NAD+ injections: legal status

Short answer: NAD (nicotinamide adenine dinucleotide) and NADH are in FDA’s Category 1 for 503A compounding: substances under evaluation [1]. FDA says it does not intend to take action against a state-licensed pharmacy, federal facility or licensed physician that compounds with a Category 1 substance, if the conditions in its guidance are met [2]. NAD injections are not FDA-approved.

At a glance

NAD and NADH	FDA Category 1, under evaluation [1]
Beta-NAD disodium salt trihydrate	FDA Category 3, nominated without adequate support [1]
503A compounding	FDA does not intend to act, if its guidance conditions are met [2]
503B outsourcing facilities	FDA cited NAD+ as not eligible for one 503B firm (warning letter, January 2026) [3]
FDA-approved	No
Last checked	November 6, 2026

What Category 1 means

FDA keeps three lists of substances nominated for the 503A bulks list. Category 1 substances may be eligible, were nominated with enough information for FDA to evaluate them, and do not appear on any other list [2]. They stay under FDA’s interim policy until FDA decides whether to add them to the 503A bulks list, or until FDA removes them from Category 1, for example because of safety information [2].

Which form matters. FDA lists NAD and NADH in Category 1, but a different salt form (beta-nicotinamide adenine dinucleotide disodium salt trihydrate) in Category 3 [1]. Ask the pharmacy which form it uses.

503A pharmacy or 503B outsourcing facility

The Category 1 policy is for 503A compounding. In January 2026, FDA sent a warning letter to a 503B outsourcing facility that said NAD+ was not an eligible bulk substance for its 503B products [3]. See how to check a compounding pharmacy.

What is not known

FDA has not finished its evaluation of NAD for the 503A bulks list [1], [2]. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed. Talk to a licensed clinician before you use it.

Change log

• November 6, 2026: page created.