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WASHINGTON: Retail pharmacies will now be allowed to offer abortion pills in the United States under a regulatory change made by the Food and Drug Administration on Tuesday, the two companies that make the pills said on Tuesday.
Pharmacies can apply for certification to distribute mifepristone with the drugmakers and if successful will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber, said Danco Laboratories, one of two companies that make mifepristone.
“Pharmacies who become certified in the Mifepristone REMS Program may dispense Mifeprex directly to patients upon receipt of a prescription from a certified Mifeprex prescriber, provided a Prescriber agreement is provided or on file with the certified pharmacy,” it said in a statement on its website.
Mifeprex is the brand name version of mifepristone, which in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy.
The FDA had first said it would be making those changes in December 2021 when it announced it would relax risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily by the government in 2021 due to the pandemic.
The announcement will not provide equal access to all people, however, GenBioPro, which 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 U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped its landmark 1973 Roe v. Wade ruling last year.
Retail pharmacies will have to weigh whether or not to offer the pill and determine where they can do so.
“We’re reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy,” a spokesperson for drugstore chain owner CVS Health said.
Pharmacies can apply for certification to distribute mifepristone with the drugmakers and if successful will be able to dispense it directly to patients upon receiving a prescription from a certified prescriber, said Danco Laboratories, one of two companies that make mifepristone.
“Pharmacies who become certified in the Mifepristone REMS Program may dispense Mifeprex directly to patients upon receipt of a prescription from a certified Mifeprex prescriber, provided a Prescriber agreement is provided or on file with the certified pharmacy,” it said in a statement on its website.
Mifeprex is the brand name version of mifepristone, which in combination with a second drug called misoprostol that has various uses including miscarriage management, induces an abortion up to 10 weeks into a pregnancy.
The FDA had first said it would be making those changes in December 2021 when it announced it would relax risk evaluation and mitigation strategies, or REMS, on the pill, that had been in place since the agency approved it in 2000 and were lifted temporarily by the government in 2021 due to the pandemic.
The announcement will not provide equal access to all people, however, GenBioPro, which 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 U.S. Supreme Court overturned the constitutional right to terminating pregnancies when it scrapped its landmark 1973 Roe v. Wade ruling last year.
Retail pharmacies will have to weigh whether or not to offer the pill and determine where they can do so.
“We’re reviewing the FDA’s updated Risk Evaluation and Mitigation Strategy (REMS) drug safety program certification requirements for mifepristone to determine the requirements to dispense in states that do not restrict the dispensing of medications prescribed for elective termination of pregnancy,” a spokesperson for drugstore chain owner CVS Health said.
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