FDA allows abortion pills to be sold in retail pharmacies, say two drug makers – Times of India

Washington: retail pharmacies will now be allowed to present abortion pills in the United States under a regulatory change made by Food and Drug Administration Two companies making the tablets said on Tuesday.
Pharmacists can apply for certification with drug manufacturers to dispense mifepristone and, if successful, dispense it directly to patients after obtaining a prescription from a certified prescriber, said dance labsOne of the two companies that make mifepristone.
“Pharmacies that get certified in Mifepristone REMS The program may dispense Mifeprex directly to patients upon receipt of a prescription from a certified Mifeprex prescriber, provided the prescriber agreement has been provided or is on file with the certified pharmacy,” it said in a statement on its website.
Mifeprex is the brand name version of mifepristone, in combination with another drug called misoprostol which has various uses including abortion management, to induce abortion up to 10 weeks into pregnancy.
FDA previously said it would make those changes in December 2021 when it announced it would relax the Risk Evaluation and Mitigation Strategies, or REMS, on the pill, which had been in place since the agency approved it in 2000 and was temporarily suspended by the government. was removed from Due to the pandemic in 2021.
The Declaration will not provide equal access to all people, however. GenBioProwhich makes the generic version of mifepristone, said in a statement.
Abortion bans, some targeting mifepristone, have gone into effect in more than a dozen states since the US Supreme Court overturned the constitutional right to terminate pregnancy when it overturned the 1973 Roe v. Wade decision last year. Had given.
Retail pharmacies will need to see whether or not to offer the pill and determine where they can do so.
“We are reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) Drug Safety Program certification requirements for mifepristone to determine distribution requirements in states that allow distribution of prescribed drugs for elective termination of pregnancy.” don’t ban it,” said a spokesperson for drugstore chain owner CVS Health.