Which products do not require TTB formula approval for MNBP drawback?

Formulas for products that include alcohol as an ingredient, and that are listed in the current editions of the United States Pharmacopoeia (U.S.P.), National Formulary (N.F.), or Homeopathic Pharmacopoeia of the United States (H.P.U.S.) are automatically considered approved. These formulas can be used for drawback products without needing to submit a formula application in Formula’s Online. 

There are a few exceptions to this rule. Alcohol (including dehydrated alcohol and alcohol injections), U.S.P., alcohol with dextrose injections, U.S.P., and tincture of ginger, H.P.U.S. are considered suitable for beverage use and therefore do not qualify for drawback. In addition, other H.P.U.S. products that are diluted beyond one part in 10,000 (referred to as “4×”) are also not eligible for drawback, unless the manufacturer receives approval.