The United States Food and Drug Administration (FDA) has published a new regulations about the abortion pills of mifepristone that would allow pharmacy chains, such as CVS or Walgreens, to sell it in their stores.
Under the new guidelines, these chains could offer the drug if it has been prescribed by a doctor and meet certain requirements. Until now, only certified doctors or clinics could dispense it.
The decision could expand access to abortion medication in states where it is already legal, but in other territories access has been restricted. access to pills following the decision of the Supreme Court last June, which removed protection abortion constitutional.
Thus, the January 2023 amendment to the mifepristone REMS Program has removed the requirement that prevented dispensing this pill in retail pharmacies. However, they make it clear that pharmacies require certification to be able to market them, a validation that they can obtain if they meet a series of requirements.
According to several American media, close to half of all abortions that are made in the country are through pills.
Mifepristone is one of two drugs commonly used to end a pregnancy, along with misoprostol, which causes emptying of the uterus and that it is not so strictly regulated.
The FDA authorizes the use of mifepristone during first ten weeks of pregnancy, although it is safe to do so, at least until the thirteenth week, according to studies cited by The New York Times.
In a statement collected by local media, Danco Laboratories, one of the manufacturers of the pill, ensures that this modification is “vitally important” at a time when people across the country “have difficulty obtaining abortion services.”
In this way, it ensures that this measure “will provide health professionals with an additional method to offer their patients a safe and effective option to end an early pregnancy.”
Requirements to market the abortion pill
The FDA has clarified that pharmacies must comply a series of requirements to get the certification that allows them to sell these pills. To do this, the first thing they must do is know and follow the applicable REMS requirements. In addition, they must ensure that mifepristone is only distributed according to prescriptions written by certified prescribers.
Any pharmacy that meets the requirements of the mifepristone REMS Program is eligible to be certified.
For get certified pharmacies should be able to receive prescriber agreement forms by email and fax; be able to ship mifepristone using a shipping service that provides tracking information; designate an authorized representative to carry out the certification process on behalf of the pharmacy; and ensure that the authorized representative oversees the implementation and compliance of the mifepristone REMS program, including, among other requirements, completing a Pharmacy Agreement Form.
In addition, it is essential to take into account that only those people who have a prescription. If you don’t have it, you’ll need to provide enough information that consumers can use the drug safely without a doctor’s supervision.
Source: Lasexta
Mario Twitchell is an accomplished author and journalist, known for his insightful and thought-provoking writing on a wide range of topics including general and opinion. He currently works as a writer at 247 news agency, where he has established himself as a respected voice in the industry.
