Description
*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.
Key Topics
Terms and concepts identified from this document
Scope & Applicability
Product Classes
3Regulatory status of inert glandulars making false representations.
Nonprescription human drug products marketed without an approved application.
Glandular products with little hormonal activity intended for medicinal use.
Stakeholders
1Entity responsible for receiving written comments regarding the guidance
Regulatory Context
Document Types
1FDA regulatory reference documents (CPG 527.300, 555.300)
Technical Details
Substances
4Exemption for stomach and duodenum preparations.
Exemption for liver preparations limited to vitamin content.
Form of animal glands subject to regulatory action.
Produced by glands; many preparations contain very little.
Related CFR Sections (2)
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
- 21CFR201.300§ 201.300 Notice to manufacturers, packers, and distributors of glandular preparations.
(a) Under date of December 4, 1941, in a notice to manufacturers of glandular preparations, the Food and Drug Administration expressed the opinion that preparations of inert glandular materials intended for medicinal use should, in view of the requirement of section 201(n) of the Federal Food, Drug,Read full regulation →
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CVM GFI #55 Supportive Data for Cat Food Labels Bearing "Reduces Urinary pH Claims: Protocol Development (Status: Final)