GHK-Cu, glycyl-L-histidyl-L-lysine copper
GHK-Cu is currently not an approved drug for fda-approved drug product.
Not legal or medical advice.
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A tripeptide-copper complex. It is not a component of an FDA-approved drug. FDA's categorization differs by route of administration.
Current status
FDA-approved drug product: Not an approved drug; 503A pharmacy compounding: Category 1 except injectable; Category 2 for injectable
| Activity | Status | As of | Jurisdiction | Qualification | Sources |
|---|---|---|---|---|---|
| FDA-approved drug product | Not an approved drug | Sep 27, 2024 | United States federal | No FDA-approved application is in effect for GHK-Cu. | |
| 503A pharmacy compounding | Category 1 except injectable; Category 2 for injectable | Sep 27, 2024 | United States federal | FDA placed GHK-Cu in 503A Category 1 for non-injectable routes and Category 2 for injectable routes due to immunogenicity concerns. |
What this means
- ✓ FDA-approved drug product: Not an approved drug. No FDA-approved application is in effect for GHK-Cu.
- ✓ 503A pharmacy compounding: Category 1 except injectable; Category 2 for injectable. FDA placed GHK-Cu in 503A Category 1 for non-injectable routes and Category 2 for injectable routes due to immunogenicity concerns.
What this does not mean
- ✗ Status in one jurisdiction does not automatically apply elsewhere.
- ✗ An approved active ingredient is not the same as an approved finished product.
- ✗ “Research use” labeling does not make an unapproved drug lawful for human use.
Timeline
FDA updates GHK-Cu categorization
final503A bulk list places GHK-Cu in Category 1 except for injectable routes, which are Category 2.
Controlling sources
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
U.S. Food and Drug Administration · Agency list · FDA-2015-N-3534
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks (GHK-Cu)
U.S. Food and Drug Administration · Safety summary