FDA to Allow Pharmacists to Sell Abortion Drugs
FDA to Allow Pharmacists to Sell Abortion Drugs: Abortion pills containing mifepristone are now legally available for purchase from licensed pharmacies in the United States.
It is possible to terminate a pregnancy with the use of mifepristone and misoprostol. The ordering, prescribing, and dispensing of these medications had previously been restricted to medical professionals alone.
Because of the widespread nature of the Covid-19 outbreak, the FDA waived the requirement that the first of two medications be obtained in person at a clinic or hospital and instead authorized the pills to be mailed out.
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FDA to Allow Pharmacists to Sell Abortion Drugs
Mifeprex is manufactured by Danco Laboratories and sold under the brand name Mifeprex. The company announced on Tuesday that the necessity for an in-person consultation would no longer be in effect. To those who have a prescription from a licensed physician and a pharmacy that is certified to administer the drugs, the drugs can be given without any intermediate steps. Tuesday saw the new data go live on the FDA’s website.
Danco said in a statement that the change was “critically vital” to extending access to medication abortion services and giving doctors more ways to help their patients terminate pregnancies safely and effectively.
— APHA (@PublicHealth) January 4, 2023
The drugs can be used for up to 11 weeks following the start day of the previous menstrual period (though this varies by state). Some states allow for telehealth prescriptions, and/or residents can travel to other states where abortion is permitted to obtain the necessary medication.
The Guttmacher Institute, a pro-choice think tank, predicts that by 2020 the number of abortions performed with medication would have surpassed the number of surgical operations in the United States.
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CVS stated in a statement Tuesday that it is evaluating the new regulations.
According to the FDA’s website: “We are reviewing the 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.”
Walgreens added that it is also evaluating the updates.
A new Justice Department legal opinion has declared that federal law allows the US Postal Service to deliver abortion drugs, a move that the Biden Administration believes could help protect access to abortion in states that have enacted bans in the wake of the Supreme Court’s decision to overturn Roe v. Wade. The FDA’s action comes days after this opinion was released.
Medication abortion in retail pharmacies!
Absolutely ridiculous it took this long, but a very important step forwardhttps://t.co/lPPf8woHWf
— Garnet Henderson (@garnethenderson) January 3, 2023
In an opinion dated December 23, 2022, the Office of Legal Counsel stated that the 1873 Comstock Act “does not prohibit the sending of certain pharmaceuticals that can be used to perform abortions if the sender lacks the intent that the recipient of the drugs will use them unlawfully.”
Because “there are manifold ways in which recipients in every state may lawfully use such drugs,” including to produce an abortion, “the mere mailing of such drugs to a particular jurisdiction is an insufficient basis for concluding that the sender intends them to be used unlawfully,” the opinion continued.
After Roe v. Wade’s overturns last year, the USPS consulted the OLC to find out if sending mifepristone and misoprostol over the mail was illegal.
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BREAKING: The FDA will allow pharmacies like Walgreens and CVS to hand out the deadly abortion pill.
Disgusting that pharmacists will now be dispensing lethal poison alongside antibiotics and allergy medication. https://t.co/b2gnaiJLx2
— Lila Rose (@LilaGraceRose) January 4, 2023
Merrick Garland, the current Attorney General, made a statement after the Supreme Court decision offers to work with the Food and Drug Administration and other federal agencies to safeguard access to these treatments, which have been banned in some states.
“States may not ban Mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy,” Garland stated.
Frequently asked questions
Are pharmacies regulated by FDA?
FDA regulates most commercial pharmaceutical production. States regulate pharmacies, including “drug stores,” huge chains, in-store pharmacy counters, and specialized pharmacies.
How does the FDA impact pharmacists?
To prevent patients from receiving potentially unsafe medications, it lays forth protocols pharmacists must follow. The following are mandatory procedures that must be followed by your pharmacy: Verify that you are registered and licensed. Verify the companies you’ll be working with have appropriate FDA registrations or licenses.
Why is the FDA important to the pharmacy setting?
The Food and Drug Administration’s (FDA’s) mission is to protect the public’s health by ensuring that people have access to safe and effective medicines and foods, and by facilitating the dissemination of accurate, evidence-based information about these goods and foods.
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