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FDA Provided Clarity on GHK-Cu On May 14, 2026, the FDA restored non-injectable GHK-Cu to Category 1 of the 503A bulk drug substances list, confirming that the earlier withdrawal applied only to injectable routes of administration

This is why bacteriostatic water, rather than plain sterile water, is the standard diluent: its preservative content allows the vial to be safely accessed multiple times without the risk of microbial contamination that plain sterile water carries once a seal is broken

Note that PA isn't caused by not eating foods that contain B12, but rather by your body's inability to absorb B12

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Additional quality assessments evaluate physicochemical characteristics relevant to laboratory use, including solubility, molecular integrity, and stability under recommended storage conditions

Clinical translation remains speculative