Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US | Clinical Pharmacy and Pharmacology | JAMA Network Open | JAMA Network

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US | Clinical Pharmacy and Pharmacology | JAMA Network Open | JAMA Network





FDA Publishes Study Analyzing Quality of Difficult-to-Make Pharmaceuticals Marketed in the US

Today, the U.S. Food and Drug Administration published a study titled “Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US” in the Journal of the American Medical Association Network Open. To date, this is the largest sampling study of pharmaceutical manufacturers for the U.S. market. These data provide objective insight into the quality of some prescription drugs with high manufacturing risk for quality problems. The study found that all 252 drug products the FDA sampled met the U.S. market standards for the major quality attributes of dosage unit uniformity and dissolution. However, there is evidence of differences in the consistency of these attributes between regions and manufacturers.

Health care professionals and patients can better understand the quality of prescription pharmaceuticals in the U.S. by knowing the tested samples met the U.S. market standards regardless of manufacturer or manufacturing region and brand or generic distinction. The study also identified opportunities for regulatory outreach to manufacturers and markets to improve the overall quality of the U.S. prescription pharmaceutical supply. Although FDA will use these findings to continue examining differences in drug product quality, consumers can feel confident that drug products marketed in the U.S. meet quality standards.