News
March 31, 2025: Senator asks how FDA will be accountable for unregulated active pharmaceutical ingredient (API) imports
Senator Jim Banks asked pointed questions about how FDA will stem the tide of semaglutide and tirzepatide coming from unknown facilities.
[...]March 24, 2025: Cost-saving AFPs are exposing Americans to risky, unregulated medicine
“Alternative funding programs” are shifting expensive prescription coverage to illegal drug importation schemes.
[...]PSM submits comment on CBP’s proposed rules to improve screening of low-value shipments
On March 14, the Partnership for Safe Medicines submitted comment on Customs and Border Protection’s proposed update to regulations around low-value, “de minimus” shipments.
[...]March 17, 2025: A Texas Pharmacist gets 17 years for $145m skin cream billing fraud
A Texas man billed government programs millions for creams compounded by untrained teenagers. News about counterfeit medicine in six U.S. states.
[...]March 10, 2025: Patients transitioning from compounded diabetes / weight loss injections: Stick to licensed sources
FDA’s shutdown of GLP-1 compounding could lead to a new era of risk for U.S. patients.
[...]FDA Alert: Update on Previous Nationwide Warning About Presence of Undeclared API in Capsules
The FDA published an update to a previous alert about undeclared active pharmaceutical ingredients in a dietary supplement to expand the package styles affected by this warning.
[...]FDA Alert: Recall Issued on Nasal Wash System Due to Microbial Contamination
An FDA alert shared information on a nationwide recall of a nasal wash system due to microbrial contamination.
[...]FDA Alert: Recall Issued on Injectable Product Due to Potential Particulate Matter
An FDA alert warned that Central Admixture Pharmacy Services issued a nationwide recall of Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag due to the detection of black particulate matter in a single sealed vial of Phenylephrine Hydrochloride.
[...]FDA Alert: Recall Issued on Dietary Supplement Containing Active Pharmaceutical Ingredient
An FDA alert warned that Vitafer-L has been found to contain undeclared tadalafil, an active pharmaceutical ingredient. Products containing tadalafil cannot be marketed as dietary supplements.
[...]March 3, 2025: Men who allegedly sold fake cancer drugs arraigned in Washington State
The U.S. Attorney’s Office in the Western District of Washington has charged two Indian nationals with selling Americans counterfeit Keytruda.
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