Increase in Online Sale of Non-Prescription Drugs, FDA Editorial Guidelines

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The Food and Drug Administration could allow non-prescription drugs to be sold online by establishments without physical stores, its chief said Wednesday.

The FDA is drafting “online pharmacy” guidelines that will be released for public comment, FDA chief Oscar Gutierrez said.

“There is a limit. We will only allow the sale of drugs without a prescription,” he told a televised public lecture.

“In the future, establishments will no longer need to have a physical store. But they will certainly be required to have an office and an identified warehouse where the drugs will be purchased. We will post the draft guidelines for public comment,” Gutierrez added.

Meanwhile, Gutierrez said the FDA had raided 50 sari-sari (assorted goods) stores that sell counterfeit painkillers and antipyretic drugs, as he urged consumers to check the FDA’s verification portal. agency.

The stores were located in Cavite, Laguna, Albay, Caloocan, Quezon City and Parañaque, he said.

“We continue to collect reports from our regional offices in the field,” the FDA chief said.

Additionally, the agency has approved emergency use of multiple brands of the COVID-19 drug molnupiravir, including a local manufacturer, and is evaluating Pfizer’s COVID-19 treatment course, Paxlovid.

Gutierrez, in a recorded public briefing with President Rodrigo Duterte, said the following brands had received emergency use authorization: Molnarz (Faberco), Molnaflu (Medethix), Auxilto (German Quality Pharma), Molxvir (Sun Pharma), Molnatris (Mykan), and Generic Molnupiravir (Lloyd Laboratories/Dr. Zen’s Research).

Lloyd Laboratories can produce 1 million capsules a year that can accommodate 25,000 to 50,000 COVID-19 patients, according to the FDA chief.
Generic products are typically 30 to 50 percent cheaper than branded products, he said. Products with an EUA can only be purchased by the national government, Gutierrez added.

“These will be delivered by the DOH to health care facilities and health care providers, who will administer them and provide them to patients,” he said during a televised public briefing on Wednesday.

Molnupiravir is a prescription drug used to treat mild to moderate COVID-19 patients, Gutierrez said.

“The patient should take this under the strict supervision of a physician,” he said.

The FDA has also approved Getein Biotech Incorporated’s antigen self-test kit, Gutierrez said. It has forwarded some 54 self-test kits to the Tropical Medicine Research Institute for performance validation, he added.

“If the candidate does not comply with the RITM assessment requirements, they may not receive performance validation,” he said.

Meanwhile, Pfizer has submitted its emergency use authorization request for Paxlovid, Gutierrez said. Willie Casas

“It is now being assessed. I can give updates in the next few days,” he said on Duterte’s “Talk To The People” show that aired Monday.

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