Internal medicinal preparations and flavoring extracts—(1) Manufacture. No person shall use denatured spirits in the manufacture of medicinal preparations or flavoring extracts for internal human use where any of the spirits remain in the finished product.
Sale. No person shall sell or offer for sale for internal human use any medicinal preparations or flavoring extracts manufactured from denatured distilled spirits where any of the spirits remain in the finished product.
Labeling and advertising. Labeling and advertising of articles shall not imply that the article is intended for or suitable for internal human use.
Beverage use. No person shall sell or offer for sale any article containing denatured spirits for beverage purposes. Labeling and advertising of articles shall not imply that the article is intended for or suitable for use as a beverage.
Trafficking in articles. The appropriate TTB officer may impose the requirements of § 20.133 on any person who reprocesses, rebottles, or repackages articles, deals in articles, or receives articles in containers exceeding one gallon.
Analytical tolerance. In the case of an article manufactured in accordance with a formula that specifies exact amounts of ingredients, including denatured spirits, TTB will apply an analytical tolerance of ±5% and use standard rounding rules in determining whether the article complies with the formula.
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