The U.S. Food and Drug Administration has gone on to create a green list import alert in order to stop unapproved as well as unverified glucagon-like peptide 1 (GLP-1) drug ingredients from entering into the United States.
Because of the shortages of the FDA-approved GLP-1 drugs such as semaglutide and tirzepatide, which are predominantly made use of in case of type 2 diabetes and weight management, some patients have gone on to make use of the compounded versions of the drugs.
The fact is that these compounded drugs aren’t approved by the FDA, and there are certain very serious concerns with these drugs that have been identified, which include dosing errors, salt forms that are unapproved, and also other adverse events that have even led to hospitalization.
Apparently, the green list happens to include active pharmaceutical ingredients (APIs) in the GLP-1 drugs category, which have been inspected by the FDA and are also determined to be in sync and in compliance with the FDA benchmarks. Those ingredients that are not on the green list are subject to detention without any sort of an examination at the border.
According to the FDA in a statement, this happens to be a part of decisive steps that are taken by the agency so as to safeguard consumers from illegal GLP-1 active ingredients that are imported from overseas in order to make sure of patient safety and at the same time also secure drug supply chains.
The FDA states that the compounded drugs should only be made use of when an FDA-approved drug does not happen to meet the medical needs of a patient. Patients are thereby advised to get a prescription from their respective doctor and to fill the prescription at the licensed pharmacy or make use of the BeSafeRx campaign in order to determine where to go ahead and safely buy medications online.
FDA Commissioner Marty Makary, M.D., M.P.H., in a statement stressed the fact that the Americans should be confident that the prescription drugs that they are taking are safe. Through strengthening oversight of the imported APIs and at the same time also cracking down on illegal drugs that are entering the U.S., they are indeed taking aggressive action in order to protect consumers from the poor-quality or dangerous GLP-1 drugs.
According to the Director of the FDA’s Center for Drug Evaluation and Research, George Tidmarsh, M.D., Ph.D., their priority is safeguarding the public health by making sure that all the active ingredients that are used in GLP-1 drugs are getting obtained from the compliant manufacturers. Targeting the illegal GLP-1 active ingredients at the border happens to be a very crucial aspect of this work. It is well to be noted that the FDA had in the past identified serious concerns regarding compounded versions of semaglutide as well as tirzepatide, which included the likes of dosing errors, use of unapproved salt forms, and even adverse events, which led to hospitalization in certain cases.
FDA, apparently, is going to continue to work with the state regulators, track the market, and also take enforcement actions that are deemed necessary so as to safeguard unsafe or fraudulent GLP-1 drugs from reaching consumers in the US.
