Title 21

SECTION 357.250

357.250 Labeling of cholecystokinetic drug products.

§ 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”:

(1) “Take only when instructed by a doctor:”

(2) For products containing 50-percent aqueous emulsion of corn oil.

(i) “Shake well before using.”

(ii) Oral dosage is 60 milliliters 20 minutes before diagnostic gallbladder x-ray or as directed by a doctor.

(3) For products containing hydrogeneated soybean oil. Oral dosage is 12.4 grams in a suitable, water-dispersible powder in 2 to 3 ounces of water. Stir briskly to prepare a suspension before using. Drink 20 minutes before diagnostic gallbladder x-ray or as directed by a doctor.

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

[48 FR 27005, June 10, 1983, as amended at 51 FR 16267, May 1, 1986; 52 FR 7830, Mar. 13, 1987; 54 FR 8321, Feb. 28, 1989]

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