(CNN)The US Food and Drug Administration has issued a warning letter to Dollar Tree for receiving over-the-counter drugs produced by foreign manufacturers that have been found to be adulterated, including acne treatment pads and Assured brand drugs. FDA targets illegally marketed dietary supplements The letter -- sent earlier this month to Greenbrier International Inc., which does business as Dollar Tree -- describes Dollar Tree's receipt of adulterated drugs from manufacturers and suppliers that had received separate FDA warning letters last year and were placed on "import alert." The letter outlines "multiple violations" of manufacturing practices at those contract manufacturers used to produce Dollar Tree's Assured Brand over-the-counter drugs as well as other drug products sold at Dollar Tree and Family Dollar stores. Now, in its warning letter to Dollar Tree, the FDA is requesting that the company implement a system to ensure that it does not import adulterated drugs. … [Read more...] about FDA issues warning to Dollar Tree about selling ‘potentially unsafe drugs’
Warning letter sample for violation of rules and regulations
Dollar Tree received a warning letter from U.S. regulators for buying over-the-counter drugs from foreign manufacturers that were made in such substandard conditions that they had been barred from entry to the U.S. The letter sent to Greenbrier International, which does business as Dollar Tree, outlines flaws at facilities in Shanghai and other foreign cities that were detected and flagged by the U.S. Food and Drug Administration between 2017 and 2019. The agency informed the manufacturers and Dollar Tree at the time that the defects made the finished products adulterated drugs. The medicine was produced for Dollar Tree's Assured Brand label. Dollar Tree continued to receive the defective products, a violation of the Federal Food, Drug and Cosmetic Act, the agency said in a statement. The warning letter, dated Nov. 6, comes as drugmakers have increasingly moved their operations abroad to take advantage of lower costs and lesser regulation. The FDA and other regulators have struggled to … [Read more...] about Dollar Tree gets FDA warning for potentially dangerous drugs
(CNN)The US Food and Drug Administration has issued a warning letter to the Canadian company CanaRx for playing a role in "the introduction of unapproved new drugs and misbranded drugs" to the United States, according to the letter. "These drugs are potentially dangerous to U.S. consumers," the FDA said in a news release Thursday. Vermont legalizes importing cheaper Canadian drugs, needs federal approval An unapproved new drug has not been approved for use by the FDA. A misbranded drug fails to bear either adequate directions for its intended use or adequate warnings relating to its use. CanaRx helps residents of the United States purchase medications from pharmacies in Canada, Australia and the United Kingdom, according to its website. Hundreds of the most commonly prescribed brand-name drugs are included in the CanaRx program, according to its website. Joseph Morris, counsel for CanaRx Services, said in a statement Friday that the FDA's description of the CanaRx business … [Read more...] about FDA warns Canadian company about distributing ‘potentially dangerous’ drugs in US
The City watchdog has admitted that its rules are so complex that even its staff may not understand which investment products come under its jurisdiction. The chairman of the Financial Conduct Authority made the concession during a tempestuous annual public meeting in London on Wednesday, where consumers criticised the regulator for failing to protect them from a growing list of scandals. Attendees demanded answers over the collapse of London Capital & Finance, which is now at the centre of a mounting £236m financial scandal in which more than 11,000 investors lost money. The FCA’s enforcement team was warned three years ago about the company, but failed to act. One victim claimed FCA staff assured her that dealings with LC&F were protected by the regulator. But complex regulation meant that while LC&F was authorised by the regulator, the mini-bond products it sold were not. It left investors unable to recover their cash through the Financial Services … [Read more...] about City watchdog admits investment rules too complex for staff
Story highlights "Gag rules" may be keeping your pharmacist from telling you about cheaper drug prices Over 20 states have banned such rules; President Trump plans to tackle them on a federal level (CNN)Independent pharmacist Ira Katz has been serving the eclectic community of Little Five Points in Atlanta for 37 years. But it wasn't until Georgia passed a law last year banning "gag rules" that Katz could legally tell his patients they might save big bucks on their prescriptions if they paid cash or used a lower-priced generic. The gag rule was a clause in his contract with one of the pharmaceutical benefit managers, also known as PBMs, that manage most of our nation's prescription drug programs. "We're not supposed to be in violation of the contract, or they can cut you off," Katz said. "I did it. I don't give a damn what the PBMs say. I did it. It's a travesty." The 5 most expensive drugs in the United States Invisible to consumers, these benefit managers are the … [Read more...] about Is your pharmacist under a ‘gag rule’ about drug prices?