Healthy Skepticism Library item: 9445

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Bolger G, Goetsch R, Reinstein P.
Monitoring drug product quality.
Am Pharm 1992 Feb; NS32:(2):47-9

Abstract:

The Food and Drug Administration’s (FDA) Drug Quality Reporting System (DQRS) for reporting problems such as contamination, labeling errors, packaging and defective drugs is discussed. The history of the FDA’s voluntary reporting program for potential problems with the quality of prescription and nonprescription drugs, a summary of 1990 DQRS reporting, the mechanisms for receiving reports, and a copy of the DQRS report form, are included.

Keywords:
Adverse Drug Reaction Reporting Systems/organization & administration* Drug Monitoring/methods* Humans Product Surveillance, Postmarketing/methods* Quality Assurance, Health Care* United States United States Food and Drug Administration