General Merchandise/HBC

FDA Approves Sale of 1st Nonprescription Contraceptive

C-Stores, other retail channels can begin selling pill when available from manufacturer
Photograph courtesy of Perrigo

Convenience stores and other retailers will be able to sell the first daily oral contraceptive pill approved for use in the United States without a prescription. The U.S. Food and Drug Administration (FDA) has approved Opill (norgestrel) for nonprescription use to prevent pregnancy.

Approval of this progestin-only oral contraceptive pill provides an option for consumers to purchase oral contraceptive medicine without a prescription at drug stores, c-stores and grocery stores, as well as online, the agency announced Thursday.

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, 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.

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