CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims
*When it was discovered that some glands produce hormones, a variety of glandular products were placed on the market for OTC medicinal use. Many of these commercial glandular preparations contained very little hormonal activity.
Our policy on inert glandular preparations is expressed in 21 CFR 201.300. It is our policy that inert glandular preparations intended for medicinal use are not exempt from Section 502(f)(1), that they bear adequate directions for use including indications for use and any such representations offering these articles for use as drugs would be false and misleading, and cause such articles to be unapproved new drugs*.
REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to the *Division of Drug Labeling Compliance, HFD-310*.
Any desiccated whole or aqueous extracts of the following animal glands:
Adrenal Cortex Parathyroid
Such inert glandular preparation is offered for *OTC* drug use, other than, use limited to vitamin content in the case of liver preparations; use limited to intrinsic factor content in the case of stomach and duodenum, and parenteral use in the case of parathyroid.
*Material between asterisks is new or revised*
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:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.