Code of Federal Regulations Title 21. Food and Drugs § 21.357.250 Labeling of cholecystokinetic drug products

(a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as a “gallbladder diagnostic agent.”

(b) Indications. The labeling of the product states, under the heading “Indications,” the following:  “For the contraction of the gallbladder during diagnostic gallbladder studies.” Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b), may also be used, as provided in § 330.1(c)(2), subject to the provisions of section 502 of the act relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act.

(c) Warnings. [Reserved]

(d) Directions. The labeling of the product contains the following statements under the heading “Directions”:

(e) The word “physician” may be substituted for the word “doctor” in any of the labeling statements in this section.