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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec. 400.335 Fructose-Containing Drugs May 1987

Final
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs

BACKGROUND:

Hereditary fructose intolerance is a metabolic error due to the deficiency of fructose 1-phosphate aldolase in the liver. It is thought to be inherited as an autosomal recessive trait. The condition is characterized by symptomatic hypoglycemia and vomiting. Prolonged fructose ingestion in young children results in their failure to thrive and in jaundice, liver damage, renal impairment, and sometimes cachexia. <> There have been deaths involving the administration of IV solutions containing "Invert Sugar" to patients with hereditary fructose intolerance.

There are many drug products which contain fructose. In many cases, fructose has been identified on the product label as either levulose or invert sugar. FDA has learned that the public and many professionals are not always aware of the fact that levulose is a synonym for fructose, or that "invert sugar" is a mixture of glucose and fructose. Clearly identifying *the* presence of fructose in drugs which may be used by persons with hereditary fructose intolerance would help insure that they are not unknowingly being treated with such drugs.

POLICY:

All oral dosage form drugs and all parenteral drugs which contain fructose should clearly identify this ingredient as "fructose" on labels and labeling. The words "Fructose/Dextrose" should immediately follow the words "Invert Sugar" whenever they appear. The word "Fructose" should immediately follow the word "Levulose" whenever it appears.

*Material between asterisks is new or revised*
<> Indicates material has been deleted

Issued: 1/21/75
Revised: 10/1/80, 5/22/87

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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