FDA approves sale of 1st over-the-counter birth control pill

Grocers, convenience stores and other retailers will be able to sell the first daily oral contraceptive pill approved for use without a prescription after the U.S. Food and Drug Administration (FDA) on Thursday approved Opill (norgestrel).

Approval of this progestin-only oral contraceptive pill provides an over-the-counter option for consumers to purchase oral contraceptive medicine at drug stores, c-stores and grocery stores, as well as online.

Availability of nonprescription Opill may help reduce the number of unintended pregnancies and their potential negative effects, the FDA said. It is not for use as emergency contraception and does not prevent pregnancy after unprotected sex nor does it protect against sexually transmitted infections, it said.

The FDA granted the approval to Laboratoire HRA Pharma, recently acquired by Perrigo Co. plc, based in Dublin, Ireland, with U.S. headquarters in Grand Rapids, Michigan.

The timeline for availability and price of this nonprescription product will be determined by the manufacturer. Other approved formulations and dosages of other oral contraceptives will remain available by prescription only. 

The contraceptive efficacy of norgestrel was established with the original approval for prescription use in 1973, said the FDA.

In March, the FDA approved Narcan, a medication that rapidly reverses the effects of opioid overdose, for over-the-counter sale and use—the first naloxone product approved for use without a prescription. The action also allows the medication to be sold directly to consumers in places such as c-stores, gas stations, grocery stores and drug stores, as well as online.

This story originally appeared in WGB sister publication CSP Daily News.